input
stringlengths 798
36.8k
| output
stringlengths 218
19.2k
| __index_level_0__
int64 0
214k
|
|---|---|---|
Target Study Title: Triple Arm, Prospectively Randomized Multi Centre Study Phase IV to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation in Non-risk Patients
Target Study Description: #Study Description
Brief Summary
Current practice of immune suppressive standard therapy after renal transplantation in non-risk patients is a triple therapy consisting of steroids, a calcineurin inhibitor and MMF. The aim of this clinical trial is to combine a reduction of CNI using tacrolimus and a concept of not using steroids in order to establish an immunosuppressive regimen in immunologically non-risk patients that is efficient and causes as few side effects as possible.
Detailed Description
In this triple arm, prospectively randomized multi centre phase IV study 200 patients per study arm will be investigated for 12 months.
Based on the results of the Symphony study the low dose tacrolimus study arm will be modified to further improve efficacy (prevention of BPAR, best possible renal function) and safety (adverse event profile regarding infections, cardiovascular risk factors, malignant tumours) of immunosuppression. For this, CNI will be reduced and in addition the rate of steroid free patients after 1 week will be maximized to achieve a long lasting improved post surgical cardiovascular risk profile (in particular concerning de novo induction of diabetes mellitus and other adverse events caused by steroids). Safety should be increased without loss of efficacy of immunosuppression (measured in rejection rate and allograft loss rate) as compared to an immune suppressive therapy comprising steroids. Therefore, following the successful study arm of the Symphony study, immunosuppression in the first of the three study arms comprises a steroid in combination with Advagraf and CellCept in addition to a two dose induction therapy with Simulect (group A). The regimen of the second study arm is similar but discontinues steroids on day seven after transplantation (group B). Therapy of group three is similar to group B but Simulect is replaced by T-cell depleting polyclonal antibodies (Thymoglobulin) (group C).
#Intervention
- DRUG : Basiliximab, Tacrolimus, MMF, Prednisolon
- Control group. Therapy with Prednisolon.
- Other Names :
- Simulect, Advagraf, CellCept, Decortin
- DRUG : Basiliximab, Tacrolimus, MMF
- No Prednisolon after 7 days
- Other Names :
- Simulect, Advagraf, CellCept
- DRUG : Tacrolimus, MMF, rATG
- Induction therapy: rATG instead of Basiliximab. No Prednisolon.
- Other Names :
- Advagraf, CellCept, Thymoglobulin
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Post mortal kidney donation or living donation
* Primary and secondary renal transplantation, unless the graft was lost due to severe rejection within the first year
* PRA level <= 20%.
* Recipient >= 18 <= age <= 75 of age
* AB0-compatible
* Negative crosshatch
* Patients with a signed informed consent form
* Women of child-bearing age must agree to an efficient contraception
Exclusion Criteria:
* Third or multiple transplantation
* Transplantation per a 'non-heart beating' donor
* HLA-identical living donation
* Incompatibility to study medication (allergy, intolerance, hypersensitivity)
* Patients with existing malignant underlying disease or tumour anamnesis < 5 years. Exception: basaloma or squamous cell carcinoma of the skin after successful therapy
* Female patients who do not use a safe method of contraception
* Patients with clinically significant, uncontrolled infectious diseases (incl. HIV) and/or severe diarrhoea, emesis, active malabsorption of the upper gastrointestinal tract or active peptic ulcer
* Patients currently, resp. within the last 30 days, participating in other studies
* Primary focal-sclerosing glomerulonephritis and membranoproliferative glomerulonephritis as an underlying disease
* Autoimmune disease as underlying disease (collagen diseases, colitis, HUS, SLE) which might require chronic cortisone therapy
* Additional disease requiring temporary or chronic cortisone therapy (including inhalation medicine)
* Chronic hepatitis B and hepatitis C infection
* Thrombopenia < 70.000/mm3 or leukopenia < 2.500/mm3 or neutropenia < 1500/ mm3.
* Patients with hepatocirrhosis Child B or C or another severe disease of the liver
* Patients with symptoms of a significant somatic or psychiatric / mental illness. Patients who are not able to realize nature, relevance and consequences of the clinical trial and who are not able to comply, to cooperate and communicate adequately and to follow the instructions of the study or even to give their informed consent (according to § 40 article 4 and § 41 article 2 and 3 AMG).
* Patients who possibly depend on the sponsor or the trial physician
* Patients with signs of drug abuse or alcohol abuse
* Patients taking additional medicines with known interactions with the immune suppressive substances (MMF and tacrolimus) that preclude an adequate control of the immunosuppression
* Cold ischemia time of donor kidney > 30 hours
* Pregnant or nursing patients
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 200 |
Target Study Title: A Comparison of the Videolaryngoscope and Macintosh Laryngoscope for NIM-EMG Endotracheal Tube Placement: Prospective, Double Blind, Randomized Study
Target Study Description: #Study Description
Brief Summary
Laryngeal nerve monitoring is performed to prevent intraoperative nerve damage in thyroidectomy operations. NIM-EMG intubation tube is used while monitoring the recurrent laryngeal nerve. Care should be taken when placing this tube. Ensure that the electrodes on the tube are in contact with the vocal cords. Both the macintosh laryngoscope and the videolaryngoscope can be used when inserting the NIM-EMG tube. The aim of our study is to compare these two intubation methods.
Detailed Description
Anesthesiologists play a key role for the medications used for anesthesia and placement of the endotracheal tube in operations with intraoperative monitoring. While placing the NIM-EMG tube, the size of the endotracheal tube is very important so that the tube can contact the vocal cords.
The placement of the tube may change due to reasons such as movement of the neck during the operation. In addition, endotracheal tube placement may be problematic due to poor vision during direct laryngoscopy. Incorrect placement of the tube may result in equipment inoperability and increase the likelihood of injury to the recurrent laryngeal nerve.
Laryngoscopy is a term for tracheal intubation that provides visualization and evaluation of the larynx with its upper airway structures.
Until recently, direct laryngoscopy was considered the standard technique for endotracheal intubation. Recently, a wide variety of methods have been developed for endotracheal intubation. Video laryngoscopes are similar to direct laryngoscopes but provide laryngeal imaging with a small video chip on their blade. This imaging is superior compared to direct laryngoscopy. The aim of the study was to compare the use of direct laryngoscopy and video laryngoscopy in intubation with the NIM-EMG tube, which is routinely used in operations where the recurrent laryngeal nerve (RLN) may be damaged, in terms of intubation success, intubation time, tracheal intubation comfort, hemodynamic responses, surgical satisfaction, and complications that may develop after anesthesia or surgery.
#Intervention
- DEVICE : Macintosh Laryngoscope
- After the induction, laryngoscopy will be performed with a Macintosh laryngoscope after 2 minutes of manual ventilation after muscle relaxant by an anesthesiologist with at least 4 years of experience. Patients will be intubated with the 'Medtronic Xomed Nerve Integrity Monitor Standard Reinforced ElectromyographyEndotracheal Tube' (size 6.0, 7.0 or 8.0). The cuff of the intubation tube will be connected to a manometer and inflated at a pressure of 20-30 mmHg until there is no air leak. Intubation will be confirmed by the appearance of end-tidal carbon dioxide (CO2). Failed intubation will be considered if not achieved within 2 minutes
- DEVICE : Video Laryngoscope
- After the induction, laryngoscopy will be performed with a Video laryngoscope after 2 minutes of manual ventilation after muscle relaxant by an anesthesiologist with at least 4 years of experience. Patients will be intubated with the 'Medtronic Xomed Nerve Integrity Monitor Standard Reinforced ElectromyographyEndotracheal Tube' (size 6.0, 7.0 or 8.0). The cuff of the intubation tube will be connected to a manometer and inflated at a pressure of 20-30 mmHg until there is no air leak. Intubation will be confirmed by the appearance of end-tidal CO2. Failed intubation will be considered if not achieved within 2 minutes
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* The American Society of Anesthesiologists (ASA) physical status classification system 1 <= age <= 2
* Age 18 <= age <= 65
* Undergoing Elective Thyroid and Parathyroidectomy surgery
* undergoing Intraoperative Recurrent Laryngeal Nerve Monitoring
Exclusion Criteria:
* History of head and neck surgery
* Body mass index less than 19 or greater than 30
* Muscle relaxant allergy
* Lidocaine allergy
* IDS score >5
* Uncontrolled hypertension, bronchial asthma, tracheal pathology
* undergoing emergency surgery
* Cases that cannot give informed consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 201 |
Target Study Title: Long-term Tracing for Axillary Lymph Nodes Dissection in the Patients With Fusion Lymph Node Before Neo-adjuvant Chemotherapy
Target Study Description: #Study Description
Brief Summary
To investigate this regression model by injecting and tracing carbon nanoparticles (CNs) into the fusion node prior to NAC in patients with breast cancer.
Detailed Description
Guided by ultrasound, 0.3 mL of CNs suspension was injected in a fusion node prior to NAC in 110 patients with local advanced breast cancer. Patients underwent breast surgery and total axillary lymph node dissection following 2-6 cycles of NAC. The distribution by intercostobrachial nerves (ICBN) of positive nodes, black-stained nodes and lymphovascular invasion was investigated by response to NAC.
#Intervention
- PROCEDURE : complete remission (CR) group
- According to the RECIST 1.1, 32 patients were allocated into the complete remission (CR) group based on their responses to neoadjuvant chemotherapy (NAC).
- PROCEDURE : partial remission (PR) group
- According to the RECIST 1.1, 61 patients were allocated into the partial remission (PR) group based on their responses to neoadjuvant chemotherapy (NAC).
- PROCEDURE : stable disease (SD) group
- According to the RECIST 1.1, 12 patients were allocated into the stable disease (SD) group based on their responses to neoadjuvant chemotherapy (NAC).
- PROCEDURE : progressive disease (PD) group
- According to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC).
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* invasive ductal carcinoma diagnosed by biopsy;
* clinically positive node diagnosed by contrast enhance computer tomography (CECT), the number of strengthened nodes at Level I >= 1 with the longest diameter of the strengthened node >= 2cm;
* NAC regimen followed the NCCN guideline;
* no prior history of breast cancer or other malignancies.
Exclusion Criteria:
* the cycle number of neo-adjuvant chemotherapy is equal to or less than 2
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 202 |
Target Study Title: Effect of Individual Cognitive Stimulation on Memory and Executive Functioning in Older Adults With Mild to Moderate Alzheimer's Disease: A Multicentre Randomised Controlled Trial
Target Study Description: #Study Description
Brief Summary
This multicentre study, with a randomised controlled repeated measures experimental design, will be conducted in several Portuguese institutions, which provide care and supportive services for older adults diagnosed with mild or moderate Alzheimer's disease (AD), with an aim to assess the effect of individual cognitive stimulation (CS) on memory and executive functioning. Participants in the intervention group will attend 24 individual CS sessions, twice weekly for 12 weeks. Participants in the control group will complete their usual routines without any activity restrictions.
Detailed Description
Neurocognitive disorders (NCD) currently affect around 55 million people worldwide and expected to increase to 78 million by 2030 and 139 million by 2050, with Alzheimer's disease (AD) potentially accounting for 60-70% of dementia cases. Dementia is a syndrome, generally chronic or progressive in nature, that causes deterioration of cognitive function, particularly memory and executive functions, beyond what is expected in normal aging. However, there is evidence that in the early stages of NCD, people can learn and improve their cognitive functions through interventions such as CS. CS is a psychosocial intervention and a non-pharmacological therapy recommended by international practice guidelines for people with mild-to-moderate stage AD. However, it is also important to investigate whether NCD generates new skills or only preserves acquired skills, given that AD manifests initially and notably with deficits in memory and learning, sometimes accompanied by deficits in executive functions. Testing the effectiveness of CS by recruiting a representative sample from several Portuguese districts and using a CS programme with detailed and comprehendible content, may elicit relevant evidence in clinical practice, contribute to the development of social development programs and initiatives to ensure social protection and inclusion, promote recurrent therapeutic interventions in Portuguese institutions with provide care and supporting services for older adults with dementia, and strengthen research on non-pharmacological therapies. Thus, this multicentre, randomised controlled study is essential to analyse the effects of the individual CS on global cognitive function and specific cognitive domains (e.g., executive functioning, memory) in older adults with mild or moderate AD.
#Intervention
- BEHAVIORAL : Cognitive stimulation
- The intervention program will have 24 sessions (base scheme of 4 series of 6 sessions), lasting approximately 45 min and will be developed according to the following structure: - welcoming (greeting to the participant) (5 min); - orientation to reality (10 min); - main cognitive stimulation activity (25 min); - return to calm and evaluation of the session (5 min).
The CS sessions will have an individual format and will be conducted by a professional with experience in CS and previously trained in this intervention. The intervention sessions will include several activities based on the CS principles, with evidence suggesting positive participant effects. The CS sessions will be carried out using material, developed by the principal investigator, in digital format (power point presentations). There will be no repetition of activities, and throughout the base CS program, the degree of difficulty of the exercises will be adjusted based on the dementia stage of the participant.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Age 65 or over.
* Receive care and support services for older adults for at least three months.
* Alzheimer's disease, according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition.
* Ability to communicate and understand.
* Native speakers of Portuguese.
* To have given informed consent for the project, duly completed and signed, after previous information.
* Total scores between 10 and 24 points on the Mini Mental State Examination.
Exclusion Criteria:
* Cannot read and write.
* Severe sensory and physical limitations and/or an acute or serious illness preventing participation in the CS sessions.
* Evidence of aggressive and disruptive behaviour, as indicated by the reference technicians of the institution to which the participant is linked.
* Consumption of psychoactive substances, taking neuroleptics and/or antipsychotics in the last two months.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 203 |
Target Study Title: Swedish External Support Study is Randomized Trial of the Effect of External Support of PTFE-grafts for Bypass to Below Knee Arteries.
Target Study Description: #Study Description
Brief Summary
Randomized study to evaluate the effect of adding external support to PTFE-grafts used for bypass to below knee arteries in patients with critical limb ischemia with respect to primary patency, secondary patency, and limb salvage.
#Intervention
- PROCEDURE : External support
- Bypass surgery with externally supported graft
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
Critical limb ischemia Need for bypass surgery
Exclusion Criteria:
Can participate in follow-up Has suitable saphenous vein
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 204 |
Target Study Title: Evaluation of Medical and Nursing Management for Bronchiectasis
Target Study Description: #Study Description
Brief Summary
The purpose of this research is to retrospectively evaluate current clinical care of Bronchiectasis (non-cystic fibrosis \[CF\]) in adults from a multidisciplinary management perspective. This evaluation aims to address the important gaps in current clinical care in 2011, 2013 and July 2016- Jun2017. The primary outcome of this evaluation is to compare the efficacy of current multidisciplinary clinical practice to the British Thoracic Society (BTS) \& Thoracic Society of Australia and New Zealand (TSANZ) guidelines for bronchiectasis. Secondary outcomes of this evaluation will determine the impact of clinical care in 2011, 2013 and July2016-June2017 through quantification of:hospital utilization for using hospital admission data, average length of stay, readmission rates within 28 days, emergency service attendance, outpatient review, exacerbations use of antibiotics, use of Hospital and Home (H@H), number of contacts with the respiratory nursing service and type of contacts with the respiratory nursing service.
Detailed Description
Project design: The study will be a 12 month retrospective observational cohort study conducted through a review of medical records, internal respiratory databases and electronic hospital patient record (OACIS, HOMER \& EPAS). Participants: Participants in the study will include all patients who have emergency service presentations or admissions to The Queen Elizabeth Hospital (TQEH) with new or existing bronchiectasis in 2011(Jan 1st to Dec 31st). This will be repeated using the same criteria in 2013. An additional year of July2016- Jun2017 has been added for recency of management and to assess if change occurred with introduction of electronic patient record. Data collection: Demographics, clinical data, hospital service utilization, and clinical outcomes such as exacerbation frequency and disease progression. All data will be extracted into a standardized data extraction form, which a random subset will be checked by a second researcher.Analysis of results:Demographic and descriptive data will be given in means + standard deviation and compared using a two-tailed and Student t-test. Categorical variables will be compared using chi-squared or Fisher exact tests, and when appropriate the Mann Whitney U test for non-parametric data. Statistical significance will be determined using an alpha of p \<0.05. All analyses will be examined using SPSS software (version x). A subgroup analysis for primary and secondary admission diagnosis will also be performed.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria: Admission or attendance to emergency services at The Queen Elizabeth hospital with primary or secondary diagnosis of Bronchiectasis in 2011. Repeated using same criteria in 2013 and July2016-June2017
Exclusion Criteria: Patients who do not have bronchiectasis. Patients with traction bronchiectasis. Patients who do not have outpatient follow up. Patients who have follow up by private physicians or other hospitals and records are unavailable.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 205 |
Target Study Title: Carbidopa for the Treatment of Nausea and Vomiting in Familial Dysautonomia
Target Study Description: #Study Description
Brief Summary
This is a pilot clinical trial of carbidopa to treat disabling attacks of nausea and vomiting in patients with familial dysautonomia (FD, also known as Riley Day syndrome or hereditary sensory and autonomic neuropathy type III). FD is a rare autosomal recessive disease in which the growth and development of selective nerves is impaired. Patients with FD suffer recurrent uncontrollable nausea and vomiting crises accompanied by skin flushing, tachycardia and arterial hypertension. Current treatments of nausea are ineffective or have intolerable side sides. Our long-term goal is to treat nausea effectively and without side effects, a therapeutic intervention that would markedly improve the quality of life of patients with FD.
The investigators have recently found that resting plasma dopamine levels are high in patients with FD and increase up to 40-fold during nausea and vomiting attacks. This led us to postulate that stimulation of dopamine receptors in the chemoreceptor trigger zone of the brainstem is the likely mechanism of vomiting.
Carbidopa is a reversible competitive inhibitor of aromatic L-amino acid decarboxylase (also known as dopa-decarboxylase) that cannot cross the blood brain barrier. It has been used successfully for many years to block the extracerebral synthesis of dopamine and avoid nausea and vomiting in patients with Parkinson's disease taking levodopa. The investigators reasoned that carbidopa could have a similar antiemetic effect in patients with FD.
The investigators propose to conduct a pilot trial to assess the safety, tolerability and efficacy of carbidopa for the treatment of nausea in patients with FD. The pilot trial will recruit 25 patients with FD who complain of severe nausea that affects their quality of life. The trial will be divided into two consecutive, but independent parts. Part 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Part 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design.
The investigators hope to demonstrate that carbidopa is a safe, well-tolerated drug that blocks the peripheral formation of dopamine and thus prevents dopamine-induced nausea and vomiting attacks in patients with FD.
Detailed Description
Patients with familial dysautonomia (FD), also called Riley Day syndrome or hereditary sensory and autonomic neuropathy type III, suffer recurrent attacks of uncontrollable nausea and vomiting that can last several hours or days and are severely disabling. Hypertension, tachycardia and skin blotching frequently accompany these attacks. Our long-term objective is to develop an effective treatment for nausea and vomiting in patients with FD.
In preliminary studies we found that plasma levels of dopamine were very high during attacks. Stimulation of dopamine receptors in the chemoreceptor trigger zone in the brainstem is a well-known cause of nausea and vomiting. The investigators postulate that acute increases in circulating dopamine levels are the cause of paroxysmal nausea and vomiting in FD.
Dopamine is synthesized by decarboxylation of the aminoacid L-dihydroxyphenylserine (L-DOPA) by the enzyme aromatic L-aminoacid decarboxylase, also known as DOPA decarboxylase. Patients with Parkinson's disease suffer nausea and vomiting when they receive treatment with L-DOPA. However, when L-DOPA is administered together with carbidopa, a reversible competitive inhibitor of DOPA decarboxylase that does not cross the blood brain barrier, nausea and vomiting are prevented. The investigators hypothesize that by blocking the conversion of DOPA to dopamine and thus preventing its increase in plasma, treatment with carbidopa will decrease nausea and vomiting in patients with FD.
Although carbidopa has been used for many years in patients with Parkinson's disease, it has never been used in patients with FD. The first specific aim of this proposal is to assess the safety and tolerability of carbidopa in patients with FD.
The second specific aim of this proposal is to determine whether blocking the peripheral synthesis of dopamine with carbidopa will improve recurrent nausea in patients with FD.
#Intervention
- DRUG : Carbidopa
- The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design.
- Other Names :
- Lodosyn
- DRUG : Placebo
- The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Male of female patients aged 12 and older
* Confirmed diagnosis of familial dysautonomia by genetic testing.
* Symptoms of severe nausea
* Written informed consent or ascent to participate in the pilot trial and understanding that they can withdraw consent at anytime without affecting their future care.
* Ability to comply with the requirements of the study procedures, including taking blood pressure measurements at home.
Exclusion Criteria:
* Patients taking metroclopromide, domperidone, risperidone or other dopamine blockers
* Patients taking MAO-inhibitors
* Patients taking tricyclic antidepressants
* Patients taking neuroleptic drugs (haloperidol and chlorpromazine)
* Patients with a known hypersensitivity to any component of this drug.
* Patients with atrial fibrillation, angina or an electrocardiogram documenting significant abnormality that may jeopardize the patient's health.
* Patients with significant pulmonary, liver, renal (creatinine >2.0 mg/ml) or cardiac illness
* Patients who are unable to clearly identify and rate their symptoms of nausea.
* Women who are pregnant or lactating
* Patients who have a significant abnormality on clinical examination that may, in
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 206 |
Target Study Title: The Possible Effects of Roflumilast on Obesity Related Disorders
Target Study Description: #Study Description
Brief Summary
Evaluation of the possible effects of roflumilast on weight, glucose and lipid metabolism, insulin resistance, oxidative stress and inflammatory process in prediabetic obese subjects.
#Intervention
- DRUG : Roflumilast
- administration of roflumilast 500 mcg tablet once daily for 3 months.
- DRUG : placebo
- administration of placebo tablet once daily for 3 months.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Prediabetic patients (fasting blood glucose between 100 mg/dl and 125 mg/dl or HbA1C within the range 5.7% and 6.4%).
* Obese subjects (BMI >=30 kg/m2 and <40 kg/m2).
Exclusion Criteria:
* Patients with morbid obesity (BMI > 40 kg/m2).
* Patients already on weight lowering agents or weight loss program.
* History or current diagnosis of major depressive disorder or other psychiatric disorders that in the opinion of the investigator would make participation unsafe for the participant.
* Moderate to severe liver disease (Child-Pugh B or C), renal disease, thyroid disease, cardiovascular disease, peripheral vascular disease or coagulopathy.
* Women will be excluded from our study if they are pregnant, breastfeeding, currently on contraceptive pills or if they plan to become pregnant prior to the end of the study.
* Patients on medications that can interfere with glucose or lipid metabolism (e.g. hypoglycemic agents, corticosteroids, anti-hyperlipidemics, non-selective β-blockers thiazides, etc.) and subjects with organic causes of obesity.
* Diabetic patients and patients with any inflammatory disease.
* Smokers.
* Patients on cytochrome P450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin, etc.)
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 207 |
Target Study Title: The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
Target Study Description: #Study Description
Brief Summary
This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants. Also to assist in the development process it would be beneficial to get feedback from users on certain aspects of the design. The aim of this investigation is to get feedback on the first impressions (look and feel) from users of nasal pillows PAP therapy.
A total number of 15 participants who currently use a nasal pillows mask will be recruited for the trial. Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher \& Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).
Participants will undergo an overnight polysomnography session at the Fisher \& Paykel Healthcare sleep lab.
The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the overnight in-lab study.
#Intervention
- DEVICE : New Nasal Pillows Mask
- Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Adult (18+ years of age)
* Able to give consent
* AHI >= 5 on diagnostic night
* Prescribed a CPAP device after successful OSA diagnosis
* Existing nasal pillows mask user
Exclusion Criteria:
* Inability to give consent
* Patients who are in a coma or a decreased level of consciousness.
* Anatomical or physiological conditions making APAP therapy inappropriate
* Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
* Current diagnosis of CO2 retention
* Pregnant or may think they are pregnant.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 208 |
Target Study Title: Secondary Adult's Hemophagocytic Lymphohistiocytosis and Innate Immunity
Target Study Description: #Study Description
Brief Summary
Hemophagocytic lymphohisticytosis (HLH) is a rare and severe disease of genetic origin in children (familial-HLH, F-HLH) or affecting adults secondary to infections, hematologic malignancies or auto-immune diseases (secondary_HLH, S-HLH). F-HLH are due to genetic mutations affecting the genes of perforin or proteins involved in its secretion, resulting in the complete loss of lymphocyte cytotoxicity without affecting lymphocyte number. In S-HLH, the investigators have observed a severe NK cell lymphopenia and a transient loss of cytotoxicity of unknown mechanism. In this study, the investigators will dissect macrophage activation mechanisms as well as NK cytotoxicity inability in adults patients suffering of S-HLH.
Macrophage activation could result from the loss of the retro-control normally exerted by NK cells, thus the investigators will analyze reciprocal interactions of macrophages and NK cells during the acute phase and after recovery of S-HLH.
#Intervention
- OTHER : blood sample
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
Patients Hemophagocytic lymphohisticytosis group:
* Of more than 18 years
* affected by secondary LH infections with the exception of the HIV, the lymphomes, the néoplasies or the autoimmunes / inflammatory diseases following the criteria of the HLH Society modified in 2004
group control
* Of more than 18 years
* At the time of the diagnosis either of firstly viral infection (EBV, CMV, parvovirus B19, HSV), is of lymphome cunning(malignant) not - Hodgkinien or of epithelial métastasés cancers, or auto-immune disease (erythemic lupus and disease of Still of the adult only) without associated criteria corresponding to the diagnosis of LHS
* have agreed to benefit from a pregnancy test and from a screening sérologique by the infection by the HIV. These tests that must be negative. In case of positivity of the screening HIV, the patients will be directed to an adequate service.
* Have still received no preliminary treatment for this pathology
* Have agreed to participate in the study and to have signed the form of consent
group healthy control They will have to be unhurt of active infectious pathology, hématologique, auto-immune or neoplastic and have by receipt of immunosuppresseurs treatments during the last 2 years.
Exclusion Criteria:
Patients Hemophagocytic lymphohisticytosis group:
* Minor patients under age 18 or vulnerable (encircled women, private persons of freedom judicially or administratively, adults under guardianship, under guardianship and to express their consent)
* histories of established LHF or episode of LH during the childhood
* patients reached(affected) by infection by the HIV: either histories known for seropositivity and / or of disease, or because of the positivity of the test sérologique realized in the inclusion after consent of the patient.
* Have already benefited from a specific treatment of the LHS
group control
Patients under age 18 and not to belong in one group of vulnerable persons (encircled women, private persons of freedom judicially or administratively, adults under guardianship, under guardianship and to express their consent)
* Patients answering the criteria of diagnosis of LHS
* Patients having already had histories of LH
* Patients having already received the specific treatments of these diseases
* patients reached(affected) by infection by the HIV: either histories known for seropositivity and / or of disease, or because of the positivity of the test sérologique realized in the inclusion after consent of the patient.
group healthy control Patients under age 18 and not to belong in one group of vulnerable persons (encircled women, private persons of freedom judicially or administratively, adults under guardianship, under guardianship and to express their consent)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 209 |
Target Study Title: The Diagnosis and Treatment of Chlamydia Trachomatis and Neisseria Gonorrhoeae in Pregnant Women to Prevent Adverse Neonatal Consequences.
Target Study Description: #Study Description
Brief Summary
To assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs).
Detailed Description
In this study investigators are conducting a two-arm, cluster randomized trial to assess the effectiveness of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment during pregnancy to reduce adverse pregnancy and birth outcomes compared to the standard of care (treatment based on symptoms and signs). Investigators will enroll 500 asymptomatic pregnant women in the testing and treatment clinics, and they will receive CT and NG testing and appropriate treatment at their first antenatal care visit and at a visit during their third trimester. An additional 250 asymptomatic pregnant women will be enrolled in the standard of care clinics, and they will receive syndromic management with additional support for partner notification. All participants will be tested for CT and NG at the first postnatal visit and those who test positive will be offered infant testing. Investigators will determine if antenatal testing and treatment reduces maternal infections at delivery, preterm birth, low birth weight, and neonatal CT/NG infection. This study will provide evidence to help evaluate the effects of testing on vertical transmission and clinically important pregnancy neonatal health outcomes, and to evaluate and understand biological correlates of transmission.
#Intervention
- OTHER : Chlamydia trachomatis and Neisseria gonorrhoeae screening using the GeneXpert
- Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 15 years,
* Currently pregnant,
* Attending first ANC visit,
* 27 weeks gestation or less
* Not currently experiencing CT/NG-related symptoms (determined by validated screening tool),
* Not treated for CT/NG in the past 30 days,
* Willingness to provide self-collected specimens for CT/NG testing (for the STI-testing group, this will take place at their first ANC visit, at another visit in their third trimester, and at postnatal care. For the standard of care group, samples will only be collected at postnatal care),
* Willingness to return for a test of cure if CT/NG test is positive during antenatal care,
* Will reside in Gaborone through the time of delivery and 1st postnatal visit,
* Willingness to have neonates tested for CT/NG at their first postnatal visit,
* Mentally competent to understand the informed consent.
Exclusion Criteria:
* Not mentally competent to understand study procedures or give informed consent,
* Individuals < 15 years,
* Men,
* Women who are not pregnant,
* Pregnant women not attending their first antenatal visit,
* Pregnant women at >27 weeks gestation
* Pregnant women with current STI-related symptoms (will receive standard of care),
* Treated for an STI in the past 30 days.
Sex :
FEMALE
Ages :
- Minimum Age : 15 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 210 |
Target Study Title: Effectiveness of Prophylactic Bolus Ephedrine Versus Norepinephrine for Management of Post Spinal Hypotension During Elective Caesarean Section in Resource Limited Setting: a Prospective Cohort Study
Target Study Description: #Study Description
Brief Summary
This study was conducted to compare the effectiveness of ephedrine versus norepinephrine for management of hypotension after spinal anesthesia for mothers undergoing elective cesarean section
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* ASA class II and ages ranging from 18 <= age <= 35 years were included in the study
Exclusion Criteria:
* pregnant women with preeclampsia/eclampsia, baseline hypertension (SBP> 140 mm Hg), BMI> 30 kg/m2, failed spinal, spinal anaesthesia converted to general anaesthesia, contraindication for spinal anaesthesia and mother with cardiovascular, renal or hepatic disease.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 211 |
Target Study Title: A Randomized Multicenter Study of the Efficacy, Safety, and Toleration of Fluconazole or Clotrimazole Troches in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
Target Study Description: #Study Description
Brief Summary
To compare the efficacy, safety, and tolerance of fluconazole single daily capsule for 14 days versus clotrimazole troche 5 x daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS.
#Intervention
- DRUG : Clotrimazole
- DRUG : Fluconazole
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Cimetidine.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
* Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
* Moderate or severe liver disease defined by specified lab values.
Concurrent Medication:
Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:
* Barbiturates.
* Phenytoin.
* Coumarin-type anticoagulants.
* Rifampin.
* Oral hypoglycemics.
* Cyclosporin.
Patients with the following are excluded:
* Known history of intolerance or allergy to imidazoles or triazoles, or the non-azole components of clotrimazole troches (dextrose, cellulose, povidone, magnesium stearate).
* Unable to tolerate oral medication.
* Moderate or severe liver disease defined by specified lab values.
* Life expectancy < 4 weeks.
* Unable or unwilling to be followed at the same center for the conduct of this study.
Prior Medication:
Excluded within 3 days of study entry:
* Other antifungal agents.
* Excluded pending results of phase I studies to determine whether interaction between fluconazole and these agents occurs:
* Barbiturates.
* Phenytoin.
* Coumarin-type anticoagulants.
* Rifampin.
* Oral hypoglycemics.
* Cyclosporin.
Patients meeting CDC criteria for diagnosis of AIDS, or having serologic or virologic evidence of HIV infection (but without AIDS-defining opportunistic infections as of yet).
* Patients who have given informed consent in writing to their participation in the study.
* Patients with signs of oropharyngeal candidiasis, i.e., with typical white plaques.
Sex :
ALL
Ages :
- Minimum Age : 13 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 212 |
Target Study Title: A Randomized, Double-Blind, Placebo-Controlled, 3 Way Crossover Study Evaluating The Relative Abuse Potential Of Crushed Embeda Compared To Morphine Sulfate Controlled Release Tablets (Crushed) And Placebo In Non-Dependent, Recreational Opioid Users Following Intranasal Administration
Target Study Description: #Study Description
Brief Summary
This was a single-dose, randomized, double-blind, placebo-controlled, 3 way crossover study designed to evaluate the relative abuse potential of crushed EMBEDA® compared to morphine sulfate CR tablets and placebo in healthy male and female, non-dependent, recreational opioid users. An appropriate dose of morphine sulfate CR (i.e., 30 mg, 60 or 90 mg) was to be selected during Part A of the study (Dose Selection Phase). Each subject participated in the study for up to (approximately) 16 weeks and was confined in the clinic for a total of up to 12 nights.
#Intervention
- DRUG : Placebo
- Lactose (100 mg) placebo tablets crushed; single dose
- DRUG : EMBEDA - morphine sulfate/ naltrexone hydrochloride
- EMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose
- DRUG : morphine sulfate CR crushed.
- Morphine sulfate controlled release 30 mg tablet crushed
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female subjects 18 <= age <= 55 of age, inclusive.
* Subject is a recreational opioid user who is NOT dependent on opioids based on Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) criteria and the Naloxone Challenge. A recreational opioid user is defined as use of opioids for non-therapeutic purposes (i.e., for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks before the Screening Visit (Visit 1).
* Subjects must have experience with intranasal drug administration, defined as intranasal use on at least 3 occasions within the last year prior to the Screening Visit.
Exclusion Criteria:
* Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine), as assessed by the Investigator using the DSM IV-TR criteria.
* Has participated in, is currently participating in, or is seeking treatment for substance- and or alcohol-related disorders (excluding nicotine and caffeine).
* Has any condition in which an opioid is contraindicated; e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or is suspected of having paralytic ileus.
* Allergy or history of hypersensitivity to morphine sulfate, other opioids, naltrexone hydrochloride, naloxone, and/or lactose.
* History or current clinically significant neurological, cardiovascular, renal, hepatic, endocrine, gastrointestinal, hematologic, or metabolic disease as evaluated by the Investigator.
* History or current pulmonary disease including asthma, chronic obstructive pulmonary disease, exercise-induced asthma, bronchitis, and obstructive sleep apnea.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 213 |
Target Study Title: A Phase II Study of Pazopanib in Patients With Relapsed or Refractory Small Cell Lung Cancer (SCLC)
Target Study Description: #Study Description
Brief Summary
Pazopanib is a drug that inhibits proteins thought to be important for new blood vessel formation. This drug has been used in other cancer research studies and information from those studies suggests that pazopanib may help block proteins that are important for the growth, invasion, and spread of cancer cells.
Detailed Description
OBJECTIVES:
Primary
- To determine the progression-free survival rate in participants with relapsed or refractory small cell lung cancer who have received one prior regimen of systemic chemotherapy at 8 weeks
Secondary
* To determine the response rate (as measured by RECIST 1.1 criteria and changes in blood flow/perfusion as measured by perfusion CT)
* To determine median and overall survival
* To characterize the toxicity profile of pazopanib in this patient population.
Exploratory
* To analyze levels of circulating biomarkers from blood and urine samples obtained serially throughout the study and assess the utility of individual or subsets of these proteins to serve as a surrogate marker for treatment effect, treatment efficacy, and for tumor progression
* To measure and investigate the use of monocytes as surrogate markers of angiogenesis inhibition
* To analyze the subject population by identification of intra-tumoral biomarkers (such as c-kit, VEGF receptors, and microvessel density measured in available tumor biopsies) associated with the efficacy, safety and resistance to pazopanib
* To assess the utility of perfusion CT scan in evaluating changes in anti-angiogenic activity as a measure of treatment efficacy
STATISTICAL DESIGN: This study uses a two-stage design to evaluate efficacy of cetuximab based on progression-free rate (PFR) at week 8 defined as complete response (CR), partial response (PR) or stable disease (SD) per RECIST 1.1 criteria. The null and alternative PFR are 30% and 50%. If fewer than 4 patients enrolled in the stage one cohort (n=15 patients) achieve SD or better than accrual would not proceed to stage two (n=15 patients). If 13 or more patients are progression-free of the 30 patients then the null hypothesis will be rejected. The probability that the treatment will be considered promising if the true PFR rate was 30% is 8.4% and 82% if the true PFR rate was 50%.
#Intervention
- DRUG : Pazopanib
- Other Names :
- Votrient
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of small cell neuroendocrine carcinoma based on either histology or cytology with radiologically-confirmed progressive disease.
* Participants should have received first-line chemotherapy and may have had up to two prior chemotherapy regimens. Radiation therapy may have been part of the permitted prior therapy.
* Participants with brain metastases will be allowed if they have been treated with surgery and/or radiation therapy more than 21 days prior, are asymptomatic, and are stable for at least one week off steroids.
* 18 years or older
* ECOG Performance status of 0, 1 or 2
* Ability to swallow and retain oral medication
* Disease must be measurable according to RECIST 1.1
* Adequate organ function as defined in the protocol
Exclusion Criteria:
* Prior malignancy except for participants that have been disease-free for 3 years or with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma
* History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for one week prior to first dose of study drug.
* Clinically significant gastrointestinal abnormalities
* Presence of uncontrolled infection
* Prolongation of corrected QT interval (QTc) > 480msecs
* History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting; myocardial infarction; unstable angina; symptomatic peripheral vascular disease; Class III or IV congestive heart failure
* Poorly controlled hypertension
* History of cerebrovascular accident including transient ischemic attack, pulmonary embolism or insufficiently treated deep venous thrombosis within the past 6 months
* Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture or ulcer
* Evidence of active bleeding or bleeding diathesis
* Hemoptysis in excess of 2.5mL within 6 weeks of first dose of study drug
* Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
* Use of any prohibited medication within the timeframes listed in the protocol
* Use of an investigational agent, including an investigational anti-cancer agent, within 28 days or 5 half-lives, whichever is longer, prior to the first dose of study drug
* Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors
* Is now undergoing and/or has undergone in the 14 days immediately prior to first dose of study drug, any cancer therapy
* Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 214 |
Target Study Title: Effect of Preoperative Oral Carbohydrates on the Insulin Resistance of Elderly Patients
Target Study Description: #Study Description
Brief Summary
Postoperative cognitive dysfunction (POCD) is more common in older patients, and increased insulin resistance is an important factor for POCD. Fasting before surgery is performed to reduce the incidence of pulmonary aspiration after anesthesia. However, prolonged fasting increases insulin resistance. Recently, it is recommended to minimize fasting times and consume carbohydrate drinks before surgery. Therefore, the investigators investigate whether preoperative carbohydrate drinks can reduce insulin resistance in the elderly patients. Fifty patients (age\>65 years) scheduled for arthroplasty will be divided into carbohydrate (n=28) and control (n=28) groups. Randomly selected patients of the carbohydrate group are given 400ml of 12.8 g/100 ml carbohydrate beverage 2-3 hours before their scheduled operation. In contrast, patients in the control group are fasted from water 2 h before surgery according to standard protocol.
#Intervention
- DIETARY_SUPPLEMENT : carbohydrate group - carbohydrate (400ml)
- Randomly selected patients of the carbohydrate group are given oral carbohydrate (400ml) 2-3 hours before surgery. In contrast, patients in the control group are fasted water 2 hours before surgery according to the standard protocol.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Patients undergoing arthroplasty
* age>65 years
Exclusion Criteria:
* The subject is a foreigner or illiterate
* Patients with gastroesophageal reflux disease, gastric emptying disorders, inflammatory bowel disease, or previous treatment for intra-abdominal cancer
* Patients with chronic renal disease or severe cardiovascular disease
* HbA1c >69 mmol/mol or BMI >30 kg/m2
* A duration of >=5 h between consumption of CHO and initiation of surgery.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 215 |
Target Study Title: Quadrivas Therapy® to Reduce Lipedema Subcutaneous Adipose Tissue (QUADRIVAS)
Target Study Description: #Study Description
Brief Summary
Quad Rivas Therapy has been developed by Alyna Eekma from the Netherlands for over thirteen years; anecdotally she has been able to significantly reduce lipedema SAT in women with Stage 1 and 2 lipedema, and can reduce lipedema SAT by 80% in women with Stage 3 lipedema. The study will last for one month, for a total of 12 treatments per subject, seven subjects total, to see if there is a change in percent body fat percentage over the course of these treatments.
Detailed Description
Lipedema
According to an epidemiological study by Földi E and Földi M, lipedema affects 11% of the female population. Rarely, men with hypogonadism, growth hormone deficiency, or liver disease may develop lipedema. Drs. Allen and Hines from the Mayo clinic defined lipedema in 1940 and shortly thereafter provided the diagnostic criteria for lipedema:
1. Almost exclusive occurrence in women developing by the third decade of life
2. Bilateral and symmetrical nature with minimal involvement of the feet, resulting in an ''inverse shouldering'', ''bracelet'' or 'cuff' effect at the ankle
3. Minimal pitting edema (non-pitting edema is present)
4. Pain, tenderness, and easy bruising
5. Persistent enlargement despite elevation of the extremities or weight loss.
6. Increased vascular fragility; easy bruising
There are three stages of lipedema Stage 1: Normal skin surface with enlarged hypodermis Stage 2: Uneven skin with a peau d'orange or mattress-like texture with larger mounds of tissue the size of a walnut or apple including the formation of lipomas and angiolipomas, and larger indentations in the fat Stage 3: Much larger mounds or huge lobules of tissue occurs causing deformations especially around the knees
Progression to lymphedema, called lipolymphedema (Stage 4) can develop during any Stage but most commonly occurs in people with Stage 3. Obesity can occur along with lipedema especially in Stage 3. Lifestyle improvements should always be considered for obesity associated with lipedema but lifestyle is not the cause of lipedema nor the cure.
Women with lipedema have an obvious disparity between the larger quantity of gynoid distributed painful fat on the lower body (hips, buttocks, legs) compared to the trunk, head and face resulting in a low waist to hip ratio (WHR). The disparity results from the failure of lipedema SAT to reduce in response to extreme caloric restriction, including bariatric procedures, or intensive daily exercise. It is unclear why there is a drive to maintain lipedema SAT on the body. The SAT begins in typical gynoid locations (hips, buttocks, legs) and few women with lipedema have diabetes or metabolic syndrome suggesting that the lipedema SAT may be protective against cardiovascular disease similar to gynoid fat. However, in addition to being cosmetically devastating to many women, lipedema fat increases the risk of development of mobility issues, joint damage, chronic pain and lymphedema.
Quad Rivas Therapy®
The Quad Rivas Therapy® is a deep tissue 'hands on' touch therapy of SAT which treats the body as an anatomical and physiological unit - all areas containing SAT are treated with a focus to improve functioning of blood vasculature, lymph vasculature, nerves, and the biomechanical system (muscle, tendons and fascia). The Quad Rivas Therapy® ensures these four systems are improved, but focuses on the vascular system. Tissues with decreased blood supply due to enlarged SAT mass, fibrosis or fascia disease need manipulation to be able to function properly again, allowing easy flow through the tissue. The Quad Rivas Therapy, therapist uses specialized grip techniques which enable the therapist to 'open' and 'unravel' tissues for an optimal blood supply. Another tissue technique, called the 'hook technique' allows the therapist to ensure stimulation of blood flow. Blood vessels gain elasticity back, fibrosis in the veins resolves and the body is able to repair itself.
The Quad Rivas Therapy® theory is that during puberty under the influence of hormones, the lipedema SAT outgrows the ability of muscles to use and break down fat resulting in excess SAT mass. This in combination with vascular, especially venous, insufficiency, which affects many women at a young age, creates a progressive disease that generates a blockage in metabolism associated due to setting up a hypoxic environment for the fat cells. Stimulating the affected area with Quad Rivas Therapy®, focusing on getting vessels back in top condition ensures the disappearance of lipedema SAT.
Quad Rivas Therapy® results in the following:
1. Recovery of the walls of the veins;
2. Increased basal metabolic rate in muscles;
3. Improved condition of the connective tissue.
#Intervention
- OTHER : Quadrivas Therapy
- Quadrivas therapy will be applied to subjects. Quadrivas therapy is a intensive massage therapy for different tissues. Subjects will receive 12 treatments. The first lasting 2.5 hours and the remaining 11 lasting 1.5 hours.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Ambulatory females of any race able to understand the consent process.
* 19 <= age <= 70 years.
* Diagnosis of lipedema Stage 1 or Stage 2 although early Stage 3 will be considered.
* Weight stable for past three months per personal report of the subject.
* Must be able to attend all 12 treatments and pre and post procedures
Exclusion Criteria:
* Use of medications that might cause weight gain and prevent fat loss (e.g., second generation anti-psychotics, corticosteroids).
* Current use of weight loss medications.
* Tobacco or marijuana use which may alter inflammation in the body.
* Pregnancy due to the risks associated with deep tissue treatment.
* Two or more alcoholic beverages per day, chronically.
Sex :
FEMALE
Ages :
- Minimum Age : 19 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 216 |
Target Study Title: Neovascular Morphology and Persistent Disease Activity Among Patients With Neovascular Age-Related Macular Degeneration
Target Study Description: #Study Description
Brief Summary
Neovascular Age-Related Macular Degeneration (NV AMD) remains the leading cause of vision loss among people over 65. Intravitreal injections with drugs that block VEGF have revolutionized treatment of NV AMD. However, less than 40% of treated patients have clinically significant imporovement in vision. In this study, we will determine the relative frequency of neovascular subtypes in two groups: 1) a representative, treatment-naive NV AMD patient population, and 2) a population of patients who develop recurrent NV AMD activity while off treatment and assess the frequency of persistent disease activity (PDA) according to specific neovascular morphologic subtypes. This information will clarify the scope of the PDA problem and will identify patients with PDA who may benefit from additional therpeutic strategies.
Detailed Description
Neovascular Age-Related Macular Degeneration (NV AMD) remains the leading cause of vision loss among people over 65. Intravitreal injections with drugs that block VEGF, a major protein mediator of angiogenesis and vascular leakage, have revolutionized treatment of NV AMD. However, less than 40% of treated patients have clinically significant improvement in vision. Further, in spite of continuous monthly anti-VEGF therapy, up to 40-50% of patients demonstrate sustained persistent disease activity (PDA), defined as (1) unresolved intraretinal, subretinal, or sub-retinal pigment epithelium fluid; (2) progressive lesion enlargement and fibrosis; and/or (3) persistent or new hemorrhage, assessed after either loading dose therapy or after sustained treatment with anti-VEGF. Since affected patients are at increased risk for long-term vision loss, PDA remains a vital clinical unmet need.
We are interested in the relationship between NV lesion morphology and response to therapy. Specifically, we hypothesize that specific NV morphologic subtypes are more frequently associated with PDA, based on preliminary retrospective analyses of indocyanine green (ICG) imaging data from NV AMD patients in our Duke Medical Retina practice. We have observed that eyes with Capillary pattern, seen as a discrete homogenous focus of microvessels, are highly responsive to anti-VEGF therapy and rarely exhibit PDA (\<20% of cases). In contrast, eyes with Arteriolar pattern (large-caliber feeding artery, many branching arterioles, and minimal capillary component) and eyes with polypoidal choroidal vasculopathy (variably sized and numbered, discrete saccular dilations of choroidal vasculature), demonstrate PDA in up to 70% of cases. A third subtype, choroidal leak syndrome, visible as choroidal hyperpermeability and leakage, manifest PDA in over 60% of cases. These data suggest that complex NV lesion morphology is the primary cause of PDA, and that anti-VEGF therapy alone is insufficient for these patients. However, the relative frequency of these subtypes and the association of PDA and NV lesion morphology, in a treatment-naive population free of selection bias, are unknown.
In this study, we will determine the relative frequency of NV subtypes in two groups: (i) a representative, treatment-naïve NV AMD patient population, and (ii) a population of patients who develop recurrent NVAMD activity while off treatment and assess the frequency of PDA according to specific NV morphologic subtypes. This information will clarify the scope of the PDA problem, and will identify patients with PDA who may benefit from additional therapeutic strategies.
#Intervention
- OTHER : No Intervention
- No intervention
- OTHER : No Intervention
- No intervention
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of either treatment naive NVAMD or newly reactivated NVAMD which has been previously quiescent off treatment
* Men and women aged >= 50 years
* Able to provide written informed consent
Exclusion Criteria:
* Potential study eye with ongoing (within previous 6 months of diagnosis of NVAMD disease activity) treatment for CNV, including anti-VEGF medications, corticosteroids, photodynamic therapy, thermal laser photocoagulation, transpupillary thermotherapy, or pneumatic displacement of macular hemorrhage
* CNV secondary to causes other than AMD
* Known or suspected sensitivity or allergy to ICG dye
* Known or suspected sensitivity or allergy to fluorescein dye
* Significant medial opacity (e.g. cataract) precluding clincial imaging adequate for interpretation
* Prior history of vitrectomy surger in potential study eye
Sex :
ALL
Ages :
- Minimum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 217 |
Target Study Title: Clinical Evaluation of Three Dental Adhesive Systems in Class V Restorations
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to compare the clinical performance of three dental adhesive systems used to bond Class V cavity fillings in adult teeth.
#Intervention
- DEVICE : Adhesive A
- Applied per manufacturer's instructions.
- Other Names :
- Adper Scotchbond SE (3M ESPE)
- DEVICE : Adhesive B
- Applied per manufacturer's instructions.
- Other Names :
- Adper Easy Bond (3M ESPE)
- DEVICE : Adhesive C
- Applied per manufacturer's instructions.
- Other Names :
- Single Bond Plus (3M ESPE)
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Must be at least 19 years
* Must have at least 3 qualifying noncarious Class V lesions of appropriate depth
* Must be willing to sign consent form
* Must be willing and able to return to UAB clinic for 4 study appointments
* Must be in good medical health and able to tolerate dental procedures
Exclusion Criteria:
* Current participation in other restorative product studies
* Severe salivary gland dysfunction
* Rampant caries (cavities)
* Chronic periodontitis (gum disease)
* Known allergies to the study materials
* Unacceptable level of oral hygiene
* Inability or unwillingness to attend study appointments
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 218 |
Target Study Title: Validating PROMIS Instruments in Congestive Heart Failure Patients Receiving a Heart Transplant
Target Study Description: #Study Description
Brief Summary
The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range of chronic diseases and demographic characteristics. In the first four years of its existence, the PROMIS network developed item banks for measuring patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical function, and social functioning. During the item banking process, the PROMIS network conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses to refine the meaning, clarity, and literacy demands of all items. The item banks were administered to over 20,000 respondents and calibrated using models based on item response theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were developed and implemented. The network has designed a series of studies using clinical populations to evaluate the item attributes, examine their utility as CATs, and validate the item banks. More information on the PROMIS network can be found at www.nihpromis.org.
The purpose of this research study is to learn about the experience and impact of having congestive heart failure (CHF). In particular, we hope to develop better questionnaires that can measure heart failure patients' quality-of-life.
Detailed Description
This project will assess the validity (including responsiveness) of selected Patient Reported Outcome Measurement Information System (PROMIS) instruments in patients with severe CHF who receive heart transplants. The following is a list of goals for this project:
* To estimate the responsiveness of PROMIS domain scores by comparing scores in patients with severe heart failure before and after a clinically significant event (heart transplant). The specific PROMIS domains assessed are physical functioning, fatigue, satisfaction with discretionary social activities, depression, and global health.
* To estimate the responsiveness of a disease-specific patient-reported outcome (PRO) measure, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short Form-36 Vitality subscale (SF-36v2), and the Patient Health Questionnaire (PHQ-2).
* To collect cross-sectional and longitudinal data on traditional clinical measures of heart failure outcome (6-minute walk test and New York Heart Association \[NYHA\] class) that can inform the definition of a minimally important difference (MID) for the PROMIS domains of physical functioning, fatigue, satisfaction with discretionary social activities, depression, and global health.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Heart failure had to represent the greatest medical limitation on daily function for the patient in the judgment of the attending cardiologist
* Ability to read, write, and speak in English
* Ability to understand and provide informed consent
* Placement on heart transplant registry (awaiting heart transplant surgery)
Exclusion Criteria:
* Current diagnosis of psychosis or dementia
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 219 |
Target Study Title: ESTUDIO FASE II DE BEVACIZUMAB EN COMBINACIÓN CON CAPECITABINA Y RADIOTERAPIA COMO TRATAMIENTO PREOPERATORIO EN PACIENTES CON CÁNCER RECTAL LOCALMENTE AVANZADO RESECABLE
Target Study Description: #Study Description
Brief Summary
The project objective is to evaluate the efficacy of the neoadjuvant treatment with bevacizumab, capecitabine and radiotherapy, in patients with rectal adenocarcinoma resectable locally advanced (stage T3 or T4), with or without presence of ganglionar metastases and without distant metastases.
#Intervention
- BIOLOGICAL : Bevacizumab
- Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg.
- DRUG : capecitabine (Xeloda)
- Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period
- RADIATION : Rectal Radiotherapy
- Radiotherapy in rectum 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* The patient has given written informed consent prior to any study related procedure
* Male and female aged 18 <= age <= 75
* ECOG performance status 0 or 1
* Histologically confirmed diagnostic of adenocarcinoma of the rectum < 15 cm from anal verge
* Clinical stage of T3, T4 with/without regional lymph node metastases, without metastatic disease
* Disease evaluable by imaging techniques
* No tumour haemorrhage in the week prior to start of study treatment
* External derivation in symptomatic occlusive tumours
* Not prior cancer treatment
* Adequate bone marrow, hepatic and renal function, defined as:
1. White blood cells >= 4 x 109 /l
2. Absolute neutrophil count >= 1.5 x 109 /l
3. Platelets >= 100 x 109 /l
4. Haemoglobin >=10 g/dl
5. Bilirubin < 1.25 x upper limit of normal
6. Aspartate transaminase and alanine transaminase < 2.5 x upper limit of normal
7. Serum creatinine <= 106 µmol/l
* Less than 10% weight loss
Exclusion Criteria:
* Rectal cancer no amenable to resection
* Any other malignancy which has been active or treated within the past 5 years , with the exception of in situ carcinoma of the cervix and non-melanoma skin lesions adequately treated
* Pregnant or breast-feeding women
* Women oh childbearing potential unless effective methods of contraception are used
* No prior or concurrent significant medical conditions, including any of the following:
* Cerebrovascular disease (including transient ischemic attack and stroke) within the past year
* Cardiovascular disease, including the following:
* Myocardial infarction within the past year
* Uncontrolled hypertension while receiving chronic medication
* Unstable angina
* New York Heart Association class II-IV congestive heart failure
* Serious cardiac arrhythmia requiring medication
* Major trauma within the past 28 days
* Serious nonhealing wound, ulcer, or bone fracture
* Evidence of bleeding diathesis or coagulopathy
* No lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication
* No evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug
* No known dihydropyrimidine dehydrogenase deficiency
* Major surgery in the 4 weeks prior to the start of study treatment
* No concurrent chronic, daily treatment with aspirin (> 325 mg/day)
* More than 10 days since prior use of full-dose oral or parenteral anticoagulants for therapeutic purposes
* No participation in another clinical trial with any investigational drug within 30 days prior to randomization or during study participation
* No other medical history or condition that, in the opinion of the investigator, would preclude study participation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 220 |
Target Study Title: International, Multicenter Study of a Twenty-eight Week, Open-label, Titrated Oral Lixivaptan Administration in Patients With Chronic Hyponatremia: Extension to Studies CK-LX3401, 3405, and 3430
Target Study Description: #Study Description
Brief Summary
To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects with euvolemic and hypervolemic hyponatremia
Detailed Description
Phase I and Phase II clinical trials have demonstrated that lixivaptan may play an important role in treating hyponatremia and the signs and symptoms of water retention associated with HF, LCWA and SIADH. Lixivaptan was previously evaluated in disease states characterized by hyponatremia with euvolemia (SIADH) and hyponatremia combined with fluid overload (HF, LCWA). Lixivaptan demonstrated correction in serum sodium concentration together with marked aquaresis in patients with hyponatremia.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Men and women 18 years or older
* Ability to provide informed consent or assent
* Prior participation in a lixivaptan hyponatremia trial with evidence of continued need or desire for therapy
Exclusion Criteria:
* A current medical condition where long-term treatment with an aquaretic agent may present an undue risk to the patient
* Hyponatremia which is acute, reversible, artificial or due to conditions not associated with vasopressin excess or likely to respond to aquaretic therapy
* Hyponatremia due to reversible medical condition or therapy
* Conditions associated with an independent imminent risk of morbidity and mortality
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 221 |
Target Study Title: Mefloquine Bioequivalence Among Three Commercial Tablet Formulations in Peruvian Subjects With Uncomplicated Plasmodium Falciparum Malaria
Target Study Description: #Study Description
Brief Summary
The objective of this study was to determine the bioequivalence among three commercial tablet formulations of MQ, i.e. Lariam, Mephaquin, and Mefloquine-(AC Farma) when given in combination with artesunate.
Detailed Description
Pharmacokinetic parameters were determined for mefloquine in whole blood from Peruvian subjects with uncomplicated falciparum malaria administered Mephaquin®, Mefloquine-AC Farma, and Lariam®. The Mefloquine-AC Farma arm comprised 13 patients while the reference (Lariam) and Mephaquin arms consisted of 12 patients. Although Cmax was significantly less (p=0.04) in the Mephaquin arm (AUC0-t = 2500 ng/ml/day) relative to the reference (AUC0-t = 2820 ng/ml/day) arm, there were no significant differences in the AUC∞, tmax, and t1/2 for Mefloquine-AC Farma or Mephaquin relative to the reference. Except for the Cmax of the Mefloquine-AC Farma, the 90% confidence intervals for all parameters of both treatments were outside the specified FDA range of 80-125%. Therefore both formulations were not considered bioequivalent to the reference.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* The inclusion criteria for enrolling patients included; male or non-pregnant female >= 18 years, infection with P. falciparum alone, with a parasite density between 250 and 50,000 asexual parasites/mm3 as determined by microscopic examination of a thick blood smear, informed consent from patient, and a willingness to be hospitalized for the first 24 hours after therapy is initiated and to return for follow-up visits through day 56.
Exclusion Criteria:
* Patients exhibiting evidence of severe malaria or with a history of an underlying chronic disease or illness that could interfere with the absorption of MQ, a history of hypersensitivity to MQ, or a history of neuropsychiatric illness or cardiac conduction problems were excluded.
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 222 |
Target Study Title: Natural History of Postoperative Cognitive Function, Quality of Life, and Seizure Control in Patients With Supratentorial Low-Risk Grade II Glioma
Target Study Description: #Study Description
Brief Summary
This trial studies the natural history of brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery. Learning about brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery may help doctors learn more about the disease and find better methods of treatment and on-going care.
Detailed Description
PRIMARY OBJECTIVES:
I. To determine if there is difference in the average changes of neurocognitive function (NCF) scores from baseline to the time of radiologic tumor progression or up to 5 years (whichever occurs first), between radiologically progressed and non-progressed patients.
SECONDARY OBJECTIVES:
I. To determine if there is difference in the time to neurocognitive decline, as defined by the Reliable Change Index - Within subjects Standard Deviation (RCI-WSD), between radiologically progressed and non-progressed patients.
II. To evaluate NCF during the postoperative observational period of progression-free survival (PFS) and after radiological progression for a total time on study of 5 years.
III. To determine if the changes in cognitive functioning are an early warning biomarker for radiological progression.
IV. To explore the effect of salvage therapy on cognitive outcomes in patients who progress during the study period for up to 5 years.
V. To evaluate quality-of-life (QOL) as measured by the European Organization for Research and Treatment of Cancer (EORTC) QOL-30 and QOL brain module (BCN20) and health utilities as measured by the European Quality of Life-5 Dimensions (EQ-5D), for a total time on study of 5 years.
VI. To evaluate seizure control for a total time on study of 5 years. VII. To evaluate molecular correlates of QOL, NCF, seizure control, and PFS. VIII. To characterize aberrant molecular pathways in low-grade gliomas (LGGs) and test the hypothesis that activation of signaling pathways will predict worse PFS and overall survival (OS).
IX. To explore the relationship between change in cognitive function and symptomatic progression (defined as worsening seizures or new or progressive neurologic deficits) or clinical progression (defined as initiation of treatment interventions such as radiotherapy, chemotherapy, or additional surgery).
OUTLINE:
Patients undergo neurocognitive assessment using the CogState Test battery (the Detection Test (DET), the Identification Test (IDN), the One Card Learning Test (OCLT), and the Groton Maze Learning Test (GMLT)) at baseline\* and at 12, 24, 36, 42, 48, 54, and 60 months. Patients also complete the EORTC Quality of Life Questionnaire-Core 30 (QOL-30), the Brain Cancer Module-20 (BCM20), and the European Quality of Life-5 Dimensions (EQ-5D) questionnaires at baseline\*, at 12, 24, 36, 48, and 60 months afterwards, and before undergoing any further treatment. Patients are instructed to complete a seizure and medication diary during study.
Patients undergo MRI scans at baseline\*, at 12, 24, 36, 48, and 60 months, and at the time of radiological, clinical, or neurological failure.
NOTE: \* 12 weeks after surgery.
#Intervention
- PROCEDURE : cognitive assessment
- Undergo neurocognitive assessment
- PROCEDURE : magnetic resonance imaging
- Undergo MRI
- Other Names :
- MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
- OTHER : laboratory biomarker analysis
- Correlative studies
- OTHER : questionnaire administration
- Ancillary studies
- PROCEDURE : quality-of-life assessment
- Ancillary studies
- Other Names :
- quality of life assessment
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Central pathology confirmed diagnosis of supratentorial grade II oligodendroglioma, astrocytoma, or mixed oligoastrocytoma prior to step 2 registration
* No multifocal disease, based upon the following minimum diagnostic work-up:
* History/physical examination, including neurologic examination, within 84 days prior to step 2 registration
* Brain MRI with and without contrast within 84 days prior to Step 2 registration (Note: MRI 70 days after surgery is preferred and highly encouraged)
* The patient must be within one of the following categories:
* Maximal safe resection with minimal residual disease defined as follows:
* Removal of T2/fluid-attenuated inversion recovery (FLAIR) abnormalities thought to be primarily tumor, with a residual <= 2 cm maximal tumor diameter/T2 FLAIR abnormality on MRI to be done within 84 days post-operatively
* If there is > 2 cm post-operative residual T2/FLAIR abnormality and the neurosurgeon believes this represents edema and not primarily tumor, the neurosurgeon is encouraged to repeat imaging within the allowed study period (up to 84 days post-operatively) to confirm resolution of edema
* MRI at the time of enrollment must document a <= 2 cm residual maximal tumor diameter/T2 FLAIR abnormality
* Patients who required a second surgery to obtain a maximal safe resection will be eligible if the second surgery is performed within 84 days of the initial diagnostic procedure
* Age < 40 (any extent of resection)
* Age < 50 and preoperative tumor diameter < 4 cm (any extent of resection)
* Karnofsky performance status >= 80%
* No prior invasive malignancy (except non-melanomatous skin cancer) unless disease-free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
* Must be able to undergo MRI of the brain with gadolinium
* No plans for adjuvant radiotherapy or chemotherapy after surgery
* No more than 84 days (12 weeks) since prior surgery
* No brain tumor recurrence
* No prior brain tumor surgery, radiation therapy and/or chemotherapy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 223 |
Target Study Title: REduction of Myocardial Necrosis Achieved With Nose-dive Manual Thrombus Aspiration
Target Study Description: #Study Description
Brief Summary
Although successful, percutaneous coronary interventions (PCI) with stent implantation may be hampered by periprocedural myocardial necrosis. In acute ST-elevation myocardial infarction (STEMI), the reduction of thrombus burden through manual thrombus aspiration (TA) of an occluded coronary artery has been documented to produce an improved myocardial perfusion rate and significant survival advantage. To date, beyond feasibility and safety studies no clinical benefit has been yet documented with the use of TA before stent deployment in the setting of acute coronary syndromes (ACS) outside acute STEMI. The investigators hypothesize that TA before stent deployment reduces the thrombus/plaque burden - as assessed by intravascular imaging systems - in the setting of acute coronary syndromes (ACS) outside acute STEMI.
Detailed Description
Periprocedural myocardial infarction (MI) has an independent adverse prognostic relevance. Several trials have documented a reduction in the occurrence of periprocedural MI through various pharmacological strategies, with enhanced inhibition of platelet aggregation or high dose statins. However, real-world registries still document an incidence of periprocedural MI in 30-40% of patients. Currently available intravascular imaging techniques, Intravascular Ultrasound (IVUS) and more recently available Optical Coherence Tomography (OCT) allow a precise evaluation of the coronary plaque and can be extremely useful for monitoring plaque modifications obtained with thrombus aspiration (TA). Plaque burden will be assessed as plaque + media (P+M), commonly measured with IVUS by subtracting lumen (L) to external elastic membrane (EEM) cross sectional area (P+M= EEM-L).
Expecting a mean plaque volume of 160±50 mm3 in a population of patients with ACS undergoing PCI, a sample size of at least 45 patients (52 lesions) with a recent (\<15 days, but after 24 hours) STEMI or a non-ST elevation (NSTE)-ACS within 72 hours of symptoms would provide a 90% power to detect a 20% reduction in the plaque volume after TA with an alpha (probability value) of 0.05.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Age between 18 <= age <= 75 years.
* Recent(<15 days, >24 hrs)STEMI or NSTE-ACS within 72 hrs of symptoms.
* Presence at least one 'culprit' high-grade (>90%)lesion.
Exclusion Criteria:
* STEMI within 24 hours.
* Cardiogenic shock, decompensated heart failure, LVEF<30%.
* Serum creatinine >= 2.5 mg/dl.
* Contraindication to aspirin, heparin, thienopyridines.
* Total occlusion of target vessel.
* Diseased vein graft or a restenosis.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 224 |
Target Study Title: Nivolumab Plus Stereotactic Body Radiotherapy (SBRT) in II and III Line of Patients With Metastatic Renal Cell Carcinoma (mRCC)
Target Study Description: #Study Description
Brief Summary
NIVES study is an ongoing phase II, single arm, multicenter study. In this trial pts received SBRT to one non-brain measurable lesion and concomitant NIVOLUMAB, an anti-programmed cell death (PD-1). Combining SBRT with NIVO may enhance the antitumor immune responses and improve clinical outcomes, how it was demonstrated for other solid tumors with a phenomenon known as the abscopal effect . It was planned to enrolled a total of 68 pts within 12 months. The objective of the current analysis is to describe the first report of safety profile of NIVO in combination with SBRT.
#Intervention
- DRUG : Nivolumab
- Hypofractionated radiation will be administered to a metastatic disease site at a dose and schedule of 30 Gy in 3 consecutive fractions. The day of first administration of Nivolumab will be designated as Time 1. Nivolumab will be given as flat dose of 240 mg in intravenous infusion beginning on day 1 every 14 days for 6 months, than switch to 480 mg q4-weekly in responding (CR, PR, SD) patients until PD or unacceptable toxicity .
SRT will be administered between the first and second administration of Nivolumab (7 days after the first infusion of Nivolumab).
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Age >= 18 years on day of signing informed consent
* Performance status of 0, 1 on the ECOG Performance Scale
* Histologically confirmed metastatic RCC not suitable for curative-intent local therapy
* Disease progressed after <= 2 prior anti-angiogenic therapies
* Life expectancy > 12 weeks
* 2 or more measurable non-brain sites of disease based on RECIST 1.1, whose at least one potentially suitable for treatment with SBRT. In the case of a non measurable bone lesion suitable for treatment with SBRT, even only one measurable non-brain site of disease is allowed
* Patients are eligible if CNS metastases are treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 14 days prior to enrollment. In addition, patients must either be off corticosteroids or on a stable dose or decreasing dose of <= 10 mg daily prednisone (or equivalent)
* Adequate organ function
Exclusion Criteria:
* Prior therapy with an agent directed at PD-1, PD-L1, or PD-L2
* Currently participating in or has participated in a study of an investigational agent or using an investigational device within 2 weeks of the first dose of treatment
* Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (> 10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger
* Any condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
* Active brain (CNS) metastases and/or carcinomatous meningitis
* Prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
* Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., <= Grade 1 or at baseline) from adverse events due to a previously administered agent. Subjects with <= Grade 2 neuropathy are an exception to this criterion and may qualify for the study
* Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
* Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment
* Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection
* Additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
* Evidence of interstitial lung disease, active non-infectious pneumonitis, or a history of grade 3 or greater pneumonitis
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
* Live vaccine within 30 days prior to the first dose of trial treatment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 225 |
Target Study Title: HEART Camp: Promoting Adherence to Exercise in Patients With Heart Failure
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine the efficacy of the Heart Failure Exercise and Resistance Training (HEART) Camp behavioral exercise training intervention on long-term adherence to exercise at 18 months in patients with heart failure. The central hypothesis is that the HEART Camp intervention group (HC) will have significantly better adherence to exercise at 18 months.
Detailed Description
The objective of this prospective randomized two-group repeated measures experimental design is to determine the efficacy of the HEART (Heart Failure Exercise and Resistance Training) Camp behavioral exercise training intervention on long-term adherence to exercise at 18 months in patients with HF. A sample size of 246 subjects with heart failure will be recruited over a 3 year period. All subjects will receive a cardiopulmonary exercise test and 9 supervised exercise training sessions during a 3 week run-in period prior to randomization. Subjects completing 6 of 9 training sessions will be randomized to the HEART Camp Intervention group (HC) or to an enhanced usual care (EUC) exercise group. The HC intervention group will receive cognitive-behavioral strategies that address the intervention components of knowledge, attitudes, self-efficacy, behavioral self-management skills and social support. The EUC group is provided access to the exercise facility and regular facility staff for the 18 month study period. Our central hypothesis is that the HC group will have significantly better adherence to exercise at 18 months. We will test our hypothesis with the following Specific Aims: Aim 1. To evaluate the effect of HEART Camp on adherence to exercise (measured by self-report and validated by heart rate monitor); Aim 2. To evaluate which components of the HEART Camp intervention mediate the effects of the intervention on adherence; Aim 3. To evaluate the effect of HEART Camp on specific health outcomes; Aim 4. To explore selected demographic variables (age, race, gender, body mass index and left ventricular ejection fraction) as potential moderators of the effect of the HEART Camp intervention on adherence; and Aim 5. To explore the perceptions and experiences that contextualize exercise adherence.
#Intervention
- BEHAVIORAL : Enhanced Usual Care Group
- The EUC group is provided access to the exercise facility and regular facility staff for the 18 month study period.
- BEHAVIORAL : HEART Camp (HC) Intervention Group
- The HC intervention group will be provided access to the exercise facility for the 18 month study period and will also receive the cognitive-behavioral intervention (knowledge, attitudes, self-efficacy, behavioral self-management skills and social support) delivered using both group-based and individual-based strategies.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of heart failure (stage C chronic HF confirmed by echocardiography and clinical evaluation)
* 19 years or greater
* able to speak and read English
* telephone access in home
* Stable pharmacologic therapy per guidelines for past 30 days
Exclusion Criteria:
* clinical evidence of decompensated HF
* unstable angina pectoris
* myocardial infarction, coronary artery bypass surgery, or biventricular pacemaker within the past 6 weeks
* orthopedic or neuromuscular disorders preventing participation in aerobic exercise and strength/resistance training
* participation in 3 times per week aerobic exercise during the past 8 weeks
* cardiopulmonary stress test results that preclude safe exercise training
* plans to move more than 50 miles from the exercise site within the next year
* peak oxygen uptake (pVO2) in women>21mL kg min and in men >24mLkg min
* planned or current pregnancy
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 226 |
Target Study Title: Effect of Neutralization of Endogenous Acid Production on Bone Mineral Density and Microarchitectural Composition of Bone in Humans
Target Study Description: #Study Description
Brief Summary
Hypothesis: Neutralization of acid production induced by the Western diet with oral administration of potassium citrate increases bone mineral density and bone mass as well as skeletal muscle mass and strength in elderly people (\> 65y).
Detailed Description
We will perform a prospective, randomized, placebo-controlled trial evaluating the effect of K citrate on bone mineral density, microarchitectural composition of bone,nutritional parameters, lean body mass, parameters of skeletal muscle mass and strength, 24h and exercise induced blood pressure changes in otherwise healthy, elderly ambulatory subjects of both genders.
Potassium citrate (60 mEq) is supplied as tablets with a wax matrix (10 mEq of citrate per tablet) and ingested in three doses/day. All subjects will receive daily oral 500 mg of calcium and 400 IU of vitamin D to ensure adequate calcium and vitamin D supply.
#Intervention
- DRUG : potassium citrate
- 6 times 10 mEq per day, oral for 24 months
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Men and women, 65 to 80y, tscores at L2-L4 0 to -2.5
Exclusion Criteria:
* Treated or necessity to treat low BMD (t-score L2 to L4 <-2.5)
* Any major medical illness that would possibly need hospitalization and/or be followed by foreseeable complications within 12 months and/or have a life-expectancy of less than 5 years
* Stable serum creatinine > 150 umol/l and/or known Type IV renal-tubular acidosis (hyperkalemia)
* vegetarians
* concommitant drug prescriptions: systemic and topical glucocorticoids, systemically acting estrogens (topical allowed): both within the last 6 months. antiosteoporosis drugs: bisphosphoponates, fluoride, calcitonin, all within the previous 12 months.
* vitamin D deficiency at screening visit
* technical difficulties to delineate bone area of interest during the screening visit
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 227 |
Target Study Title: A Photo-irritation and Photo-sensitisation Study in Healthy Subjects for Three Developmental Cosmetic Facial Products
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to demonstrate the absence of sensitisation and irritation potential of a product when applied to the skin and exposed to ultraviolet (UV) radiation. Photo-sensitisation potential will primarily be evaluated through a subsequent semi-occluded application and UV exposure (challenge phase) after a 2-week rest period. Photo-irritation potential will primarily be evaluated through the repeated occluded application and UV exposure of the study products over 3 weeks (induction phase).
Detailed Description
A single-center, randomised, evaluator (single) blind study in healthy adult participants aged 18 to 65 years with no dermatological disorders to evaluate the cutaneous photo- irritation and photo-sensitisation potential of three cosmetic facial skincare products. During Screening (Visit 1), the participants will sign an informed consent, will undergo dermatological assessment to ensure they have no dermatoses on their dorsum that might impact their safety, Fitzpatrick Phototype of II to IV and colorimetry analysis of their skin type using the Individual Typology Angle, which will be used to estimate minimal erythemal dose (MED). At Visit 2, the eligible participants will undergo MED irradiation where the participant will be administered a series of 6 controlled doses of UV radiation. At Visit 3, the participants will undergo MED determination, where a trained evaluator will evaluate the exposed skin to determine the lowest dose of UV radiation required to induce uniform, unambiguous erythema for signs of visible erythema. Further, the study will progress in 3-phases: Induction phase, Rest Phase and Challenge Phase. The Induction phase (3 weeks: Visit 4 to Visit 18); at visit 4, the area for applying 2 consecutive patches will be designated between the scapula and waistline. A controlled amount (0.02 mL/cm\^2) of each study product will be randomly assigned within the patch system of each participant into the appropriate separate cell (3 cells for each of the test products and 1 cell for the saline solution). Every Monday, patch sites will be evaluated, 2 patches will be applied, post 24 hours (Tuesday) the patches will be removed, patch sites can be cleaned, patch sites will be evaluated, test products/ saline will be re-applied and 1 of the 2 sites will be irradiated with 2.5 Joules per centimetre square UVA radiation with a Schott UG11+WG335 filter (or equivalent) in place, and then with 0.3 MEDs of UVA+UVB radiation (filters UG11+WG320). The sites will be assessed immediately after irradiation and 24 hours post irradiation (Wednesday) and duplicate patches will be re-applied as applied on Monday. Same procedure will be repeated on Thursday as done on Tuesday and on Friday the patch sites will be evaluated. The same process will continue for 3 consecutive weeks. Then there will be 2 weeks of Rest phase; where there will be no product or patch applications. Rest phase is further followed by Challenge phase at week 6 (Visit 19 to Visit 23) where there will be a duplicate parallel series of product applications under semi-occlusive patches to 2 naïve areas on Monday. Post 24 hours (Tuesday) patches will be removed and 1 of the 2 sites will be irradiated similar as done in induction phase. The sites will be assessed immediately post irradiation and after 24 hours (Tuesday), 48 hours (Wednesday) and 72 hours (Thursday) of irradiation. At visit 23, after the challenge phase the final assessments will be performed by the dermatologist.
#Intervention
- OTHER : Serum
- Participants will be topically applied adhesive patch containing developmental serum
- OTHER : Lotion
- Participants will be topically applied adhesive patch containing developmental lotion
- OTHER : Cream
- Participants will be topically applied adhesive patch containing developmental cream
- OTHER : Normal Saline
- Participants will be topically applied adhesive patch containing normal saline
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
* A participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
* A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon dermal examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
* A participant with Fitzpatrick phototype II to IV.
* A participant with healthy, intact skin at the proposed test area dorsum (below the shoulder, above the waist), as evaluated by a dermatologist, to ensure participant is free of clinically relevant dermatological conditions.
Exclusion Criteria:
* A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a GSK CH employee directly involved in the conduct of the study or a member of their immediate family.
* A participant who has participated in other studies involving investigational product(s) within 30 Days prior to study entry and/or during study participation.
* A participant who has participated in other studies including non-medicinal, cosmetic studies within 7 Days prior to study entry and/or during study participation.
* A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
* A participant who is pregnant (self-reported).
* A participant who is breastfeeding.
* A participant with known or suspected intolerance or hypersensitivity to the study materials/product (or closely related compounds) or any of their stated ingredients, to hypoallergenic tape, or to the cotton patches.
* A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
* A participant unwilling or unable to comply with the Lifestyle Considerations; a) applying other product to test site, using cosmetics, b) changing dietary habits, c) getting patch test site wet, d) removing the patch, e) wearing tight or restrictive clothing that can remove patch, f) engaging in activities that result in excessive sweating, and g) intentional exposure to artificial ultraviolet light or cosmetic procedures.
* A participant with current or recent (within last 6 months before the start of the study) history of atopic lesions and/or eczema, psoriasis or skin cancer.
* A participant with a history of allergic reactions to topical-use products, cosmetics or medications or their ingredients.
* A participant with any history of significant diseases or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
* A participant considered immune-compromised.
* A participant with active dermatosis (local or disseminated) that might interfere with the results of the study.
* A Participant with history of diseases aggravated or triggered by ultraviolet radiation.
* A participant currently using any medication, which in the opinion of the investigator, may affect the evaluation of the investigational product, or place the participant at undue risk (e.g. any photosensitising medication such as tetracycline, thiazides, fluoroquinolones, etc.) within one month prior to inclusion.
* A participant who has used any of the following topical or systemic medications up to two weeks before the screening visit: immuno-suppressants, antihistamines, nonsteroidal anti-inflammatory drugs (NSAIDS), and particular aspirin (>200mg/d), within two weeks prior to inclusion and/or corticosteroids.
* A participant who has used oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit.
* A participant who has been vaccinated up to 1 month before the screening visit or is intending to receive a vaccination during their participation in the study.
* Currently receiving allergy injections or received an allergy injection within 7 days prior to Visit 1 or expects to begin injections during study participation.
* A participant with any skin marks on the back that might interfere with the evaluation of possible skin reactions (e.g. pigmentation disorders, vascular malformations, scars, tattoos, excessive hair, numerous freckles, open sores, pimples, or cysts).
* A participant that intends bathing (in the sea or a pool), using a sauna, or partaking in water sports, or activities that lead to intense sweating for the duration of the study.
* A participant who has used a transcutaneous electrical nerve stimulation (TENS) machine 1 day before the screening visit or intends to use a TENS machine at any point during the study.
* A participant with history of sensitisation in a previous patch study.
* A participant with history of abnormal reaction to sun exposure.
* A participant who had intense sunlight exposure or sun tanning sessions up to 30 days before the screening evaluation.
* A participant with recent history (within the last 5 years) of alcohol or other substance abuse.
* A participant who has previously been enrolled in this study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 228 |
Target Study Title: Evaluation of the Effectiveness of Kinesiotaping and Inactivation of Trigger Points in Chronic Myofascial Pain of Temporomandibular Joint Dysfunction
Target Study Description: #Study Description
Brief Summary
In patients with a long-lasting TMD syndrome, especially of a muscular nature, palpation examination can locate the trigger points of pain (TrP) in the chewing muscles, i.e., the nodules in the shape of bumps the size of rice or pea grains. Kinesiotaping (KT) is considered as an intervention method that can be used to release latent myofascial trigger points. It is a method that involves applying specific tapes to the patient's skin surface in order to use the natural self-healing processes of the body. The aim of the study was to evaluate the effect of Kinesiotaping methods and inactivation of Trigger Points on nonpharmacological elimination of pain in patients with functional disorders of the masticatory motor system.
Detailed Description
BACKGROUND:
Temporomandibular Dysfunction (TMD) is a disease characterized by a set of signs and symptoms that may include joint noise, pain in the mastication muscles, limitation of mandibular movements, facial pain, joint pain and / or dental wear. Pain appears as a very present and striking symptom, with a tendency to chronicity. This is a difficult treatment condition often associated with psychological factors such as anxiety. In patients with a longlasting TMD syndrome, especially those of a muscular nature, palpation can locate the trigger points of pain (TrP) in the chewing muscles, i.e. the nodules in the shape of bumps the size of grains of rice or peas. Of particular importance in the treatment of pain syndromes of temporomandibular joint disorders is physiotherapy and physical therapy. Some studies have shown improvement in subjects with chronic pain using different physiotherapy treatments, but this requires further investigation to determine the effectiveness of individual therapies in the fight against pain.
PROBLEM:
The multiple manifestation of symptoms causes a multitude of treatment methods and indicates that there is still no consensus in the understanding of the pathophysiology of the underlying TMD mechanisms. Treatment of pain syndrome in temporomandibular dysfunction due to heterogeneity of causes should have a multiprofile character. Despite the wide range of strategies used to treat patients with TMD, some patients have a temporary and / or unsatisfactory relief response. There are many physiotherapeutic methods to fight pain, among others: compressive mobilization, positional release, myofascial relaxation, active relaxation technique, postisometric relaxation technique. Of the commonly used methods, a deep tissue massage and stretching. Some of them are very unpleasant for patients, because in the first phase they intensify pain, eg active inactivation (therapy) of trigger points (TrP). Kinesiotaping is a painless method that does not intensify pain symptoms. Reports from various researchers are contradictory in this regard, hence the attempt to compare both methods in the aspect of non-pharmacological analgesic activity in patients with TMD.
HYPOTHESIS:
Researchers believe that in patients with severe pain symptoms, patients with TMD who are often accompanied by anxiety before symptom intensification, it is very important to use physiotherapeutic methods, which can eliminate or reduce pain in a non-pharmacological manner. In this type of patients, the psychological aspect is important in the form of immediate relief without aggravating the symptoms at least in the first phase, because it can cause patients psychological reluctance to the entire treatment process. Because of the mutual influence between pain and psychological factors, it is expected that the analgesic effect will have a positive effect influence on the level of anxiety before further often long-term therapeutic treatment.
AIM:
Evaluation and comparison of the analgesic efficacy of two physiotherapeutic methods: Kinsiotapinng (KT) and active inactivation of trigger points (TrP) in the pain levels in individuals with chronic pain due muscular TMD.
#Intervention
- DIAGNOSTIC_TEST : Kinesiotaping
- Dynamic adhesive taping is a method that involves the application of specific tapes to the surface of the patient's skin in order to use the natural self-healing processes of the body. It is often used as an element that sustains the therapeutic effect. Its action is based mainly on the action normalizing muscle tone, supporting the work of joints, improving the function of weakened muscles, increasing microcirculation at the site of application.
- Other Names :
- Dynamic adhesive plaster, Dynamic adhesive tape
- DIAGNOSTIC_TEST : inactivation of trigger points (TrP)
- A procedure for releasing trigger points using physiotherapy using the ischemic compression method, which involves applying pressure to the active trigger point, until it is switched off, i.e. pain ceases.The location of the trigger point is done palpatively, with a pliers grip, covering the strained tissue on the inside and outside of the cheek with the thumb and index finger.
- Other Names :
- compressive mobilization
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Age between 18 <= age <= 35 years, both male and female
* Provide informed consent to participate in the study;
* Having a diagnosis of muscular pain TMD(Temporomandibular Disorders) according to group -I A, axis I RDC/TMD(Research Diagnostic Criteria)
* Visual analogic scale (VAS) score from 4 to 10 for 14 days
* Not have history of alcohol or drugs abuse within the past 6 months as self-reported
* Not use ot carbamazepine (or similar) within the past 6 months as self reported
* Not have history of neurosurgery as self-reported
* Not have history of major psychiatric disorders such as schizophrenia and bipolar disorder
* Not have any other previously diagnosed disorder with symptoms similar to the TMD, such as fibromyalgia.
Exclusion Criteria:
* One absence during therapeutic sessions;
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 229 |
Target Study Title: Formulation and Clinical Evaluation of Ethosomal and Liposomal Preparations of Anthralin in Psoriasis
Target Study Description: #Study Description
Brief Summary
Psoriasis is a common immune mediated inflammatory skin disease characterized by red heavily scaled plaques. Anthralin (1,8-dihydroxy-9-anthrone) which was introduced over 80 years ago has shown excellent efficacy in the management of psoriasis.Although anthralin is remarkably effective in the management of psoriasis, its side effects are equally disturbing. Its use is messy as it stains the skin, clothing, and any furniture that it may come in contact with. Further, anthralin has irritating, burning, brown discoloration and necrotizing effect on the normal and the diseased skin. This troublesome profile has discouraged wide-spread use of the drug.
Ethosomes are attractive vesicular carriers mainly composed of phospholipids, ethanol and water. The intriguing features of ethosomes are due to their high ethanol content which facilitate their penetration through stratum corneum and target deep skin layers. This is advantageous over conventional liposomes which have limited penetration through the skin and remain confined in the upper layer of the stratum corneum. Compared to liposomes, ethosomes had greater retention of methotrexate into the skin for a longer period of time, suggesting better therapeutic outcome.
Detailed Description
Psoriasis is a common immune mediated inflammatory skin disease characterized by red heavily scaled plaques. Anthralin (1,8-dihydroxy-9-anthrone) which was introduced over 80 years ago has shown excellent efficacy in the management of psoriasis.Anthralin mechanism of action involves inhibition of the proliferation of keratinocytes. Further, accumulation of anthralin inside the mitochondria impairs energy supply to the cell, probably due to the free radicals resulting from oxidation of the drug. Anthralin also interferes with the replication of DNA and slows down the extreme cell division that occurs in psoriatic plaques. Although anthralin is remarkably effective in the management of psoriasis, its side effects are equally disturbing. Its use is messy as it stains the skin, clothing, and any furniture that it may come in contact with. Further, anthralin has irritating, burning, brown discoloration and necrotizing effect on the normal and the diseased skin. This troublesome profile has discouraged wide-spread use of the drug.
Ethosomes are attractive vesicular carriers mainly composed of phospholipids, ethanol and water. The intriguing features of ethosomes are due to their high ethanol content which facilitate their penetration through stratum corneum and target deep skin layers. This is advantageous over conventional liposomes which have limited penetration through the skin and remain confined in the upper layer of the stratum corneum. Compared to liposomes, ethosomes had greater retention of methotrexate into the skin for a longer period of time, suggesting better therapeutic outcome.
#Intervention
- DRUG : ethosomal preparation of anthralin
- once daily with short contact topical application
- DRUG : liposomal preparation of anthralin
- once daily with short contact topical application
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* patients with mild to moderate, stable chronic plaque psoriasis.
Exclusion Criteria:
* patients with severe psoriasis.
* Patients received any topical or systemic treatment for psoriasis one month before the start of the study.
Sex :
ALL
Ages :
- Minimum Age : 9 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 230 |
Target Study Title: Prevention of Weight Gain in Young Adults
Target Study Description: #Study Description
Brief Summary
The purpose of the present study is to determine whether weight gain may be prevented by a small group seminar-based two-year educational intervention on healthy lifestyle in freshmen at the Faculté de médecine de l'Université de Sherbrooke.
Detailed Description
This is a 2-year randomized, controlled intervention study to test the effectiveness of a small group seminar-based educational intervention on healthy lifestyle to prevent weight gain in young healthy university students.
Hypothesis : We hypothesize that a small group seminar-based educational intervention on healthy lifestyle may prevent weight gain in young healthy adults.
PROTOCOL:
Recrutment of participants : First and second year students will be recruted at the 'Faculté de médecine et des sciences de la santé' of the University of Sherbrooke.
A pre-randomisation visit will be performed to verify eligibility and exclusion criteria and to perform the following:
* Anthropometric measurements (please, see below);
* medical questionnaire;
* physical exam;
* standard questionnaire on dietary and physical activity habits;
* Canadian fitness test (to estimate VO2 max)(www.ecoledudos.uqat.uquebec.ca/chroniquep/03preparationphysique/evaluer/#physitest);
* A fasting blood sample to mesure plasma glucose, insulin, plasma lipids. Serum samples will be stored at -80C for future analyses (adipokines, inflammation markers).
Randomisation: Block randomization according to gender and tertile of BMI of each participant to either the control (no intervention) or intervention (small group seminars) group will be performed once the entire cohort will be recruited at the beginning of the academic year using computer-generated numbers. One investigator will enroll all the study participants and another that will have no contact with the participants will generate the allocation sequence.
Measurements :
A standard questionnaire will be administered to collect the following data: gender, age, study program, medical history, and physical exam results.
Anthropometric measures will be performed at baseline and 3, 6, 12, 18 and 24 months and include:
* Weight (kg),
* height (m) (by standing stadiometre- mean of three measures),
* Waist circumference (cm) (midway between iliac crest and last rib end of a normal expiration - mean of 3 measures),
* lean mass by electrical bio-impedance.
Recording of physical activity : Using a standard questionnaire (Sallis JF et al. Am J Epidemiol 1985;121:91-106) (reported in METs) and performed at 0, 12 and 24 months.
Recording of dietary habits : Standard 3-day food record at 0, 12 and 24 months.
Physical fitness (VO2 max): Canadian Home Fitness Test at 0, 12 and 24 months.
Blood samples (60 ml) at 0 and 24 months: Plasma (15 ml) and serum (15 ml) will be collected after a 8 to 12 hour fast to measure blood glucose; total cholesterol, HDL-cholesterol, total triglycerides (with calculation of LDL-c using the Friedwal formula). Samples will be stored at -80C for future determination of plasma insulin, adipokines and serum inflammatory markers. These analyses will allow us to explore the relationship between weight gain and change in these biological parameters in our study population and to determine whether prevention of weight gain may also be associated with early prevention of metabolic abnormalities associated with obesity.
Intervention:
Small group seminars (10 to 12 students) in the treatment group vs. no specific intervention (other than measurements described above) in the control group. The duration of seminars will be approximatively 30 to 60 minutes and will be given every two weeks for the first two months of follow up and every four weeks for the remaining follow up period, except for summer break (July and August) when seminars will not be given. A multidisciplinary team including endocrinologists, a physical education specialist and a dietician designed the seminars that will be delivered by an endocrinology resident and a physical education graduate student. The first three seminars will be aimed at increasing knowledge on weight gain and its complications, national dietary recommendations (Canadian Food Guide) and exercise categories, expected benefits and recommendations for the maintenance of health. The remaining seminars will be designed to introduce behavioral modification methods using discussion on problem-solving, goal-setting and monitoring strategies. Some seminars will focus on behavioral strategies to maintain a healthy lifestyle during specific periods such as final exams, holidays, winter and vacations. The monitors themselves as well as older students successful at keeping an active lifestyle will be offered as role models to promote a positive image of a healthy lifestyle. Compliance with the intervention will be defined as attending at least 60% of the seminars.
#Intervention
- BEHAVIORAL : Small group seminar-based educational intervention
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Being first or second year in one of the Baccalaureate programs of the Faculté de médecine de l'Université de Sherbrooke.
* Aged between 18 and 30 years
* BMI between 18 and 30 kg/m2
* Having left parental house less than one year ago
Exclusion Criteria:
* Planned pregnancy or pregnancy occurring during the two-year follow up
* Chronic medical condition that may affect weight present before or occurring during the two-year follow up.
* Use of any medication other than birth control pills.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 231 |
Target Study Title: The Role of CD34 + Stem Cells and Biological Markers of Angiogenesis in the Development of Coronary Allograft Vasculopathy in Patients After Heart Transplantation
Target Study Description: #Study Description
Brief Summary
Coronary allograft vasculopathy represents one of the major limiting factors of long-term survival in heart transplant recipients. While extensively researched, the underlying mechanisms of coronary allograft vasculopathy (CAV) after heart transplantation remain incompletely understood. As CD34+ cells represent one of the key determinants of coronary vascular homeostasis we investigated the potential association between CAV and CD34+ cell count in heart transplant recipients.
Detailed Description
In a single-center prospective pilot cohort study, we aim to enroll 55 adult heart transplant recipients. All patients will undergo coronary CT angiography and the presence of CAV will be defined in accordance with the ISHLT criteria. At the time of CT angiography, patient will undergo detailed clinical evaluation, cardiac echo and we will also collect blood samples, perform extensive biochemical analysis and measure CD34+ cell count in peripheral venous blood using Beckman-Coulter Navios EX flow cytometry with standard antibodies according to ISAGE protocol. Biomarkers of angiogenesis will be evaluated using Luminex assay kit.
#Intervention
- DIAGNOSTIC_TEST : coronary CT angiography
- Coronary CT angiography will be performed on multislice Siemens Somat Force CT scanner
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* heart transplant recipient
* > 18 yearsyears
* signed informed consent
Exclusion Criteria:
* multiorgan transplantation
* eGFR < 30 ml/min
* known hypersensitivity to the contrast media
* history of any malignancy treated with radiation or chemotherapy
* therapy with mTOR inhibitors
* rejection > 1R within 90 days before enrollment
* G-CSF therapy within 30 days of enrollment
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 232 |
Target Study Title: A Phase 1 / 2, Open-Label, Multi-Arm Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN1884 in Combination With AGEN2034 in Subjects With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors
Target Study Description: #Study Description
Brief Summary
This is a Phase 1/2, open-label study of AGEN1884 in combination with AGEN2034 in subjects with locally advanced, recurrent and/or metastatic solid tumors including cervical cancer. AGEN2034 is a novel, fully human monoclonal immunoglobulin G4 (IgG4) antibody, designed to block program cell death-1 (PD-1). AGEN1884 is a novel, fully human monoclonal immunoglobulin G1 (IgG1) antibody, designed to block cytotoxic T-lymphocyte antigen-4 (CTLA-4).
Detailed Description
The trial consists of 2 phases:
* Phase 1: Dose escalation
* Phase 2: Expansion in advanced cervical cancer
Phase 1: Dose Escalation:
The enrollment to the Phase 1 portion of the study is completed. The trial will consist of a 3+3 dose escalation that will evaluate different combination dose levels (CDL) of AGEN1884 and AGEN2034 in subjects with locally advanced, recurrent and/or metastatic solid tumors.
Subjects may be enrolled to the following CDL cohorts:
* CDL1 - AGEN1884 1 mg/kg every 6 weeks + AGEN2034 1 mg/kg every 2 weeks (starting CDL)
* CDL2 - AGEN1884 1 mg/kg every 6 weeks + AGEN2034 3 mg/kg every 2 weeks (maximum planned CDL)
* CDL-1 - AGEN1884 0.3 mg/kg every 6 weeks + AGEN2034 1 mg/kg every 2 weeks (potential de-escalation CDL)
Combination Dose Level 1 (CDL1) will be the first to be tested. Dose escalation will continue until the maximum planned CDL (CDL2) is shown to be safe or the maximum tolerated dose (MTD) is reached. The MTD is defined as the CDL below which ≥ 33% of subjects develop dose-limiting toxicities (DLT). The decision to escalate to the next cohort will be made by a Safety Monitoring Committee (SMC), based on safety assessments after all subjects of a cohort reached the end of the DLT observation period of 21 days. Should ≥2 DLTs be observed in CDL1, the SMC may open enrollment to CDL-1. The SMC will also select the CDL for Phase 2.
Each subject will receive the combination treatment for a maximum of 24 months or until confirmed disease progression, unacceptable toxicity, or any criterion for withdrawal from the trial or the investigational medicinal products (IMPs) occur. Subjects who do not complete the DLT observation period of 21 days after the first dose, for reasons other than a DLT will be replaced. Additional subjects will be backfilled, concurrently with the 3+3 dose escalation schema at the lower cleared CDL, to ensure that each cohort enrolls at least 10 subjects. These additional subjects at each dose level will have the purpose of generating additional safety, PK, and receptor occupancy (RO) data, and will not undergo formal DLT observation.
The SMC selected CDL2 (AGEN1884 1 mg/kg every 6 weeks + AGEN2034 3 mg/kg every 2 weeks) as the Recommended Phase 2 dose (RP2D).
Phase 2: Expansion in Select Tumors
To further characterize safety and efficacy, the following expansion cohort will be enrolled:
Advanced cervical cancer In Phase 2, the RP2D of AGEN2034 and AGEN1884 will be administered for a maximum of 2 years or until confirmed progression, unacceptable toxicity, or any criterion for stopping the study drugs or withdrawal from the trial occurs.
For the Phase 2 portion of the trial, an Independent Data Monitoring Committee (IDMC) will be established to evaluate safety and efficacy and an IERC will be established to adjudicate tumor response.
#Intervention
- DRUG : AGEN1884 + AGEN2034
- AGEN1884 + AGEN2034 according to protocol design
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
To be eligible for participation in this trial the subject must:
* Voluntarily agree to participate by giving written informed consent. (Participation in pharmacogenomics testing is optional.)
* Be >=18 years.
* Diagnosis:
1. Phase 1: Male or female having a histologically or cytologically confirmed diagnosis of a locally advanced, recurrent, and/or metastatic solid tumor for which no standard therapy is available or standard therapy has failed.
2. Phase 2:
I. Female having (1) a histologically or cytologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix, and (2) locally advanced, recurrent, and/or metastatic disease at the time of enrollment. Histologic confirmation of the original primary tumor is required via pathology report.
Note: The following cervical tumors are not eligible: minimal deviation/adenoma malignum, gastric type adenocarcinoma, clear cell carcinoma, and mesonephric carcinoma.
II. Has cervical cancer and has relapsed after a platinum-based treatment (first line) regimen for locally advanced, recurrent, and/or metastatic disease; Note: Subjects who only received platinum-based chemotherapy concurrently with primary radiation (e.g., weekly cisplatin) or adjuvant chemotherapy following completion of radiation therapy (e.g., paclitaxel and carboplatin for <=4 cycles) and progressed within 6 months after treatment completion will be eligible as this systemic therapy will be considered first line.
* Measurable Disease:
1. Phase 1: Have objective evidence of disease; the presence of measurable disease is not required.
2. Phase 2: Have measurable disease on imaging based on RECIST version 1.1. Note: Subjects must have at least one 'target lesion' to be used to assess response, as defined by RECIST version 1.1. Tumors within a previously irradiated field will be designated as 'non-target' lesions unless progression is documented, or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
Note: Measurable disease by RECIST 1.1 must be confirmed by independent central radiologic review prior to first dose. Subjects without centrally confirmed measurable disease at baseline will not be eligible for this trial.
* Have a life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Have adequate organ function as indicated by the following laboratory values:
1. Adequate hematological function defined by absolute neutrophil count (ANC) >=1.5 x 10^9/L, platelet count >=100 x 10^9/L, and hemoglobin
>=8 g/dL (without transfusions within 1 week of first dose).
2. Adequate hepatic function based on a total bilirubin level <1.5 x the institutional upper limit of normal (IULN), aspartate aminotransferase (AST) level <=2.5 x IULN, alanine aminotransferase (ALT) level <=2.5 x IULN, and alkaline phosphatase <=2.5 IULN.
3. Adequate renal function defined as creatinine <=1.5 x IULN OR calculated creatinine clearance >=50 mL/min for subjects with creatinine levels >1.5 x IULN (if no local guideline is available, creatinine clearance should be calculated using the Cockcroft-Gault Method).
4. Adequate coagulation defined by international normalized ratio (INR) or prothrombin time <=1.5 x IULN (unless the subject is receiving anticoagulant therapy); and activated partial thromboplastin time (aPTT) <=1.5 x IULN (unless the subject is receiving anticoagulant therapy)
* Other than the cancer for which the subject is enrolled, have no history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous-cell carcinoma of the skin, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
Note: In Phase 2, the history and time requirement for no evidence of disease for 5 years does not apply to the cancer for which the subject is enrolled in the trial.
* In Phase 2, subjects must provide a sufficient and adequate formalin fixed paraffin embedded (FFPE) tumor tissue sample preferably from the most recent biopsy of a tumor lesion, collected either at the time of or after the diagnosis of locally advanced, recurrent, and/or metastatic disease has been made AND from a site not previously irradiated. If no tumor tissue is available, a fresh biopsy will be required.
Note: Tissue from needle or excisional biopsy or from resection is required.
* Female subjects must have a negative serum pregnancy test at screening (within 72 hours of first dose of study drug) if of childbearing potential or be of non- childbearing potential. Non-childbearing potential is defined as (by other than medical reasons):
1. >=45 years and has not had menses for greater than 1 year,
2. Amenorrheic for >= 2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone (FSH) value in the postmenopausal range upon pretrial (screening) evaluation,
3. Whose status is post hysterectomy, oophorectomy, or tubal ligation.
* If of childbearing potential, female subjects must be willing to use 2 highly effective contraceptive measures (defined in the informed consent form [ICF]) throughout the study, starting with the screening visit through 120 days after the last dose of study drug.
Note: Abstinence is acceptable if this is the established and preferred contraception for the subject.
* Male subjects with a female partner(s) of childbearing potential must agree to use 2 highly effective contraceptive measures (defined in the ICF) throughout the trial starting with the screening visit through 120 days after the last dose of study drug is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.
Note: Abstinence is acceptable if this is the established and preferred contraception for the subject.
* Is willing and able to comply with the requirements of the protocol.
Exclusion Criteria
The subject must be excluded from participating in the trial if the subject:
* Is currently participating and receiving trial therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
* Has an inadequate washout period prior to first dose of study drug defined as:
1. Received systemic cytotoxic chemotherapy or biological therapy within 3 weeks before first dose,
2. Received radiation therapy within 3 weeks before first dose, or
3. Had major surgery within 4 weeks before first dose.
* Has received prior therapy with:
1. Any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibodies
2. For Phase 2: >1 systemic treatment regimen for the locally advanced recurrent, and/or metastatic cervical cancer for which the subject is considered for the study. Subjects who received a systemic regimen immediately after progressing within 6 months of completing chemotherapy concurrent with primary radiation or adjuvant chemotherapy after radiation will only be considered as having 1 prior systemic regimen for the purpose of this criterion.
Note: In Phase 1, prior treatment with a CTLA-4 antibody is permissible for subjects with metastatic melanoma.
* Has persisting toxicity related to prior therapy of National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI-CTCAE) Grade >1 severity.
Note: Sensory neuropathy or alopecia of Grade <=2 is acceptable.
* Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection).
* Has known severe hypersensitivity reactions to fully human monoclonal antibodies (NCI-CTCAE Version 4.03 Grade >=3), any history of anaphylaxis, or uncontrolled asthma.
* Is receiving systemic corticosteroid therapy <=7 days prior to first dose of study treatment or receiving any other form of systemic immunosuppressive medication (corticosteroid use on study for management of immune-related adverse events (AE), and/or a premedication for intravenous (IV) contrast allergies/reactions is allowed). Subjects who are receiving daily corticosteroid replacement therapy are an exception to this rule. Examples of permitted therapy are daily prednisone at doses of 5 to 7.5 mg or equivalent hydrocortisone dose, and steroid therapy administered by topical, intraocular, intranasal, and/or inhalation routes.
* Has a central nervous system (CNS) tumor, metastasis(es), and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the screening period OR identified prior to consent.
Note: Subjects with history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions at screening (based on 2 sets of brain images performed >=4 weeks apart, and obtained after the brain metastases treatment). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be minimal and be expected as sequelae from treated lesions. For individuals who received steroids as part of brain metastases treatment, steroids must be discontinued >=7 days prior to first dose of study drug.
* Has active or history of autoimmune disease that has required systemic treatment within 2 years of the start of study treatment (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of immunosuppressive systemic treatment.
Note: Subjects with diabetes type 1, vitiligo, psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
* Has had an allogeneic tissue/solid organ transplant.
* Has or had interstitial lung disease (ILD) OR has had a history of pneumonitis that has required oral or IV corticosteroids.
* Has an active infection requiring IV systemic therapy.
* Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
* Has known active Hepatitis B, Hepatitis C, or tuberculosis. Active Hepatitis B is defined as a known positive HBsAg result. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class >=II), or serious uncontrolled cardiac arrhythmia requiring medication.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Is, at the time of signing informed consent, a regular user (including 'recreational use') of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
* Is legally incapacitated or has limited legal capacity.
* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of AGEN2034 and/or AGEN1884.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 233 |
Target Study Title: Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteers.A second objective is to determine the safety of combined use of fosamprenavir with posaconazole in healthy volunteers.
Detailed Description
Infections with fungi and yeast frequently occur in patients infected with the human immunodeficiency virus type 1 (HIV-1).
Fosamprenavir is a PI that is used to treat HIV-infection in combination with ritonavir. Once hydrolyzed to amprenavir, this substance is a substrate for CYP3A4. Ritonavir is an extremely potent inhibitor of CYP3A4 and serves as a booster of the pharmacokinetics of amprenavir. Posaconazole is a very potent CYP3A4 inhibitor and therefore might enhance amprenavir pharmacokinetics in a similar way as ritonavir.
The current study is designed to test this hypothesis. When there is an indication for antifungal therapy in an HIV-infected patient, temporal replacement of ritonavir by posaconazole would be an attractive option for combined treatment of HIV and fungal infection.
#Intervention
- DRUG : Posaconazole
- Posaconazole oral solution 40mg/mL; 400mg BID treatment for 10 days, including dose escalation
- Other Names :
- Noxafil
- DRUG : Fosamprenavir
- fosamprenavir tablet 700mg; 1 tablet BID for 10 days
- Other Names :
- Telzir / Lexiva
- DRUG : Ritonavir
- Ritonavir 100mg capsule; 1 capsule BID for 10 days
- Other Names :
- Norvir
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Subject is at least 18 and not older than 55 years on the day of the first dosing.
* Subject does not smoke more than 10 cigarettes, 2 cigars, or 2 pipes per day for at least 3 months prior to the first dosing.
* Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2, extremes included.
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
* Subject is in good age-appropriate health condition as established by medical history, physical examination, electrocardiography, results of biochemistry, haematology and urinalysis testing within 4 weeks prior to the first dose.
* Subject has a normal blood pressure and pulse rate, according to the Investigator's judgement.
Exclusion Criteria:
* Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
* Positive HIV test.
* Positive hepatitis B or C test.
* Pregnant female (as confirmed by an HCG test performed less than 4 weeks before the first dose) or breast-feeding female.
* Therapy with any drug (for two weeks preceding dosing), except for paracetamol.
* Subjects with an ECG with QTc interval greater than 450 ms for men, and greater than 470 ms for women at screening.
* Relevant history or presence of pulmonary disorders (especially COPD), cardiovascular disorders, neurological disorders (especially seizures and migraine), gastro-intestinal disorders, renal and hepatic disorders, hormonal disorders (especially diabetes mellitus), coagulation disorders.
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* History of or current abuse of drugs, alcohol or solvents.
* Inability to understand the nature and extent of the trial and the procedures required.
* Participation in a drug trial within 60 days prior to the first dose.
* Donation of blood within 60 days prior to the first dose.
* Febrile illness within 3 days before the first dose
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 234 |
Target Study Title: Does Intraoperative Application of TachoSil Reduce the Number of Lymphocele After Pelvic Lymphadenectomy?
Target Study Description: #Study Description
Brief Summary
The prevention of lymphoceles was assessed using collagen patch coated with the human coagulation factors (TachoSil, Nycomed International Management GmbH, Zurich, Switzerland; NCT Number ICMJE NCT01192022; Other Study ID Numbers ICMJE TC-2402-040-SP; U1111-1130-9121 Registry Identifier: WHO) on 50 consecutive patients with endometrial and cervical cancer stages IB to II who had undergone open hysterectomy and pelvic lymphadenectomy (PL).
Methods:
Each patient was simultaneously randomized in two groups: as a control (side without Tachosil applied) and study group (side with Tachosil applied). All surgical parameters were collected and patients underwent ultrasound examination on postoperative days 1, 6, and 30, and at the end of treatment.
Detailed Description
The study was approved by the Bioethics Committee of the Medical University of Lublin, Lublin, Poland (KE-0254/276/2013). The study population consisted of 50 women undergoing pelvic lymphadenectomy for cervical and endometrial cancer and meeting the inclusion/exclusion criteria requirements. Inclusion criteria for the study included women undergoing open hysterectomy and lymphadenectomy for cervical or endometrial cancer, age between 18 and 70 years, who signed a written informed consent. Exclusion criteria included women with previously diagnosed lymph edema or disease of the lymphatic system or a known disease of the immune system. Prospective randomized clinical intervention trial of 50 open surgery during 2013-2014 at 2nd Department of Gynecology in Lublin. Women were centrally randomized by the principal investigator (TR). Surgeons allocated Tachosil for one side (left or right) after lymphadenectomy, second side was as a control side without Tachosil. Allocation was communicated by telephone after informed consent had been obtained and after lymphadenectomy had been completed. Outcome assessment was performed by the independent reviewers. Outcome assessors were blinded to the treatment allocation. The open surgery were performed as follows: in women who underwent routine pelvic lymphadenectomy, lymph node tissue was removed from the external iliac vessels, the obturator fossa, the interiliac region, and the common iliac region after identification and appropriate preparation of iliac vessels and obturator nerve. At the end of the procedure, hemostasis was checked. A Tachosil® patch of 4.8x4.8 cm was attached to one side of the obturator fossa (study group) and the same patient constituted also control group, because no Tachosil® patch was used on the second side of lymphadenectomy. Specific drainage of the retroperitoneum was performed. Patients had to agree to participate in the study and signed informed consent at least one day before surgery. Taking into consideration the examined group the patient was allocated to, the surgeon applied either one Tachosil® patches in the study group or no Tachosil® in the control group. After placing for 4 minutes, a uniform pressure was applied to it to provide rapid haemostasis by forming a strong, fibrin clot adjacent to the tissue surface. Tachosil was placed alternately once in the left, once in the right obturator fossa, so that each of the patients participating in the study could be their own control. The next step was a radical hysterectomy with adnexa. After completion of the procedure, the stump of the vagina stitching to the hollow was performed by passing the vaginal seam through the vaginal wall, the right-side sacro-uterus ligament, the right round ligament, the peritoneal uterine vesiculitis, the left round ligament, the left sacro-uterine ligament and finally the vaginal wall. This way of fixation allowed free lymphatic drainage of the retroperitoneal space. Two drains from the vicinity of the pits of the curtains were removed through the abdominal wall, which were left to the second day after surgery or longer if the volume of secretion in the drainage exceeded 40 ml per day. The urinary bladder catheter was removed on the third day after surgery and ultrasound after voiding (PVR) was evaluated. Surgical procedures were performed by four doctors with extensive experience in oncological gynecology. The surgical protocols were blinded to other researchers who controlled patients in the postoperative period. The data obtained by them were analyzed by an independent reviewer. The evaluation criteria of the study were the development of lymph cysts and their volume. Antibiotic prophylaxis was implemented according to local hospital recommendations. In addition, metronidazole was administered at a dose of 500 mg every 8 hours. i.v. for the first three days after the procedure. Patients also received small-molecule heparin at a dose of 4,000 IU from the day preceding the surgery up to 30 days after its completion. Due to the fact that lymphatic cysts usually appear 7 to 15 days after lymphadenectomy, the ultrasound examination of the presence and volume of lymphocele was performed on the 7th and 30th day after the surgery and after completing the oncological complementary treatmentThe criteria proposed by Tinelli et al. were used to define lymphocele.
#Intervention
- BIOLOGICAL : TACHOSIL GROUP
- Other Names :
- NCT01192022
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* cervical cancer (FIGO IA1, IA2, IB1, IB2)
* endometrial cancer (FIGO IA, IB, II)
* age between 18 and 70 years
* signed a written informed consent
Exclusion Criteria:
* lymph edema
* disease of the lymphatic system
* a known disease of the immune system
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 235 |
Target Study Title: Musculoskeletal Symptoms and Related Factors in Post Acute Covid-19 Patients
Target Study Description: #Study Description
Brief Summary
The patients whose musculoskeletal symptoms initiated or aggravated with Covid-19, were compared with the patients whose musculoskeletal symptoms did not change with Covid-19. The variables; the demographic and treatment datas, admission symptoms, post acute-Covid-19 symptoms, laboratory, chest computed tomography findings.
Detailed Description
There is a lack of an overview of the factors associated with post acute-Covid-19 musculoskeletal symptoms. The aims are;1-to evaluate the most frequent admission symptoms and the frequency of musculoskeletal symptoms in post acute-Covid-19 patients,2-to determine the related factors with the post acute-Covid-19 musculoskeletal symptoms.
In this retrospective study; the patients whose musculoskeletal symptoms initiated or aggravated with Covid-19, were compared wthe patients whose musculoskeletal symptoms did not change with Covid-19. The variables; the demographic and treatment datas, admission symptoms, post acute-Covid-19 symptoms, laboratory (complete blood count, C-reactive protein, ferritin, D-dimer), chest computed tomography findings.
#Intervention
- OTHER : Survey
- A detailed anamnesis was retrospectively recorded about age, gender, body mass index, education, working, the presence of any chronic disease (diabetes mellitus, hypertension, chronic obstructive pulmonary disease, cardiac disease, cancer, rheumatological disease...), smoking, duration of symptoms, usage of supplementing vitamins such as vitamin D,C, zinc..., treatment place (home quarantine, hospital, intensive care unit), duration of home quarantine and hospital treatment, the number of months since the onset of Covid-19 symptoms, usage of anticoagulants, treatment drugs such as hydroxychloroquine, favipiravir. Also the symptoms during the period of Covid-19 infection were recorded from patient files; cough, fever, dyspnea, chest pain, loss of smell and taste, sore throat, headache, no symptom, musculoskeletal symptoms such as: muscle, low back, back, joint pain.
- OTHER : Laboratory parameters
- The laboratory values of 182 patients, presence of chest computed tomography findings of 206 patients and symptoms of all patients during the period of Covid-19 infection, were retrospectively recorded. Laboratory values of hemoglobin, leucocyte, lymphocyte, platelet, C-reactive protein, erythrocyte sedimentation rate, ferritin, d-dimer, were recorded.
- OTHER : chest computed tomography
- Typical findings of chest CT were; bilateral, multifocal, peripheral ground glass opacities with/without consolidation, including the fissures, close to visceral pleural surfaces. Covid-19 Reporting and Data System (CO-RADS) was used for chest CT. CO-RADS assigns scores from 1 (very low suspicion of Covid-19) to 5 (very high suspicion of Covid-19).
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Being >= 18 years
* Having Covid-19 treatment (home quarantine / hospital / intensive care unit) according to a positive polymerase chain reaction (PCR) test in a nasopharyngeal + oropharyngeal swab or chest CT.
Exclusion Criteria:
* Patients who did not have musculoskeletal symptom records (admission symptoms and musculoskeletal symptoms such as; fatigue, spine / joint /muscle pain/ numbness) in patients files
* Acute Covid-19 patients whose symptoms started less than 1 month
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 236 |
Target Study Title: A Randomized, Double-blind Placebo-controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo
Target Study Description: #Study Description
Brief Summary
The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment with depot octreotide prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.
#Intervention
- DRUG : Octreotide
- Octreotide 30 mg intramuscularly (i.m.) every 28 days.
- Other Names :
- Sandostatin LAR® Depot
- DRUG : Placebo
- A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo.
- DRUG : Everolimus
- A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus.
- Other Names :
- RAD001
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion criteria:
* Advanced (unresectable or metastatic) carcinoid tumor
* Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
* Documented progression of disease within 12 months prior to randomization.
* Measurable disease determined by triphasic computer tomography (CT) scan or magnetic resonance imaging (MRI).
Exclusion criteria:
* Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoma, or small cell carcinoma.
* Hepatic artery embolization within the last 6 months or cryoablation of hepatic metastasis within 2 months of enrollment.
* Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (sirolimus, temsirolimus, everolimus)
* Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins.
* Severe or uncontrolled medical conditions
* Chronic treatment with corticosteroids or other immunosuppressive agent.
* Other primary cancer within 3 years.
Other protocol-defined inclusion/exclusion criteria applied
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 237 |
Target Study Title: A Multicenter, Randomized Trial Evaluating 30-day and 6-month Clinical Outcomes With Three Different Treatment Strategies (Coronary Angioplasty + Abciximab, Intracoronary Stent + Abciximab, and Intracoronary Stent + Placebo) in Patients Undergoing Percutaneous Coronary Intervention
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to compare the effectiveness and safety of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention.
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and effectiveness of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention. Patients will be randomly assigned to one of three treatment groups: coronary angioplasty plus abciximab, intracoronary stent plus abciximab, or intracoronary stent plus placebo. The primary measures of effectiveness will be a 30-day composite, clinical outcome as determined by the number of deaths, myocardial infarctions, or urgent repeat revascularizations. Please see attached results.
Patients will receive one of three different treatments: Coronary angioplasty plus abciximab; Intracoronary stent plus abciximab; or Intracoronary stent plus placebo.
#Intervention
- OTHER : Angioplasty
- OTHER : Intracoronary Stent
- DRUG : Abxicimab
- DRUG : Heparin
- DRUG : Placebo
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Patients referred for elective or urgent percutaneous coronary intervention
* Who are suitable candidates for either conventional angioplasty or primary intracoronary stent implantation
* Having a target artery (native or graft) stenosis of >= 60% (visual estimation)
Exclusion Criteria:
* Patients with acute ST-segment elevation myocardial infarction within the previous 12 hours
* With a planned staged procedure or having an unprotected left main coronary artery stenosis > 50%
* With active internal bleeding, having a condition that may increase the risk of bleeding, or receiving ongoing treatment with an oral anticoagulant at the time of study entry
* Having had a percutaneous coronary intervention within the previous 3 months or prior intracoronary stent placement in a target vessel
* Having hypertension with systolic blood pressure > 180 mm Hg or diastolic blood pressure > 100 mm Hg at the time of study entry, or a platelet count < 100,000/μL at baseline
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 238 |
Target Study Title: Phase I/II Trial Examining Dose-per-Fraction Escalation Using Intensity Modulated Radiation Therapy in the Treatment of Prostate Cancer
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to examine the clinical feasibility of using Intensity-modulated radiation therapy (IMRT) combined with daily pretreatment prostate localization to deliver increasingly hypofractionated treatment courses. Progressively larger fraction sizes will be delivered in a phase I design based on both acute and long-term tolerances to the treatment. The dose-per-fraction escalation design utilizes schemas that maintain an isoeffective dose for late effects, while predicting that tumor control will actually improve. The delivery of fewer, larger fractions of radiation, if proven effective and safe, would result in significant cost saving and more efficient use of resources. Phase II will commence with Maximum Tolerated Dose (MTD) finding with up to 200 additional patients being enrolled during this phase of the study.
#Intervention
- RADIATION : Radiotherapy
- Daily radiation to prescribed dose
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
Histologically proven adenocarcinoma of the prostate.
* Stage <= T2b disease, as defined by 1997 American Joint Committee on Cancer (AJCC) classification
* Predicted risk of lymph node involvement (by standard nomograms) of 15% or less (24), OR histologically negative pelvic nodes
* Gleason score <= 7
* No evidence of distant metastasis
* Age 18+
* Informed consent signed in accordance with institutional protocol
* Pretreatment evaluations must be completed as specified in Section 7.0.
* ECOG performance status 0 <= age <= 1
* No previous or concurrent cancers, other than localized basal cell or squamous cell skin carcinoma, unless continually disease free for at least 5 years
* No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
* Gonadotropin-releasing hormone agonist (GnRH-a) use permitted (maximum of 6 months duration). Anti-androgen therapy permitted concurrently with GnRH-a.
* No previous or concurrent cytotoxic chemotherapy
* No radical surgery or cryosurgery for prostate cancer
* The absence of any co-morbid medical condition which would constitute a contraindication for radical radiotherapy
* The absence of serious concurrent illness of psychological, familial, sociological, geographical or other concomitant conditions which do not permit adequate follow-up and compliance with the study protocol.
* No current use of anticoagulation therapy, other than aspirin.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 239 |
Target Study Title: The Effect Of The Check List Developed For Drug Administration From Enteral Nutrition Tube On Administration Errors
Target Study Description: #Study Description
Brief Summary
Enteral nutrition protocols are applied in patients who do not have gastrointestinal dysfunction but in whom oral feeding is contraindicated. In these patients, where drug use is also necessary but alternative drug administration routes are not possible, drugs can be given to the patient through enteral nutrition tubes. However, there are studies reporting errors and complications during drug administration from the enteral nutrition tube. With the planned thesis study, it is aimed to develop an evidence-based checklist and to reduce the rate of errors and complications in drug administration through enteral feeding tube with this checklist.
Detailed Description
Enteral nutrition protocols are applied in patients who do not have gastrointestinal dysfunction but in whom oral feeding is contraindicated. In these patients, where drug use is also necessary but alternative drug administration routes are not possible, drugs can be given to the patient through enteral nutrition tubes.
When adding drugs to parenteral nutrition admixtures or using concomitant drugs from the same catheter, it has become a general rule to check for drug incompatibility. The same level of care is not taken in drug administration from the enteral nutrition tube. There are studies reporting errors and complications in enteral drug administration in the literature Today, one of the most important parts of corporate culture in healthcare is patient safety. Patient safety is all of the measures taken by health institutions and employees in these institutions in order to prevent the harm that health care services may cause to individuals. The main goal here is; It is the establishment of a system that will protect the patient from possible harm and eliminate the possibility of error due to errors that will prevent the occurrence of errors during care delivery.
The checklists used in recent years are also an evidence-based practice list and have become one of the effective methods used to prevent errors and reduce complications. A checklist standardizes the process, streamlines maintenance delivery, and improves performance to ensure all actions are covered. The checklist allows cross-checking what was done and in what order. These reassurances are important in situations where time is short and distractions.
With this study, it is aimed to develop an evidence-based checklist and to reduce the rate of errors and complications in drug administration through enteral feeding tube with this checklist.
#Intervention
- OTHER : Checklist
- the experimental group will practice using the checklist
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Being an intensive care nurse
* Have experience in administering enteral medication
* Administering enteral medication to an adult patient
* Agree to participate in the research
Exclusion Criteria:
* Administering enteral medication to a patient with fluid restriction
* Change of position
* Wanting to leave research
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 240 |
Target Study Title: Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance in SCLC a Randomized Phase III Trial
Target Study Description: #Study Description
Brief Summary
Using Intensity Modulated radiotherapy it is possible to treat the entire brain to standard dosages of whole-brain radiation, while keeping the radiation dose to the hippocampus low. However, a clear relationship between radiation dose and damage to the hippocampal stem cells has not been established yet.
This study is initiated to investigate the early and delayed neurotoxicity of PCI and to assess in a randomised design the benefits and risks of sparing the hippocampus in Small Cell Lung Cancer patients who receive PCI.
#Intervention
- RADIATION : Radiation Prophylactic Cranial Irradiation
- RADIATION : Radiation Hippocampal Avoidance PCI
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* - Small Cell Lung Cancer patients (stage I-III or stage IV without clinical or radiological evidence of brain metastases) candidate for PCI, i.e. without progressive disease after chemo-radiotherapy in stage I-III or after a remission after chemotherapy in stage IV
* Sufficient proficiency in Dutch
Exclusion Criteria:
* Prior radiotherapy to the brain
* Clinical evidence for brain metastases or primary brain tumors- Evidence of progressive extracranial metastatic disease
* Previous malignancy < 2 years ago except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
* Any systemic anticancer treatment during PCI or within 3 weeks before start PCI
* Pregnancy or lactation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 241 |
Target Study Title: Sleep Length and Circadian Regulation in Humans
Target Study Description: #Study Description
Brief Summary
This research will examine why sleep restriction reduces the body clock's response to bright light. The results will enable the optimization of the bright light treatment of people who suffer from circadian rhythm sleep disorders, which include shift work sleep disorder, jet lag, delayed sleep phase syndrome and winter depression, thereby improving public health and safety, well-being, mood, mental function, and quality of life.
Detailed Description
Millions of Americans suffer from circadian rhythm sleep disorders, which include shift work sleep disorder, jet lag, delayed sleep phase syndrome and possibly winter depression. These conditions are typically characterized by persistent insomnia and/or excessive daytime sleepiness, impaired performance, and gastrointestinal distress. These negative symptoms result from a misalignment between the timing of the external social world and the timing of the internal circadian (body) clock. Circadian rhythm sleep disorders are effectively treated with bright light, which phase shifts the circadian clock, thereby realigning it with the timing of the external social world.
It is widely recognized that social influences have led to an increasing prevalence of sleep restriction in modern society. We recently demonstrated for the first time that short sleep episodes, when compared to long sleep episodes, markedly reduce phase advances to bright light. Thus when people cut their sleep short, they inadvertently reduce their circadian responsiveness to bright light. The mechanism(s) behind these reduced phase shifts to light are unknown. However, there are at least two aspects of short sleep episodes that could be responsible for this effect. First, short sleep episodes are associated with partial sleep deprivation. Second, as humans sleep with their eyes closed and are usually exposed to light when awake, short sleep episodes are also associated with short dark lengths. Our overall goal is to determine the biobehavioral mechanisms by which short sleep episodes impair phase shifts to bright light. Specific Aim 1 is to determine the effect of partial sleep deprivation on phase advances to light, while controlling for dark length. Specific Aim 2 is to determine the effect of short dark lengths on phase advances to light while minimizing sleep deprivation. We will estimate the timing of the human circadian clock by measuring salivary melatonin, a neuroendocrine hormone released from the pineal gland, and collecting measures of sleep via actigraphy, and sleepiness, mood, gastrointestinal distress and cognitive performance via computerized assessment.
Characterization of the separate effects of sleep deprivation and dark length on circadian phase shifts to light in humans is critical to understanding how humans respond to light during their daily life activities. Furthermore, the findings of this research will produce important and practical recommendations for avoiding decrements to phase shifts to light, thereby optimizing the bright light treatment of circadian rhythm sleep disorders, and thus improving public health and safety, well-being, mood, cognitive function, and quality of life.
#Intervention
- DEVICE : Bright light box
- Bright light of about 5000 lux, administered while sitting at a desk.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* healthy adult volunteers
Exclusion Criteria:
* color blindness with the Ishihara test
* obese people (BMI > 30)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 242 |
Target Study Title: Phase 3 Study to Establish the Efficacy and Safety of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium Dosed Twice Daily in Achieving Clinical Improvement in Subjects With Mildly to Moderately Active Ulcerative Colitis After 8 Weeks of Therapy
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately active ulcerative colitis after 8 weeks of therapy.
Detailed Description
The primary efficacy endpoint is the proportion of subjects that achieve clinical improvement and improvement in the rectal bleeding subscale of the MMDAI at the end of eight weeks of therapy, where clinical improvement is defined as a greater than or equal to 3 point improvement from baseline in the MMDAI.
The secondary endpoints are as follows:
1. The change from baseline over the duration of treatment in total MMDAI score and in the individual MMDAI subscales.
2. The change from baseline to Weeks 1, 2, 4 and 8 in total MMDAI score and in each individual MMDAI subscale (endoscopy/sigmoidoscopy at Weeks 2 and 8 only).
3. The proportion of subjects with treatment failure, defined as withdrawal due to significant disease progression or lack of significant improvement, as determined by the Investigator.
4. The proportion of subjects with mucosal healing at Weeks 2 and 8, where mucosal healing is defined as an endoscopy/sigmoidoscopy score of 0 or 1
5. The proportion of subjects achieving complete remission at Week 2 and Week 8, where complete remission is defined as a MMDAI score of less than or equal to 1.
6. The proportion of subjects with improvement from baseline to Weeks 1, 2, 4 and 8 in total MMDAI score and in each individual MMDAI subscale (endoscopy/sigmoidoscopy at Weeks 2 and 8 only).
7. Change from baseline to Weeks 1, 2, 4 and 8 in diarrhea, abdominal discomfort, and subjective sense of well being, as recorded in the subjects' diaries.
8. The proportion of subjects achieving clinical remission at Weeks 1, 2, 4 and 8, where clinical remission is defined as a score of 0 for rectal bleeding and a combined score of less than or equal to 2 for bowel frequency and physician assessment using the MMDAI.
9. Time to clinical remission, where clinical remission is defined as in secondary endpoint number eight.
Safety endpoints are as follows:
* incidence of treatment-emergent AEs grouped by body system and evaluated by treatment group;
* changes from baseline in clinical laboratory parameters at each treatment visit by treatment group; and
* changes from baseline in vital sign measurements at each treatment visit by treatment group.
#Intervention
- DRUG : 5 ASA, enemas, suppositories, corticosteroids
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
* An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities.
* Subject is a male or, if the subject is female, she is eligible to enter if she is of:
Non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who has undergone sterilization [hysterectomy or bilateral tubal ligation] or is post-menopausal. For purposes of this study, postmenopausal is defined as 1 year without menses);
OR,
Childbearing potential, has a negative serum pregnancy test at screen and, if heterosexually active, agrees to one of the following:
* Double barrier method of contraception, specifically, use of a condom and spermicide, for 1 week prior to study drug administration, throughout the 8 week Treatment Phase.
* Oral contraceptives administered for at least 2 monthly cycles prior to study drug administration during all 6 months of study drug administration and administered for 1 monthly cycle following completion of the study.
* An intrauterine device (IUD), inserted by a qualified clinician, with published data showing that the lowest expected failure rate is less than or equal to 1% per year (not all IUDs meet this criterion).
* Medroxyprogesterone acetate (DEPO-PROVERA) administered for a minimum of 1 monthly cycle prior to the study drug administration, during all 6 months of study drug administration, and administered for 1 monthly cycle following study completion. Norelgestromin/ ethinyl estradiol transdermal system (Ortho Evra patch) administered for at least 2 monthly cycles prior to study drug administration and administered for 2 monthly cycles following study completion
* Partner has undergone vasectomy and subject is in a monogamous relationship. The investigator is responsible for determining whether the subject is using appropriate birth control for study participation.
* Subject is greater than or equal to 18 years.
* Subjects with mildly to moderately active ulcerative colitis experiencing symptoms of an acute flare within the past 4 weeks.
* Subject has not taken more than 2.4 grams of mesalamine or equivalent for a continuous period of 4 weeks preceding the screening visit
* Subjects must have a baseline Modified Mayo Disease Activity Index (MMDAI) score between 6 and 10, inclusive. Additionally, subjects must score greater than or equal to 2 on Bleeding and greater than or equal to 2 on Endoscopy/Sigmoidoscopy.
* Subject is capable and willing to comply with all study procedures.
* Disease extends at least 20 cm from the rectum on screening sigmoidoscopy.
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply (Note: Development of any of the following exclusion criteria on-study will be considered a basis for subject discontinuation.):
* Subject has a significant medical, including psychiatric, condition which in the opinion of the investigator precludes participation in the study.
* Subject has a history of allergy or intolerance to aspirin, mesalamine, or other salicylates.
* Subject has recently (within the past 30 days) failed therapy with balsalazide disodium
* Subject has received immunosuppressive therapy (e.g. azothioprine, 6 mercaptopurine) within 30 days, or corticosteroids (oral, intravenous [IV] or topical rectal) within 30 days prior to screening.
* Subject has received intra-rectal aminosalicylates within 14 days of screening.
* Subject has had any prior bowel surgery, excepting appendectomy.
* Subject has participated in an investigational drug or device study within the 30 days prior to study screening, with the exception of Salix protocols 3003 & 3004 entitled: 'A multicenter, randomized, double-blind, placebo controlled trial to evaluate the use of mesalamine pellet formulation 1.5G QD to maintain remission from mildly to moderate ulcerative colitis.'
* Subject is pregnant or at risk of pregnancy, or is lactating (female subjects only).
* Subject shows evidence of current excessive alcohol consumption or drug dependence.
* Subject has a history of human immunodeficiency virus (HIV) or hepatitis (B and C).
* Subject has other infectious, ischemic, or immunologic diseases with GI involvement.
* Subject has twice the upper limit of normal (ULN) for any of the following LFTs: alanine aminotransferase (ALT/SGPT), aspartate aminotransferase (AST/SGOT), alkaline phosphatase, or total bilirubin (except isolated elevation of unconjugated bilirubin).
* Subject has uncontrolled, clinically significant renal disease manifested by 1.5 × ULN of serum creatinine or blood urea nitrogen (BUN) levels.
* Subject has calculated creatinine clearance level of less than or equal to 60 mL/min.
* Subject has unstable cardiovascular, coagulopathy or pulmonary disease.
* Subject has active malignancy within the last 5 years, except basal cell carcinoma of the skin, or if female, in situ cervical carcinoma that has been surgically excised.
* Subject has any condition or circumstance that would, in the opinion of the investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits.
* Subject has sclerosing cholangitis.
* Subject has positive stool culture for ovum and parasites (O and P) or C. difficile.
* Subject has been treated with infliximab, cyclosporine, natalizumab, or methotrexate for ulcerative colitis within the last 30 days prior to screening.
* Regular use of NSAIDS except cardioprotective ASA (i.e., less than or equal to 162 mg ASA per day).
* Subject has received cell-depleting therapies such as the Adacolumn.
* Subject requires antidiarrheal therapy during screening.
* Subject has clinical or radiographic findings suggestive of serious UC complications such as toxic megacolon or colonic perforation.
Females of Reproductive Potential:
If a female subject becomes pregnant while on this study, the study drug will be discontinued immediately and the subject followed until the outcome of the pregnancy is known. If a pregnancy occurs, it will be reported in the same manner as an unexpected AE using the guidelines provided in Section 6.4.1.9.
Premature Subject Discontinuation:
A subject may be discontinued from the study for the following medical or administrative reasons:
* Occurrence of an AE, which in the judgment of the investigator suggests an unacceptable risk to the subject (The investigator will follow the subject until satisfactory resolution of the AE or the AE is determined to be stable);
* Development on-study of any condition which, in the opinion of the investigator or the study sponsor, places the subject at an unacceptable medical risk if he/she continues;
* Pregnancy;
* Subject request;
* Institution of additional medical (rescue) therapy for UC. The investigator may discontinue individual subjects from the study at any time. Subjects will be encouraged to complete the study; however they may voluntarily withdraw at any time. The investigator must provide written documentation of the reason for discontinuation on the CRF. Regardless of the reason for withdrawal, all subjects will be asked to undergo an end of therapy evaluation. Every attempt will be made to obtain all the end of study assessments, including all of the subscales of the MMDAI (i.e., bowel frequency, bleeding, physician's assessment, and endoscopy/sigmoidoscopy score).
Subjects who withdraw or are withdrawn will not be replaced under this protocol.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 243 |
Target Study Title: Efficacy of an Internet-delivered Intervention Based on the Diabetes Prevention Program for Weight Loss in Overweight and Obese Mexican Adults: 3 and 6 Months Randomized Controlled Trial
Target Study Description: #Study Description
Brief Summary
In Mexico, 7 out of 10 adults are overweight or obese. The diseases associated with these conditions (diabetes, cardiovascular disease and some cancers) are those that impact the most on the disability-adjusted life years of Mexicans and on their mortality rates. A reduction in body weight of 5-10% can reduce the incidence of obesity related diseases. The gold standard for treating obesity is an intensive lifestyle change program such as the Diabetes Prevention Program (DPP) whose effectiveness has been evaluated in various formats and populations with positive results, including in Mexico. However, the DPP is not accessible to all sectors of the population. To increase its dissemination, the implementation of online interventions based on the DPP (oi-DPP) has been proposed. A systematic review of oi-DPP showed promising results, however, the evidence is limited and the lack of studies of high methodological quality is highlighted. The main objective of this project is to evaluate the efficacy of an oi-DPP for weight loss in Mexican adults with overweight or obesity at 3 months. The study design is a randomized controlled trial with 2 arms: oi-DPP and wait-list control. A 3 months pilot study (n=30) will be conducted prior to the main study to estimate sample size, considering an alpha error of 0.05 and power of 80%. The primary outcome is the mean change in body weight from baseline to 3 months post-baseline between the 2 groups. Secondarily, differences in biochemical parameters (fasting glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides and gamma glutamyl transferase) from baseline to 3 months will be evaluated, as well as mean changes from baseline to 3 and 6 months in body mass index, waist circumference, systolic and diastolic blood pressure, depression and quality of life scales and the number of participants achieving a weight loss greater than 5% of initial body weight. Body weight will be also evaluated at 6 months post-baseline. The previous measurements will apply both in the pilot study and the study except for the biochemical parameters that will only be included in the main study. The differences between the 2 groups for each variable will be analyzed using a t test for independent samples, in case of having a parametric sample. Otherwise, the Mann-Whitney U test will be used. Analysis will follow the intent-to-treat principle.
#Intervention
- BEHAVIORAL : ID-DPP group
- This group will receive a 6 month long online behavioral change protocol adapted from the Diabetes Prevention Program. It includes 18 sessions, 12 delivered weekly (during the first 3 months) and 6 delivered biweekly (during the last 3 month period). A web page will be used to deliver the sessions, while the nutritional counseling will be delivered using video calls via Facebook chat. Participants will receive an hypocaloric (1200-1800 kcal, carbohydrates: 45-65%, fats: 20-35% and protein: 10-35%), personalized diet.
- OTHER : Wait-list Group
- This group will only receive written information with recommendations on healthy eating. When the study has finished this group will receive a behavioral change protocol with nutritional counseling using a face-to-face format.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Mexican adults (>= 18 years and <=60)
* Residents of the city of Hermosillo, Sonora
* Overweight or obese (BMI >= 25 and <=45)
* Internet access at home
* Basic computer skills
* Facebook active account
* Candidates must make records of their food consumption for 5 days.
Exclusion Criteria:
* Substance abuse
* Consumption of more than 14 alcoholic beverages per week (equivalent to 280 g of alcohol)
* Diagnosis of psychiatric conditions that could prevent adherence to treatment
* Previous diagnosis of medical conditions with significant effect on body weight
* Diagnosis of diabetes
* Systolic blood pressure> 160 mm / Hg
* Pregnant women who are breastfeeding or who plan to become pregnant during the study period
* Consumption of medications with an effect on body weight such as metformin, orlistat or glucocorticoids.
* Participating in another program to reduce weight or performing structured physical exercise other than walking> 180 min / week
* Plan to participate in some treatment for weight loss during the study
* Any other condition in which weight loss or physical activity is contraindicated
* Previous diagnosis of kidney failure, cancer or any other condition that requires special treatment
* Relatives participating in the study
* Have plans to change residence
* Criteria of the researcher - for clinical reasons or adherence to the protocol
* Weight loss>5% of total body weight in the previous 4 months
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 244 |
Target Study Title: The Impact of Misclassification of Obesity by Body Mass Index on Mortality in Patients With Chronic Kidney Disease
Target Study Description: #Study Description
Brief Summary
Unlike the general population, a higher body mass index (BMI) is associated with greater survival among patients with chronic kidney disease (CKD). However, obesity is defined as excess body fat that associated with clearly elevated health risks according to the World Health Organization. In addition, muscle wasting is prevalent among CKD subjects. Thus, we hypothesized that different definition of obesity, based on BMI or body fat percentage, might have different impact on clinical outcomes among CKD population.
#Intervention
- OTHER : No intervention
- No intervention
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Subjects with non-dialysis CKD defined as estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2
Exclusion Criteria:
* subjects with liver cirrhosis
* subjects with malignancy
* subjects with an acute cardiovascular event within the 3 months before screening for inclusion
* amputee
* pregnancy
* subjects with pacemaker
* subjects with metallic implant
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 245 |
Target Study Title: Multicenter Endoscopist-blinded Randomized Parallel-group Comparative Study to Assess Efficacy, Safety and Tolerance of Morning-only Dosing Compared to Control Split-dosing With Nocturnal Pause in MOVIPREP® Bowel Preparation Prior to Colonoscopy
Target Study Description: #Study Description
Brief Summary
To compare colon cleansing quality induced by the 2 different modes of MOVIPREP® intake in 5 colon segments prior to colonoscopy.
Detailed Description
All participants enrolled to the study will be allocated to one of two arms. Patients of the experimental morning-only regimen arm will prepare and take MOVIPREP® solution in the full dose - 2 litres of MOVIPREP® preparation in the early morning on the day of the colonoscopy clinical procedure. Participants in the standard split-dose regimen arm will prepare and take MOVIPREP® solution in split doses - ½ of dose (1 litre) the evening before + ½ of dose (1 litre) of MOVIPREP® preparation in the morning of the day of the colonoscopy.
The study consists of three visits. Participation in the study lasts no more than 11 days; 3 days as minimum.
There is no follow-up period planned except in case of any adverse events (AEs) when the follow-up period will last until the participant has recovered or until all AE-related queries for the participant have been resolved.
#Intervention
- DRUG : MOVIPREP
- MOVIPREP solution
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* male or female >=18 years and <= 85 years
* colonoscopy procedure indicated
* willing to stay in the outpatient clinical site for colonoscopy and questionnaire completion
* willing and able to undergo study-related procedures
* informed consent signed by a patient for participation in the study
* negative pregnancy test in women with childbearing potential and consent for double barrier method birth control for subjects, men and women, during the study
Exclusion Criteria:
* ileus
* suspected colonic tumor with manifestations of intestinal obstruction
* delayed gastric emptying (gastroparesis), weak vomiting reflex, tendency to aspiration and regurgitation
* toxic megacolon which is a result of severe inflammatory conditions of the colon including Crohn's disease and ulcerative colitis
* suspected intestinal perforation or risk of gastrointestinal perforation
* signs of severe intestinal bleeding
* acute inflammatory anal or perianal pathology
* severe concomitant diseases of internal organs
* psychiatric diseases in aggravation stage
* hypersensitivity to polyethylene glycol and/or any component of MOVIPREP® preparation
* phenylketonuria or diagnosed glucose-6-phosphate dehydrogenate deficiency
* unconsciousness
* dehydration
* severe inflammatory diseases
* acute abdominal pain of unknown etiology
* pregnancy and lactation period
* participation in any other clinical study (including studies of experimental devices) in 30 days prior participation in the present trial
* patients who test positive for human immunodeficiency virus (HIV)/autoimmune disease (AID), Wasserman reaction (RW) or hepatitis B virus (HBC)
* any condition or circumstance that, in the opinion of the Investigator, would compromise the safety of the participant or the quality of study data
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 246 |
Target Study Title: A Novel Smartphone-based Intervention to Support Smoking Cessation and Adherence to Antiretroviral Therapy Among People Living With HIV: A Pilot Randomized Clinical Trial
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to learn if a mindfulness-based smoking cessation smartphone app can help people quit smoking and stay on antiretroviral therapies.
Detailed Description
The current study aims to test the feasibility of a three-arm randomized clinical trial testing the combined mindfulness training + Emocha apps intervention versus the mindfulness training app only with brief advice to improve ART adherence and usual care (UC; brief advice to quit and improve ART adherence). Our primary hypothesis is that the combination of mindfulness training + Emocha apps would be superior to the mindfulness training app with brief advice to improve ART adherence, and these two interventions would be superior to the UC in terms of the feasibility, acceptability, and potential efficacy (3-month smoking cessation; improvement in adherence to ART).
#Intervention
- DRUG : Nicoderm C-Q Transdermal Product
- 6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)
- Other Names :
- NRT
- BEHAVIORAL : Adherence to Antiretroviral Therapy Counseling
- Brief counseling on adhering to antiretroviral therapy with self-help materials.
- BEHAVIORAL : Behavioral Smoking Cessation Counseling
- One time face-to-face smoking cessation counseling and 2 follow-up phone calls.
- BEHAVIORAL : "Crave-to-Quit' app
- Evidence-based mindfulness smoking cessation smartphone app ('Crave-to-Quit') adapted from an in-person mindfulness training relapse prevention smoking cessation intervention.
- BEHAVIORAL : vDOT 'emocha' app
- Video Directly Observed Therapy (vDOT) smartphone app ('emocha') that allows participants to take a video of themselves taking medication to ensure adherence.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* >= 18 years
* Diagnosed with HIV
* Have been prescribed ART medication in the prior 6 months
* Have smoked >= 5 cigarettes/day in the past year
* Be interested in making a quit attempt in the next 30 days
* Own a smartphone (apple/android)and plan to keep it active for the following 3 months
* Read/speak English
* Be able to provide consent
* Have no plans to move in the next 3 months
* Not pregnant or planning to be pregnant in the following 3 months
Exclusion Criteria:
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Have contraindication to NRT (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder)
* Currently being treated for a psychiatric condition
* Currently being treated for smoking cessation, alcoholism, or illicit drug use
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 247 |
Target Study Title: Digital Health Feedback System (DHFS) for Anti-Retroviral Therapy Medication Adherence and Transitions of Care Support During Hospital Admissions for Persons Living With HIV
Target Study Description: #Study Description
Brief Summary
This study is a prospective single arm open label intervention study over 16 weeks using the DHFS and a telemedicine platform with persons living with HIV who are not virologically suppressed, admitted to UCSD Hillcrest Medical Center and initiating or restarting anti-retroviral therapy (ARVs). This proof of concept study will investigate the feasibility of using the DHFS in hospitalized individuals living with HIV to support ARV adherence. The Study intervention has an initiation phase of 2 weeks, a persistence phase of 14 weeks and a follow-up phase out to 48 weeks. Once study consent is obtained, the participant will receive a focused case navigation, psychiatric and substance abuse evaluation and will initiate digitized ARVs, either in hospital or at the AVRC within 14 days of hospital discharge, in collaboration with their providers. The study intervention will be considered to start from the point at which the DHFS is started. The study team will ensure the participants continue to utilize the DHFS both in hospital and after discharge. Following the 16 week intervention the study team will continue to follow participants to evaluate retention in care and viral suppression up to 48 weeks in collaboration with the outpatient care providers.
#Intervention
- DEVICE : Digital Health Feedback System(DHFS)
- We will investigate the feasibility of using the DHFS in hospitalized individuals living with HIV to support ARV adherence.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* HIV seropositive status, as documented by positive licensed HIV antibody testing and a detectable viral load > 1000 copies/ml.
* Persons admitted to UCSD Hillcrest Medical Center with an HIV associated diagnosis and to receive HIV care through UCSD Owen Clinic, FHCSD HIV Clinic or San Ysidro Health HIV Clinic post hospital discharge.
* Persons initiating or continuing treatment for HIV infection by their HIV provider, that includes either:
1. Dolutegravir/Tenofovir alafenamide/Emtricitabine: IS-DTG/TAF/FTC (Tivicay® and Descovy®)
2. Bictegravir/ Tenofovir alafenamide/Emtricitabine: IS-BIC /TAF/FTC (Biktarvy®)
3. Darunavir/Cobistat/Emtricitabine/Tenofovir alafenamide: IS-DRV/C/F/TAF (Symtuza™)
* Eligible for antiretroviral medications and in possession of prescriptions for above noted study eligible regimens.
* Laboratory values obtained by screening laboratories within 30 days of entry:
1. Absolute neutrophil count (ANC) >= 1,000/mm3.
2. Hemoglobin >= 7.0 g/dL.
3. Platelet count >= 50,000/mm3.
4. AST (SGOT), ALT (SGPT), and alkaline phosphatase <= 5 x ULN.
5. Total bilirubin <= 3 x ULN and direct bilirubin.
6. Estimated GFR by Cockcroft-Gault equation of greater than 30 ml/min.
* Females of childbearing potential (defined as girls who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e. who have had menses within the preceding 24 months, or have not undergone surgical sterilization (e.g. hysterectomy, bilateral oophorectomy, or salpingotomy) must have a negative serum or urine pregnancy test performed within 72 hours prior to study entry.
If participating in activity that could lead to pregnancy, the participant must use at least one of the following forms of contraception throughout the protocol and for 6 weeks after stopping the IS-ARV medications.
* Condoms (male or female) with a spermicidal agent
* Diaphragm or cervical cap with spermicide
* IUD
* Oral contraception. Condoms in addition to other methods are highly recommended because their appropriate use is the only contraception method effective for preventing HIV-1 transmission.
* Men and women age >= 18 years.
* Basic competency in understanding written and verbal information as it applies to DHFS use. English and Spanish will be used for study documents and communication.
* Ability and willingness to follow all protocol requirements.
* Ability to use mobile device per investigator determination, and to wear PDH wearable sensor (i.e., no skin conditions precluding use).
* Ability and willingness of participant to give written informed consent.
Exclusion Criteria:
* Female who is pregnant, breast-feeding, or of childbearing potential and disagrees to use contraception throughout the study period.
* Use of any of the prohibited medications or other non-informed medications (Section 5.5.2) within 30 days of study entry (Day 0).
* Known allergy/sensitivity to any of the study drugs.
* Known sensitivity to skin adhesives.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 248 |
Target Study Title: Comparison of Effectiveness of Preoperative Gabapentin With Celecoxib in Reducing Acute Postoperative Pain in Abdominal Hysterectomy, A Randomized Double Blindcontrolled Trial
Target Study Description: #Study Description
Brief Summary
Comparison of effectiveness of preoperative Gabapentin with Celecoxib in reducing acute postoperative pain in abdominal hysterectomy, A randomized double blind controlled trial
Detailed Description
Total abdominal hysterectomy (TAH) is the most common gynecological operation worldwide.Some studies noticed about overused of opioids in postoperative care , leaded to more adverse effect of opioids , slowly recovery , prolong length of hospitalized stay and consequently increase unnecessary cost of treatment.
ERAS guidelines has considered to use preoperative analgesics for reducing post-operative opioids consumption, including Gabapentin and Celecoxib.
Gabapentin and celecoxib widely used for treatment of pain and many studies have demonstrated the preoperative efficacy and safety of Gabapentin and Celecoxib in variety procedures involving hysterectomy.However, no definite conclusion of optimal dose and timing for preopearive uptake ,apart from no good evidences based supported preoperative Gabapentin or Celecoxib in hysterectomy in Thailand . In addition, the protocol for preoperative analgesics in hysterectomy, has not been performed in the investigator's center.
Therefore the aim of this study is to assess and compare the efficacy and safety of preoperative Gabapentin and Celecoxib to reduce acute postoperative pain in non-gynecological cancerous woman undergoing total abdominal hysterectomy
#Intervention
- PROCEDURE : Total abdominal hysterectomy
- Each drug group undergo elective total abdominal hysterectomy with the same general anesthesia
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Women ranging age between 18 <= age <= 65 years and having non-gynecological cancerous women who undergoing elective total abdominal hysterectomy
* Women who has ASA physical status I-II
* Women who agrees to participate in this study
Exclusion Criteria:
* Women who pregnancy
* Women who have abnormal kidney function test (Cr > 1.5 )
* Women who have abnormal liver function test
* Women with history or present of thrombosis such as myocardial infarction, ischemic stroke, deep venous thrombosis or pulmonic embolism
* Women with history of gastrointestinal bleeding -Women with history of gastrointestinal bleeding -Women with history of gastrointestinal bleeding
* Women who take the antiplatelet or anticoagulant medications
* Women with history of allergy to Gabapentin ,Celecoxib and Sulfa
* Women who have used or known Gabapentin or Celecoxib before
* Women who have chronic alcoholism
* Women who underwent previous surgery
* Women who undergo extended low midline incision
* Women who undergo lysis adhesion
* Women who undergo further operations except salpingo-oophorectomy
* Women who cannot evaluated pain score
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 249 |
Target Study Title: An Open-Label, Two-Way Crossover, Drug-Interaction Study to Determine the Effect of Omeprazole on the Pharmacokinetics of an Immediate-Release Capsule of CG5503 in Healthy Subjects
Target Study Description: #Study Description
Brief Summary
This was a single center, open-label, two-way crossover, drug-drug-interaction study to determine the effect of multiple dosing of omeprazole on 4 consecutive days on the pharmacokinetics of a single dose of an immediate-release capsule of CG5503 (tapentadol) in healthy participants.
#Intervention
- DRUG : Tapentadol IR capsule
- Tapentadol IR capsule containing 93 mg tapentadol hydrochloride.
- DRUG : Omeprazole capsule
- Omeprazole capsule containing 40 mg omeprazole.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Man or woman, between 25 and 55 years, inclusive.
* Body mass index between 20 and 28 kg/square meter, inclusive, with a minimum body weight of 50 kg.
* Signed the informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
* Women must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or practicing or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study (effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier method, and male partner sterilization). Women must have a negative serum beta-human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test on Day -1 of Treatment Period 1.
* Healthy on the basis of pre-study physical examination, medical history, 12-lead electrocardiogram, vital signs, and clinical laboratory parameters (serum chemistry, serology, hematology, and urinalysis) performed within 21 days before administration of the first dose of study drug. NOTE: If the results of the chemistry, hematology, or urinalysis testing are not within the normal limits of the laboratory reference ranges, the participant may be included in the study only on the condition that the investigator judges the deviations not clinically relevant.
* Signed informed consent for pharmacogenomic testing indicating whether they do or do not wish to participate in the genetic part of the study. NOTE: Participation in the genetic testing component is not mandatory for participation in the study.
* Blood pressure (after the subject is supine for 5 minutes) between 100 and 140 mmHg systolic, inclusive, and 50 and 90 mmHg diastolic, inclusive.
* Are willing to follow the prohibitions and restrictions as specified in the protocol.
Exclusion Criteria:
* History of
* seizure disorder or epilepsy, or
* mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm within 1 year of screening, or
* severe traumatic brain injury (consisting of one or more of the following: brain contusion; intracranial hematoma; or episode(s) of more than 24 hours duration of unconsciousness or post-traumatic amnesia) within 15 years of screening, or
* severe traumatic brain injury resulting in ongoing sequelae consisting of transient changes in consciousness or symptoms suggestive thereof at any time.
* History of clinically significant pulmonary, gastrointestinal, immunologic, endocrine, neurologic, psychiatric, thromboembolic disease or metabolic disturbances, or any current physical conditions that could interfere with the interpretation of the study results.
* History of clinically significant allergies, especially known hypersensitivity or intolerance to opioids, opioid antagonists (e.g., naloxone), benzodiazepines (e.g., diazepam, clonazepam, lorazepam), or any study drug formulation component or any of the excipients, or heparin (should the use of a heparin lock be necessary).
* Positive test for human immunodeficiency virus (HIV 1 and 2), hepatitis B, or hepatitis C.
* History of substance abuse or a positive test for drugs of abuse or alcohol at screening (including on the day before the initial administration of study drug in the first treatment period).
* Blood donation or acute loss of blood (more than 500 mL) during the 3 months before study drug administration or intention to donate blood or blood products during the study or within 1 month after the completion of the study.
* Women who are pregnant, or plan to become pregnant during the study, or who are breast-feeding.
* Participants for whom omeprazole treatment is contraindicated.
* Participants who have used or plan to use the following during the study:
* prescription medication (except for birth control medications and hormone replacement therapy) within 14 days before the first study drug administration
* monoamine-oxidase inhibitors (MAOIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) within 21 days before the first study drug administration
* over-the-counter (OTC) medication, especially nonsteroidal anti-inflammatory drugs (NSAIDS) (e.g., ibuprofen) or herbal medication, within 14 days before the first study drug administration
* alcohol, grapefruit, grapefruit juice, or Seville orange products within 48 hours before the first study drug administration.
* Have taken an investigational drug within the 30 days before study administration (Day 1) or within a period of less than 5 times the drug's half-life, whichever is longer.
* Plan to undergo surgery or other procedures during the course of the study.
* Consume alcohol in quantities greater than 3 drinks every day (1 drink is defined as 12 ounces [approximately 360 mL] of beer, 4 ounces [approximately 120 mL] of wine, or 1 ounce [approximately 30 mL] of hard liquor).
* Regularly smoke more than 10 cigarettes/day or the equivalent.
* Unable to refrain from smoking or limit intake of caffeine or methylxanthine-containing foods or beverages (including chocolate) for 2 hours before and for 24 hours after study drug administration in both treatment periods.
* Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug).
* Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of the investigator or study center, and family members of the employees or the investigator.
* In the opinion of the investigator, are subjects who are not likely to complete the study for whatever reason or who have an inability to communicate meaningfully with the investigator and staff.
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 250 |
Target Study Title: Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of AD04 (Ondansetron) in Adults With Alcohol Use Disorder (AUD) and Selected Polymorphisms in the Serotonin Transporter and Receptor Genes
Target Study Description: #Study Description
Brief Summary
Randomized, multi-center, double-blind, parallel-group, placebo-controlled study. Eligible subjects will be randomized to receive either 0.33 mg AD04 or placebo orally twice-daily for 24 weeks in conjunction with brief psychological counseling. Randomization will be stratified by:
1. Level of alcohol consumption prior to enrollment in the study (heavy drinkers averaging \<10 drinks per day of drinking or very heavy drinkers averaging ≥10 drinks per day of drinking), and
2. Gender (male or female).
Detailed Description
Target enrollment of subjects with AUD who regularly engage in risk alcohol consumption (i.e. \>6/day or more heavy alcohol consumption in the 4 weeks preceding the screening visit), and have selected genotypes (LL/TT genotype and/or 1, 2 or 3 of the SNPs on the genes for the 5-HT3 receptor subunits: rs1150226-AG or rs1176713-GG in the gene that encodes the 5-HT3A receptor subunit, and rs17614942-AC in the gene that encodes the 5-HT3B receptor subunit), and who are eligible to participate in the study based on meeting the remaining study inclusion/exclusion criteria. Eligible subjects will be randomized to receive either 0.33 mg AD04 or placebo BID for 24 weeks.
The trial will have a 16-week grace period to enable medication effects to be optimal for comparison with placebo. The grace period starts immediately after beginning of study drug treatment, in which consumption of alcohol is not counted as a failure. All primary and secondary efficacy endpoints will be assessed during the last 8 weeks of treatment (i.e. weeks 17-24). The primary measure of efficacy, incidence risk alcohol consumption, will be assessed over the last 8 weeks of treatment. The secondary measure of efficacy evaluating the incidence of risk alcohol consumption over the last 4 weeks of treatment, important because it has been used commonly to validate efficacy for regulatory agencies such as the European Medicines Agency, was also calculated. To enhance study feasibility, subjects will be evaluated every week during the first 8 weeks of treatment and every other week for the remaining 16 weeks of the treatment period.
#Intervention
- DRUG : AD04 (ondansetron)
- AD04 (ondansetron) 0.33 mg, orally (p.o.) twice a day (BID)
- DRUG : Matching placebo
- Matching placebo to AD04 (ondansetron), orally (p.o.) twice a day (BID)
- DEVICE : Companion Diagnostic for Genetic Testing
- Companion Diagnostic for Genetic Testing
- BEHAVIORAL : Brief Psychological Counseling
- Brief Psychological Counseling
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* The subject has signed the Informed Consent Form.
* The subject has breath alcohol concentration (BAC) of 0.00% at the Screening and < 0.02 % at the Baseline visit.
* The subject has moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
* Males and females aged 18 and over.
* Able to provide Timeline Follow-back Method (TLFB) alcohol consumption information for the 28-day period prior to Screening Visit.
* A subject is eligible for participation in the study if he/she had:
1. >=6 HDDs (HDD is defined as a day with alcohol consumption of 60 g or more for males and 40 g or more for females) in the 4 weeks prior to the Baseline Visit,
2. an average alcohol consumption at the medium risk level (defined by the WHO 'International guide for monitoring alcohol consumption and related harm' as >40 grams of ethanol/day for males and >20 grams of ethanol/day for females) for the 4 weeks prior to the Screening Visit,
3. <=14 consecutive abstinent days in the 4 weeks preceding the Screening Visit.
* Willingness to provide a blood sample for DNA analysis at the Screening visit. The blood sample collected for DNA testing contains at least one of the following genotypes as measured by Adial's validated method:
* rs4795541-LL genotype of the insertion-deletion polymorphism (5'-HTTLPR) in the 5'-regulatory region and rs1042173-TT SNP in the 3'-untranslated region of SLC6A4 gene that encodes the serotonin transporter
* rs1150226-AG SNP in HTR3A, the gene that encodes subtype A of the serotonin-3 receptor
* rs1176713-GG SNP in HTR3A, the gene that encodes subtype A of the serotonin-3 receptor
* rs17614942-AC in HTR3B, the gene that encodes subtype B of the serotonin-3 receptor
* Expressed a wish to reduce or stop alcohol consumption.
* Willingness to participate in behavioral and medicinal treatments for AUD.
* Has had a stable residence in the 28 days prior to the Baseline Visit in the study and has no plans to move in the next 9 months. A stable residence is a domicile in which an individual can operate as if it were his or her own homestead and does not include shelters or halfway houses.
* Provides contact information for 2 individuals who can be used to contact the subject.
* Able to read and understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments.
* The subject, if female must:
* have a negative urine pregnancy test prior to the initiation of treatment and agree not to try to become pregnant during the study
* use two adequate methods of contraception [intrauterine device, oral contraceptives, progesterone implanted rods, or regular medroxyprogesterone acetate injections in addition to condom or diaphragm, or double barrier method (condom or diaphragm + spermicide)], or
* be post-menopausal having had the last natural menstruation at least 24 months prior to the Screening Visit, or
* have had a hysterectomy or been surgically sterilized prior to baseline.
Exclusion Criteria:
* Patients with withdrawal symptoms requiring additional medication for withdrawal. If present at Screening/Baseline Visit, subjects must complete a medically supervised detoxification program prior to being able to enroll in the study.
* Subjects with diagnosis of any of the following concomitant psychiatric disorders: non-treated, unstable schizophrenia, bipolar disorder, other psychotic disorder during the lifetime of the subject. Recent (within last 12 months) diagnosis of a major depressive disorder, post traumatic stress disorder, panic disorder or eating disorders. Subjects with nicotine use disorder, phobic or other anxiety disorders (other than post-traumatic stress disorder or panic disorder) can be included.
* The subject reports current or recent (within 8 weeks prior to Baseline Visit) treatment with antipsychotics or antidepressants medications, which can have an effect on serotonin receptor or transporter actions.
* The subject has been treated with any investigational medicinal product within 30 days or 5 half-lives (whichever is longer) prior to the Baseline Visit.
* The subject is currently participating or has recently (4 weeks prior to the Baseline Visit) participated in a treatment program for alcohol use disorders.
* Any subject who has suicidal thoughts as evaluated by the Columbia Suicide Severity Rating Scale (C-SSRS) (i.e., has any suicidal ideation of type 4 or 5 on the C-SSRS in the last month).
* The subject has a clinically significant untreated and unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance.
* The subject has clinically significant abnormal vital signs.
* The subject has a clinically abnormal ECG at the Screening/Baseline Visit, clinically significant cardiovascular disease requiring regular or intensive clinical monitoring, a current history of arrhythmias, or a current or past history of clinically significant QT prolongation, including:
* QTcF > 450 ms (one ECG at screening and average of 3 12-lead measurements at baseline)
* serum potassium, magnesium or calcium levels outside the central laboratory's reference range
* receiving medications (within the last 7 days prior to the Baseline Visit) that have the potential of prolonging the QT interval or may require such medications during the course of the study
* clinically unstable cardiac disease, including unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia or indwelling pacemaker
* complete left bundle branch block
* history of Long QT Syndrome or an immediate family member with this condition
* The subject with elevated liver function tests or diagnosis of hepatic failure, esophageal variceal disease or any other clinically significant hepatic disease. The clinical evidence may include any of the following: prolonged prothrombin time (International Normalized Ratio, INR>=1.7) with bilirubin > 10% above the upper limit, and/or serum glutamic oxaloacetic transaminase (SGOT), and/or serum glutamic pyruvic transaminase (SGPT) and/or lactate dehydrogenase (LDH) > 3x the upper limit of normal at screening.
* The subject reports treatment, either current or within 28 days prior to the Baseline Visit, with any medications having a potential effect on alcohol consumption and related behaviors or mood. These include opiate antagonists (e.g., naltrexone, Vivitrol®, Selincro®), glutamate antagonists (e.g., acamprosate), anticonvulsants (e.g., topiramate), serotonin reuptake inhibitors (e.g., fluoxetine), serotonin antagonists (e.g., buspirone), other antidepressants (e.g., tricyclic antidepressants or monoamine oxidase inhibitors), dopamine antagonists (e.g., haloperidol), and disulfiram (Antabuse®). Note benzodiazepines are allowed if used chronically.
* Previous or current abuse of benzodiazepines.
* At Baseline Visit, the subject's urine contains prescription and non-prescription drugs with abuse potential or other psychotropic agents not otherwise specified, including herbal agents such as St John's Wort that could interfere with the drug treatment.
* The subject has a history of allergic reactions or other known intolerance to ondansetron or other 5-HT3 antagonists.
* Female subjects of childbearing potential who have a positive pregnancy test at Screening/Baseline Visit or are pregnant, breast feeding and who are unwilling to adhere to an acceptable form of contraception or meet the other criteria for inclusion as specified for females in the inclusion criteria (See Inclusion Criteria, Item # 13).
* The subject received in-patient or out-patient treatment for alcohol use disorder within the 28 days prior to the Baseline Visit.
* As of the Baseline Visit, the subject is compelled to participate in an alcohol treatment program to maintain his/her liberty.
* As of Baseline Visit, the subject is sharing a household with a subject randomized to any investigational trial of ondansetron.
* Any other condition or therapy that in the investigator's opinion may pose a risk to the subject, prevent the subject from completing the required study procedures or interfere with the study objectives.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 251 |
Target Study Title: Cisplatin or ImmunoTHerapy in Association With Definitive Radiotherapy in HPV-related oropharyngEal Squamous Cell Carcinoma: a Randomized Phase II Trial.
Target Study Description: #Study Description
Brief Summary
This study is a phase II, multicenter, open-label study that has been designed to evaluate the efficacy and the safety of definitive Radiotherapy (RT) (70 Gy) delivered in combination with the anti-PD-L1 Durvalumab immunotherapy in patients with Human Papilloma Virus (HPV)-related oropharyngeal squamous cell carcinoma.
In this phase II trial, patients will be assigned in one of the two treatment arms:
* Arm A (standard arm): Chemoradiotherapy arm
* Arm B (Experimental arm): Immunotherapy + Radiotherapy arm
Total duration of treatment will be 6 months (at maximum in the experimental arm).
Patients will be followed for a maximum of 2 years following the date of randomization.
#Intervention
- DRUG : Chemoradiotherapy arm
- Radiation Therapy in combination with Chemotherapy (Cisplatin)
- DRUG : Immunotherapy + Radiotherapy arm
- Radiation Therapy in combination with Immunotherapy drug (Durvalumab)
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed, histologically proven squamous cell carcinoma of oropharynx T1 N1-N2 or T2-T3 N0 to N2 (AJCC 2018)
* HPV positive status (positive staining for p16 in immunochemistry)
* Presence of at least one measurable lesion according to RECIST v1.1 criteria (longest diameter recorded >=10 mm with CT scan)
* No prior anticancer therapy for OSCC
* Patient eligible for definitive radiochemotherapy
* Age >= 18 years
* WHO performance status < 2 i.e. 0 or 1
* Body weight >30kg
* Life expectancy more than 3 months
* Adequate Hematology laboratory data within 6 weeks prior to start of treatment: Absolute neutrophils> 1.5 x 109/L, Platelets >= 100 x 109/L, Hemoglobin >= 9 g/dL
* Adequate Biochemistry laboratory data within 6 weeks prior to start of treatment: Total bilirubin <= 1.5 x upper the normal limit, Transaminases <= 2.5 xUNL, Alkalin phosphatases <= 5 x UNL, Creatinin clearance >= 60 mL/min (Cockcroft), Glycemia <= 1.5 x UNL
* Adequate Hemostasis laboratory data within 6 weeks prior to start of treatment: TP within the normal range
* Women should be post-menopaused or willing to accept the use an effective contraceptive regimen during the treatment period and at least 3 months (durvalumab arm) or 6 months (cisplatin arm) after the end of the study treatment. All non-menopaused women should have a negative pregnancy test within 72 hours prior to registration. Men should accept to use an effective contraception during treatment period and at least 3 months (durvalumab arm) or 6 months (cisplatin arm) after the end of the study treatment
* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
* Signed written informed consent
Exclusion Criteria:
* T1 N0, T1-T3 N3, T4 N0-N3, p16 + OSCC
* Previous treatment with another check-point inhibitor
* Other histologies : UCNT, p16- SCCHN, sino-nasal tumors
* Patient ineligible for Cisplatin according to the updated SmPC of the drug (including patient with auditory deficiency, patient with neuropathy induced by previous Cisplatin treatment or patient treated with prophylactic phenytoin)
* Metastatic disease
* Previous radiotherapy, except anterior strictly out of field radiotherapy, received for treatment of another primary tumor considered in remission in the past 5 years
* Participation in another therapeutic trial within the 30 days prior to entering this study
* Uncontrolled disease such as diabetes, hypertension, symptomatic congestive heart or pulmonary failure, renal or hepatic chronic diseases... (non-exhaustive list)
* Clinically significant cardiac disease or impaired cardiac function, such as:
* Congestive heart failure requiring treatment (New York Heart Association (NYHA) Grade >= 2), left ventricular ejection fraction (LVEF) < 50% as determined by multi-gated acquisition (MUGA) scan or echocardiogram (ECHO), or uncontrolled arterial hypertension defined by blood pressure > 140/100 mm Hg at rest (average of 3 consecutive readings),
* History or current evidence of clinically significant cardiac arrhythmias, atrial fibrillation and/or conduction abnormality, e.g. congenital long QT syndrome, high- Grade/complete AV-blockage
* Acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass graft (CABG), coronary angioplasty, or stenting), < 3 months prior to screening
* QT interval adjusted according to Fredericia (QTcF) > 470 msec on screening ECG
* Current or prior use of immunosuppressive medication within 28 days before the first fraction of RT (exception: systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or equivalent are allowed as well as steroids as premedication for hypersensitivity reactions (eg, CT scan premedication) - Topical, inhaled, nasal and ophthalmic steroids are not prohibited)
* Active suspected or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, irritable bowel syndrome, Wegner's granulomatosis and Hashimoto's thyroiditis, diverticulitis with the exception of diverticulosis, systemic lupus erythematosus, Sarcoidosis syndrome). Note: participants with vitiligo or alopecia, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, patients with celiac disease controlled by diet alone, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger, are permitted to enroll
* Known primary immunodeficiency or active HIV (positive HIV 1/2 antibodies)
* Known active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months indicated by positive test for hepatitis B surface antigen (HBV sAG) or hepatitis C virus ribonucleic acid (HCV antibody)
* History of organ transplant requiring use of immunosuppressive medication
* History of active tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice)
* Current pneumonitis or interstitial lung disease
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
* History of another primary malignancy except for:
1. Malignancy treated with curative intent and with no known active disease >=5 years before the first dose of IP and of low potential risk for recurrence
2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
3. Adequately treated carcinoma in situ without evidence of disease
* History of severe allergic reactions to any unknown allergens or any components of the study drug
* History of leptomeningeal carcinomatosis
* Any unresolved toxicity NCI CTCAE Grade >=2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
1. Patients with Grade >=2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician
2. Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician
* Uncontrolled severe infectious disease, active hemorrhagic syndrome
* Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP
* Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
* Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP
* Vaccination for yellow fever
* Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or 180 days after the last dose of cisplatin
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 252 |
Target Study Title: Assessing the Impact of Control-IQ Technology on Quality of Life and Glycemic Control in Children and Youth With Type 1 Diabetes in a Canadian Context
Target Study Description: #Study Description
Brief Summary
This is a single-centre, mixed-methods, prospective study in pediatric patients with T1D initiating Control-IQ technology on the Tandem t-slim X2 insulin pump.
Primary Objective:
To determine pediatric T1D patients' and their parents' perceptions of the impact of Control-IQ on their psychosocial functioning and quality of life.
Detailed Description
Background Information \& Rationale
The management of type 1 diabetes (T1D) is rapidly evolving to offer technology that aims to improve metabolic control and decrease the burden of diabetes management. Hybrid-closed loop systems are at the forefront of this technology. They are comprised of an insulin pump and continuous glucose monitoring (CGM) system that interface in order to automatically adjust the delivery of basal insulin through the pump, based on CGM data. Insulin boluses for meals and snacks must still be entered manually by the user.
Studies of hybrid closed loop systems have primarily focused on clinical trials that show improved glycemic outcomes.1-3 Few studies have assessed real-world glycemic outcomes or patient-reported outcomes, and none have focused on a pediatric population.
A recent study published by Pinsker et al.4 showed improvement in psychosocial outcomes and persistent achievement of glycemic targets in a real-world setting in adults with T1D using the Tandem t:slim X2 pump with Control-IQ technology.
The Tandem t:slim X2 pump with Control-IQ is a hybrid closed loop system (using Dexcom G6 CGM) that has recently been approved for use by Health Canada, but has been used in the U.S. for the last year. This new technology will launch in Canada in March 2021, at which time existing Tandem t:slim X2 insulin pump users (with concurrent CGM use) will be able to upgrade their insulin pump software to access this technology (following review of an online module).
The Children's Hospital of Eastern Ontario (CHEO), is located in Ottawa, ON Canada. CHEO follows approximately 800 children with diabetes, approximately 85 of whom are managed on the Tandem t:slim X2 pump with concurrent Dexcom G6 CGM use.
The upcoming launch of Control-IQ presents a unique opportunity to gain a better understanding of the real-world impact of this technology on our Canadian pediatric population. The benefits of conducting this study in our population are two-fold:
1. The Canadian context offers the study a diverse patient population given our universal healthcare system and provincially-funded insulin pump program. Because pumps and supplies are funded by the government, they are available to all of our patients, regardless of socio-economic status and whether or not they have private health insurance.
2. Studying a pediatric population offers the unique perspective of children and youth (and their parents) whose management practices and goals differ from those of adults. While adult patients and parents of children with T1D are motivated by attaining glycemic targets for long term health outcomes, children and youth live in moment with emphasis on how they feel now. As such, patient reported outcomes, while important to all ages, are often the most important motivator for children and youth when choosing a treatment regimen.
Study Design This is a single-centre, mixed-methods, prospective study in pediatric patients with T1D initiating Control-IQ technology on the Tandem t-slim X2 insulin pump.
Participants will enroll in the study prior to initiating use of Control-IQ on their Tandem insulin pump.
Recruitment will occur over an eight-week period starting mid-March 2021. Participation in this study will last 16 weeks.
Study Objectives
Primary Objective: To determine pediatric T1D patients' and their parents' perceptions of the impact of Control-IQ on their psychosocial functioning and quality of life (as measured by the INSPIRE Questionnaire, post assessment).
Secondary Objectives:
1. To assess the effect of Control-IQ technology on other patient and parent reported outcomes (PROs) including:
* Diabetes Impact and Device Satisfaction (DIDS) scale,
* Hypoglycemia Fear Survey (child and parent version),
* WHO-5 (emotional well-being)
2. To determine the impact of Control-IQ technology on glycemic control in pediatric T1D patients who are experienced sensor-augmented pump users.
Exploratory Objectives:
1. To explore the effect of Control-IQ technology on patient and parents' sleep, school, activities/ sports, mood and family dynamics.
2. To explore whether or not youth and parents' expectations of Control-IQ align with their experience of using this this automated insulin delivery system.
Participant Characteristics:
The following data will be collected from each chart at baseline:
* Date of birth
* Gender
* Date of T1D diagnosis
* Date of initiation of insulin pump therapy
* Date of first insulin pump start
* Date of Tandem t:slim X2 pump start
* Current use of CGM (yes/ no)
* Last measured HbA1c ( if available within the last 3 months
* Number of hospitalizations due to diabetes complications within the past year
Sociodemographic measures will be collected by questionnaire at baseline, including:
* Family structure
* Parental education - highest level achieved
* Household income
* Private health insurance
* Ethnicity (self-reported)
Statistical Plan The patient population will be described using descriptive statistics. The study team will compare patient reported outcomes, measures of glycemic control, and measures of insulin pump management pre and 16 weeks post-initiation of Control-IQ technology, using paired t-test and Wilcoxon signed-rank test, depending on the distributional characteristics of the outcomes. Analysis of open-ended questions will be done by a qualitative research specialist.
Sample Size Determination CHEO currently has 85 patients on the Tandem t:slim X2 pump with CGM, with an estimated 10-15 patients more estimated to start before March 2021. Historically, the patient population at CHEO has been highly engaged with research with an anticipated participation rate of 90-95%. The Investigator expects that recruitment rates would be similar for this study, allowing for a sample size of 70 participants.
This sample size is sufficient to provide \> 80% power for detecting a 'medium size' effect (Cohen's d = 0.5), which corresponds to a mean score of 70 from the post assessment INSPIRE Questionnaire, 10 units larger than a mean score of 60 (the null hypothesis). Cohen's d is expressed by the ratio of the mean difference over the standard deviation. Here, we use sd = 20 as an estimate of the standard deviation of the score, which is conservative considering previously presented estimates (e.g. sd = 16.44 described in Weissberg-Benchell et al \[5\]).
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of T1D
* Age 6 <= age <= 18 years
* Currently using the Tandem t:slim X2 insulin pump with Dexcom G6 CGM, who are initiating Control-IQ
Exclusion Criteria:
* Patients under the age of 6 years
* Patients who are not English or French speaking
* Patients unwilling to provide consent (assent where applicable).
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 253 |
Target Study Title: Alpha Omega Trial: A Randomised, Placebo Controlled, Double Blind Intervention Study of the Effect of Low Doses of Omega-3 Fatty Acids on Cardiovascular Diseases in Patients With a History of Myocardial Infarction
Target Study Description: #Study Description
Brief Summary
The Alpha Omega Trial is a randomized, placebo-controlled, double-blind dietary intervention study in 4837 postmyocardial infarction patients in the Netherlands to examine whether incidence of cardiovascular diseases during 40 months of follow-up can be prevented by low doses of omega-3 polyunsaturated fatty acids. The key objectives are:
* to examine the effect of low-dose supplementation (400 mg/day) of eicosapentaenoic acid and docosahexaenoic acid on incidence of cardiovascular diseases; and
* to examine the effect of low-dose supplementation (2 g/day) of alpha-linolenic acid on incidence of cardiovascular diseases.
Detailed Description
Whether dietary omega-3 (or n-3) polyunsaturated fatty acids are causally related to risk of cardiovascular diseases (CVD) is a major, unresolved question in preventive cardiology. Essential n-3 fatty acids are eicosapentaenoic acid (EPA; C20:5, n-3) and docosahexaenoic acid (DHA; C22:6, n-3) on one hand, and their parent compound alpha-linolenic acid (ALA; C18:3, n-3) on the other hand. The intake of n-3 fatty acids is below recommended levels in most Western populations. The Alpha Omega Trial is a randomized, double-blind, placebo-controlled study of the effect of low-dose supplementation of ALA and EPA-DHA on CVD. A total of 4837 Dutch men and women aged 60-80 years who had a myocardial infarction in the past 10 years are randomly allocated to 2 g/d of ALA, 400 mg/d of EPA-DHA, 2 g/d ALA + 400 mg/d EPA-DHA, or placebo, for 40 months. Increased intake of n-3 fatty acids is achieved through daily use of 20 g of margarine on bread. Margarines for all treatment groups are similar in taste and appearance. The primary outcome of the trial is 'major cardiovascular events', which comprises incident CVD and cardiac interventions (PCI and CABG) during follow-up. Secondary endpoints are incident CVD, fatal CVD, fatal CHD and all-causes mortality. Complete follow-up for vital status is achieved. Cause-specific mortality is coded by an independent Endpoint Adjudication Committee. Physical examination, blood sampling and data collection on diet and lifestyle are performed in all subjects at baseline, in 810 randomly selected subjects after 20 months of intervention, and in 58% of the cohort at the end of follow-up. Cardiovascular health, serious adverse events, lifestyle, fish intake and margarine use are monitored in all subjects by yearly telephone interviews. Compliance is continuously monitored by registration of margarine tubs. An objective biomarker of compliance (i.e. plasma n-3 fatty acids) is obtained in randomly selected subjects at baseline and after 20 and 40 months of intervention. The Alpha Omega Trial could provide a sound scientific basis for dietary recommendations on intake of ALA and EPA-DHA, in order to reduce the burden of cardiovascular diseases.
#Intervention
- DIETARY_SUPPLEMENT : margarine spread
- Daily use of margarine spread (approximately 20 grams) during 40 months
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion criteria:
* Men and women
* Aged 60 through 80 y
* Verified clinically diagnosed myocardial infarction up to 10 y before randomization
* Written informed consent
Exclusion criteria:
* Living in a nursing home or other institution
* Participation in another scientific study
* Habitual margarine intake < 10 g per day
* Habitual fish intake > 150 g per day
* Habitual alcohol intake > 6 drinks per day
* Use of fish oil capsules or other supplements containing omega-3 fatty acids
* Presence of cancer with < 1 y of life expectancy
* Cognitive impairment, as indicated by the Mini Mental State Examination (score <= 21)
* Unintended weight loss > 5 kg in the past year
* Lack of facilities for cooled margarine storage at home
* Inability or unwillingness to comply with study procedures
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 254 |
Target Study Title: A Pilot Monocentric, Open Phase II Study to Investigate the Efficacy and Safety of a New Oral Gut Cleansing Solution ('Low Dose Bowel Prep') in 30 Patients Submitted to Colonoscopy
Target Study Description: #Study Description
Brief Summary
Monocentric, cleansing evaluation pilot study in patients undergoing colonoscopy.
Detailed Description
Open prospective pilot monocentric phase II clinical trial evaluating the therapeutic efficacy of a new 'Low Dose Bowel Prep' formulation for gut cleansing prior to colonoscopy.
Thirty patients admitted to the hospital (inpatients) planned to undergo a complete colonoscopy will have gut cleansing with the 'Low Dose Bowel Prep' using a one-step intake mode.
#Intervention
- DRUG : macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* male or female, inpatients 18 <= age <= 65 old with indication for complete colonoscopy
* the patient's written informed consent must be obtained prior to inclusion
* willing and able to complete the entire procedure and to comply with study instructions
Exclusion Criteria:
* ileus or toxic megacolon
* intestinal obstruction or perforation
* known of G6PD insufficiency
* history of any colonic surgery
* ischaemic cardiovascular disease
* untreated or uncontrolled arterial hypertension (max >170mmHg, min >100mmHg)
* renal insufficiency (creating above 45µmol/l)
* abnormal laboratory values (clinically significant) for sodium, potassium,chloride, creatinine and hematocrit
* cirrhosis of liver (Child-Pugh grade B or C)
* females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception.
* concurrent participation in an investigational drug study or participation within 30 days of study entry
* subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results or may interfere significantly
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 255 |
Target Study Title: A Prospective Single-Center Evaluation of SureForm™ Staplers in Robotic-assisted Colorectal Procedures
Target Study Description: #Study Description
Brief Summary
The primary objective of this study is to evaluate the performance of SureForm™ Staplers (60 and 45) for transection and/or creation of anastomosis during robotic-assisted colorectal procedures.
Detailed Description
This is a prospective, single-center observational study to evaluate the performance of SureForm™ Staplers during robotic-assisted resections of either ascending or transverse or descending or sigmoid colon or rectum. Subjects with either a suspected or confirmed benign or malignant disease of the colon and rectum who are scheduled to undergo a robotic-assisted resection of the colon or rectum will be asked to provide informed consent for their participation in the study.
The study will be conducted at one institution with two surgeons performing the colorectal procedures. The surgeons will be using either the da Vinci Xi or X Surgical System which ever they use as per their standard of care for the colorectal procedure. Stapling will be performed with SureForm™ Staplers and any of the reloads as per the surgeon's standard of care for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures.
#Intervention
- PROCEDURE : Colorectal resection
- Robotic-assisted resection of the colon or rectum in subjects with benign or malignant colon or rectal disease, where SureForm™ Staplers are utilized for transection and/or creation of anastomosis.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* The subject must be 18 years or older at the time of consent
* Subject undergoing robotic-assisted colorectal procedure for benign or malignant colon or rectal disease, where SureForm™Staplers are utilized for transection and/or creation of anastomosis
Exclusion Criteria:
* Subject has had prior neoadjuvant (chemotherapy and/or radiation) therapy
* Subject with active bacterial or fungal infection
* Subject is contraindicated for general anesthesia or surgery
* Subject is undergoing an emergency procedure
* Subject has other major concomitant procedures (e.g. hepatectomies, incisional ventral hernia repair, nephrectomies, hysterectomy) planned along with colorectal procedure.
* Subject has metastatic disease and/or subject has life expectancy of less than 1 year
* Subject is under an immunomodulatory or immunosuppressive regimen (e.g. transplant patient, steroid requirement) within 30 days prior to the planned surgical procedure
* Subject has history of coagulation or hematologic disorder
* Pregnant or suspect pregnancy
* The subject is unable to comply with the follow-up visit schedule
* Subject has perforated, obstructing or locally invasive neoplasm (T4b)
* Subject with inflammatory bowel disease
* Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
* Subject belonging to other vulnerable population, e.g, prisoner or ward of the state
Intra-Operative Exclusion Criteria:
* Subjects who require extensive dissection to release adhesions or with advanced cancer which may result in anastomotic leak and/or bleeding unrelated to the stapler.
* Inadequate visualization making an endoscopic approach not feasible
* Anatomy determined intra-operatively to be unsuitable for minimally invasive surgery
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 256 |
Target Study Title: Phase 2 Study of ADI PEG 20 in Non-Hodgkin's Lymphoma Subjects Who Have Failed Prior Systemic Therapy
Target Study Description: #Study Description
Brief Summary
Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that have arginine. In this study, the primary efficacy variable will be assessment of tumor response rate.
#Intervention
- DRUG : ADI-PEG 20
- Other Names :
- arginine deiminase formulated with polyethylene glycol
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria
* Histologically proved NHL (B and T cells) according to WHO criteria and have relapsed or are refractory to at least 2 prior systemic chemotherapies (excluding chronic lymphocytic leukemia and Waldenstrom's macroglobulinemia).
* Measurable disease as assessed by IHP criteria (Appendices A and B).
* Age >= 20 years.
* ECOG performance status of 0 <= age <= 2.
* No prior systemic therapy, immunotherapy, investigational agent, or radiation therapy within the last 2 weeks prior to first dose of study treatment.
* Fully recovered from any prior surgery and no major surgery within 4 weeks of initiating treatment. Surgery for placement of vascular access devices is acceptable.
* Post-menarche female subjects and male subjects must be asked to use appropriate contraception for both the male and female for the duration of the study. Subjects must agree to use two forms of contraception or agree to refrain from intercourse for the duration of the study. Females must not be pregnant at the start of the study, and a serum human chorionic gonadotropin (HCG) pregnancy test must be negative before entry into the study.
* Informed consent must be obtained prior to study initiation.
* No concurrent investigational studies are allowed.
* Absolute neutrophil count (ANC) >750/µL.
* Platelets >50,000/µL.
* Serum uric acid <= 8 mg/dL (with or without medication control).
* Creatinine clearance must be >= 30 mL/min. This can be calculated using the Cockcroft-Gault equation: estimated creatinine clearance = [(140 - age) x weight (in kg)] / serum creatinine (in mg/dl) x 72; for females, multiple result by 0.85.
Exclusion Criteria
A subject will not be eligible for study participation if he/she meets any of the exclusion criteria:
* Patients with infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study; patients on prophylactic antibiotics or antivirals are acceptable.
* Pregnancy or lactation.
* Expected non-compliance.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III or IV), cardiac arrhythmia, or psychiatric illness, social situations that would limit compliance with study requirements.
* Subjects who have had any anticancer treatment prior to entering the study and have not recovered to baseline (except alopecia) or <= Grade 1 AEs, or deemed irreversible from the effects of prior cancer therapy. AEs > Grade 1 that are not considered a safety risk by the Sponsor and investigator may be allowed upon agreement with both.
* Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current ASS negative cancer diagnosis.
* Subjects who had been treated with ADI-PEG 20 previously.
* History of seizure disorder not related to underlying cancer.
* Known HIV positivity (testing not required).
* Autologous or allogenic stem cell transplantation within 3 months before the first dose of study treatment.
* Systemic steroids that have not been stabilized to the equivalent of ≧ 15 mg/day of prednisone 7 days prior to first dose of study treatment.
* CNS lymphoma.
* Allergy to pegylated compounds.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 257 |
Target Study Title: GLP-1 Inhibits Prandial Antro-duodeno-jejunal Motility in Humans: Native GLP-1 Compared With Analogue ROSE-010 in Vitro
Target Study Description: #Study Description
Brief Summary
The inhibitory effect of low dose GLP-1 is investigated on prandial motility of the stomach, duodenum and jejunum in vivo in humans. Supplementary in vitro studies on the mechanism of action of the GLP-1 inhibition of motility as carried out on muscle strips from the upper gastrointestinal tract in man.
Detailed Description
Twelve healthy volunteers will undergo antroduodenojejunal manometry. Baseline recording with infusion of saline for 1 hour is compared with infusion of GLP-1 0.7 and 1.2 pmol per kg minute for another 1 hour. Plasma GLP-1 and GLP-2 is measured by RIA. Responses to GLP-1 will be measured after food intake as prandial response to GLP-1. The outcome will be evaluated as change in motility index from baseline to meal-stimulated conditions and during influence of GLP-1. Further in vitro studies of gastrointestinal muscle strips, precontracted with bethanechol or electric field stimulation, are planned to investigate the response to GLP-1 or GLP-1 analogue ROSE-010. GLP-1 and GLP-2 receptor immunoreactivity is localized by immunohistochemistry. Receptor mediated mechanisms are studied with GLP-1 receptor blocker exendin(9-39)amide, nitro-monomethyl arginine to block nitric oxide synthase and tetrodotoxin to block sodium channels and nerve conduction.
#Intervention
- BIOLOGICAL : GLP-1
- Intravenous infusion of GLP-1
- Other Names :
- Glucagon-like peptide-1
- BIOLOGICAL : Intravenous saline
- Control
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers > 18 years.
Exclusion Criteria:
* Any medical condition.
* Any drug treatment.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 258 |
Target Study Title: A Pilot Study of Infusional Cyclophosphamide and Pulse Dexamethasone With Rapamycin or Hydroxychloroquine in Patients With Relapsed or Refractory Multiple Myeloma
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine the feasibility of giving (i) rapamycin or (ii) hydroxychloroquine (HCQ), with standard doses of infusional cyclophosphamide and pulse dexamethasone (cy/dex) for patients with relapsed/refractory multiple myeloma, as well as the feasibility of obtaining multiple blood and bone marrow samples during treatment to assess the pharmacodynamic effects of the treatment.
Detailed Description
Multiple myeloma is a plasma cell neoplasm with median survival of 3 to 5 years. Recent advances have improved patient outlook, but the disease remains incurable and patients become refractory to treatments, develop organ dysfunction from myeloma itself, and encounter severe toxicities from therapies, limiting further treatment options. Subjects over the age of 18 with relapsed or refractory multiple myeloma who have had at least one prior therapy, have a life expectancy of at least 4 weeks and an ECOG performance status of 0,1 or 2 will be included. The investigators propose an initial pilot trial to test the feasibility of giving standard chemotherapy with infusional cyclophosphamide and pulse dexamethasone (cy/dex) for four days, together with the investigational agents, oral rapamycin (cohort A), and in a separate parallel arm, oral hydroxychloroquine (HCQ) (cohort B). The investigators will enroll 3 patients on cohort A and 3 patients on cohort B, both at the planned 1st dose level for the overall phase I/II trial which will succeed this trial if feasibility is demonstrated. The 6 patients from this pilot trial will be included in total number of patients for the overall study which will be completed when further funding is secured. Feasibility will be defined by the ability to deliver the regimen as planned and the ability to perform the planned correlative studies. Subjects will receive up to 12 cycles and will be followed for 12 months after the last cycle. Data collected will include toxicity, response rates, correlative studies to examine the pharmacodynamics of mTOR inhibition and autophagy and the pharmacokinetics of rapamycin and HCQ.
#Intervention
- DRUG : Hydroxychloroquine
- Dose level 1: 800mg by mouth daily Dose level -1: 600 mg by mouth daily
- DRUG : Rapamycin
- Dose level 1: Loading dose 12mg, daily dose 4mg Dose level -1: Loading dose 9mg,daily dose 3mg
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
Each subject must meet ALL of the following criteria during screening to be enrolled:
* Histologically confirmed multiple myeloma
* Documented relapse or persistent disease after at least one prior therapy (which may include autologous and allogeneic bone marrow transplantation)
* Need for further therapy for myeloma, as determined by the patients treating physician
* Age 18 years
* ECOG PS 0 <= age <= 2
Exclusion Criteria:
History of allergic reactions to compounds of similar chemical or biological composition to rapamycin or hydroxychloroquine
* Patients may not take any of the following medications while on study (in the rapamycin arms only), but will be considered eligible if medication is discontinued 72 hrs prior to first dose of Rapamycin:
* Carbamazepine (e.g. Tegretol)
* Rifabutin (e.g. Mycobutin)
* Rifampin (e.g. Rifadin)
* Rifapentine (e.g. Priftin)
* St. Johns Wort Clarithromycin (e.g. Biaxin)
* Cyclosporin e.g. (Neorla or Sandimmune)
* Diltiazem (e.g. Cardizem)
* Erythromycin (e.g. Akne-Mycin, Ery-Tab)
* Itraconazole (e.g. Sporonox)
* Fluconazole (e.g. Diflucan)
* Ketoconazole (e.g. Nizoral)
* Telithromycin (e.g. Ketek)
* Verapamil (e.g. Calan SR, Isoptin, Verelan)
* Voriconazole (e.g. VFEND)Tacrolimus (e.g. Prograf)
* Known macular degeneration or retinopathy (diabetic or otherwise), porphyria, or psoriasis (well-controlled psoriasis allowed provided under the care of a specialist who agrees to monitor the patient for exacerbations)
* Patients with the following cytopenias: ANC 1.0 x 109/L; Platelets 50 x 109/L
* Serum Creatinine 2.5 mg/dL; Total or Direct Bilirubin 2.0 mg/dL; Fasting Glucose 200mg/dL
* Other conditions that would require therapy with hydroxychloroquine, including but not limited to, any of the following:
* Systemic lupus
* Rheumatoid arthritis
* Porphyria cutanea tarda
* Malaria treatment or prophylaxis
* Other active malignancy, except:
* Basal cell or squamous cell carcinoma of the skin
* Treated carcinoma in situ
* Localized prostate adenocarcinoma (stage T1a or T1b) with a stable PSA for a period of at least 4 months allowed
* Patients with a prior malignancy treated with chemotherapy, biologic agents, and/or radiation are eligible for this study if they have completed therapy 4 years previously with no evidence of recurrent disease
* Patients with a prior malignancy treated with surgery alone are eligible for this study if they have completed therapy 2 years previously with no evidence of recurrent disease
* Uncontrolled intercurrent illness including, but not limited to, any of the following:
* Uncontrolled ongoing infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Uncontrolled cardiac arrhythmia
* Psychiatric illness or social situations that would limit compliance with study requirements
* Inability to understand or unwillingness to sign the informed consent document
* Concurrent anti-myeloma therapy within:
* 7 days of prior corticosteroids
* 14 days of prior antimyeloma agents, including thalidomide or lenalidomide
* 28 days of a different investigational regimen
* 14 days of any radiation
* Women of child-bearing who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 30 days after the last dose of study drug.
* Women who are pregnant or breastfeeding
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 259 |
Target Study Title: Food Rx + CHW: a Community Health Worker-led Medically Tailored Grocery Intervention to Address Food Insecurity and Type 2 Diabetes
Target Study Description: #Study Description
Brief Summary
Food insecurity increases an individual's risk of poor health outcomes from some of the most costly and preventable chronic diseases, including type 2 diabetes. The goal of this interventional pilot study is to see if primary care patients with self-reported food insecurity and a diagnosis of type 2 diabetes who receive 12 weekly home deliveries of fresh produce and diabetes-appropriate, shelf-stable food will have improved diabetes management. Half of these patients also received support from a community health worker (CHW) including nutrition and cooking education and tailored assistance accessing food resources and other social needs (example: transportation). The investigators hypothesized that participants receiving support from a CHW along with food boxes would have greater improvement in health outcomes compared to those participants who received only food.
Detailed Description
Food Rx + CHW is a 3-month community health worker led medically tailored grocery intervention for patients with self-reported food insecurity and a diagnosis of type 2 diabetes at one academic medical center in the Midwest United States. Prior to contact and recruitment, eligible patients were randomly assigned to receive 12 weekly food deliveries and support from a CHW (Food + CHW group) or food deliveries only (Food-only group).
All participants receive 12 weekly contactless deliveries of food. CHWs conduct three virtual study visits with participants to administer surveys and/or collect biomarker measurements at weeks 1, 12, and 24. No changes in the frequency of visits with the patient's provider are recommended. Virtual visit 1 involves the completion of study forms, assessment of household size for most meals, cultural preferences, food allergies, baseline cooking and eating habits, and assessment for knowledge and usage of local and/or federal food support programs. At week 12, participants use at home kits and devices (provided by the study) to measure and report their HbA1C, weight and blood pressure and complete post-intervention surveys on diet, knowledge and usage of food access programs and resources, and an anonymous feedback questionnaire on the strengths and opportunities for improvement in the program. At week 24, participants measured and reported their final HbA1C, weight and self-collected blood pressure result.
In addition to food, participants in the Food + CHW group also received 7 weekly virtual sessions with a CHW (four 90-minute ZOOM counseling sessions and three 30 to 60-minute check-in phone calls). CHW sessions included diabetes-appropriate cooking and nutrition education and personalized benefit enrollment and linkage to existing food access resources (for example Supplemental Nutrition Assistance Program, Double up Food Bucks, and Kansas Senior Farmers Market Vouchers).
Each weekly food box contained approximately $8 worth of shelf-stable food items purchased from a local food bank (beans, canned vegetables and no-sugar added fruit, shelf-stable dairy products, canned tuna, and whole grains) and $25 of fresh produce (5-7 items including leafy greens, peppers, potatoes, broccoli, carrots, zucchini, cauliflower, celery, cabbage, asparagus, apples, or strawberries). When seasonably available, fresh vegetables and fruit were sourced from local farmers via a local food hub. When local produce was not available, CHWs sourced produce from grocery stores.
#Intervention
- BEHAVIORAL : Healthy food box
- All participants received 12 weekly deliveries of food containing approximately $8 worth of shelf-stable food items purchased from a local food bank (beans, canned vegetables and no-sugar added fruit, shelf-stable dairy products, canned tuna, and whole grains) and $25 of fresh produce (5-7 items including leafy greens, peppers, potatoes, broccoli, carrots, zucchini, cauliflower, celery, cabbage, asparagus, apples, or strawberries). When seasonably available, fresh vegetables and fruit were sourced from local farmers via a local food hub. In addition to food, participants in the Food + CHW group also received 7 weekly virtual sessions with a CHW (four 90-minute ZOOM counseling sessions and three 30 to 60-minute check-in phone calls). CHW sessions included diabetes-appropriate cooking and nutrition education and personalized benefit enrollment and linkage to existing food access resources (for example SNAP, Double up Food Bucks, and Kansas Senior Farmers Market Vouchers).
- Other Names :
- Community health worker
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* English or Spanish speaking,
* Diagnosis of type 2 diabetes with a most recent HbA1C > 7,
* Previously answered 'yes' to the food insecurity needs question ('In the last 12 months, did you ever eat less than you should because there wasn't enough money for food?') on a SDOH screener during a patient care visit
Exclusion Criteria:
* Participant address was outside the delivery zone (the Kansas City Metro area),
* Participant resides in a facility that provides all meals.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 260 |
Target Study Title: An Open-Label Trial of the Immunogenicity and Safety of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine [Diphteria CRM197 Protein Conjugate]) in Healthy Infants at 2, 4 and 6 Months of Age
Target Study Description: #Study Description
Brief Summary
To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age. To determine the antibody responses to the seven pneumococcal vaccine serotypes one month after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6 months of age.
#Intervention
- BIOLOGICAL : Prevenar
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female children 2 months of age (42 to 100 days) in good health.
* An informed consent must be signed by a parent or legal guardian following a detailed explanation of participation in the study.
* Infants whose parent(s)/guardian(s) will be available for the entire study period.
Exclusion Criteria:
* Hypersensitivity to any component of the vaccine, including diphtheria toxoid
* Infants with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
* Infants with known or suspected impairment of immunologic functions including HIV or those receiving immunosuppressive therapy.
Other exclusions apply.
Sex :
ALL
Ages :
- Minimum Age : 42 Days
- Maximum Age : 100 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 261 |
Target Study Title: Screening for Actionable Atrial Fibrillation During Preoperative Consultation With the MyDiagnostick
Target Study Description: #Study Description
Brief Summary
Atrial Fibrillation (AF) It is the most common arrhythmia in the world. It carries great public health significance because of its prevalence, additional morbidity and mortality. It provides a 4-5 times higher risk of developing a ischemic stroke or transient ischemic attack. In term, this risk can be 70% reduced by taking oral anticoagulants. Actionable AF is the overarching term for silent AF (asymptomatic AF) and undertreated AF (known AF, but not sufficiently protected against ischemic stroke). It is recommended that over the age of 65, patients should be screened with pulse palpation or rhythm strip for the presence of AF. The MyDiagnostick is a single-lead I, compact hand-held device that analyses heart rhythm during one minute. During preoperative consultation, this device will be used to value the yield of screening for actionable AF.
Detailed Description
Atrial fibrillation (AF) is the most common arrhythmia in the world, with a prevalence ranging from 1.9 - 2.3% and rising. It is known that the disease occurs more often as age progresses: 70% of affected cases are aged between 65 and 85, over 80 years, one is 10-18% likely to be carrying the illness. Multiple risk factors for developing AF have been determined, like hypertension, myocardial infarction, heart failure, valvular heart disease, obesity, DM and hyperthyroidism.
AF potentially leads to thrombus formation, resulting in a 4-5 times increased risk of getting a TIA or ischemic infarction.
Taking a 12 lead electrocardiogram (ECG) remains the golden standard, with the absence of distinct P-waves and a RR interval that is irregularly irregular.
AF is a risk factor and a risk marker for developing ischemic stroke, by providing a prothrombotic environment. This makes a patient with AF 4-5 times more susceptible for getting an ischemic stroke. Protection for this risk is done by prescribing oral anticoagulants (OAC) (according to an individuals CHA2DS2VASc-score) by either Vitamin-K antagonists (VKAs) or Novel Oral Anticoagulants (NOACs). This allows for a 70% stroke risk reduction.
Not all AF is known to its carrier, it has been proven that 30% of all cases proceeds asymptomatic. These patients are unknowingly exposed to a higher stroke risk. Undertreated AF is when AF is known, but OAC is unrightfully withheld. In approximately 20% of all AF-related strokes, AF was known but undertreated.
In view of the increasing prevalence of AF, it seems there is a need for screening for prevention of actionable AF-associated strokes. The European Society of Cardiology discloses in their most recent guideline that opportunistic screening appears feasible and cost-effective in patients older than 65 years, to be performed by either pulse taking or ECG rhythm strip. The MyDiagnostick, a compact hand-held, 1-lead ECG recorder was created to fulfil the need for better large scale screening devices. In one minute it distinguishes irregular rhythms from normal cardiac rhythms and it can store over 120 ECGs. In a study of 192 patients the MyDiagnostick showed to be 100% sensitive for detecting AF and had a specificity of 95.9%. It provided in a study in which the prevalence of silent AF was examined during influenza vaccination in 10 general practices with more than 3000 patients. From a total of 3269 screened patients, 121 (3,7%) cases of AF were detected, whereof 37 (1,1%) had not yet been diagnosed before.
In this study, the yield of opportunistic screening will be tested of all patients aged 65 or older during preoperative consultation with the MyDiagnostick
#Intervention
- DEVICE : MyDiagnostick
- The MyDiagnostick is a compact hand-held device that registers and stores I-lead ECG strips. In one minute, t analyses the rhythm for the presence of AF. It distinguishes AF from normal cardiac rhythms by measuring RR-irregularity.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* >64 years, visiting preoperative consultation
Exclusion Criteria:
* <64 years
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 262 |
Target Study Title: Validation of Handheld Ultrasound Devices for Point of Care Use in Rheumatology
Target Study Description: #Study Description
Brief Summary
The goal of this clinical trial is to test the concurrent validity of the Clarius handheld ultrasound devices versus gold-standard device to detect characteristic features of healthy and rheumatic joints in adults Psoriatic Arthtritis patients (i.e. anatomical structures and vascular flow).
Detailed Description
This study is a clinical trial testing the concurrent validity of Clarius handheld ultrasound devices against the gold-standard device to detect characteristics (i.e., anatomical structures and vascular flow) of healthy and rheumatic joints in adult Psoriatic Arthritis patients.
The study will be conducted in 3 centers and 10 patients will be included in each center. Study patients will not be randomized to any group.
Both B mode and Doppler images of the participants' predetermined nail, joint, tendon and enthesitis areas will be recorded with both handheld (Clarius Mobile Health Inc, HD3 L15 scanner, HD3 L20 scanner) and the gold standard device (GE LogicE9/E10) at baseline visit.
Two paper CRFs, patient and physician CRFs, will be filled for each patient during the visit and these will be the source document. The CRFs (eCRFs) will be scanned and uploaded to the SharePoint at each center, within 3 days after the visit. In addition, US images of each patient will be uploaded to the SharePoint. The paper CRFs (source documents) will be kept on site. US images and CRFs uploaded from each center will be reviewed by the research assistant at Ottawa Hospital Research Institute (OHRI) center. If there are any missing or erroneous data in the CRF copy, research assistant will contact the site to ensured that the errors and deficiencies are corrected in source document according to Good Documentation Practice. Site should then re-scan the CRF to the SharePoint, ensuring sequential versioning. Any queries will be confirmed with the site within a week of the data entry. Then the analyzed CRFs data will be transferred to Research Electronic Data Capture (REDCap) ( version 12.4.18 - © 2023 Vanderbilt University) by the research assistant at OHRI. Before each analysis (interim and final), all the paper CRFs and REDCap data will be compared for quality assurance.
The scoring of the US images will be done blindly by the principal investigator at OHRI as stated below.
At the central site (OHRI), the research assistant will give a unique identifier number to each image, for a random quality control and for cross referencing whenever needed. The cropped images, as detailed below, will not have the subject ID visible to the PI at the time of reading but will be accessible for the quality control. (read-only access). The research assistant at OHRI is the only site personnel who has the capacity to uncrop the images in the PowerPoint file (password protected files).
Images will not contain any identifiable information such as Date of Birth (DOB) or initials. The US images will be transferred to a PowerPoint file by the research assistant at OHRI in JPEG format. The research assistant will generate an unblinded master list, inaccessible to other site personnel, to link the slide numbers with the patients and scanned anatomical sites and the slide will have no other information on the patient number or ID. For scoring the images by the PI, a random order slide show will be conducted, irrespective of the machine used or the anatomical site or patient assessed, to ensure blindness to data related to the patient identifiers (The PI will not be blinded to the machine that the image was taken with as the JPEG format that is achieved from different machines are identifiable, but due to the random order scoring, images that belong to the same joint by the different machines are not to be scored consecutively). There will be nine separate powerpoint files, for images of joints, tendons, entheses, nail including power Doppler and gray scale findings; and grey scale file for erosions.
If there are missing images for some sites for any of the probes, the images that were obtained for the same site using other probe(s) will also be excluded. The number of missing joint/tendon/entheses and nail images will be reported. Missing data will not be imputed.
After the images are evaluated blindly, statistical analysis will be completed as described below.
The primary endpoint analysis will be the interrater agreement of detecting any synovitis in B mode with the Clarius and gold standard machine. The kappa coefficients will be evaluated using the guideline outlined by Landis and Koch, where the strength of the kappa coefficients are: 0.01-0.20 slight; 0.21-0.40 fair; 0.41-0.60 moderate; 0.61-0.80 substantial; 0.81-1.00 almost perfect.
For secondary outcomes, the interrater agreement for the presence of Doppler signals within the joints, tenosynovitis, erosions, nail, as well as features of enthesitis (hypoechogenicity, thickening, erosions, enthesophytes, calcifications) will also be evaluated using the same method. The agreement of the semiquantitative grading of the intraarticular findings' severity (synovitis in B mode, Doppler signals, erosions, each being on a scale between 0-3) will be done using weighted kappa analysis.
The study will be completed after the imaging of all patients is completed and the analysis of data is done.
#Intervention
- DEVICE : Ultrasound
- All patients having ultrasound with Clarius L15/L20 and GE logic E9/E10 in same visit.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Age >=18
* Meets the classification for psoriatic arthritis (CASPAR) criteria
* Able to provide an informed consent
* Having peripheral disease phenotype of PsA
* At least one tender and swollen join on the day of US
Exclusion Criteria:
* Having isolated axial PsA
* Being in MDA with no tender and swollen joints
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 263 |
Target Study Title: Efficacy of a Multi-faceted Intervention Combining an Educational Outreach Visit to General Practitioners and Patient Education Material to Deprescribe Proton Pump Inhibitors (PPI): a Population-based, Pragmatic, Cluster-randomized Controlled Trial
Target Study Description: #Study Description
Brief Summary
Deprescribing is defined as 'the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing the polypharmacy and improving outcomes'. Inappropriate use of proton pump inhibitors (PPI) is associated with severe adverse drug reactions and a major economic impact. Deprescribing should be considered when inappropriate prescription of PPI is identified.
DeprescrIPP DAM is a pragmatic trial, population-based, designed in clusters. It wil assess the efficacy of a multi-faceted intervention (an educational outreach visit to general practitioners associated with the sending of patient education material to their patients) to deprescribe PPI.
#Intervention
- OTHER : GP will receive the educational outreach visit by a DAM (healthcare representative).
- GP will receive the educational outreach visit by a DAM (healthcare representative).
- OTHER : Patient education material on PPI deprescribing will be sent to the patients
- Patient education material on PPI deprescribing will be sent to the patients
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* General practitioners (GP)
* All GP settled in the French region Pays-de-la-Loire having seen more than 100 different patients in the year before baseline, will be eligible.
* Patients
* Aged more than 18 years
* Affiliated to the French health insurance CPAM
* Treated with PPI> 300DDD/year in the year before baseline (estimated with reimbursement databases).
* Whose GP is included in the study
Exclusion Criteria:
* General practitioners (GPs) :
* Participation refusal
* Patients
* Participation refusal
* Patients at risk of gastroduodenal lesions i.e. treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and > 65 years or treated with either corticosteroids or anticoagulants or platelet aggregation inhibitors
* Patients under legal protection
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 264 |
Target Study Title: Licorice Botanical Dietary Supplements - Metabolism and Safety in Women
Target Study Description: #Study Description
Brief Summary
Human safety studies will be carried out to test whether red clover botanical dietary supplements used by peri- and post-menopausal women are safe to use with Food and Drug Administration (FDA)-approved drugs. To test this, a red clover dietary supplement (previously tested in women at the University of Illinois at Chicago without any harmful effects) will be given with four selected FDA-approved drugs to determine if the Licorice supplement can increase or decrease how these medications are absorbed, metabolized and excreted by the human body. Preclinical studies predict that the licorice supplement might affect the metabolism or break down of these probe drugs.
Detailed Description
At the start of a study, subjects will be administered low doses of a mixture of four FDA-approved drugs (caffeine, tolbutamide, dextromethorphan, and alprazolam), and serial blood samples will be drawn and analyzed for the concentration of each drug over time. Afterwards, participants will take the licorice dietary supplement twice daily for 14 days to allow for potential inhibition or induction of drug metabolizing enzymes and transporters. Thereafter, the same drugs will be taken again to obtain a second measure of drug concentrations in blood over time. Changes in the concentration-time curve values for each probe drug obtained before and after ingestion of the supplement would indicate that metabolism of the probe drugs is impacted by the licorice dietary supplement.
#Intervention
- DIETARY_SUPPLEMENT : Licorice
- Experimental :G. glabra Licorice extract: 2 gelatin capsules (75 mg) per day for 14 days
- Other Names :
- G. glabra
- DRUG : Alprazolam 2 MG
- probe substrate
- Other Names :
- CYP3A4/5 substrate
- DRUG : Caffeine 100 MG
- probe substrate
- Other Names :
- CYP1A2 substrate
- DRUG : Tolbutamide 250 mg
- probe substrate
- Other Names :
- CYP2C9 substrate
- DRUG : Dextromethorphan 30mg
- probe substrate
- Other Names :
- CYP2D6 substrate
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* healthy peri- and post-menopausal women ages 40 - 79
* non-smokers
* no-significant medical conditions as assessed by subject-reported medical history, physical examination and blood and urine chemistry screens
* no medical condition that requires chronic use of medication
Exclusion Criteria:
* known allergies or hypersensitivity to caffeine, dextromethorphan, sulfonylureas (tolbutamide), benzodiazepines, or licorice
* positive pregnancy test
* use of hormone therapy within 8 weeks of study initiation for oral agents, 4 weeks for transdermal or other topical agents
* use of caffeine products 7 days before study participation or during the study
* use of citrus products 7 days before study participation or during the study
* other prescription (with the exception of the Mirena® IUD) or non-prescription medicines within the 2 weeks prior to study initiation or during the study
* chronic diseases, such as inflammatory bowel disease, that could alter the absorption or metabolism of the probe substrates
* unwillingness to comply with study requirements
* current participation in another clinical trial
* CYP2D6 deficiency based on phenotyping at screening
* smoker
* licorice (whether as a botanical dietary supplement, candy, food, drink or otherwise) within the previous two weeks and during the study
* use of any dietary supplements within the last 2 weeks prior to study initiation and during the study
* extreme obesity (defined as >40 BMI)
* alcohol or drug abuse
* chronic diseases such as diabetes.
Sex :
FEMALE
Ages :
- Minimum Age : 40 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 265 |
Target Study Title: The Effects of Cortisol and Norepinephrine Modulation on Emotional and Nonemotional Processing
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to examine how hormonal changes that occur during stressful situations affect thought and emotions. Results from this study may lead to treatments that can alleviate the psychological effects of trauma.
Levels of cortisol and norepinephrine increase in response to stress; these hormones also influence thought processes. This study will give hydrocortisone and/or yohimbine (a stimulator of central norepinephrine) to healthy adults in order to model the stress response and to better understand the way people process information during traumatic events.
This study comprises two experiments in which the stress response is pharmacologically modeled. Participants in the study will have two study visits. During Visit 1, participants will undergo a psychiatric assessment, complete neuropsychological tasks, and have their IQ measured. During Visit 2, participants will be given hydrocortisone and/or yohimbine. Blood will be collected before and during this. Participants will then perform two experiments. In one experiment, participants will hear a story with emotional and non-emotional segments; in a second experiment, participants will view both emotional and non-emotional stimuli.
Detailed Description
Memories for traumatic events are fundamentally different from typical memories. Individuals who witness or are involved in an extremely stressful event, such as a robbery or a violent act, retain highly accurate memories for the information directly related to the trauma (e.g., a gun or verbal threat), while surrounding details are poorly remembered. This so-called weapon focus phenomenon has been found in both naturalistic and laboratory studies with humans. However, difficulties with the control of naturalistic studies and approximating trauma in the lab limit the validity of these findings.
Neurophysiologically, cortisol and norepinephrine are principal mediators of the stress response, and both influence memory function. In particular, cortisol improves memory at low levels but impairs memory at higher doses. Similarly, some evidence indicates that norepinephrine also enhances memory in low doses and either impairs or does not influence memory at high doses. Much of the experimental work in this area has been conducted with animals. Studies have recently begun to extend these paradigms to humans.
To better understand memory processing during trauma, hydrocortisone and/or yohimbine (a stimulator of central norepinephrine) will be administered to healthy adults in two experiments in order to pharmacologically model the stress response. Following infusion, participants will hear a story with emotional and nonemotional segments in one experiment (N = 80) and emotional as well as nonemotional stimuli (faces and scenes) in another experiment (N = 80). It is predicted that relative to the placebo, hydrocortisone will impair memory for both emotional and nonemotional information, yohimbine will improve memory for both types of information, and the combination of hydrocortisone and yohimbine will enhance memory for emotional aspects and impair memory for the nonemotional segments of the story. Results from this study will permit a better understanding of how emotionally charged memories are encoded and will potentially lead to treatments to mitigate the psychological effects of traumatic exposure.
#Intervention
- DRUG : Yohimbine
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
Age: 18 <= age <= 36
IQ: all subjects will have IQ greater than 85
Follicular cycle: Women will participate in the encoding task between days 3 <= age <= 10.
Exclusion Criteria:
Pregnancy/Nursing
Only healthy individuals will participate; special attention will be taken to ensure that no subject has: hypertension, glaucoma, cataracts, ulcers, renal insufficiency, osteoporosis, hypothyroidism, cirrhosis, ocular herpes simplex and myocardial infarction.
Use of hormonal contraception
Use of glucocorticoids within past 3 years
Use of any psychoactive substance; current or past psychiatric diagnosis.
Irregular sleep pattern as defined as getting less than 6 hours of sleep per night, going to sleep after 2:00 AM; waking up before 5:00 AM or after 11:00 AM
Weight that is 15% more or less than ideal body weight for sex and height
History of panic attacks or first degree relative with history of panic attacks
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 266 |
Target Study Title: Development of a New Patient Reported Outcome (PRO) Measure for Refractive Surgery Patients as Part of the National Dataset in Refractive Surgery
Target Study Description: #Study Description
Brief Summary
The development and validation of a concise, practical, on-line, self-administered, self-archiving, and self-scoring PRO questionnaire for routine clinical use in refractive surgery is the primary study objective. Secondary objectives are to gather outcome data from patients before and after surgery in each of the following domains comprising key elements of vision related quality of life: spectacle dependence; quality of vision; eye comfort; freedom; emotional well-being; and overall satisfaction with the results of surgery. Patients undergoing refractive surgery at Moorfields Private Outpatient Clinic will be enrolled in the study in the validation phase.
Detailed Description
Specific aims of the study The investigators aim to take a novel PRO questionnaire from the conceptual framing stage through a well-defined validation pathway including cognitive interviews, field data collection in the target population, and Rasch modification. Secondary aims are to take the modified instrument through prospective studies of repeatability and sensitivity to change. The investigators´ ultimate goal is to develop a concise, screen based, self-administered, self-archiving and self-scoring PRO instrument for use as part of the National Dataset in Refractive Surgery.
Study Design
Step 1. Conceptual framing and draft development Conceptual framing and draft development for the questionnaire is complete. This was based on a comprehensive literature review, patient and surgeon feedback during RCOphth Refractive Surgery Standards development consultation, and advice from a panel of expert collaborators.
The investigators began with a literature review of existing refractive error specific questionnaires, including the following: (1) National Eye Institute Refractive Quality of Life (NEI-RQL), (2) Refractive Status and Vision Profile (RSVP), (3) Quality of Life Impact of Refractive Correction (QIRC), (4) Quality of Vision (QoV), (5) Canadian Refractive Surgery Research Group Quality of Vision Questionnaire (QVQ), (6) PERK Study Questionnaire, (7) Multidimensional Quality of Life for Myopia (MQLM) Scale, (8) Myopia-Specific Quality of Life Questionnaire (MQLQ), (9) Subjective Vision Questionnaire (SVQ), (10) Refractive Error Quality of Life Scale (REQ-Thai), (11) The Freedom from Glasses Value Scale (FGVS), (12) Near Activity Visual Questionnaire (NAVQ), Catquest questionnaire (CatQuest 9SF), and ocular comfort index (OCI).
Those questionnaires have been identified as refractive error specific in a recent review article published in JRS. The ocular comfort index (OCI) addresses ocular surface irritation. Unlike previous instruments designed to measure eye comfort such as the widely used ocular surface disease index (OSDI), it is unidimensional and was developed using Rasch fitting.
According to FDA recommendations, a conceptual framework is helpful in guiding the development of a PRO instrument . Following these recommendations, the investigators first identified the aspects of PRO for refractive surgery to be measured. Each of these aspects or 'domains' is measured by a set of items. The investigators identified and included the following subscales:
* Spectacle dependence
* Quality of vision
* Ocular comfort symptoms /Eye comfort (Eye comfort is used in the questionnaire)
* Freedom
* Looking and Feeling Well
* Overall satisfaction
Having defined the domains of interest, the next task was to reduce and adapt the pool of candidate questionnaire items. Winnowing refers to reducing the item pool to the smallest number of items, making sure that the domain of interest will still be adequately measured. DeWalt et al. stated that winnowing helps to accurately define and identify those item characteristics relevant to each domain. Items are deleted if they are considered to duplicate the information captured, or if they are deemed to be potentially confusing to respondents. The investigators focused preferentially on items from Rasch weighted instruments. The investigators also reviewed items within each domain attempting to ensure, with input from patients and experts, that the most relevant aspects of each domain are captured by the item sets in the draft instrument. The investigators intended to keep a set of non-redundant items that are consistent with the domain, universally understood, and relevant to a wide range of the adult population. Items were revised so they would be understood by the largest possible number of people. In addition, consistency was sought to the extent possible in wording, recall interval, and response options.
The investigators opted to use four response options based on a balance between parsimony and adequate sampling. Both the most widely used current instruments (QIRC and CatQuest), after Rasch modification in development, focus on four response option scales.
To make items more universally understood, slight modifications to item stems and/or response options from their original form were made in those cases where we believed simplification was necessary. All changes in wording were then tested versus original versions in cognitive interviews. Items that were too long or confusing were shortened.
Step 2. Cognitive interviews Cognitive interviews will be conducted to optimise face validity (comprehensibility) of items and response options. Forty participants will be recruited from the waiting rooms of the Refractive Surgery Service at Moorfields Private Eye Hospital (Consultant Bruce Allan MD). The sample should include 20 males and 20 females of different age and educational background (highest degree). A trained interviewer (Andreas Frings MD) will conduct all of the cognitive interviews. Participants will be asked to describe in their own words what each item is asking, and in some cases to compare different ways of asking the same question. These interviews will be helpful because subjects can directly provide input and suggestions on every item considered for inclusion. As a result of these interviews, items could be further simplified, some words could be deleted, some items could be reworded, and some parts of the stems could be added to response options for clarity. The revised survey will then be used for field testing.
Step 3. Field testing and item calibration After questionnaire refinement resulting from cognitive interviews, the investigators will gather completed questionnaire data from a representative cross-section of the target patient population for Rasch fitting. Step 2 is the major component of the validation study and is described in detail below.
#Intervention
- DEVICE : LASIK, PRK, Phacoemulsification
- Please see:
https://en.wikipedia.org/wiki/LASIK https://en.wikipedia.org/wiki/Photorefractive_keratectomy https://en.wikipedia.org/wiki/Phacoemulsification
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
Refractive Surgery
Exclusion Criteria:
Participation denied.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 267 |
Target Study Title: Utilizing MyChart to Assess the Effectiveness of Interventions for Vasomotor Symptoms: A Feasibility Study (REaCT-Hot Flashes Pilot)
Target Study Description: #Study Description
Brief Summary
Vasomotor symptoms (VMS) are a common consequence of systemic therapies for breast cancer. Breast cancer treatments can cause VMS in approximately 30% of postmenopausal women and 95% of premenopausal women with early stage breast cancer (EBC). There are many non-estrogen-based interventions available to manage VMS, including; lifestyle modifications, complementary and alternative medicine (CAM) therapies. However, a recent systematic review and meta-analysis of pharmacological and CAM interventions conducted by our team, found no single optimal treatment for VMS management in breast cancer patients. Given the complex patient, cancer and treatment variables influencing the experience of VMS, the numerous potentially effective VMS interventions available and the varying expectations for an effective intervention, the investigators believe Machine Learning (ML) is ideally suited to the analysis of this common and bothersome treatment related toxicity. The EPIC electronic medical record, and MyChart application has provided both clinicians and patients with increased tools for the documentation of health related outcomes. The investigators believe that the MyChart platform, and ML techniques can be utilized to collect, and analyze outcome data for breast cancer patients experiencing VMS.
Detailed Description
Vasomotor symptoms (VMS) are a common consequence of systemic therapies for breast cancer. Breast cancer treatments can cause VMS in approximately 30% of postmenopausal women and 95% of premenopausal women with early stage breast cancer (EBC). In addition to their negative impact on quality of life, unmanaged VMS are the most common reason for discontinuation of potentially curative treatment in 25-60% of EBC patients. Estrogen replacement is a common treatment for VMS in the general population, however, it is contraindicated in breast cancer patients. There are many non-estrogen-based interventions available to manage VMS, including; lifestyle modifications, complementary and alternative medicine (CAM) therapies. However, a recent systematic review and meta-analysis of pharmacological and CAM interventions conducted by our team, found no single optimal treatment for VMS management in breast cancer patients. The investigators recently conducted a survey in 373 patients with EBC which found that while the majority of patients were interested in receiving an intervention to mitigate their symptoms, only 18% received a treatment for this problem. In addition, more than one third of patients experiencing VMS report that they are not routinely asked about their symptoms in routine follow up. Given the complex patient, cancer and treatment variables influencing the experience of VMS, the numerous potentially effective VMS interventions available and the varying expectations for an effective intervention, the investigators believe Machine Learning (ML) is ideally suited to the analysis of this common and bothersome treatment related toxicity. Prior breast cancer studies have successfully applied to ML models to examine risk of developing breast cancer, as well as breast cancer prognosis. The EPIC electronic medical record, and MyChart application has provided both clinicians and patients with increased tools for the documentation of health related outcomes. The investigators believe that the MyChart platform, and ML techniques can be utilized to collect, and analyze outcome data for breast cancer patients experiencing VMS.
#Intervention
- OTHER : Standard of care treatments
- Interventions will consist of 4 classes of standard of care treatments, namely, lifestyle modifications, complementary and alternative medicine (CAM) therapies, prescription medications, or adjustment of anti-cancer therapy.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Patients over the age of 18 who have histologically confirmed breast cancer, of any stage
* Patients experiencing vasomotor symptoms
* While the study is intended to evaluate the feasibility of the MyChart platform, patients without a MyChart account, who are interested in participating in the study, will have access to a paper or electronic email version. As participation in the MyChart program has benefits outside of this intended study, all patients without a MyChart account will be encouraged to sign up for the service
Exclusion Criteria:
* Those who are unable to complete questionnaires in English
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 268 |
Target Study Title: Effect of LY2216684 on Heart Rate and Blood Pressure in Healthy Subjects Receiving Oral Doses of Albuterol or Propranolol
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine the effect of LY2216684 on heart rate of participants receiving Albuterol and Propranolol. Information about any side effects that may occur will also be collected.
#Intervention
- DRUG : LY2216684
- administered orally
- DRUG : albuterol
- administered orally
- DRUG : propranolol
- administered orally
- DRUG : placebo for LY2216684
- administered orally
- DRUG : placebo for albuterol
- administered orally
- DRUG : placebo for propranolol
- administered orally
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Are overtly healthy, as determined by medical history and physical examination.
* Male participants - Agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
* Female participants - Are women of child-bearing potential who test negative for pregnancy at the time of enrollment, have used a reliable method of birth control for 6 weeks prior to administration of study drug, and agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or Women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause [at least 1 year without menses or 6 months without menses and a follicle stimulating hormone (FSH) >40 milli-international units per milliliter (mIU/mL)].
* Have a body weight >50 kilograms (kg).
* Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
* Have venous access sufficient to allow blood sampling as per the protocol.
* Have normal blood pressure and pulse rate (sitting position) as determined by the investigator.
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
* Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.
Exclusion Criteria:
* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device other than the study drug, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
* Have known allergies to LY2216684, albuterol (Group 1 only), propranolol (Group 2 only), or related compounds.
* Are persons who have previously completed or withdrawn from this study or any other study investigating LY2216684 within 6 months prior to screening.
* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study.
* Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
* Have a history of or current asthma, including exercise induced asthma.
* Have a history or show evidence of significant active neuropsychiatric disease or have a history of suicide attempt or ideation.
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening.
* Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.
* Show evidence of hepatitis C and/or positive hepatitis C antibody.
* Show evidence of hepatitis B and/or positive hepatitis B surface antigen.
* Are women with a positive pregnancy test or women who are lactating.
* Intend to use over-the-counter or prescription medication (including hormonal contraceptives) within 14 days prior to dosing unless deemed acceptable by the investigator and Sponsor's medical monitor
* Have donated blood of more than 500 milliliters (mL) within the last month.
* Have an average weekly alcohol intake that exceeds 14 units per week, or are unwilling to stop alcohol consumption 48 hours prior to check-in in each period and while resident at the Clinical Research Unit (CRU) [1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits].
* Consume 5 or more cups of coffee (or other beverages of comparable caffeine content) per day, on a habitual basis, or any participants unwilling to adhere to study caffeine restrictions.
* Have used any tobacco-containing or nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to enrollment.
* Have consumed grapefruit or grapefruit-containing products 7 days prior to enrollment and during the study.
* Have a documented or suspected history of glaucoma.
* Participants determined to be unsuitable by the investigator for any reason.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 269 |
Target Study Title: Clinical Study of Self-gripping Mesh in Transabdominal Preperitoneal (TAPP) Versus Lichtenstein Hernia Repair
Target Study Description: #Study Description
Brief Summary
The goal of this prospective study is to compare the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair, in order to improve the outcome of inguinal hernia treatment. The main question it aims to answer is, in which procedure is the self-gripping mesh more effective.
Participants will be divided into the TAPP group and the Lichtenstein group by random number table method, the TAPP group underwent laparoscopic transperitoneal preperitoneal hernia repair, and the Lichtenstein group underwent Lichtenstein hernia repair, both groups used self-gripping meshes.
Researchers will compare the operation time, postoperative time out of bed, postoperative hospital stay, hospital costs and postoperative complications between the two groups to see the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair.
#Intervention
- PROCEDURE : Laparoscopic transabdominal preperitoneal hernia repair.
- The TAPP group used self-gripping mesh for laparoscopic transperitoneal preperitoneal hernia repair.
- PROCEDURE : Lichtenstein hernia repair.
- The Lichtenstein group used self-gripping mesh for Lichtenstein hernia repair.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Male patients aged 18 years and older.
* Patients with a definite diagnosis of unilateral primary inguinal hernia.
* Patients and their families were informed about the study protocol and agreed to participate in the study.
Exclusion Criteria:
* Patients with femoral, recurrent, bilateral, incarcerated and strangulated hernias.
* Patients with previous history of lower abdominal surgery.
* Patients with contraindications to anaesthesia.
* Patients with contraindications to laparoscopic surgery.
* Failure to follow up patients as scheduled.
* Patients with abdominal infections.
* Those who cannot tolerate general anaesthesia surgery due to serious coagulation disorders, cardiopulmonary disorders, etc.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 270 |
Target Study Title: Walking for Health: The Feasibility of a Walking Intervention to Increase Physical Activity and Reduce Sedentary Behaviour in People With Severe Mental Illness
Target Study Description: #Study Description
Brief Summary
People who have a severe mental illness can have poorer physical health and higher mortality rates than the general population. Their medications combined with low levels of physical activity and increased sedentary behaviour can general population and may help people with severe mental illness to be more active.
A previous feasibility study has been conducted in the UK in a large city with positive findings. The current study will be conducted in rural settings in Northern Ireland and Republic of Ireland. The intervention will last 13 weeks. People with Severe Mental Illness will be randomly assigned into one of two groups. Both groups will get information on the benefits of physical activity. In addition, one group will be shown how to use a step counter to measure their steps, be invited to a weekly group walk, and meet their coach every 2 weeks contribute to this. Walking is a good way to increase physical activity in the to see how they are getting on and to support them.
The research team are interested in finding out how willing clinicians are to recruit people into the study, how willing people are to take part, do people then stick with the programme, and if not the reasons for people dropping out. Qualitative findings will explore whether participants feel they benefited from and enjoyed the programme. Findings will be used to investigate the feasibility to conduct a larger trial like this in the future.
#Intervention
- BEHAVIORAL : Group walk and one to one coaching
- Participants will be invited to attend a group education session, weekly group walks and fortnightly coaching sessions
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inactive adults (Male or Female; aged >=18 years)
* Diagnosis of any SMI (schizophrenia, psychosis, bipolar disorder and major depression).
Exclusion Criteria:
* Significant movement impairment
* Identified as 'Active' using the GPPAQ screening tool
* Unable to understand English or lack comprehension to understand the purpose of the study and given written informed consent.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 271 |
Target Study Title: A Multi-Center Single Arm Observational Registry of the Cardiogenesis Holmium: YAG Laser System Transmyocardial Revascularization for Angina Reduction
Target Study Description: #Study Description
Brief Summary
The objectives of the registry are as follows:
* Track 'real world' performance outcomes and physician experience using the Cardiogenesis Laser System;
* Further define the disease characteristics of the population being treated;
* Examine transmyocardial revascularization (TMR) usage characteristics and 30-day outcomes;
* Further assess the 30-day postoperative risk factors for adverse events. To limit the potential for bias, all patients eligible for TMR treatment who meet the Inclusion and Exclusion Criteria are to be offered the opportunity to enroll in the study at participating centers.
Detailed Description
The objectives of this patient registry, which collects data on the Cardiogenesis Laser System, include: provide further information on the disease characteristics of the population being treated, examine TMR usage characteristics, monitor 30-day postoperative mortality and MACE rates, and assess preoperative and operative risk factors for adverse events.
To limit the potential for bias, all patients eligible for TMR treatment who meet the Inclusion and Exclusion Criteria are to be offered the opportunity to enroll in the study at participating centers. Patient consent indicates approval to allow collection of their confidential data; nonetheless, their identity will not be disclosed in any publication of this study.
The primary endpoint to be assessed in this study is:
• All-cause 30-day mortality
Additional endpoints to be assessed in this study are:
• Major adverse cardiovascular events (MACE) rate, defined as the incidence of cardiac-related death, myocardial infarction (Q-wave and non Q-wave), congestive heart failure, cerebrovascular accident, and serious arrhythmia in the 30-day postoperative period.
The definitions for these events are as follows:
Cardiac-related death: any death that is not clearly attributable to a non-cardiac cause and includes death due to any of the following: acute myocardial infarction, heart failure, cardiogenic shock, pulmonary edema, cardiac tamponade, arrhythmia, or post-procedural complications (i.e., bleeding).
Q-wave myocardial infarction: the appearance of new Q waves of 40 or more milliseconds in 2 or more contiguous leads and elevation of CK-MB.
Non Q-wave myocardial infarction: the elevation of total CK more than twice normal with elevated CK-MB.
Congestive heart failure: Symptoms of pulmonary vascular congestion or a low output state that is due to left ventricular failure and is new in onset or results in re-hospitalization.
Cerebrovascular accident: Any sudden development of neurological deficits due to vascular lesions of the brain such as hemorrhage, embolism, or thrombosis that persists for \> 24 hours.
Serious arrhythmia: Supraventricular or ventricular arrhythmias that require sustained intravenous pharmacologic treatment, temporary or permanent pacing, or immediate electrical cardioversion or defibrillation. Arrhythmias resulting in syncope, myocardial ischemia, or death are also classified as serious.
Any other serious operative complications related to the procedure: example: major bleeding requiring transfusion.
Each contributing site is required to complete the Enrollment Failure Log Form for all patients undergoing TMR, but not enrolled into the registry due to inclusion/exclusion criteria failure or did not consent for registry participation. If the decision to perform TMR is done intra-operatively, the patient will be approached for participation in the registry after the procedure. No data should be collected prior to patient consent to take part in the registry.
All data collected must be supported by source documents found at the site. Patient medical records, hospital charts, operative reports, laboratory and diagnostic testing results, office visits, source document worksheets as supplied by the Sponsor, etc. will be utilized for collection of relevant data. All data is subject to 100% source document review by Sponsor personnel and/or a representative of the Sponsor at Sponsor's discretion.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Class IV angina (according to Canadian Cardiovascular Society Angina Scale)
* Patients with regions of myocardium in the distal two-thirds of the left ventricle with reversible ischemia and who are not eligible for direct coronary revascularization (e.g., CABG or PTCA)
Exclusion Criteria:
* Age less than18 years
* Severely unstable angina (un-weanable from intravenous anti-anginals for 48-hours)
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 272 |
Target Study Title: Cerebral Protection in Transcatheter Aortic Valve Replacement
Target Study Description: #Study Description
Brief Summary
The PROTEMBO SF Trial is a prospective, observational, multi-center, intention-to-treat study of the safety and feasibility of the ProtEmbo Cerebral Protection System in subjects with severe symptomatic native aortic valve stenosis indicated for TAVR.
Detailed Description
The PROTEMBO SF Trial is a prospective, single arm, observational, multi-center, intention-to-treat study of the safety and feasibility of the ProtEmbo Cerebral Protection System in subjects with severe symptomatic native aortic valve stenosis indicated for TAVR.
#Intervention
- DEVICE : ProtEmbo Cerebral Protection System
- A catheter-based embolic deflection device will be positioned in the arch of the aorta to prevent debris liberated during the TAVR procedure from entering the three major vessels of the aortic arch.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Approved indications for commercially available transcatheter aortic valves by transfemoral route. Refer to the selected valve IFU for additional details.
* Compatible left subclavian artery (>= 4 mm diameter) without significant stenosis (> 70%) and distance between the origin of left subclavian artery and valve plain is >= 90mm as determined by Multi-Slice Computed Tomography (MSCT) scan or equivalent imaging modality.
* The subject and the treating physician agree that the subject will undergo the scheduled pre-procedural testing and return for all required post-procedure follow-up visits.
* The subject has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the national or local regulatory authorities of the respective clinical site.
* Subject is a minimum of 18 years.
Exclusion Criteria:
* Left upper limb vasculature precluding 6Fr sheath (radial or brachial access).
* Inadequate circulation to the left extremity as evidenced by signs of artery occlusion (modified Allen's test) or absence of radial/ brachial pulse.
* Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature.
* TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
* Evidence of an acute myocardial infarction <= 1 month before the intended treatment.
* Aortic valve is a congenital unicuspid or bicuspid valve.
* Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
* Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease).
* Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency.
* Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy.
* Hemodynamic instability requiring inotropic support or mechanical heart assistance.
* Need for emergency surgery for any reason.
* Severe hypertrophic cardiomyopathy with or without obstruction.
* Severe ventricular dysfunction with LVEF <=30%.
* Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation.
* Symptomatic or asymptomatic severe (>= 70%) occlusive carotid disease requiring concomitant CEA/ stenting.
* Subject has undergone carotid stenting or carotid endarterectomy within the previous 6 weeks.
* Active peptic ulcer or upper GI bleeding within the prior 3 months.
* A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or clopidogrel, device component material, or sensitivity to contrast media, which cannot be adequately pre-medicated.
* Recent (within 6 months) CVA or a TIA.
* Renal insufficiency (creatinine > 3.0 mg/ dL or GFR < 30) and/ or renal replacement therapy at the time of screening.
* Life expectancy < 12 months due to non-cardiac comorbid conditions.
* Subjects in whom anti-platelet and/ or anticoagulant therapy is contraindicated, or who will refuse transfusion.
* Subjects who have active bacterial endocarditis or other active infections.
* Currently participating in an investigational drug or another device study.
* Subjects who have a planned treatment with any other investigational device or procedure during the study follow-up period (30 days).
* Subjects with planned concomitant surgical or transcatheter ablation for Atrial fibrillation during the study follow-up period (30 days).
* Any subject with a balloon valvuloplasty (BAV) within 30 days of the procedure.
* Subject is a woman of child bearing age.
* Patient with Heparin-Induced Thrombocytopenia Syndrome.
* Inner diameter of aortic arch is less than 25mm.
* Type I Aortic Arch: Distance of the origin of the innominate artery from the top of aortic arch is less than one times the diameter of left common carotid artery.
* Brachiocephalic trunk originating from the aortic arch that splits into the bilateral subclavian arteries and a bicarotid trunk (Origin D).
Neurological:
* Subject has active major psychiatric disease.
* Subject has severe visual, auditory, or learning impairment and is unable to comprehend English or local language and therefore unable to be consented for the study.
* Subjects with neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
Angiographic:
* Excessive tortuosity in the left radial/ brachial/subclavian artery preventing ProtEmbo System access and insertion.
* Subject whose left radial/ brachial/ subclavian artery reveals significant stenosis, calcification, ectasia, dissection, or aneurysm.
Magnetic Resonance Imaging:
* Subject Body Mass Index (BMI) precluding imaging in scanner.
* Contraindications to MRI (subjects with any implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure).
* Patients who have a high risk of complete AV block after TAVR, with the need of permanent pacemaker (e.g. patients with pre-existing bifascicular block or complete right bundle branch block plus any degree of AV block).
* Planned implantation of a pacemaker or defibrillator implantation within the first 7 days after TAVR.
* Claustrophobia precluding MRI scanning.
* No scanner hardware, software, coil or protocol changes should occur during the course of the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 273 |
Target Study Title: Cervicothoracic Transcutaneous Electrical Nerve Stimulation Attenuates Cardiac Sympathetic Overdrive in Heart Failure: A 123l-MIBG Myocardial Scintigraphy, Randomized Double-Blind Crossover Trial
Target Study Description: #Study Description
Brief Summary
Introduction: Cardiac sympathetic drive provides inotropic support to the failing heart and preserves cardiovascular homeostasis. Nonetheless, as myocardial insult evolves, this compensatory response leads to a progressive decline in contractile function, increases the vulnerability to arrhythmias and constitutes an independent mortality predictor. Despite advanced pharmacological therapies, side effects and persistent cardiac sympathetic overdrive highlights the modulation of the adrenergic system as a primary target for non-pharmacological strategies in the heart failure (HF) treatment. In this scenario, we will propose cervicothoracic transcutaneous electrical nerve stimulation (TENS) as a non-pharmacological therapy to attenuate cardiac sympathetic overdrive in patients with heart failure. Methods: In this prospective, randomized, sham-controlled, double-blind crossover trial, ten (10) HF patients under optimal pharmacological treatment will be randomly assigned to either an in-home cervicothoracic transcutaneous electrical nerve stimulation therapy (TENS: 30 min twice a day with 80 Hz frequency and pulse duration of 150 μs) or a sham control intervention (SHCI) for two weeks. Following a two-month washout phase from TENS/SHCI, patients crossed over and started the opposite condition. Washout rate and heart-to-mediastinum ratio (planar 123l-metaiodobenzylguanidine myocardial scintigraphy images), indexes of cardiac sympathetic activity and innervation density, muscle sympathetic nerve activity (microneurography) and brachial artery blood flow (Doppler ultrasound) during dynamic handgrip exercise will be obtained at the beginning and end of each condition.
Detailed Description
Introduction: Cardiac sympathetic drive provides inotropic support to the failing heart and preserves cardiovascular homeostasis. Nonetheless, as myocardial insult evolves, this compensatory response leads to a progressive decline in contractile function, increases the vulnerability to arrhythmias and constitutes an independent mortality predictor. Despite advanced pharmacological therapies, side effects and persistent cardiac sympathetic overdrive highlights the modulation of the adrenergic system as a primary target for non-pharmacological strategies in the heart failure (HF) treatment. In this scenario, we will propose cervicothoracic transcutaneous electrical nerve stimulation (TENS) as a non-pharmacological therapy to attenuate cardiac sympathetic overdrive in patients with heart failure. Methods: In this prospective, randomized, sham-controlled, double-blind crossover trial, ten (10) HF patients under optimal pharmacological treatment will be randomly assigned to either an in-home cervicothoracic transcutaneous electrical nerve stimulation therapy (TENS: 30 min twice a day with 80 Hz frequency and pulse duration of 150 μs) or a sham control intervention (SHCI) for two weeks. Following a two-month washout phase from TENS/SHCI, patients crossed over and started the opposite condition. Washout rate and heart-to-mediastinum ratio (planar 123l-metaiodobenzylguanidine myocardial scintigraphy images), indexes of cardiac sympathetic activity and innervation density, muscle sympathetic nerve activity (microneurography) and brachial artery blood flow (Doppler ultrasound) during dynamic handgrip exercise will be obtained at the beginning and end of each condition.
#Intervention
- RADIATION : Scintigraphy
- Scintigraphy
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
Patients with a diagnosis of heart failure, New York Heart Association (NYHA) functional classification between II to III and left ventricular ejection fraction <= 50%
Exclusion Criteria:
* Regular physical activity, pregnancy, unstable angina, acute myocardial infarction in the last 6 months, pacemaker, history of chronic kidney disease (on dialysis) and cardiac surgery.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 274 |
Target Study Title: Season Surveillance Study of Viral Infections in Lung Transplant Recipients
Target Study Description: #Study Description
Brief Summary
The present study was conducted to study the impact community acquired respiratory virus (CARV) infections in an outpatient setting on graft function of lung transplant recipients. The study was aimed to identify risk factors for CARV infections.
The study was further intended to investigate an association of Epstein-Barr virus (EBV), cytomegalovirus (CMV) and human adenovirus (HAdV) with the development of BOS and to identify risk factors for virus detection in blood.
Detailed Description
Informed consent was obtained from the LTx recipients and the study was approved of by the institutional review board of Hannover medical school.
LTx recipients are screened for CARV infections during the cold season (end October until end April) in a single-centre outpatient clinic. Symptoms of upper (URTI) and lower respiratory tract infections (URTI) are recorded by questionnaires and findings.
Nasopharyngeal and oropharyngeal swabs (NOS) were performed to detect RV-antigens by immunofluorescence testing (IFT) of respiratory-syncytial virus (RSV), adenovirus, parainfluenza (PIV), influenza and cultures for CARV are performed. BAL was performed when clinically indicated and processed by IFT. Multiplex-PCR to detect 14 CARV are processed in symptomatic patients.
In addition blood samples are monitored at each contact to investigate an association of Epstein-Barr virus (EBV), cytomegalovirus (CMV) and human adenovirus (HAdV) with the development of BOS and to identify risk factors for virus detection in blood.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* adults 18 <= age <= 70 years
* lung transplantation (including single, double, combination and re-do transplants)
Exclusion Criteria:
* refused consent
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 275 |
Target Study Title: Insulin Fast Dissolving Film for Intranasal Delivery Via Olfactory Region
Target Study Description: #Study Description
Brief Summary
The study aimed to investigate the efficacy of insulin in a new dosage form ( fast dissolving film) in treatment of anosmia in patients post infested with Covid-19. The study implication based in two methods evaluations
1. Threshold test
2. identification test.
Detailed Description
This study was designed to improve smell disorders after corona infection that is very anxious for all patients.
Inclusion criteria were loss of smell, post covid-19 infection, age from 18 to 70 years and accept sharing and follow up.
The application of dosage form by ENT specialist at otorhinolaryngology clinic at Minia University hospital. Dose was 100iu of insulin 3 times weekly for 4 weeks. The new dosage form with insulin was compared with a placebo to ensure statistical improvement.
The tests were performed in each visit. Primary outcome was the improvement of smell sensors in those patients
#Intervention
- COMBINATION_PRODUCT : Insulin film
- Insulin suspension vials
- DEVICE : Fast dissolving film
- Fast dissolving film
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* anosmia post covid-19 infection
Exclusion Criteria:
* nasal polyps or fractions or syrgery in nose from 6 months or less
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 276 |
Target Study Title: Evaluating SMS Messaging for Immunization Demand Generation in Nigeria
Target Study Description: #Study Description
Brief Summary
In 2016, only 33% of Nigerian children aged 12-23 months had been vaccinated with the 3rd dose of the pentavalent vaccine. Lack of knowledge was the leading reason for non-vaccination. To overcome this knowledge gap, this project, 'Tunatar da ni', will deliver targeted text messages to community leaders and individualized text messages to parents and caregivers in Kebbi state, Northwest Nigeria, a state with very low coverage of immunization (19% penta 3 coverage in 2018).
These text messages, also known as Short Messaging System (SMS) messages will be managed, scheduled and sent from a purpose-built, cloud-based Immunization Reminder and Information SMS System (IRISS). The messages will be deployed in three ways, as:
1. General broadcast of messages on the importance of immunization to all active mobile phone subscribers in the intervention area.
2. Targeted educational, informational, normative and motivational messages on immunization, and reminders on the local immunization clinic schedules, to community members who voluntarily registered into IRISS for these messages, and to traditional and religious leaders who then share these information with their communities.
3. Individualized reminders of a child's immunization due dates and local clinic schedule to parents who voluntarily registered their child's information on IRISS in order to receive these reminders.
Study investigators hypothesize that providing community leaders with positive and actionable messages on immunization services will improve their understanding of the value of vaccines and provide them facts to drive discussions, build positive norms and increase acceptance of vaccination. Providing targeted reminders to parents about their child's vaccination due date and the schedule of their local vaccination clinics will motivate their timely action to seek vaccination services for their children.
Intervention will be evaluated using a two-arm cluster randomized controlled trial design. All 21 Local Government Areas (LGAs) in Kebbi state will be involved. Based on a 2:1 ratio, 14 LGAs will be randomly assigned to receive the SMS intervention while 7 LGAs will serve as controls.
The primary outcome measure will be the proportion of children aged 0-11 months who are appropriately vaccinated for age. The data to compare this outcome between the intervention and control arms, will be obtained from the quarterly lot quality assurance surveys done by the Nigerian government.
Detailed Description
Background and rationale:
Vaccines are one of the most effective and cost-effective interventions available to public health today. But the benefits of vaccines are not getting to all children, particularly in Nigeria. The 2016 National Immunization Coverage Survey (NICS) reports that only 33% of children aged 12-23 months received the third dose of the pentavalent vaccine nationally. In addition, as much as 40% of children had zero dose of vaccines from the routine immunization (RI) program by the age of two years, having been left out of the 'service grid'. Even among children that have access, retention and utilization is poor; as much as 31% of children who received their first pentavalent vaccine dose, drop out. They do not return to complete the third dose in the series.
In the 2016 NICS, barriers related to lack of knowledge were the most frequently cited barriers by parents of under-vaccinated children. In Nigeria, RI is delivered through fixed sessions at health clinics and outreach sessions in the communities. To complete the RI schedule, caregivers are required to proactively take their infants to the service sites a total of 5 times in the child's first year of life. As much as 42% of parents cited knowledge-deficits such as, not appreciating the importance of vaccines, not knowing the schedule or not recognizing the need to seek out vaccination services as reasons for not vaccinating their children. The complacency to seek RI services may be linked to some parent's erroneous belief that the door-to-door vaccination of their children during polio eradication campaigns (with oral polio vaccine) provides their children with all the vaccines they need. Low confidence, inconvenient clinic schedules and location may also underline the poor demand for RI services.
The health belief model and theory of planned behavior provides an organizing framework to articulate how knowledge, perceptions, subjective norms, self-efficacy and cues to action influence behavioral intention and action. Based on this theory, the team identified that Short Messaging System (SMS) messages and reminders could serve the three-fold purpose of providing information, shaping subjective norms and cueing caregivers to action.
Study investigators hypothesize that providing community leaders with positive and actionable messages on immunization services will improve their understanding of the value of vaccines and provide them facts to drive discussions about vaccination in the community. These discussions about vaccination will result in a common understanding of its importance, increase support for it and build greater positive norms about it in the community. Furthermore, if vaccination schedules for local clinics are sent to the community leaders through SMS, and they, in turn, ask their town announcers to announce the session times in the community, this may serve as cues to action for parents of vaccine age children. In the same vein, providing targeted reminders to parents about their child's vaccination due date and the schedule of their health center will motivate their timely action to seek vaccination services for their children.
The evidence that SMS reminders improve vaccine uptake and coverage is strong, however, most of these studies come from small research settings with tightly controlled and well-resourced program infrastructure. The feasibility of implementing an SMS messaging and reminder intervention like this, at scale, and in a rural and low coverage setting like Kebbi, will be tested by integrating the intervention into RI services, using existing government immunization providers and managers.
This is a mixed methods study comprising a qualitative component (formative study) to understand the context, test the messages and refine intervention strategies, and a quantitative component (evaluative studies) to evaluate the impact of the intervention on immunization uptake, with a cluster randomized controlled trial (CRCT), covering all LGAs, and a complementary before-and-after study, in one sentinel LGA. A costing of the program will also be done to evaluate affordability by the government. Only the CRCT is described here.
The objective of the CRCT is to: assess the impact of the SMS interventions on the age-appropriate rates of routine vaccination among children 0-11 months of age.
Methods. The intervention.
The setting: Kebbi state, is one of the 37 states in Nigeria, with an estimated population of 4.4 million and 180,000 newborns every year. Located in the Northwest of the country, Kebbi has 21 LGAs further divided into 225 wards. Each ward 1 to 3 health facilities.
The system: The project will develop the SMS platform, The Immunization Reminder and Information SMS System (IRISS), to register contacts, manage the contact database and coordinate, schedule and send the messages, as well as track messages sent. The SMS messages will be sent in three ways:
The message targets: As described above in the summary, the project will send out a general SMS broadcast to active phone users in the intervention LGAs, targeted messages to community leaders and other community members who opt-in for the messages, and individualized reminders of a child's vaccination dates and clinic schedule to parents of infants who opt-in for the messages. The SMS messages will be deployed over a period of 9 months between June 2019 to March 2020.
All individuals, including Leads, community gatekeepers, community volunteers, health workers, and caregivers living in the intervention LGAs will be eligible for enrollment into the IRISS e-registry without limitations if they meet the following criteria: for the public broadcast - have an active phone; for the targeted messages to traditional (Mai-unguwas) and religious leaders (Imams) at the community level - have a phone or access to one; for caregivers - have a vaccine-age child (less than 12 months of age), have a phone or access to one, and currently reside in the intervention area.
Based on the number of community leaders in the 14 intervention LGAs, the phone ownership rate, and an assumption of the level of uptake, the projection is that about 7,000 traditional leaders, 1,000 Leads, and 72,000 parents will be enrolled in IRISS making it a total of 80,000 enrollees. The projected enrollment of 72,000 parents of newborns is based on an assumption that 20% of the parents of the 360,000 babies born annually in the intervention LGAs will uptake the service.
The messages. Four types of messages will be sent: normative, educational, informative and motivational. Vaccination schedule reminders will also be sent.
Advertising IRISS: To sensitize community leaders about IRISS and build capacity of RI providers to assist caregivers with opting in, when needed, the study will leverage a community engagement strategy (CES) being rolled out by the government. This strategy aims to involve traditional leaders in the registration of newborns, reconciliation of the data on children vaccinated, comparing community and health facility records, and the follow up of children who missed their vaccine doses. The state immunization officers will conduct cascade of sensitization meetings from the Emirs at the top of the traditional leadership ladder to the Mai-unguwas at the lowest rung. This CES will be implemented in both intervention and control LGAs by government officials, the difference is that IRISS sensitization module will be presented only in the intervention areas. It is likely that advert for enrollment into IRISS for health information may spill over to control LGAs, particularly if information is shared by the public on social media in ways beyond the project's control. If this happens and individuals from control LGAs register into IRISS expecting a message, they will receive a general message about the importance of hand-washing. This is to avoid people losing trust in the program, if they feel SMS messages were advertised but not sent.
Evaluation - CRCT Clusters were defined as the LGAs, the next lower administrative unit below the state. In line with the goal of implementing at scale, all 21 LGAs in Kebbi state were eligible to participate. The 21 clusters (LGAs) were randomly assigned in a 2:1 ratio to maximize the number of LGAs receiving the intervention while maintaining sufficient power to detect meaningful difference between the two parallel arms. The intervention arm (14 LGAs) are to receive both the scheduled and responsive SMS messages on immunization. The control arm (7 LGAs) is designed to receive no SMS intervention, unless some individuals erroneously registered in IRISS, then only those individuals received a one-time message on hand-washing.
Randomization will be accomplished with un-stratified covariate-constrained randomization using a macro accessible from: https://github.com/ejgreene/ccr-sas to generate multiple allocations of each LGA into one of three groups. The covariates are: phone ownership/access (continuous variable) - % of population with mobile phones; target population (continuous variable) - number of children 0-11 months; immunization coverage (continuous variable) - % of children 0-11 months appropriately vaccinated for age; emirate (4 binary variables for each emirate where the variable equals 1 if the LGA is in that emirate and 0 otherwise).
Each LGA will be allocated to one of three groups, and the process is repeated 100,000 times. To achieve the 2:1 ratio, two groups will be combined later to form the intervention arm, while the third becomes the control arm. For each of the 100,000 allocations, the within-group mean for each covariate will be calculated and compared to the overall state covariate mean. The allocations where the groups' covariates means fall with 30% of the state covariate mean, will be kept, otherwise, they will be discarded. The criteria used for the emirate variables is that the groups could not differ in size by more than 1 LGA.
Once the qualifying allocations are generated, the next step is to conduct a transparent and public draw. At a meeting of stakeholders from the state primary health care development agency, a volunteer will be asked to randomly select one allocation out of those that qualified. For example, if 200 allocations met the criteria, a random number from 1 to 200 will be generated from www.numbergenerator.org. The allocation corresponding to the generated number is then taken. Next, the groups in the selected allocation are assigned to either intervention or control by having three volunteers draw three balls labelled - intervention 1, intervention 2 and control from an opaque black bag. The groups assigned intervention 1 and 2 will be collapsed into one intervention arm.
Sample size: In a CRCT, sample size depends on both the number of clusters and of respondents within each cluster. In this study, the number of clusters is 21 LGAs with 14 intervention and 7 control LGAs. Similarly, the number of respondents per LGA in the Lot Quality Assurance Surveys (LQAS) that study team plans to leverage to assess impact, is fixed at 60. The LQAS are conducted by the government quarterly. Given a fixed sample size, the power of the study to detect a meaningful difference in the primary outcome at the cluster level was calculated as follows:
A total of 60 households will be sampled from each LGA. One infant per household will be interviewed through their caregivers. Total no. of respondents is 21\*60 =1,260. Based on the 2:1 allocation ratio of the 21 clusters, a baseline rate of 12% of infants appropriately vaccinated for age in the state, assumed increase to 30% in intervention arm after 9 months of intervention, a design effect of 3, type 1 error of 5%, a one-sided test; the study has 99% power to detect a difference of 18% percent between the intervention and control LGAs.
#Intervention
- OTHER : Community engagement
- The government will conduct a cascade of sensitization meetings with traditional leaders at all levels to promote newborn line listing (birth registration), reconciliation of child's vaccination status and defaulter tracking (home-based follow up of children who have missed their vaccination doses) by health providers and community leaders
- OTHER : IRISS advert for opt-in
- A module to advertise and demonstrate how individuals can opt-in to IRISS to receive the messages will be included in the community engagement sensitization meetings.
- OTHER : One-time SMS broadcast on immunization
- General broadcast of SMS messages on the importance of immunization to all active mobile phone subscribers in the intervention LGAs
- OTHER : Scheduled weekly SMS reminder of health facility RI schedule to community leaders
- Traditional and religious leaders who have a phone or access to a phone and have been registered on IRISS will receive SMS messages on the immunization session schedule of the health facilities in their communities, so they can disseminated the information through their town announcers to inform parents and caregivers. For example, 'Ribah clinic is holding a vaccination session tomorrow from 8am to 2pm. Please take your child there to vaccinate them and encourage your neighbors to vaccinate their children.'
- OTHER : Scheduled bi weekly RI messages to community leaders
- Traditional and religious leaders who own or have access to a phone and have been registered on IRISS will receive SMS messages on immunization, to share same with community members. The message categories are: 1) Educational messages that provide facts and increase knowledge, e.g. 'Have you heard of Penta vaccine? It protects against 5 diseases: they are diphtheria, whooping cough, tetanus, HiB and Hepatitis B.' 2) Informative messages that dispel myths about immunization, e.g. 'Getting more than one vaccine at the same time does not harm a child. It is very important to completely receive all vaccine doses for full protection.' 3) Normative messages to promote positive norms, e.g. 'Our religious leaders have immunized their children, what are we waiting for'? 4) Motivational messages to inspire action, e.g. 'Each visit to the health center for vaccination will reap many health benefits. Say YES to good health, be on time and complete your child's vaccination.'
- OTHER : Responsive individualized child vaccination schedule reminder to caregivers who opt-in
- Parents and caregivers who voluntarily registered their child's information into IRISS will receive a reminder, a day before, about their child's due vaccines and the schedule of vaccination sessions in the health facilities within their locality (wards), e.g. 'Greetings! Amina is due for Penta 1 tomorrow, kindly visit Ribah clinic. They vaccinate on Mondays and Thursdays.'
- OTHER : Responsive one-time SMS message on hand washing to those that erroneously register on IRISS
- If individuals from control LGAs encounter IRISS adverts inadvertently and erroneously register into IRISS expecting a message, to avoid a loss in trust if no message is sent, they will receive a one-time general message about the importance of hand-washing, e.g. 'Wash your hand with soap and water every time you finish from to the toilet, to maintain clean hands and avoid germs that make you sick.'
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* General broadcast: active phone owners living within the 14 intervention LGAs.
* Targeted broadcast: community leaders or other individuals who:
* own or have access to a phone
* live within the 14 intervention LGAs.
* Individualized broadcast: parents or caregivers of children aged 0 <= age <= 11 months who:
* own a phone or have access to a phone
* live within the 14 intervention LGAs
Exclusion Criteria:
* Not owning or having access to a phone that can receive text messages
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 277 |
Target Study Title: The Effect of Education and Telephone Counseling Given to Hypertension Patients on Drug Medıcation Adherence and Rational Medication Use: Single-Blind Randomized Controlled Trial
Target Study Description: #Study Description
Brief Summary
This research will be conducted to determine the effects of education and telephone counseling given to hypertension patients on drug treatment compliance and rational drug use.
Detailed Description
This research will be conducted to determine the effects of education and telephone counseling given to hypertension patients on drug treatment compliance and rational drug use.
Research Hypotheses H0: Education and telephone counseling given to hypertension patients do not affect drug treatment compliance.
H1: Education and telephone counseling given to hypertension patients increase drug treatment compliance.
H0: Education and telephone counseling given to hypertension patients do not affect rational drug use.
H1: Education and telephone counseling given to hypertension patients increase rational drug use.
This study was planned as a single-blind randomized controlled experimental study.
#Intervention
- OTHER : Education and Telephone Counceling
- Drug use and rational drug use training will be given to hypertension patients in the experimental group.
The patients in the experimental group twice in the 1st month (2nd and 4th weeks), once in the 2nd month (8th week) and once in the 3rd month (12th week) phone call counseling will be providedved an average of 10-15 minutes.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* - Diagnosed with hypertension,
* Hypertension disease duration of at least 6 months,
* Using at least one drug due to hypertension,
* 18 years and over
* Literate,
* Living in the town centre,
* Owns a phone
* Open to communication and cooperation,
* Patients willing to participate in the study will be included in the study.
Exclusion Criteria:
* Having a psychiatric illness
* Hearing loss,
* Can't understand or speak Turkish and
* Patients who do not wish to continue the study will be excluded from the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 278 |
Target Study Title: A Randomized, Double-blind, Placebo-controlled, Multicentre, Phase II Dose-finding Study of Atacicept Given Subcutaneously in Subjects With Rheumatoid Arthritis and Inadequate Response to TNFa Antagonist Therapy
Target Study Description: #Study Description
Brief Summary
This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who had failed a three month therapeutic trial with a tumor necrosis factor alpha (TNFa) antagonist due to lack of efficacy.
#Intervention
- DRUG : Atacicept
- Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
- DRUG : Atacicept
- Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
- DRUG : Atacicept
- Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
- DRUG : Placebo matched to atacicept
- Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Rheumatoid arthritis (RA) satisfying American College of Rheumatology (ACR) diagnostic criteria with a disease history of at least one year
* Male or female greater than or equal to (>=)18-years of age at time of informed consent
* Active RA as defined by:
* >=8 swollen joints (66-joint count),
* >=8 tender joints (68-joint count), and
* C-reactive protein (CRP) >=10 milligram per liter (mg/L) (central laboratory) and/or erythrocyte sedimentation rate (ESR) >= to 28 millimeter per hour (mm/h)
* Failure of at least one TNFa antagonist therapy (previously or at the time of screening) as specified in the protocol
* Other protocol defined inclusion criteria could apply
Exclusion Criteria:
* Any condition, including laboratory findings or findings in the medical history or pre-trial assessments, that in the opinion of the Investigator constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation
* Treatment with biologics aiming at B cell modulation such as rituximab or belimumab within 2 years before study Day 1
* Any previous treatment with anakinra (Kineret), abatacept (Orencia) or tocilizumab within 3 months before study Day 1
* Use of etanercept (Enbrel) within 28 days before study Day 1, or of infliximab (Remicade) or adalimumab (Humira) within 60 days before study Day 1
* Participation in any interventional clinical trial with an unapproved investigational therapy within the 3 months before the start of this study (or within 5 half-lives of the investigated compound before study Day 1, whichever is longer)
* Other protocol defined exclusion criteria could apply
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 279 |
Target Study Title: Efficacy, Safety and Tolerability of Multiple Doses of Oral Cebranopadol in Subjects With Moderate to Severe Chronic Pain Due to Diabetic Peripheral Neuropathy.
Target Study Description: #Study Description
Brief Summary
The purpose of this trial is to evaluate if cebranopadol is safe and can decrease pain in patients when compared to placebo (a tablet that does not contain active product) and when compared to a marketed product containing pregabalin (Lyrica®). Furthermore, this trial will be undertaken to find out if the patient's general health and well-being improves under trial treatment.
The concentrations of cebranopadol in the blood will be investigated to get a better understanding of how it is absorbed from the gut, distributed and broken down in the body, and eliminated from the body.
#Intervention
- DRUG : Cebranopadol 100 µg
- Participants randomized to 100 μg cebranopadol will start with 100 μg per day and will remain on 100 µg per day.
- DRUG : Cebranopadol 300 µg
- Participants randomized to 300 μg cebranopadol will start with 100 μg per day and increase to 300 µg per day on day 4 and will remain on 300 µg per day.
- DRUG : Cebranopadol 600 µg
- Participants randomized to 600 μg cebranopadol will start with 200 μg per day and increase to 400 µg per day on day 4 and to 600 µg on day 7, thereafter they will remain on 600 µg per day.
- DRUG : Pregabalin
- Stepwise titration from 75 mg twice a day to 300 mg twice a day over 2 weeks.
- Other Names :
- Lyrica®
- DRUG : Matching Placebo
- Placebo will be matched to pregabalin and cebranopadol.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* written signed informed consent
* type 1 or type 2 diabetes mellitus
* clinical diagnosis of painful Diabetic Polyneuropathic Neuropathy (DPN) with symptoms and signs for at least 3 months
* must require medication (e.g., non-opioids or opioids up to an equivalent dose of 160 mg oral morphine/day) for the treatment of pain due to DPN for at least 1 month prior to Visit 1 and must be dissatisfied with the current treatment (in terms of efficacy and/or tolerability). Medication for the treatment of pain due to DPN should be required on at least 4 of 7 consecutive days.
* blood glucose to be controlled by a diet, oral anti-hyperglycemic medication, and/or insulin for at least 3 months prior. Glycosylated hemoglobin (HbA1C) should not be greater than 11%
* baseline pain intensity score greater or equal to 5 on the 11-point Numerical Rating Scale (NRS) without intake of any analgesic at allocation. For each of the last 3 days prior to allocation of treatment, a 24 hour NRS score greater or equal to 4 is required
* women of childbearing potential must have a negative urine pregnancy test at enrollment
* using medically acceptable and highly effective methods of birth control (and willing to use them during the trial).
Exclusion Criteria:
* presence of other pain that could confound the painful Diabetic Polyneuropathy (DPN) assessments, e.g. pain due to nerve entrapment (tarsal tunnel syndrome, osteoarthritis of the knee etc), peripheral vascular disease, radiculopathy, plantar fasciitis, tendonitis, mononeuritis multiplex, postherpetic neuralgia, complex regional pain syndrome, or fibromyalgia.
* neuropathy due to etiologies other than diabetes, e.g. autoimmune disorders, inflammatory neuropathies (e.g. chronic inflammatory demyelinating polyneuropathy), thyroid disease or endocrine disorders (other than diabetes), heavy metal or toxic neuropathy, nutritional deficiency, metabolic disorders, vasculitis, infections, injury, or paraneoplastic syndromes.
* severe or extensive diabetic ulcers or amputations due to diabetes
* Charcot's joints due to diabetes.
* any clinically significant disease or laboratory findings, e.g., significant unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, metabolic, neurological, or psychiatric disorders.
* inability to comply with the protocol and with the intake of trial medication that, in the investigator's opinion, might indicate that the participant is unsuitable for the trial.
* conditions that require treatment with medication that is not allowed to be taken during the trial
* previous or current alcohol or drug abuse or opioid dependency.
* severe functional hepatic impairment corresponding to Child-Pugh classification C.
* history of acute hepatitis
* impaired renal function, a creatinine clearance less than 60 mL/min at the enrollment (Cockcroft-Gault calculated).
* history of any major gastrointestinal procedures (e.g., gastric bypass) or gastrointestinal conditions (e.g. acute diarrhea, blind loop syndrome, gastric dumping syndrome, Whipple's disease) that might affect the absorption or metabolism of cebranopadol or pregabalin.
* risk factors for or history of torsade de pointes and/or marked prolongation of the QT interval (e.g. heart failure, hypokalemia, or bradycardia).
* history of seizure disorder and/or epilepsy or any condition associated with a significant risk for seizure disorder or epilepsy at the discretion of the investigator.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 280 |
Target Study Title: An Open-label, Single-center Study to Assess the Pharmacokinetics of R406 in Subjects With Hepatic Impairment and in Healthy Subjects Following Administration of a Single Dose of Fostamatinib Disodium 150 mg
Target Study Description: #Study Description
Brief Summary
A study to evaluate the amount of fostamatinib in the blood in subjects with impaired hepatic (liver) function compared with healthy volunteers with normal liver function. The study will also evaluate safety and tolerability in subjects with hepatic impairment.
#Intervention
- DRUG : Fostamatinib
- Oral tablets, single dose
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Males and females (non child-bearing potential) aged 18 years or more, with a weight of at least 50 kg and body mass index (BMI) between 18 and 40 kg/m2 inclusive
* Healthy subjects only: good health as determined by a medical history, physical examination , ECG and clinical laboratory evaluations
* Healthy subjects only: negative results for serum hepatitis B and C
Exclusion Criteria:
* Subjects who have received any medications known to alter drug absorption or elimination within 30 days of first dose.
* Subjects who smoke more than 10 cigarettes or equivalent per day
* Absolute neutrophil count <2500/mm3
* Abnormal vital signs, additional systemic disease (eg, cardiac, or renal disease) or abnormal laboratory findings that are judged to be clinically significant by the investigator
* Healthy volunteers only: use of prescribed medications within 2 weeks of first dose or use of non-prescribed medications within 1 week of first dose
* Hepatic subjects only: fluctuating or rapidly deteriorating hepatic function
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 281 |
Target Study Title: Improving Identification of Mental Health/Substance Use Disorders in HIV Primary Care: Pilot Clinical Response
Target Study Description: #Study Description
Brief Summary
This research is a feasibility pilot of an intervention to respond to positive screening tests for mental health(MH) and substance use (SU) captured through the Patient Reported Outcomes questionnaires (PROs). The PROs are currently performed in the clinic, however, the results are neither reviewed with patients nor transmitted to providers. This pilot assesses the feasibility of moving the PROs into the clinical realm by having patients review the PRO results, identifying an issue to discuss at the patient's next HIV primary care visit, and determining whether this process increases discussion of MH and SU disorders in the subsequent clinical visit and/or increases referrals to MH and/or SU treatment.
#Intervention
- BEHAVIORAL : Patient Designated Positive Screen Shared with Provider
- Patient Designated Positive Screen Shared with Provider -- In the intervention, participants will be given the opportunity to determine which positive screen, if any, that the participant would like to discuss with the participant's provider at the next HIV primary care appointment. The participant will be notified that all positive screens will be shared with the provider prior to their next HIV primary care visit, and that any positive screen the patient has chosen to discuss with the provider will be specified. The provider will receive the PROs result (score, interpretation, and recommendation) prior to their next HIV primary care visit
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* must be enrolled in the Johns Hopkins Clinical Cohort at the Johns Hopkins Moore Clinic
* must be living with HIV
Exclusion Criteria:
*
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 282 |
Target Study Title: A Phase 3 Randomized Double-Blind Study Of Ceftobiprole Medocaril Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the water-soluble prodrug \[form\] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia.
Detailed Description
Ceftobiprole medocaril (the water-soluble prodrug \[form\] of ceftobiprole) referred to as ceftobiprole is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole is not yet approved for the treatment of nosocomial (hospital-acquired) pneumonia. This is a randomized, double-blind, multicenter study of ceftobiprole versus a comparator (linezolid plus ceftazidime) to assess the effectiveness and safety of ceftobiprole in patients with nosocomial pneumonia. The patients will be randomized to ceftobiprole plus placebo or the comparator. The primary endpoint is the clinical cure rate of ceftobiprole at the test-of-cure visit. The patients will receive either ceftobiprole plus placebo or the comparator for 7 to 14 days (unless extended at discretion of medical monitor). Patient safety will be monitored throughout the study. In December 2006, this study (BAP00248) and another similar study (BAP00307, see NCT00210964) were amended (changed) to create 1 study (BAP00248/307).Therefore, the results reported for this study will be combined with the results reported for study BAP00248 Patients will receive either ceftobiprole plus placebo or a comparator by intravenous infusion for 7 to 14 days (unless extended at discretion of medical monitor).
#Intervention
- DRUG : ceftobiprole plus placebo
- ceftobiprole 500 mg every 8 hours as a 120 minute intravenous infusion and placebo administered every 12 hours as a 60-minute intravenous infusion for 7 to 14 days
- DRUG : linezolid plus ceftazidime
- linezolid 600 mg every 12 hours as a 60-minute intravenous infusion plus ceftazidime 2 g every 8 hours as a 120-minute intravenous infusion for 7 to 14 days
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Patients suffering from nosocomial pneumonia or ventilator-associated pneumonia
* Female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control, before entry and throughout the study, and have a negative serum or urine pregnancy test at the screening
Exclusion Criteria:
* Known or suspected hypersensitivity to any related antibiotic medications
* Any known or suspected condition or concurrent treatment that would be contraindicated by the prescribing information
* Treatment with any investigational drug within 30 days before enrollment
* Prior enrollment to this study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 283 |
Target Study Title: Gender Differences in Periodontal Status of Depressive and Non-Depressive Individuals
Target Study Description: #Study Description
Brief Summary
There is a relationship between depression and periodontal disease. This relationship may be double-sided. A psychological state such as anxiety, depression, body image, and self-esteem may be affected from the symptoms of periodontal disease.
Detailed Description
Background: Depression is a multifactorial disease characterized by a variety of symptoms. Individuals with psychiatric disorders seem to be more prone to periodontitis. However periodontal disease and depression can be considered bidirectional risk factors. Periodontal diseases can also be an effect on depression. The purpose of the present study was to evaluate the gender-related differences in the relationship between periodontal diseases and depression in male and female adults.
Material and methods: The study population consisted of 339 subjects. Two groups were formed from these patients: 171 females with periodontal disease (71 subjects with gingivitis, 100 subjects with periodontitis); 168 males with periodontal disease (72 subjects with gingivitis, 96 subjects with periodontitis). Clinical periodontal and psychological measures were performed on females and males group.
#Intervention
- OTHER : Psychological measurements
- A questionnaire test (Beck depression Inventory) for depression was performed.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* the presence of periodontal diseases
Exclusion Criteria:
* the presence of any systemic disease other than depression
* smoking and alcohol consumption
* the use of any drugs (antidepressants, anti-inflammatory, and antimicrobial medicaments, and hormonal supplements) that affect the periodontal condition
* have received any periodontal treatment in the last six months
* hormonal condition such as pregnancy or lactation
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 284 |
Target Study Title: Mindfulness and Cognitive Behavioral Therapy for Sleep in Cancer
Target Study Description: #Study Description
Brief Summary
Patients with hematologic cancer frequently report significant difficulties with sleep in the months after discharge from inpatient chemotherapy. Poor sleep quality can contribute to and perpetuate problems with daytime fatigue, pain, and distress that are common among patients with hematologic cancer. There is a need for behavioral interventions that address insomnia and daytime fatigue, pain, and distress once hematologic cancer patients have returned home after inpatient chemotherapy. Mindfulness-Based Therapy for Insomnia (MBTI) is a new approach to treating insomnia. This group-based intervention combines sleep restriction and stimulus control with mindfulness principles and exercises to reduce worry and promote positive responses to insomnia. To date, MBTI has not been applied to patients with hematologic cancer. If MBTI is to meet the needs of hematologic cancer patients, it must be adapted in several ways. First, because hematologic cancer patients are immunosuppressed, MBTI needs to be adapted for one-to-one delivery. Second, because hematologic cancer patients experience significant daytime fatigue, pain, and distress, MBTI needs to be adapted to include systematic training in coping skills for these symptoms. The investigators propose to develop and pilot test an adapted MBTI (MBTI+) protocol for hematologic cancer patients reporting insomnia, fatigue, pain, and/or distress after inpatient chemotherapy. The study will be conducted in two phases. In Phase I, the study team will use focus groups with hematologic cancer patients and hematology-oncology providers to guide development along with user testing with hematologic cancer patients reporting insomnia and daytime symptoms of fatigue, pain, and/or distress. Phase II will involve a small single-arm pilot to examine the feasibility, acceptability, and examine pre- to post-intervention primary (insomnia) and secondary (fatigue, pain, distress, mindfulness, self-efficacy) outcomes of the MBTI+ protocol. MBTI+ will consist of six, 60- to 75-minute therapy sessions delivered either in-person or via videoconferencing technology. Study measures will be collected at baseline, immediately post-intervention, and 1-month post-intervention.
#Intervention
- BEHAVIORAL : Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
- Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* an initial or recurrent diagnosis of hematologic malignancy
* within 8 weeks of discharge home after inpatient chemotherapy or CAR-T therapy
* total score of 8 or greater on the Insomnia Severity Index (ISI)
* score of 5 or greater on the MD Anderson Symptom Inventory Scale for 'worst' fatigue, pain, or distress, and report that these symptoms interfered with at least two activities of living (i.e., general activity, mood, work) in the last week at 3 or greater on a 0='Did not interfere' to 10='Interfered completely' scale
* ability to speak and read English, and hearing and vision that allows for completion of sessions and assessments
Exclusion Criteria:
* reported or suspected cognitive impairment subsequently informed by a Folstein Mini-Mental Status Examination of <25
* presence of a serious psychiatric (e.g., schizophrenia, suicidal intent) or medical condition (e.g., seizure disorder, narcolepsy) indicated by medical chart, treating oncologist or other medical provider that would contraindicate safe participation
* expected survival of 6 months or less
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 285 |
Target Study Title: A Phase I/II Trial of IDEC-114 (Anti-CD80 Monoclonal Antibody) in Combination With Rituxan® for Patients With Relapsed or Refractory, Follicular Lymphoma
Target Study Description: #Study Description
Brief Summary
To determine what side effects and what clinical effect, if any, the administration of this investigational product, IDEC-114 in combination with Rituxan® \[Rituxan® as a single agent is approved by the United States Food and Drug Administration (FDA) to treat patients with relapsed or refractory follicular NHL\], has in this patient population.
#Intervention
- DRUG : IDEC-114
- Dose Group 1 - 125 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 2 - 250 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 3 - 375 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 4 - 500 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Signed IRB-approved informed consent
* Greater than or equal to 18 years
* Proof of follicular lymphoma
* Progressive disease requiring treatment after at least 1 prior standard therapy
* Acceptable hematologic status, liver function, and renal function
* Patients of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment
Exclusion Criteria:
* No response to prior Rituxan® or Rituxan®-containing regimen
* Presence of CLL or CNS lymphoma
* Known history of HIV infection or AIDS
* Prior diagnosis of aggressive NHL or mantle-cell lymphoma
* Serious nonmalignant disease
* Pregnant or currently breast feeding
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 286 |
Target Study Title: Limited Neck FDG-PET Imaging for Indeterminate Thyroid Nodules
Target Study Description: #Study Description
Brief Summary
The main purpose of this study is to see how well FDG-PET scans can determine the malignancy of thyroid nodules that have already been tested (and come back positive) by fine needle aspiration.
Detailed Description
While FNA is a sensitive test for diagnosing thyroid tumors, it cannot differentiate benign from malignant follicular nodules and sometimes yields equivocal results due to inadequate sampling or indeterminate cytology. The standard of care for patients with equivocal or follicular histology is surgical removal of these nodules, most of which are benign in nature. FDG-PET, as evidenced by our prior experience and studies from other groups, may have application in discriminating benign from malignant disease in these patients with equivocal or follicular FNA results using standardized uptake value determination. We have demonstrated the feasibility and preliminary clinical utility of using limited neck FDG-PET exams in patients with indeterminate thyroid nodules in a pilot study. The purpose of this trial is to prospectively evaluate a larger series of patients with equivocal or follicular histology on FNA to more accurately define the sensitivity and specificity of FDG-PET for diagnostic imaging of these nodules. In addition, the utility of this modality in identifying metastatic foci in patients with thyroid cancer having follicular or equivocal histology on FNA will be assessed. If the sensitivity and specificity of this modality are determined to be high (≥95%) for diagnosing malignant nodules in these patients, many patients with benign disease may potentially benefit by avoiding unnecessary operations.
#Intervention
- OTHER : FDG-PET Scan
- Positron emission tomography with 18F-fluorodeoxyglucose
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Documented history of a solitary thyroid nodule or a dominant nodule within multinodular disease, with fine needle aspiration demonstrating a follicular or indeterminate cytologic examination. If a core needle biopsy was performed instead of a fine needle aspiration, demonstrating follicular or indeterminate cytology, the patient is eligible if the biopsy procedure was felt to be minimally disruptive to the nodule architecture, based on a review by the PI or nuclear medicine investigator.
* Thyroid nodule must be palpable on physical examination or have a minimum size of 1 cm in diameter by ultrasonography, CT or MRI. The minimum size criterion was established to address the spatial resolution limitations of PET/CT imaging.
* Scheduled for surgical excision of thyroid nodules within 3 months of the date of the FDG-PET/CT scan.
* Ability to tolerate lying supine for a FDG-PET/CT examination.
* Age >= 18 and <= 105 (This disease is rare in children and therefore the study will be limited to adults.)
* Willing to participate in all aspects of the study (patient may opt out of the tissue collection portion.)
* Patient must be euthyroid with a serum TSH or a free T4 level within the institutional upper and lower limits of normal, measured within 6 months of registration. NOTE: mild deviations from the institutional normal limits may be considered acceptable if the patient has achieved a clinically euthyroid state with medication at a stable dose for >3 months, and the TSH is considered to be at target by the patient's treating physician. In patients with hyperthyroidism requiring treatment, this euthyroid state may be achieved with administration of a thionamide such as propylthiouracil prior to FDG-PET/CT exam. Patients with hyperthyroid inflammatory conditions such as thyroiditis and toxic multinodular goiter often exhibit increased glucose uptake resulting in diffuse uptake of FDG which may obscure visualization of a thyroid tumor.
* If female, patient must have a negative pregnancy test at the time of registration, be post-menopausal (with no period in the last twelve months), have had a tubal ligation at least twelve months ago, or have had a hysterectomy.
* In patients with multinodular disease and a dominant nodule, the nuclear medicine physician responsible for FDG-PET/CT scan interpretation must determine whether the indeterminate nodule can be discriminated on FDG-PET/CT imaging prior to enrollment.
* A signed and dated written informed consent obtained from the patient or the patient's legally acceptable representative prior to study participation.
Exclusion Criteria:
* Patient has a fasting glucose level > 200 mg/dL at the time of the PET/CT scan
* Patient has had prior neck surgery or radiation that in the opinion of the investigator has disrupted tissue architecture of the thyroid
* Patient has evidence of infection localized to the neck in the 14 days prior to the FDG-PET/CCT scan
* Patient does not meet any of the inclusion criteria
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 287 |
Target Study Title: A Multi-center, Double-masked, Randomized, Placebo-controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis.
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.
#Intervention
- DRUG : Ketotifen/naphazoline
- One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
- DRUG : Naphazoline
- One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
- DRUG : Ketotifen
- One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
- DRUG : Vehicle
- One drop of vehicle ophthalmic solution at visit 3 and visit 4.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
* Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
* Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
* Positive bilateral CAC reaction for at least 2 out of 3 time points at visit 2.
Exclusion Criteria:
* Known contraindications or sensitivities to the study medication or its components.
* Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
* Use of disallowed medications during the period indicated prior to study enrollment or during the study.
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 288 |
Target Study Title: Comparison of the Effects of Erector Spina Plan Block and Paravertebral Block in Laparoscopic Cholecystectomies on Pain Management.
Target Study Description: #Study Description
Brief Summary
Erector spinae plane (ESP) block is a more recent method than paravertebral block (PVB) and has a lower risk of complications. The aim of this study was to compare postoperative analgesia requirements and side-effects in terms of safely reaching the maximum analgesic effect in patients.
Detailed Description
The primary aim of this study was to compare ESP block and PVB as important postoperative pain management in terms of being able to reliably reach the highest analgesic efficacy in patients who underwent laparoscopic surgery which is a frequently applied surgery. The secondary aim was to determine the incidence of postoperative nausea, vomiting and side-effects, and patient satisfaction.
#Intervention
- PROCEDURE : ESPB
- Erector spinae plane block
- PROCEDURE : PVB
- Paravertebral Block
- PROCEDURE : CONTROL
- No block has been done
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* aged >18 years
* patients with the American Society of Anesthesiologists (ASA) physical status I/II -who were planned to undergo laparoscopic cholecystectomy surgery
Exclusion Criteria:
* Did not provide informed consent,
* Had any psychiatric or mental problem that prevented understanding of the informed consent form
* They were planned to undergo emergency cholecystectomy,
* Had any allergy or hypersensitivity to local anaesthetic,
* Had an infection in the needle entry area
* History of coagulopathy or the use of anticoagulants
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 289 |
Target Study Title: A Contrast of Buffered Vs. Unbuffered Lidocaine in Bone Marrow Biopsies
Target Study Description: #Study Description
Brief Summary
Oncology patients require numerous invasive procedures throughout their disease process including bone marrow biopsies (BMB). BMB.s are performed by a significant number of health care providers. One of the biggest concerns for health care providers is to improve patient comfort. The goal of this study was to reduce pain during BMBs.
Specific aims of the study were to determine if there is a difference in patients' perceived pain during injection of the pre-procedure anesthetic when buffered versus unbuffered lidocaine is administered to patient's receiving bone marrow biopsies.
A double blind, experimental crossover design was used to examine the difference in pain levels when using buffered versus unbuffered lidocaine prior to the bilateral bone marrow biopsy procedure. Based on a power analysis for a paired t-test, a convenience sample of 48 patients was enrolled into the study. Patients served as their own control. The site of first biopsy, and which lidocaine solution was administered first, were randomized. A 100mm visual analogue scale (VAS) was used to measure pain.
All data has been collected, are currently under analysis, and results will be completed in August 2006. Differences in groups will be examined using a paired t-test. A demographic questionnaire was used to gather select demographic variables. Correlative studies will be done to examine the relationship between the patient's perceived pain scores and several exploratory variables. Results of this study may change the current type of anesthetic used pre-BMBs thus improving patient comfort.
#Intervention
- DRUG : lidocaine
- Other Names :
- Xylocaine, lignocaine
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Any newly diagnosed patient at the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute whose Hematologist or Oncologist has ordered them to undergo a bilateral bone marrow biopsy for diagnostic and /or treatment purposes.
* 18 years or older.
Exclusion Criteria:
* Pregnant or Lactating women.
* Patients with allergies to local anesthetics.
* Patients requiring a unilateral bone marrow biopsy.
* Patients that cannot lie flat in either the supine or prone position.
* Patients that have used any of the following: narcotics, non-narcotic analgesia or an anti-anxiolytic medication on the same calendar day as the scheduled procedure. These medications will not be given to the participant at any time before or during the procedure.
* Patients on long-acting narcotic medication.
* Patients with neuropathy in the posterior iliac crest area
* Patients with a platelet count less than 20,000.
* Patients who are cognitively impaired or unable to self-report pain using the VAS.
* Patients with known bone metastasis.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 290 |
Target Study Title: A Randomized, Open-label, Single Dose, 2x2 Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination or Loose Combination of PK101 in Healthy Volunteers
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to compare the safety and pharmacokinetics of PK101(fixed-dose combination of PK101-001 and PK101-002) with coadministration of the two separate drugs in healthy volunteers.
#Intervention
- COMBINATION_PRODUCT : PK101
- PK101-001 + PK101-002 (combination)
- DRUG : PK101-001, PK101-002
- coadministration
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Healthy adults >= 19 years (on the day of screening)
* Body weigth >=50.0kg, 18.5Kg/(m)^2 <= (BMI) <=30.0Kg/(m)^2
* No congenital or chronic diseases and no abnormal signs determined by medical examinations
* Not abnormal or not clinical significant lab values
* Understand the requirements of the study and voluntarily consent to participate in the study.
Exclusion Criteria:
* Clinically significant disease with liver, renal, neurologic, respiratory, digestive, endocrine, hemato-oncology, urologic, cardiovascular, musculoskeletal, psychiatric system
* Subjects who have hypersensitivity for investigational products
* AST or ALT > 2*ULN, r-GTP > 1.5*ULN, Blood creatinine > ULN (ULN, Upper Limit of Normal)
* SBP >= 140 mmHg or< 90 mmHg, DBP >= 90 mmHg or < 60 mmHg
* Subjects who were administered below medications within 30 days (barbiturates, drugs of induced or suppressive drug metabolizing enzyme, etc)
* Subjects who previously participated in other clinical trials or bioequivalence Test within 6 months
* Subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing.
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 291 |
Target Study Title: Development of Advanced Leak Detection Technologies for Positive Airway Pressure Devices Therapies
Target Study Description: #Study Description
Brief Summary
This study will take between 1-2 months (with first patient first visit to last patient last visit). Each participant will use the supplied PAP device and mask for a period of up to 14 nights. Participants will complete a series of questionnaires. The study will collect data to support the development of an advance leak detection technology.
Detailed Description
The investigation device is designed to collect leak patterns which will be analysed to develop an advanced leak detection technology to help users/patients to troubleshhot therapy issues.
This will be a multi-centre, multiphase, single arm study. The study will be conducted in the home environment.
Recruitment Recruitment will be done via phone calls/ SMS messages/ emails. Participants will be explained the details of the trial and those who wish to take part will be invited to ResMed for the first study visit.
Visit 1 Participants will provide written informed consent. If eligible, baseline participant demographics will be collected. Participants will be shown the investigation equipment. If the participant is happy to proceed, the therapy and comfort settings of the trial PAP device will be set-up to match their current PAP device and a mask similar to the participant's current mask will be provided to take home and be use in place of their own equipment.
Visit 2 After completing 7 days of the trial participants will return to the ResMed. The researcher will review the questionnaire and data quality with the participant.
Visit 2 may not be performed or completed via digital platform. For Phase 2 of this study. Visit 2 may not be completed as confidence in the system set up is achieved via Phase 1.
Visit 3
After completing another 7 days of the trial, participants will return to the ResMed. The participant will return all trial equipment researcher. The participants' questionnaire responses and data will be reviewed. This concludes the participation in the study.
#Intervention
- DEVICE : Positive Airway Pressure (PAP) Therapy
- PAP therapy supplies pressurized air from the flow generator to the upper airway via air tubing and a mask to prevent the repetitive collapse of the upper airway during sleep.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Patients willing to give written informed consent.
* Patients who have a possible risk of mouth leak.
* Patients willing to give written consent for the recording of full band audio during sleep session.
* Patients who are willing to not wearing chin strap for a period of nights during study, if they currently use one.
* Patients who can read and comprehend English
* Patients who >= 18 years
* Patients being established on PAP therapy for the treatment of OSA for >= 6 months
* Patients currently using an appropriate mask system, AirFit P10, AirFit N20, AirFit N20, AirFit N30i (2 check version is correct) or similar mask (non-full face).
* Patients who can trial the investigational device for up to 14 nights
* Patients who have been compliant to therapy for the previous 7 nights of use.
Exclusion Criteria:
* Patients willing to give written informed consent.
* Patients who have a possible risk of mouth leak.
* Patients willing to give written consent for the recording of full band audio during sleep session.
* Patients who are willing to not wearing chin strap for a period of nights during study, if they currently use one.
* Patients who can read and comprehend English
* Patients who >= 18 years
* Patients being established on PAP therapy for the treatment of OSA for >= 6 months
* Patients currently using an appropriate mask system, AirFit P10, AirFit N20, AirFit N20, AirFit N30i (2 check version is correct) or similar mask (non-full face).
* Patients who can trial the investigational device for up to 14 nights
* Patients who have been compliant to therapy for the previous 7 nights of use.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 120 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 292 |
Target Study Title: A Randomized Study to Assess the Effect of Different Fat Enriched Meats on the Hepatic Cholesterol Synthesis
Target Study Description: #Study Description
Brief Summary
The objective of the study is to assess the effect of two diets with different fat composition on cholesterol metabolism. The study was a randomized cross-over trial where volunteers follow two study periods with different types of meat (lean and fat red meat) separately by a ten days wash-out period. At the beginning of the study and after the study periods the following parameters are determined: anthropometric (weight, waist, circumference and body mass index), blood pressure, dietary (72-hours dietary registry) and exercise assessments and biochemical analysis (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, apolipoprotein A1, apolipoprotein B, iron, transferring, ferritin, uric acid, glucose, HbA1c and insulin). Serum concentration of non cholesterol sterols (sitosterol, campesterol, stigmasterol, desmosterol and lanosterol) and oxysterols (24S-hydroxycholesterol, 27-hydroxycholesterol and 7α-hydroxycholestenone) were measured by High Performance Liquid Chromatography tandem Mass Spectrometry in these subjects throughout along the study in order to demonstrate the effect of different red meat on the hepatic metabolism of cholesterol.
#Intervention
- BEHAVIORAL : Changes in cholesterol metabolism
- OTHER : Lean red meat diet
- OTHER : Fat red meat diet
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Normolipemic healthy subjects defined by levels of LDL cholesterol and triglycerides below the 90th percentile adjusted for age and sex.
* Diet and stable lifestyle with controllable feeding.
Exclusion Criteria:
* Pregnancy or intention of pregnancy during the study.
* Lipid lowering drugs in the last 3 months.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 293 |
Target Study Title: Exercise Effects on Appetite-regulating Hormones and Cardiovascular Risk Factors in South Asian and White European Men
Target Study Description: #Study Description
Brief Summary
The aim of this study is to examine the effect of a single bout of moderate exercise, standardized breakfast and buffet meal on appetite-related hormones, type two diabetes and cardiovascular risk factors with a comparison between healthy South Asian and white European men. It is of interest to see if any factor differences occur in appetite-regulating hormones and cardiovascular disease risk factors whilst exercising. If so strategies may be used to alter regulation in diet and exercise to reduce risk cardiovascular disease as this is the number one cause of death globally.
Detailed Description
Cardiovascular diseases are recognised as the number one cause of death globally. Furthermore, diabetes is a major risk factor for cardiovascular disorders with abundant evidence showing that patients with type 2 diabetes (T2D) are at higher risk of cardiovascular disease (CVD) than those with a normal glycaemia.
In contrast to the declining numbers in the Western world, the prevalence of CVD and T2D is growing in low - and middle - income countries accompanied by a rapid increase of mortality and morbidity. Of interest, a rise in CVD prevalence has been particularly observed in people of South Asian origin including India, Bangladesh, Pakistan, Sri Lanka or Nepal with a projection showing that in this population deaths attributed to CVD will rise globally to nearly 36 % in 2030 compared to 29 % in 2005. South Asians collectively form 20% of the global population while in the UK they are the largest ethnic minority group representing over 5% of the total UK population .
Although the majority of research has been conducted mainly on White individuals, recent studies have revealed that traditional CVD risk factors such as hypertension, dyslipidaemia, insulin resistance and diabetes are higher in South Asians than other ethnicities. The factors underlying the high CVD risk in this population remain largely unexplained even though genetic predisposition and physical inactivity could play a key role. In contrast to European counterparts, sedentary lifestyles or physical inactivity have been identified as an important coronary heart disease (CHD) risk factor in South Asians. A systematic review from the United Kingdom (U.K.) showed that South Asians are participating in up to 50-75% less physical activity compared to their European counterparts.
In addition to the traditional risk factors there are emerging biomarkers which could represent meaningful predictors of metabolic disorders and related complications. Specifically, appetite hormones secreted mainly by the gastrointestinal tract, such as Acylated Ghrelin or Peptide YY (PYY) have shown potential effects on glucose homeostasis and cardiovascular system. Current experimental studies suggest beneficial cardiovascular, anti-inflammatory and anti-apoptotic effects of ghrelin in the cardiovascular system.
Although evidence suggests that ghrelin may be a potential metabolic risk factor and is important in appetite regulation, no studies to the researcher's knowledge have examined changes of this peptide in South Asians despite the fact that CVD and T2D burden in the South Asian population is growing. Likewise, although studies have investigated the effects of exercise on ghrelin and other appetite hormones, no study has taken in consideration the effects of exercise on appetite gut hormones in South Asian populations.
Therefore, this research project aims to examine specific appetite hormones in response to a single bout of exercise, standardised meal and ad libitum buffet meal, with a comparison between South Asians and White Europeans identifying potential relationships with genetic and other metabolic risk factors.
#Intervention
- BEHAVIORAL : Exercise
- Participants will be required to complete two, 8-hours trials (exercise \& control) in a randomised order, preceded by 2 hours of preliminary testing (baseline) with no more than 14 days between conditions.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Non-smoker
* Non-dieting
* Physically well to participant in maximal exercise
* Male
* Not taking any anticoagulant or anti-inflammatory medication
* Between the ages 18 <= age <= 50
* White European or South Asian
Exclusion Criteria:
* Those that are taking any anticoagulant or anti-inflammatory medication
* Those with a known medical condition such as diabetes, cardiovascular disease.
Sex :
MALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 294 |
Target Study Title: Evaluation of the Effect of Different Foods, Carbohydrate Meal, and a Euglycaemic Insulin Clamp on the QT/QTc Interval Using a Single Dose of Moxifloxacin as a Positive Control in Healthy Male and Female, Caucasian and Japanese Volunteers
Target Study Description: #Study Description
Brief Summary
Moxifloxacin is routinely used as a probe to confirm assay sensitivity in thorough electrocardiogram (ECG) studies. It has been shown that a meal shortens the QT interval, which may affect pharmacokinetics (PK) and/or pharmacodynamics (PD) of the study drug. However, there is no published data clarifying this issue. There is also a paucity of data investigating ethnic differences of the effects of medicines on QTc.
The aims of the study were to compare the effect of different food contents to placebo on the changes in ECG and to demonstrate the effect of insulin, C-peptide and glucose on the ECG. This was done by giving different treatments on separate days, which included intravenous insulin, a high carbohydrate breakfast \[\>70%\], and a calorie reduced low carbohydrate American FDA standard breakfast. Moxifloxacin 400 mg was used as a positive control and was given with and without food to Caucasian and Japanese volunteers to investigate racial differences.
Detailed Description
This study was initially performed in 24 healthy Caucasian and Japanese volunteers with an option to increase the sample size to up to 54 volunteers. The decision to increase the sample size to 32 was based on the standard deviation of the ECG intervals observed in the first 24 volunteers. This analysis was performed by an independent statistician under blinded conditions.
Each volunteer participated in 2 periods. Each period consisted of 1 baseline day (D-1) followed by 3 study days (D1 - D3) when the various food effect and drug treatments or placebo were administered. All volunteers received all treatments. Moxifloxacin was always given on D3 to prevent any carryover effect and there was a minimum washout period of 3 days in between the 2 periods.
How well the treatments (insulin/glucose, high carbohydrate breakfast, calorie reduced breakfast and moxifloxacin) were tolerated by the volunteers was assessed and any side effects noted.
We compared the effects of the various treatments between Caucasian and Japanese volunteers.
Moxifloxacin and placebo were given to volunteers by mouth, i.e. they were asked to swallow them with water. The different types of breakfast were provided which volunteers were asked to eat. Insulin and glucose were administered intravenously (Insulin/glucose clamp). Hence, the study was performed as an open-label design.
This study was conducted as a single site study at Richmond Pharmacology/ St George's University of London.
#Intervention
- DRUG : Moxifloxacin 400 mg fasted
- Subjects receiving drug (400 mg moxifloxacin),having fasted overnight for 10 hours.
This is the standard probe for the assessment of assay sensitivity in Thorough QT (TQT) studies.
- Other Names :
- Moxifloxacin
- OTHER : FDA breakfast
- Calorie reduced FDA standard breakfast (58% fat, low carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a lesser effect on QTc compared to a carbohydrate rich breakfast should be observed.
- OTHER : Continental breakfast
- High carbohydrate breakfast (\>70% carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a greater effect on QTc compared to a low carbohydrate breakfast (FDA standard breakfast) should be observed.
- DRUG : Moxifloxacin 400 mg fed
- Currently, there is no published data showing the effects of a single 400 mg oral dose of moxifloxacin on the ECG/QT/QTc after food.
- Other Names :
- Moxifloxacin
- PROCEDURE : Insulin Clamp
- A euglycaemic/hyperinsulinaemic clamp, (DeFronzo, 1979) involves acutely raising the plasma insulin levels to a steady state and maintaining a state of euglycaemia with a glucose infusion, thereby effectively stopping endogenous insulin and C-peptide release. This technique will confirm whether hyperinsulinaemia has any effect on the QT/QTc interval.
- DRUG : Placebo
- Comparison of different meals effect on Moxifloxacin PK profile
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Healthy male or female, 20 - 45 years
* Signed ICF
* Japanese - a descendant of four Japanese grandparents, carrying a Japanese passport and has not been outside Japan for more than 5 years prior to screening
* The Caucasian - light to brown skin pigmentation; straight to wavy or curly hair; indigenous to Europe, northern Africa, western Asia, and India. The study may also include Caucasians from North America, Australia and South Africa
* No clinical findings on the physical examination
* Body mass index (BMI) = 18 - 25 kg/m2, body weight at least 48 kg.
* Systolic blood pressure 90 <= age <= 145 mmHg, diastolic blood pressure 40 <= age <= 90 mmHg, and heart rate 40 <= age <= 90 bpm
* Triplicate 12 lead ECG without clinically relevant abnormalities
* 24 hour 12 lead Holter ECG without clinically relevant abnormalities
* Haematology, biochemistry and urinalysis within the normal range
* Must agree to use acceptable methods of contraception
Exclusion Criteria:
* History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug
* History of clinically significant syncope.
* Family history of sudden death.
* Family history of premature cardiovascular death.
* Family history of congenital long QT syndrome or Brugada's syndrome.
* History of arrhythmias and ischemic heart disease
* Conditions predisposing to electrolyte imbalances (e.g. altered nutritional states, chronic vomiting, anorexia nervosa, bulimia nervosa).
* Abnormal ECG in the standard 12-lead ECG and 24-hour 12 lead Holter ECG
* Abnormal rhythm, conduction or morphology of resting ECG, such as:
* Sinus node dysfunction.
* Clinically significant PR (PQ) interval prolongation.
* Intermittent second or third degree AV block.
* Incomplete or complete bundle branch block.
* Abnormal T wave morphology.
* Prolonged QTcB >450 msec or shortened QTcB < 350 msec or family history of long QT syndrome.
* Abnormal blood glucose result (blood glucose >7.8mmol/l)
* Significant family history of diabetes mellitus.
* Significantly elevated fasting blood glucose level
* Signs and/or symptoms of acute illness in the four-week period prior to screening.
* Veins unsuitable for intravenous puncture or cannulation on either arm
* Known hypersensitivity to any medicines administered in the trial.
* Treatment with any prescribed medication during the 2 weeks prior to first baseline day.
* Treatment with any over-the-counter (OTC) medications during the 2 weeks prior to first baseline day.
* Treatment with vitamins and/or minerals within 48 hours prior to the first baseline day.
* Treatment with another investigational drug within 4 weeks prior to dosing or having participated in more than 3 investigational drug studies within a year prior to dosing.
* Positive urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates and methadone) or the alcohol breath test
* History or clinical evidence of alcoholism (regular weekly alcohol intake of more than 14 units if female and 21 units if male) or drug abuse (compulsive, repetitive and/or chronic use of drugs or other substances with or without problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms)
* Excessive caffeine consumption (>=800 mg per day)
* Smoking within 3 months prior to screening
* Loss of 250 mL or more blood within 3 months prior to screening.
* Positive results from the hepatitis serology, except for vaccinated subjects.
* Positive results from the HIV serology.
* Any circumstances or conditions, which may affect full participation in the study or compliance with the protocol.
* Legal incapacity or limited legal capacity.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 45 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 295 |
Target Study Title: Pharmacokinetics of Mycophenolate Mofetil Alone and in Combination With Valganciclovir in Renal and Heart Transplant Recipients
Target Study Description: #Study Description
Brief Summary
The primary objective of this study is to determine whether a clinically significant PK drug interaction ( a 30% difference in the AUC of MPA) exists between mycophenolate mofetil (under steady state conditions) and VGCV in renal and cardiac transplant recipients.
This study will provide clinically relevant information to the transplant community. It will more clearly delineate whether a clinically significant PK drug interaction exists between mycophenolate mofetil (under steady-state conditions)and VGCV. Given the established dose/efficacy relationship of both MMF and VGCV, this study will provide improved dosing guidelines and potentially avoid adverse outcomes due to empiric dosage adjustments.
Detailed Description
Mycophenolate mofetil (immunosuppressant, MMF) and valganciclovir (antiviral, VGCV) are commonly administered together in transplant patients. Following oral administration, both MMF and VGCV are metabolized to active forms, mycophenolic acid (MPA) and gancoclovir (GCV) respectively. Both MPA and GCV are eliminated through kidney and renal excretion, but there is no data on how MPA pharmacokinetic parameters are affected by GCV at steady state condition. Both MPA and GCV can cause neutropenia and although unsubstantiated, some clinicians have observed an increased occurrence of neutropenia when these agents are used in combination. In the presence of neutropenia, practitioners are often challenged when making decisions regarding whether the dosage of one or both agents should be reduced. It would be useful to know whether the neutropenia is due to increased drug concentration or whether it is due to direct effects of these agents on the bone marrow.
#Intervention
- DRUG : Mycophenolate mofetil
- DRUG : Valganciclovir
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
The subject must be able to give informed consent for the study. Stable renal or cardiac transplant patients age 18 years and older. Patients must not have had an acute rejection episode within the previous 30 days of the 1st PK study.
Renal transplant patients with serum creatinine < 2 mg/dL and with change in serum creatinine < 25% within the 2 weeks prior to the 1st PK study.
Renal and cardiac transplant patients receiving VGCV for prophylaxis of CMV while concomitantly receiving MMF.
Stable MMF dose: the dose of MMF must not have been adjusted within 1 week of the 1st PK study and must be the same during the 2nd PK study Stable renal function during the study period (change in serum creatinine < 25%)
Exclusion Criteria:
Patients who are not prescribed MMF maintenance therapy or are receiving Myfortic.
Patients who do not require VGCV prophylaxis (CMV negative recipients of CMV negative donor organs).
Patients who have their MMF doses adjusted either < 1 week before the 1st scheduled PK study or anytime during the study period.
Patients whose serum creatinine changes by > 25% within 2 weeks prior to study initiation.
Patients whose hematocrit < 28%. Patients who received other organ transplants in addition to a kidney or heart. Patients who are pregnant or breast-feeding. Patients prescribed bile acids, bile acid sequestrants, potassium binding resins, or magnesium/aluminum-containing antacids.
*
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 296 |
Target Study Title: Tailored Rapid Interactive Mobile Messaging (TRIMM) for Weight Control Among the Underserved
Target Study Description: #Study Description
Brief Summary
This project will test the efficacy of the 'TRIMM' (Tailored Rapid Interactive Mobile Messaging) program, a user-friendly, semi-individualized text-messaging intervention to facilitate lifestyle change and weight loss among obese African-American adults with or at risk for diabetes, in a pilot, controlled clinical trial.
The text-messaging intervention will be in addition to, and compared with traditional diet, behavior, and physical activity education. Tips will be designed to increase knowledge, skills, and motivation.
Detailed Description
Type-2 diabetes, and its most important risk factor, obesity, have become major strains on our nation's health care system. By 2050, one in three U.S. adults could have diabetes (Stobbe, 2010), and obesity currently contributes nearly 17% of U.S. medical costs (Cawley, 2010). Our nation's underserved urban minority populations disproportionately suffer from type-2 diabetes and obesity. African-Americans, for example, comprise 12% of the US population but 23% of the extremely obese (Livingston, 2004). To reduce diabetes, obesity must be addressed. Unfortunately, traditional obesity interventions are intrusive and costly.
This project will test the efficacy of the 'TRIMM' (Tailored Rapid Interactive Mobile Messaging) program, a user-friendly, semi-individualized text-messaging intervention to facilitate lifestyle change and weight loss among obese African-American adults with or at risk for diabetes, in a pilot, controlled clinical trial.
The text-messaging intervention will be in addition to, and compared with traditional diet, behavior, and physical activity education. Tips will be designed to increase knowledge, skills, and motivation. Participants will have the option to receive spiritually-based messages, if desired.
166 overweight or obese men and women will be recruited from 10 Baltimore inner-city churches, and will be assigned to one of two, six-month lifestyle-change programs. Participants must be overweight, aged 21-65, and own a cell phone with text-messaging capability. To be eligible for the study, participants will need to first pass a health screening and meet other study criteria.
The McKesson Foundation is funding this study, which has a total of 5 visits, ranging from ½ hr. to 3 hrs. The active intervention will last 6 months, with a follow-up visit at month 12. The TRIMM Program will feature periodic, individualized text messages and feedback via the participant's mobile phone as well as periodic follow-up appointments. The traditional program will consist of traditional diet, behavior, and physical activity education.
Qualified participants will receive individualized weight-loss plans and monetary compensation for their time, effort, \& parking.
The long-term goal is to demonstrate, using a real-life setting, the potential superiority in efficacy of a specific mHealth application (text-messaging) for an underserved population at high risk of type-2 diabetes, compared to traditional, often more costly, and currently underutilized lifestyle-change interventions.
#Intervention
- BEHAVIORAL : TRIMM Intervention
- Individuals in the TRIMM arm receive daily, individualized text-messages promoting positive lifestyle changes to support weight loss/management.
- BEHAVIORAL : Standard Care
- Individual assessment, lifestyle counseling
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Participants must be African-American,
* aged 21 <= age <= 65,
* have a phone with unlimited text/SMS capability,
* a BMI > 27, and
* be free from uncontrolled hypertension or other health or mental health condition that would make it inappropriate or unsafe for them to participate.
Exclusion Criteria:
* Following initial assessments, participants will be excluded if they are currently abusing alcohol/other substances, or
* have an Inventory of Depressive Symptomatology (IDS-SR) score > 38 ('severe to very severe' depression).
Potential participants with uncontrolled hypertension (> 160 systolic or >95 diastolic), HbA1c > 8, or symptomatic CAD will be referred for medical clearance.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 297 |
Target Study Title: An Open Label, Single-center, Phase 1 Study to Evaluate the Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cell in Patients With Chronic Kidney Disease
Target Study Description: #Study Description
Brief Summary
This clinical trial is an open, single-center, phase 1 clinical trial to evaluate the safety of allogeneic bone marrow-derived mesenchymal stem cell injection in patients with chronic kidney disease.
The purpose is to evaluate the safety for 12 months after administration of Cellgram-CKD 3 times in 10 patients with chronic kidney disease.
Detailed Description
The screening test is performed after the clinical trial subject consents in writing to participate in the clinical trial.
Subjects who meet the inclusion/exclusion criteria are registered in the clinical trial, and Cellgram-CKD is injected intravenously by puncturing a vein with a needle. After injecting Cellgram-CKD three times at an interval of 2 weeks (14 days), the subject visits the testing institution at 1 month, 3 months, 6 months, 9 months and 12 months for safety evaluation.
However, since the safety of Cellgram-CKD has not been established, proceed as follows.
In the first 3 subjects who received the investigational product, if no adverse events of Grade 3 or higher according to the NCI-CTCAE related to the investigational product occur 14 days after the 1st and 2nd administration, and 1 month after the 3rd administration, the remaining subjects were sequentially treated. Register as a member and conduct clinical trials.
If an adverse event of Grade 3 or higher according to the NCI-CTCAE standard related to the test drug occurs in two of the first three subjects, the clinical trial is terminated early. is conducted by registering three additional test subjects in the same way as the first.
If one or more of the three subjects develops a Grade 3 or higher adverse event related to the investigational product, the clinical trial is terminated early, and the remaining subjects are treated only if all three subjects do not have a Grade 3 or higher adverse reaction related to the investigational product. Register to continue the clinical trial.
#Intervention
- BIOLOGICAL : Cellgram-CKD
- Allogeneic bone marrow-derived mesenchymal stem cell therapy for the treatment of chronic kidney disease
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Male or female between the ages of 19 and 79
* Those diagnosed with CKD stage 3b or 4 [eGFR 15 - 44 ml/min/1.73 m2] within 1 year before screening
* Those who voluntarily participated in the clinical trial and signed the Informed consent form
Exclusion Criteria:
* Those with severe cardiovascular disease (angina, myocardial infarction, unstable arrhythmia, heart failure, etc.) at the screening visit
* Those with the following medical history/comorbidities A. Gentamicin hypersensitivity reaction B. Solid cancer or malignant blood disease within 5 years prior to screening C. Clinically significant cognitive disorder, dementia or psychiatric disorder D. Alcohol or drug abuse E. Severe respiratory disease (COPD, asthma, pneumonia, pulmonary embolism, pneumothorax, etc.) F. Stroke G. Systemic autoimmune disease
* Those whose test results fall under the following at the screening visit A. Pathogenic microorganism test (Hbs Ag, HCV Ab, HIV Ab, Syphilis) positive B. Uncontrolled hypertension (systolic blood pressure >190 mmHg or diastolic blood pressure >100 mmHg) or hypotension (systolic blood pressure <90 mmHg or diastolic blood pressure <50 mmHg) C. AST and ALT >= upper limit of normal x 3.0 D. Total bilirubin >= upper limit of normal x 1.5
* At screening, those who have the following treatment history A. Those who are being treated for severe systemic infection B. Those who have been treated with immunosuppressant within 28 days prior to screening
* Those with a history of renal transplantation
* Those who have received dialysis within 3 months prior to the screening visit or who are planning to undergo dialysis during the clinical trial period
* Pregnant, lactating, or planning during clinical trials
* Those who do not agree to comply with the contraceptive method specified in this protocol during the clinical trial period
* Those who are receiving drugs that are expected to affect the results of this clinical trial when judged by the investigator
* Those who participated in other interventional clinical trials within 4 weeks prior to the screening visit and received investigational products/medical devices for investigational use or received procedures
* Those who have or are planning to administer other cell therapy products
* Those who are judged by the investigator to be inappropriate to participate in this clinical trial
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 79 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 298 |
Target Study Title: Relative Bioavailability of a Mirikizumab Test Formulation Compared to the Reference Formulation in Healthy Subjects
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to compare two different formulations of mirikizumab in healthy participants. This study will compare how much of each formulation gets into the blood stream and how long it takes the body to remove it. Information about any side effects that may occur will also be collected. Participants will remain in the study for about 12 weeks, after receiving study drug.
#Intervention
- DRUG : Mirikizumab
- Reference and test formulations of mirikizumab administered as a SC injection.
- Other Names :
- LY3074828
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Are overtly healthy males or females, as determined through medical history and physical examination
Exclusion Criteria:
* Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
* Must not show evidence of active or latent tuberculosis (TB)
* Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 8 weeks of screening, or intend to during the study
* Must not have been treated with steroids within 1 month of screening, or intend to during the study
* Must not be immunocompromised
* Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1
* Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
* Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
* Must not have had breast cancer within the past 10 years
* Must not have significant allergies to humanized monoclonal antibodies
* Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 299 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.