input
stringlengths 798
36.8k
| output
stringlengths 218
19.2k
| __index_level_0__
int64 0
214k
|
|---|---|---|
Target Study Title: Three-dimensional Computed Tomography Reconstruction for Operative Planning in VATS Segmentectomy
Target Study Description: #Study Description
Brief Summary
Anatomical variations of pulmonary vessel may cause serious problems during pulmonary segmentectomy. Three-dimensional （3D）computed tomography (CT) presents 3D images of pulmonary vessels and the tracheobronchial tree and may help operative planning. Retrospective studies have identified the importance of 3-dimensional CT in the field of pulmonary segmentectomy. And the aim of this study is to compare the usefulness of 3-dimensional CT with standard chest CT in preoperative planning of video-assisted segmentectomy.
Detailed Description
Lung cancer has been the most serious malignancy around the world which has the highest morbidity and mortality amount all the malignant tumors. Due to the wide spread of lung cancer screening, more and more early stage lung cancer patients have been diagnosed. Video-assisted segmentectomy is a standard surgical procedure in treating early stage peripheral non-small cell lung cancer (NSCLC). However, anatomical variations of pulmonary vessel may cause serious problems, for example unexpected bleed during surgery. Three-dimensional computed tomography (CT), which is reconstructed based on the standard chest CT image, presents 3D images of pulmonary vessels and the tracheobronchial tree and therefore helps operative planning. There are several retrospective studies addressed the importance of 3-dimensional CT in the field of pulmonary segmentectomy. And the aim of this multicenter randomized controlled trial is to compare the usefulness of 3-dimensional CT and standard chest CT in preoperative planning of video-assisted segmentectomy.
#Intervention
- OTHER : 3D reconstruction
- 3-dimensional computed tomography reconstruction guided VATS segmentectomy
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 older than 18 years;
* Pulmonary nodules or ground glass opacification （GGO） found in chest CT examination, and conform with indications for segmentectomy:
Peripheral nodule 0.8 <= age <= 2 cm with at least one of the following:
i. Histology of adenocarcinoma in situ; ii. Nodule has >=50% ground-glass appearance on CT; iii. Radiologic surveillance confirms a long doubling time (>=400 days). Segmentectomy should achieve parenchymal resection margins >=2 cm or >= the size of the nodule.
* Adequate cardiac function, respiratory function, liver function and renal function for anesthesia and VATS segmentectomy.
* American Society of Anesthesiologists (ASA) score: Grade I-III.
* Patients who can coordinate the treatment and research and sign the informed consent.
Exclusion Criteria:
* Patients with a significant medical condition which is thought unlikely to tolerate the surgery. For example, cardiac disease, significant liver and renal function disorder.
* Patients with psychiatric disease who are expected lack of compliance with the protocol.
* Patients have history of chest trauma or surgery on ipsilateral chest which may cause pleural adhesion.
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>
| 400 |
Target Study Title: Acute and Long Term Effect of Kinesio Tape on Motor Function, Proprioception and Balance in Subjects With ACL Rupture
Target Study Description: #Study Description
Brief Summary
Thirty-two participants with ACL rupture were included in the study. All participants were divided in two groups - control and experimental. In the experimental group (n=16) participants received 4 weeks standardized physiotherapy and Kinesio tape, in the control group - standardized physiotherapy.
Experimental measurements: Anthropometric measurements, pain intensity, static and dynamic balance, proprioception, knee flexion and extension muscle torque, level of activity
#Intervention
- OTHER : standardized physiotherapy program and Kinesio tape
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 - 35 years men;
* a normal contralateral knee,
* not a longer period than 3 months after ACL rupture.
Exclusion Criteria:
Participants were excluded if either knee had previously been injured or had undergone surgery, if they had concurrent osteoarthritis, if they had injured the posterior cruciate ligament, lateral collateral ligament, or posterolateral complex of the knee, or if they had a grade III tear of the medial collateral ligament.
Sex :
MALE
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>
| 401 |
Target Study Title: Assessment of Pain in Plantar Fasciitis Managed by Histotripsy
Target Study Description: #Study Description
Brief Summary
Plantar fasciitis or plantar fasciitis is the most commonly reported cause of pain under the heel. Its prevalence varies from 3.6 to 7% in the general population. It is a painful condition of the foot that corresponds to an inflammation of the plantar fascia.
At present, histotripsy in the field of orthopedics is very little used. The concept of therapeutic ultrasound intended for the treatment of plantar fasciitis by fascial section was developed in the United States but no study evaluating its effects on pain is available.
There is no equivalent study on histotripsy in the pathology of chronic plantar fasciitis or fasciitis. In this study, histotripsy will be performed using a conventional serial ultrasound system with this focused energy function.
The research hypothesis is that histotripsy treatment may be an alternative to pain management in patients with plantar fasciitis who have failed conventional treatments.
The main objective of this study is to evaluate the evolution of the pain felt by patients with plantar fasciitis resistant to conventional medical treatment, one month after two ultrasound histotripsy sessions.
#Intervention
- PROCEDURE : Histotripsy ultrasound session
- The study will be performed with the MINDRAY DP-10 ultrasound device equipped with a linear probe and histotripsy functionality.
- OTHER : VAS questionnaire
- Pain assessment with the EVA questionnaire
- OTHER : AOFAS questionnaire
- AOFAS questionnaire at visit 1 and visit 4 (75 days after the first 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:
* Patient, male or female, aged 18 years minimum
* Patient with plantar fasciitis evolving for at least 6 months
* Patients with radiology and MRI of the foot less than 3 months old
* Visual analogue pain scale greater than 5 at inclusion
* Patient in whom conventional medical treatment has failed by the combination of radial shock waves, plantar orthoses, and corticosteroid infiltration that has not provided relief.
* Patient affiliated with or beneficiary of a social security scheme.
* Patient who has been informed and has given his/her free, informed and written consent.
Exclusion Criteria:
* Minor patient
* Major retraction of the triceps surae on the MAESTRO oblique board test: sequelae of bone trauma to the hindfoot and ankle.
* Inflammatory rheumatological diseases
* Fibromyalgia
* Patients in whom a specific underlying organic pathology (inflammatory, infectious, neoplastic, etc.) has been identified.
* Psychiatric disorders
* Patient participating in another research study.
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman.
* Patient hospitalized without 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>
| 402 |
Target Study Title: Dietary Nitrate in Japanese Traditional Foods Lowers Diastolic Blood Pressure in Healthy Volunteers.
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine whether traditional japanese diet blood pressure in healthy volunteers.
Detailed Description
Japanese traditional diet contains considerably more nitrate/nitrite than the European foods. 80% of dietary nitrate originates from vegetables. Green leafy vegetables, especially spinach, salad and seaweed are rich in nitrates. Other vegetables contain nitrate at lower concentrations, but because they are consumed in greater quantity, they may contribute more nitrate and thus nitrite from the diet. Nitrate/nitrite is attributed multiple health benefits. Japanese people have an exceptional longevity and the lowest rate of heart diseases. On the other hand, gastric cancer rate is high too. Nitrate/nitrite is strongly correlated with these phenomena. Is this high nitrate consumption protective or damaging? Understanding dietary nitrite and nitrate consumption and its metabolism therefore becomes very important.
Aim: To compare conversion of nitrate to nitrite in Japanese people, measured in blood and in saliva during consumption of traditional Japanese foods vs European diet.
#Intervention
- DIETARY_SUPPLEMENT : traditional Japanese diet
- 10 days of nitrate rich diet (Japanese traditional). After that switch to nitrate low diet for 10 days (European foods). Study nitrate/nitrite in blood, saliva and blood pressure 3 times in each person (10 min each time). A list of Nitrate rich foods are provided.
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
Exclusion Criteria:
* high/low blood pressure
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 403 |
Target Study Title: Promoting Walking in Older Adults Living in Independent Living Communities in Northern Ireland: A Feasibility Study.
Target Study Description: #Study Description
Brief Summary
The multi-level 12 week peer-led walking intervention incorporates aspects from all three levels of the ecological model (with the aim of producing sustained (\>6months) physical activity behaviour change in older adults living in independent living communities.
Detailed Description
The proposed study is a cluster randomized controlled feasibility trial of a multi-level peer-led walking intervention. The socio-ecological model and social cognitive theory provides the framework that will help inform and test the feasibility of a multi-level peer-led walking intervention for inactive older adults living in independent living communities in Northern Ireland. The behaviour change techniques identified and extracted from a previous systematic review on the effectiveness of peer-led physical activity interventions helped guide the decision-making process of which behavior change strategies should be included in this study. The logic model helped inform the design and development of the 12 week peer-led walking programme.
#Intervention
- BEHAVIORAL : The friendly walking group
- A 12 week peer led walking group for adults and older adults (\> 55 years) living in independent living communities in Northern Ireland. Designed to increase physical activity levels of inactive older adults and measure sustained changes in physical behaviour 6 months after the intervention ends.
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 over the age of 60 years recruited from fold housing associations, dependent on site; those receiving nursing care will not be included.
* Inactive/not regularly walking (less than 30 minutes
* Have the ability to read, write, understand and speak English.
* Can walk freely without human assistance (residents will be included they use a walking stick/walking aid.)
Exclusion Criteria:
* If they have fallen in the last 6 months
* Have regular nursing assistance/care within the fold
* Residents with dementia or other cognitive challenges will be excluded.
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 404 |
Target Study Title: Lottery Incentives for Moving
Target Study Description: #Study Description
Brief Summary
The purpose of the study is to learn more about effective ways to motivate people to increase their non-exercise energy expenditure exercise. This is an important research question because obesity and weight-related issues are increasingly becoming a problem in America. This project will address this research question by testing the effect of two different incentive schemes in motivating employees who are predominantly sedentary to use Walkstations at work. The Walkstations are treadmills that move at a very slow rate (maximum 2miles / hour) and are attached to a work station (i.e. with computer and telephone); they therefore are designed to increase energy spent not through heavy exercise, but through small changes in posture and movement associated with routines in daily life (called nonexercise activity thermogenesis or NEAT).
Subjects will be employees of Blue Cross Blue Shield of Massachusetts (BCBSMA). Subjects will be the control participants from the previous Walkstation study we ran with BCBSMA. All 120 control participants from this previous study will be told that they can now participate in a study that involves the Walkstations (up until now, they have not been given access to the Walkstations). These participants from the previous study will be sent an email informing them that they are eligible to participate in this new Walkstation pilot. Those who are interested in participating will then be invited to sign up for an enrollment session. There will be no incentives for participating in the initial enrollment session. For the 2 month follow-up session, participants will have a chance to win 1 of 3 prizes (1 \* $100, 2 \* $50) for completing the follow-up.
#Intervention
- BEHAVIORAL : Incentive to exercise
- Participants who attain their walkstation goal will be entered into a draw every two weeks. We are testing the effect of different prizes on walkstation usage.
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 pass ParQ
Exclusion Criteria:
* if fail ParQ
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>
| 405 |
Target Study Title: A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of Nolasiban to Increase On-going Pregnancy Rate Following Fresh Single Blastocyst Transfer Resulting From IVF
Target Study Description: #Study Description
Brief Summary
The primary objective of this study is to confirm the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks post-embryo transfer (ET) day.
Detailed Description
The study is a prospective, randomised, parallel group, double-blind, placebo-controlled, Phase 3 study to confirm the efficacy and the safety of nolasiban versus placebo to increase pregnancy and live birth rates in 820 women undergoing fresh single blastocyst transfer following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).
#Intervention
- DRUG : Nolasiban
- Nolasiban single oral administration
- DRUG : Placebo
- Placebo single oral administration
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:
* Indicated for IVF/ICSI in the context of assisted reproductive technology (ART)
* Follow a gonadotropin releasing hormone (GnRH) antagonist protocol, single injection of human chorionic gonadotropin (hCG) for triggering final follicular maturation and luteal support with vaginal micronized progesterone.
* Single fresh D5 embryo transfer
Exclusion Criteria:
* Frozen-thawed embryo transfer
* Donor egg in the current transfer
* More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle
* Serum P4 greater than 1.5 ng/mL prior to hCG administration
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 37 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 406 |
Target Study Title: Renal Function in Chronic Kidney Disease and the Effect of Exogenous Melatonin Administration (REM TRIAL)
Target Study Description: #Study Description
Brief Summary
This will be a prospective, double blinded, randomized, controlled pilot study to determine if there is any correlation between melatonin administration and proteinuria.
Detailed Description
Investigators plan to enroll up to 100 eligible participants in this pilot trial with 50 participants randomized to receive melatonin and 50 patients randomized to receive a placebo. Participants will be randomized on a rolling basis; meaning, once participants agree to enroll in the study, the participant will be placed randomly into either group.
#Intervention
- DIETARY_SUPPLEMENT : Melatonin
- Melatonin 5mg
- DIETARY_SUPPLEMENT : Placebo
- Comparable Good Neighbor Pharmacy placebo tablet
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 between ages 18 and up with chronic kidney disease (CKD) I-III (stage 3 kidney disease, kidney dysfunction)
* Random urine microalbumin of 30 mcg or greater (protein in the urine)
* Have ability to complete a sleep survey
* Currently not on melatonin therapy.
Exclusion Criteria:
* End Stage Renal Disease
* CKD Stage IV (stage 4 with severe kidney dysfunction)
* Severe liver disease
* Chronic dialysis therapy
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>
| 407 |
Target Study Title: A Phase II, Open-label, Randomized-controlled Trial Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody Atezolizumab for the Treatment in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
Target Study Description: #Study Description
Brief Summary
Most patients with locally advanced or metastatic tumors succumb to their disease. Thus, there is a substantial need for novel therapeutic strategies to improve the outcome for patients with advanced or metastatic melanoma. Targeting the the Ras/Raf signalling pathway by BRAF and MEK inhibition as well as targeting immunologic checkpoint control with an antiPD-L1 antibody have emerged as treatment option.
In this study the best timing for sequential use of both treatment options (BRAF/MEK inhibition and antiPD-L1 antibody) in patients with unresectable or metastatic BRAFV600 mutant melanoma will be assessed.
Detailed Description
At this time there is no experience concerning the sequencing strategy when using the two effective therapeutical approaches as targeting the Ras/Raf signalling pathway by BRAF and MEK inhibition or targeting immunologic checkpoint control with an antiPD-L1 antibody.
This is a prospective, open, multicenter, randomized phase II study in patients with unresectable or metastatic BRAFV600 mutant melanoma. In this study the scheduling of the treatment with a combined BRAF/MEK inhibition and the treatment with an anti-PD-L1 antibody will be assessed.
After a 3 months run-in period with vemurafenib and cobimetinib, all patients who did not show disease progression or treatment interruption for more than 28 days during run-in phase will be randomized in a 1:1 ratio:
* either to proceed vemurafenib and cobimetinib until disease progression and subsequently cross-over to atezolizumab treatment until disease progression (Arm A).
* or to receive the anti-PD-L1 antibody atezolizumab until disease progression and subsequently cross-back to vemurafenib and cobimetinib until disease progression (Arm B). In a translational research program tumor tissue, blood plasma and peripheral blood mononuclear cell will be analyzed to evaluate the biologic effects of treatment sequence on the molecular profile and biomarker expression in tissue and plasma.
#Intervention
- DRUG : Vemurafenib
- 960 mg vemurafenib BID until progression or unacceptable toxicity develops
- DRUG : Cobimetinib
- 60 mg cobimetinib QD, 21/7 until progression or unacceptable toxicity develops
- DRUG : Atezolizumab
- 1200 mg atezolizumab administered intravenously on day 1 of each 21 day-cycle. Will be given until progression or unacceptable toxicity develops
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:
* Be willing and able to provide written informed consent for the trial.
* Male or female patient being >=18 years on day of signing informed consent.
* Histologically confirmed diagnosis of locally advanced, unresectable or metastatic melanoma AJCC (unresectable stage IIIB, IIIC, IVM1a, IVM1b, or IVM1c) without active or untreated brain metastases; all known CNS lesions must have been treated with stereotactic therapy or surgery at least 4 weeks prior to the first dose of trial treatment AND the patient must be without evidence of clinical or radiographic disease progression in the CNS for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms must have returned to baseline, the patient must have no evidence of new or enlarging brain metastases, and the patient must not have used steroids for at least 3 weeks prior to trial treatment.
* No previous therapy for the advanced or metastatic stage. Prior adjuvant therapy is permitted (e.g. Interferon, Interleukin-2-therapy, chemo- or radiotherapy). Prior adjuvant therapy has to be terminated (last dose) at least 28 days before enrolment. Patients who are in follow-up period of a clinical trial in adjuvant setting and progressing may be enrolled / randomized.
* Measurable disease, i.e., present with at least one measurable lesion per RECIST, version 1.1, for the definition of a measureable lesion.
* Presence of BRAF mutation (V600) in tumor tissue.
* Performance status of 0 or 1 on the ECOG Performance Scale.
* Adequate organ function.
* Adequate cardiac function.
* Able to take oral medications.
* Female subject of childbearing potential should have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication.
* Female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use a highly effective form of contraception according to CTFG during the course of this study and for at least 6 months after completion of study therapy.
Exclusion Criteria:
* Use of any investigational or non-registered product within the 30 days before registration.
* Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study Day 1.
* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
* Prior therapy with a BRAF inhibitor (including but not limited to vemurafenib, dabrafenib, encorafenib and / or MEK inhibitor
* Prior major surgery.
* Known additional malignancy that is progressing or requires active treatment within 5 years prior to the study.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* History of leptomeningeal metastases.
* History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO) or predisposing factors to RVO or CSR.
* History of retinal degenerative disease.
* History of allogenic bone marrow transplantation or organ transplantation.
* History of Gilbert's syndrome.
* Impaired cardiovascular function or clinically significant cardiovascular diseases.
* Uncontrolled arterial hypertension despite medical treatment.
* Impairment of gastrointestinal function or gastrointestinal disease.
* Evidence of interstitial lung disease or active, non-infectious pneumonitis.
* Active infection requiring systemic therapy.
* Positive test for Human Immunodeficiency Virus (HIV).
* Positive test for Hepatitis B or Hepatitis C.
* Known hypersensitivity reaction to any of the components of study treatment.
* Medical, psychiatric, cognitive or other conditions, including known alcohol or drug abuse.
* Patients having received a live, attenuated vaccine within 4 weeks prior to the first dose of trial treatment.
* Legal incapacity or limited legal capacity.
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>
| 408 |
Target Study Title: Pre-surgical Phase IIb Trial of Transdermal 4-Hydroxytamoxifen vs. Oral Tamoxifen in Women With Ductal Carcinoma in Situ of the Breast
Target Study Description: #Study Description
Brief Summary
This randomized phase II trial is studying 4-hydroxytamoxifen to see how well it works compared with tamoxifen citrate in treating women with newly diagnosed ductal breast carcinoma in situ. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether topical tamoxifen causes less damage to normal tissue than systemic tamoxifen in treating patients with ductal carcinoma in situ.
Detailed Description
This is a randomized, double-blind, placebo-controlled presurgical trial of 0.228% 4-hydroxy-tamoxifen (4-OHT) gel vs. oral tamoxifen (TAM) 20 mg daily. The study population will consist of 112 pre- and postmenopausal women with any grade DCIS, ER positive, non-palpable DCIS with no evidence of invasion found on diagnostic core needle biopsy (DCNB). In order to accrue a total of 112 participants with DCIS over a period of 22 months, 20 eligible participants total will be screened at the three participating institutions per month with a planned average monthly recruitment of 5 participants total per month. We assume that 22 women (20% of the recruited population, 11 women per arm) will be inevaluable because of the presence of unanticipated invasive disease in the therapeutic surgical excisional (TSE) specimen, or the absence of residual DCIS in the TSE, so that a total of 90 women (45 per arm) will be evaluable for the study endpoints. These estimates are based on numbers from the Lynn Sage Database of NU: over the six-year period 2000-2005, the fraction of women diagnosed with DCIS on core needle biopsy who were found to have no residual DCIS in the TSE was 2.5% and that of women with invasive disease (T1a or greater) in the TSE when the DCNB showed pure DCIS was 13.3%, very similar to the data reported by Bonnett et. al. \[56\] who found that 13% of pure DCIS lesions seen on DCNB (29/122) were in fact invasive in the TSE. With regard to racial/ethnic groups, 25.6% of the DCIS population at NU were of non-European ancestry (18% African, 4% Hispanic, 3.5% other). WU has higher fractions of African American women with DCIS (24% and 21% respectively).
The participants will be consented following diagnostic core needle biopsy at the time of initial surgical consultation. Baseline assessments include medical history, nipple aspirate fluid (NAF) collection, explanation of gel application, BESS questionnaire (symptom assessment) and blood draw for clinical and research labs including plasma estradiol, progesterone and FSH (rushed), CBC, chemistry profile, liver and renal function tests, Factor VIII, von Willebrand Factor, Factor IX, and total protein S, plasma for insulin-like growth factor (IGF-1) and sex hormone-binding globulin (SHBG), and DNA extraction for assessment of polymorphisms in tamoxifen metabolism genes. At Northwestern plasma and RNA from blood will be collected pre- and post-treatment and will be stored for future proteomic and gene expression fingerprinting
No run-in period is planned. The intervention phase will begin within 5 days following randomization and end on the day prior to surgical resection. The 4-OHT group will apply active gel 2 mg daily to each breast for 4-10 weeks and take oral placebo. The TAM group will take 20 mg TAM orally daily and apply gel placebo. The last dose of study medication will be used on the morning of the day prior to surgery.
Participants will be shipped two 100 ml canisters of 4-OHT or placebo gel plus 130 capsules of tamoxifen or oral placebo at the time of randomization. Participants will take study agents for 4-10 week (minimum). However, if surgery needs to be delayed beyond the 8 week study period for clinical reasons (eg scheduling with plastic surgery) the participant will be sent additional medication by mail to allow continuation of therapy until the day before surgery up to a maximum duration of 10 weeks.
On the day prior to surgery, baseline assessments will be repeated (with the exception of menopausal determination and tamoxifen metabolism gene polymorphisms, but with the addition of blood draw for tamoxifen metabolites and E and Z 4-OHT isomer determination). Under unavoidable circumstances, the end of intervention visit will be allowed on the day of surgery prior to TSE. During the TSE breast adipose tissue from the surgical sample will be snap frozen and stored at -800C for measurement of TAM metabolites. The paraffin block of the DCNB and TSE samples will be acquired by the recruiting institution and 10 sections from each specimen submitted to the NU Pathology Core Facility (NU PCF). The sections will be cut in batches (with pre- and post-samples in the same batch), shipped cold, and processed for immunohistochemistry within a week of sectioning.
Compliance assessment will occur through patient diaries, pill counts and the weighing of returned drug (gel) canisters.
Patients will be assessed for adverse events at the post-surgical visit (approximately 7-14 days after surgery) and by phone at 30 days following the last dose of study agent.
#Intervention
- DRUG : oral placebo
- Oral placebo taken daily for 4-10 weeks.
- Other Names :
- PLCB
- DRUG : afimoxifene
- 2mg/breast applied daily in the form of a gel for 4-10 weeks.
- Other Names :
- 4-Hydroxy-Tamoxifen, 4-hydroxytamoxifen
- DRUG : tamoxifen citrate
- 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.
- Other Names :
- Nolvadex, TAM, tamoxifen, TMX
- DRUG : placebo gel
- Placebo gel applied to breasts daily for 4-10 weeks.
- Other Names :
- PLCB
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 hormone receptor positive (more than 5% cells staining for ER + and/ or PR +), any grade (using definition of Page and Lagios) ductal carcinoma in situ (DCIS) with or without evidence of microinvasion on diagnostic core needle biopsy within the previous 60 days.
* Women of age >= 18 years. Because no dosing or adverse event data are currently available on the use of 4-hydroxytamoxifen in participants <18 years, children are excluded from this study but will be eligible for future pediatric trials, if applicable.
* ECOG performance status >=1 (Karnofsky >=70%)
* Participants must have normal organ and marrow function as defined below:
1. Leukocytes>=3,000/uL
2. Absolute neutrophil count (ANC)>=1,500/uL
3. Platelets>=100,000/uL
4. Total bilirubin within normal institutional limits
5. AST (SGOT)/ALT (SGPT)<=1.5 X institutional ULN
6. Creatinine within normal institutional limits
* Women of child-bearing potential must agree to practice barrier birth control, abstinence, or use non-hormonal IUDs from the time that the first pregnancy test is performed throughout the duration of the study and for three months after cessation of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.
* Ability to understand and the willingness to sign a written informed consent document.
* Ability and willingness to schedule surgical resection of DCIS lesion for 4 <= age <= 10 weeks (28 <= age <= 70 days) following the start of study agent.
* Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the 4 <= age <= 10 weeks of study agent dosing.
Exclusion Criteria:
* Prior history of, or at high risk to develop, thromboembolic disease will be excluded.
* Must not have taken exogenous sex hormones since biopsy diagnosing DCIS and must agree not to use exogenous sex hormones while on study.
* Must not have taken tamoxifen or other selective estrogen receptor modulators (SERMs) within 2 years prior to entering the study. Women who have discontinued SERM therapy because of thromboembolic or uterine toxicity, will be excluded regardless of duration of use.
* May not be receiving any other investigational agents.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 4-hydroxytamoxifen or tamoxifen.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study because tamoxifen and 4-hydroxytamoxifen has the potential for teratogenic or abortifacient effects. Women are excluded from enrolling within 3 months of the most recent pregnancy. Women must avoid becoming pregnant in the 3 months following the use of study agent.
* Women must not have breastfed within three months prior to DCNB. Women who are breast feeding are excluded from entry into this trial because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tamoxifen or 4-hydroxytamoxifen. Women must agree to forego breastfeeding for three months following the use of study agent.
* Must not have any dermatologic conditions resulting in skin breakdown in the area of gel application.
* Must not have a history of previous ipsilateral radiation to the affected breast.
* Must not have had a breast reduction or augmentation within the 6 months prior to first dose of study agents. Patients who have had breast implants more than 6 months prior to first dose of study agents will be eligible.
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>
| 409 |
Target Study Title: A Phase 1, Open-Label Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to assess the pharmacokinetics and safety of a 48-hour continuous infusion of conivaptan in subjects with severe liver impairment compared to subjects with normal liver function.
Detailed Description
Subjects will be admitted to the Phase 1 unit Day -2 and will remain confined to the unit until discharge on Study Day 5 after completion of all study procedures.
#Intervention
- DRUG : conivaptan hydrochloride
- Intravenous
- Other Names :
- Vaprisol, YM087
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 Normal Hepatic Function:
Female subject must be either:
* post-menopausal prior to Screening, or
* premenarchal prior to Screening, or
* documented surgically sterile or post hysterectomy, or
* if of childbearing potential, must have a negative pregnancy test at Screening and must be using highly effective contraception prior to Screening and throughout the study period and for 28 days after final study drug administration
* Female subject must not be lactating and must not be breastfeeding at Screening or during the study period, and for 28 days after final study drug administration
* Female subject must not donate ova starting at Screening or during the study period, and for 28 days after final study drug administration
* Male subject must:
* be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 28 days after final study drug administration
* not donate sperm starting at Screening and throughout the study period, and for at least 28 days after final study drug administration
* Subject weighs at least 45 kg and has a body mass index between 18 and 40 kg/m2 inclusive
* The subject must have clinical laboratory test results within normal range, including liver function tests (LFTs)
* The subject must have had a normal 12-lead electrocardiogram (ECG)
Hepatic Impaired Subjects:
* Female subject must be either:
* post-menopausal prior to Screening, or
* premenarchal prior to Screening, or
* documented surgically sterile or post hysterectomy, or
* if of childbearing potential, must have a negative pregnancy test at Screening and must be using highly effective contraception prior to Screening and throughout the study period and for 28 days after final study drug administration
* Female subject must not be lactating and must not be breastfeeding at Screening or during the study period, and for 28 days after final study drug administration
* Female subject must not donate ova starting at Screening or during the study period, and for 28 days after final study drug administration
* Male subject must:
* be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 28 days after final study drug administration
* not donate sperm starting at Screening and throughout the study period, and for at least 28 days after final study drug administration
* Subject meets criteria for severe hepatic impairment defined by Child-Pugh method
* Subject weighs at least 45 kg and has a body mass index between 18 and 40 kg/m2 inclusive
* The subject must have clinical laboratory test results within therapeutic range except for hepatic disease
* The subject must have had a normal 12-lead electrocardiogram (ECG)
Exclusion Criteria:
Subjects with Normal Hepatic Function:
* Subject has a history of a clinically significant illness, and associated clinical symptoms, medical condition, or laboratory abnormality within past 3 months that would preclude participation in the study
* Subject has evidence of biliary obstruction or other causes of hepatic impairment
* Subject is known to have hepatitis or is a carrier of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or is known to be HIV positive or has HIV antibodies
* Subject has an impaired ability to sense thirst
* Subject has serum sodium less than 115mEg/L or greater than 140 mEg/L
* Subject has either a systolic blood pressure (BP) of greater than 140 mmHg or a diastolic BP of less than 56 mmHg
* Subject has taken any prescription or over-the-counter medications except for contraceptives, hormone replacement therapy and occasional acetaminophen, or alternative and complementary medicines within past 14 days
* Subject has a history of carcinoma, except for basal cell or cutaneous squamous cell carcinoma within past 5 years
* Subject drinks greater than 14 units of alcohol per week (Note: one unit = 12 ounces of beer, 4 ounces of wine, or 1 ounce of spirits)
* Subject has a history of substance abuse within past 6 months prior to Screening Visit or the subject tests positive at Screening or clinic admission for alcohol or drugs of abuse
* Subject is currently participating in another clinical trial or has received an investigational medication within past 30 days
* Subject is known to have hypersensitivity to conivaptan or its derivatives
* Subject has had a blood transfusion or donated/lost more than 550ml of blood within past 8 weeks
* Subject is incapable of being compliant with the protocol
Subjects with Hepatic Impairment:
* Subject has a history of a clinically significant illness, and associated clinical symptoms, medical condition, or laboratory abnormality within past 3 months that would preclude participation in the study. Subjects with controlled hypertension may be allowed
* Subject has a condition associated with hepatic disease including; biliary obstruction, or other cause of hepatic impairment not related to parenchymal disorder and/or disease of the liver, fluctuating or rapidly deteriorating hepatic function, biliary liver cirrhosis, history or presence of hepatic encephalopathy greater than Grade 1 within past 3 months or unstable encephalopathy prior to Screening, tense ascites, esophageal/gastric variceal bleeding with past 6 months, server portal hypertension, surgical portal systemic shunt or peritoneal venous shunt, thrombocyte level below 50,000 x 10^9/L and prothrombin time (PT) above 18 seconds
* Subject is hypovolemic or has evidence of orthostatic hypotension
* Subject has an impaired ability to sense thirst
* Subject has serum sodium less than 115mEg/L or greater than 140 mEg/L
* Subject has either a systolic blood pressure (BP) of greater than 140 mmHg or a diastolic BP of less than 56 mmHg
* Subject is known to be HIV positive or has HIV antibodies
* Subject has had a change in dose regimen of medication needed for their underlying medical condition with the past four weeks
* Subject is currently taking a prohibited medication
* Subject drinks greater than 14 units of alcohol per week (Note: one unit equals 12 ounces of beer, 4 ounces of wine, or 1 ounce of spirits)
* Subject has a history of substance abuse within past 6 months prior to Screening Visit or the subject tests positive at Screening or clinic admission for alcohol or drugs of abuse
* Subject is currently participating in another clinical trial or has received an investigational medication with past 30 days
* Subject has had a blood transfusion or donated/lost more than 550ml of blood within past 8 weeks
* Subject is known to have hypersensitivity of conivaptan or its derivatives
* Subject is incapable of being compliant with the protocol
Sex :
ALL
Ages :
- Minimum Age : 30 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>
| 410 |
Target Study Title: A Double-Blind, Randomised, Placebo-Controlled, Escalating, Multiple Dose Study in to Assess the Safety, Tolerability and Pharmacodynamic Effects of Birch-SPIRE
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of multiple administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic parameters and clinical outcomes.
#Intervention
- BIOLOGICAL : Birch-SPIRE
- BIOLOGICAL : 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:
* Male or female, aged 18 <= age <= 65;
* Minimum 1 year history of rhinitis with or without conjunctivitis on exposure to birch pollen
* Birch IgE >= 0.35 kU/L
* Positive skin prick test to whole birch allergen
Exclusion Criteria:
* Any past history of asthma
* FEV1 < 80% of predicted
* History of severe allergic reaction to birch allergen, severe drug allergy, severe angioedema or severe allergic reactions to food
* Acute phase skin response to whole birch allergen with a mean wheal diameter > 50mm
* Administration of adrenaline (epinephrine) is contraindicated
* History of severe drug allergy or anaphylactic reaction to food.
* History of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)
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>
| 411 |
Target Study Title: A Double Blind, Placebo-controlled, Multi-centre Study to Evaluate the Efficacy, Safety, Tolerability and Immunogenicity of Repeated s.c Administrations of 100µg NIC002 Vaccine in Cigarette Smokers Who Are Motivated to Quit Smoking.
Target Study Description: #Study Description
Brief Summary
This study is designed to determine the efficacy of high nicotine-specific antibody titers in smoking cessation.
#Intervention
- BIOLOGICAL : NIC002
- BIOLOGICAL : 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:
* Healthy male and female smoking subjects age 18 <= age <= 65 of age
* Subjects must be smoking 10 or more cigarettes per day during the past 12 months
* The exhaled breath carbon monoxide (CO) concentration must be 10 ppm or more at screening. Urine cotinine at screening must be positive.
* The Fagerström Test for Nicotine Dependence (FTND) score of 5 or above at screening.
Exclusion Criteria:
* Attempted to quit smoking in the three (3) months.
* Prior use of smoking cessation aid.
Other protocol-defined inclusion/exclusion criteria may apply
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>
| 412 |
Target Study Title: A Randomized Controlled Trial of Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia
Target Study Description: #Study Description
Brief Summary
The primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or ultrasonic aspiration.
Detailed Description
Incidence of Vulvar Intraepithelial Neoplasia (VIN) is increasing among women and there still lacks a standard of care for optimal treatment. Current treatment options aim to treat the symptoms associated with VIN and result in a high recurrence rate. Due to the high reoccurrence rate and the nature of the current treatments, a more effective treatment option is warranted. An effective treatment that targets only the diseased areas could potentially decrease recurrence rates. Additionally, a more conservative treatment modality could contribute to reduced risks of scarring, discomfort, and psychosocial and sexual distraught. The researchers hypothesize that treatment for VIN with ultrasonic aspiration will have a 60% reduction in recurrence rates over 12 months as compared to CO2 laser aspiration.
This study will employ a randomized controlled trial (RCT) design. This is a phase III study to determine the effectiveness of a more targeted treatment therapy for VIN (comparing ultrasonic aspiration versus CO2 laser ablation). Potential participants will be identified through the gynecological clinical practices following diagnosis of high grade VIN and will be randomized (1:1) to one of the treatment therapies. Randomization will be stratified for multi-focal disease and Human Papillomavirus (HPV) status. Both the Sonopet Ultrasonic Aspirator and the CO2 laser ablation devices are FDA approved devices for the treatment of vulvar dysplasia.
#Intervention
- DEVICE : Sonopet Ultrasonic Aspirator
- To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
- DEVICE : CO2 Laser Ablation
- To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
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 18 <= age <= 89 years
* Women diagnosed with high-grade VIN (diagnosed by pathology)
* Women referred for vulva sparing treatment for dysplasia
* Women available for follow-up of treatment for 12 months
Exclusion Criteria:
* Women who are pregnant
* Women with low-grade VIN dysplasia (diagnosed by pathology)
* Women with vaginal intraepithelial neoplasia(VAIN)
* Women requiring vulvectomy for treatment
* Women unable to provide informed consent
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 89 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 413 |
Target Study Title: Effect of Pregabalin or Adductor Canal Block on Postoperative Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction (ACL)
Target Study Description: #Study Description
Brief Summary
arthroscopically Anterior Cruciate Ligament Reconstruction (ACL) under spinal anesthesia were included in this study.
Detailed Description
Patients who American Society of Anesthesiologists (ASA) classification I to II scheduled to undergo arthroscopically assisted ACL reconstructions under spinal anesthesia are included in this study. The first group is administered 150 mg oral pregabalin 1 hour before surgery and the postoperative sham block was performed with an ultrasound probe. The second group is the control group; patients in this group are administered a placebo capsule 1 hour before surgery and sham block was performed with an ultrasound probe.The third group is administered a placebo capsule 1 hour before surgery and postoperative adductor canal block is performed. All patients will be received postoperative a tramadol i.v. patient control analgesia device. At the end of 24 hours, the total amount of tramadol consumed by the patient will be recorded from the patient control analgesia. NRS score, white fast track, satisfaction will be questioned.
#Intervention
- DRUG : pregabalin (lyrica)
- preoperative pregabalin and the postoperative sham block will perform.
- DRUG : Placebo oral tablet
- The preoperative placebo oral tablet and the postoperative sham block will perform.
- DRUG : adductor canal block including bupivacaine
- The preoperative placebo oral tablet and adductor channel block including 10 mL of 0.25% bupivacaine with 5 μg/mL epinephrine
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 between the ages of 18 and 70 years
* American Society of Anesthesiologists I or II
* Scheduled to undergo knee arthroscopy
Exclusion Criteria:
* allergic to any medicines
* History of drug or alcohol abuse,
* Opioids or sedative medications
* History of psychiatric conditions
* Pregnant or lactating women
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>
| 414 |
Target Study Title: Time to DMARD Treatment and Actual Work Limitation of Patients With Rheumatoid Arthritis in Turkey
Target Study Description: #Study Description
Brief Summary
The objective is to measure time delay from onset of symptoms to diagnosis and time to disease-modifying anti-rheumatic drug treatments in Turkish patients with rheumatoid arthritis. The investigators will also evaluate actual work limitation status of patients and impact of demographic and clinical factors on work limitations in rheumatoid arthritis patients.
Detailed Description
This post marketing observational study will be conducted in cross-sectional, non-interventional, multi-center format in Turkey. As this is a post marketing observational study, Abbott is not involved in the product supply since the drug is being used according to the approved marketing label and is to be prescribed by the physician under usual and customary practice of physician prescription.
Subjects will be recruited from rheumatology outpatient clinics of university hospitals and/or private offices.
Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data will be included.
Patient data will be collected with a single visit. During the single visit, all required demographic and clinical data will be recorded on the case report forms by the investigators and every subject will be asked to fill out the Work Productivity and Activity Impairment questionnaire and the Health Assessment Questionnaire - Disability Index.
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 rheumatoid arthritis by a specialist or by the treating rheumatologist
* Treated with at least one disease-modifying anti-rheumatic drug or biologics
* Patients > 18 years
* Patients already employed at a paid work
* Patients able to provide data for disease history
* Able to provide written consent to release information for this study
Exclusion Criteria:
* Patients who cannot provide necessary outcome measurements for any reason 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:
No
</FORMATTED_CRITERIA>
| 415 |
Target Study Title: Effects of Telerehabilitation After Discharge on Quality of Life, Psychosocial Status, Physical Activity, Daily Activities of Living, and Sleep Quality in Patients Treated as Inpatients With the Diagnosis of COVID-19
Target Study Description: #Study Description
Brief Summary
Effects of telerehabilitation after discharge on quality of Life, psychosocial status, physical activity, daily activities of living, and sleep quality in patients treated as inpatients with the diagnosis of COVID-19 will be investigated. Post-discharge physical activity level, psychosocial status, sleep quality, quality of life, daily activities of living, and quality of life will be determined. The effects of exercise interventions in online-based physiotherapist monitoring will be provided. Monthly comparisons of physical activity, quality of life, depression, and sleep quality responses using telerehabilitation for three months following COVID-19 will be investigated.
Detailed Description
The new type of Coronavirus (SARS-CoV-2) has progressed rapidly in our country and around the world and has caused a global health emergency, requiring the implementation of restrictive measures. While the origin of SARS-CoV-2 is still under investigation, the available information points to wild animals sold illegally in the Wuhan Seafood Wholesale Market. Common symptoms of infection are fever, cough, and dyspnea. In more severe cases, pneumonia, severe acute respiratory tract infection, renal failure, and even death may occur. Up-to-date information about physiotherapy and rehabilitation applications on COVID-19 disease is limited to positioning and mobilization in the acute phase of the disease. Current guidelines and protocols state that airway clearance techniques, respiratory exercises and practices using assistive devices, exercise training and respiratory muscle training should not be applied in the acute period. Tele-medicine is a clinical practice that connects the patient to healthcare professionals through electronic platforms, potentially improving the self-management of patients and allowing the care of patients with limited access to health services. In these days when staying at home is recommended to minimize exposure and contamination risk, telerehabilitation can be considered as an advantage, using information and communication technologies to provide remote rehabilitation services to individuals at home. It has been reported that with telerehabilitation, improvements have been achieved in health outcomes and quality of life, such as reducing hospitalization rates and re-admissions, ensuring early discharge, facilitating access to rehabilitation services, decreasing costs, and ensuring early return to work. Regular physical activity and exercise provide many health benefits, such as increasing cardiorespiratory fitness and reducing symptoms of anxiety and depression. Increasing cardiorespiratory fitness may play a preventive and facilitating role against respiratory infections. This may prevent or help treat pneumonia and acute respiratory distress syndrome, which develops with COVID-19 and causes respiratory failure. It has been stated that there is a significant decrease in the level of physical activity globally in the period of social isolation, which is accepted worldwide during COVID-19 pandemic. Decrease in the level of physical activity and increase in sedentary behavior due to isolation limitations may cause rapid deterioration and premature death in cardiovascular health in a population with high cardiovascular risk. Considering that short-term (1-4 weeks) inactivity is associated with adverse effects on cardiovascular function and structure, and increased cardiovascular risk factors, it appears to be a clinically relevant intervention to promote the health benefits of home-based physical activity programs. In this study, a brochure created by physiotherapists for post-COVID-19 patients will be sent electronically. The number of repetitions and/or sets of the exercises in the brochure will be increased weekly by the physiotherapists according to the tolerance of the patients. Physical activity levels will be questioned at the beginning and at the end of each month to be maintained for three months in total. The need for isolation due to the COVID-19 pandemic creates an unprecedented, stressful situation for many people for an unknown period of time. In addition to increasing the level of anxiety and depression, this may have negative effects on sleep quality. Since sleep plays a main role in emotion regulation, sleep disturbances may have direct consequences on emotional functioning. Therefore, it was planned to evaluate depression and sleep in individuals who survived COVID-19 at the beginning and at the end of each month, for a total of three months. It will be possible to determine whether there is a relationship between depression and sleep efficiency with exercise recommendations that will be given in a controlled manner by a physiotherapist via telerehabilitation and increase according to the patient's tolerance. It has been reported that patients hospitalized with acute respiratory distress syndrome have post-traumatic stress disorder at a rate of 22% -24%, depression at a rate of 26% -33%, and general anxiety at a rate of 38% -44% even after 2 years. It has been reported that these are concerns that may accompany a serious decrease in quality of life and function after COVID-19. Therefore, it is planned to assess quality of life at the beginning and at the end of each month for a total of three months in individuals who survived COVID-19.
Post-discharge physical activity level, psychosocial status, sleep quality, quality of life, daily activities of living, and quality of life will be determined. The effect of exercise interventions in online-based physiotherapist monitoring will be provided. Monthly comparisons of physical activity, quality of life, depression, and sleep quality responses using telerehabilitation for three months following COVID-19 will be investigated.
#Intervention
- OTHER : Telerehabilitation
- Telerehabilitation will consists of physiotherapist-guided exercises. Exercises will be designed by physiotherapists for COVID-19 survivors using the current guidelines. Exercise brochure will be prepared and will be sent to participants. Repetitions and sets of exercises will be modified according 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:
* Being clinically stable,
* Being 18 years or older
* Being a volunteer for the study and providing their consent,
* Able to read and write
* Having a smart phone and being able to use it
Exclusion Criteria:
* Having unstable clinical condition
* Having severe neuromuscular and musculoskeletal problems,
* Being unable to cooperate and respond to the questionnaires and scales
* Not being a volunteer to participate
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>
| 416 |
Target Study Title: Observational Retrospective Study to Characterise Patients Receiving Benralizumab in the Framework of an Individualized Access Program in Spain
Target Study Description: #Study Description
Brief Summary
Observational, retrospective study in adults (≥18 years) with severe asthma (maintenance treatment with high dose inhaled corticosteroids combined with long-acting agonist β2) and eosinophilic phenotype, who at the discretion of the investigator were candidates to receive benralizumab in the individualized access program approved by national health authorities.
Primary Objective: To describe the demographic and baseline characteristics in patients with severe eosinophilic asthma who participated in the individualized access program approved in Spain and received at least one dose of benralizumab.
Secondary Objectives: To describe clinical outcomes in severe eosinophilic asthma patients who received at least three doses of benralizumab in the individualized access program.
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 patients (age >=18 years)
* Diagnosis of severe eosinophilic asthma requiring stable treatment of high doses of inhaled corticosteroids and a long-acting agonist β2 ± additional asthma controller
* Received at least one dose of benralizumab during the individualized access program period (March-December of 2018)
* Informed consent signed
Exclusion Criteria:
* Patients enrolled in a clinical trial who received benralizumab during the same period of the individualized access program
* Refuse to sign the informed consent
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 417 |
Target Study Title: A Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Bioequivalence of a Generic Mupirocin Calcium Cream, 2% and Reference Listed Bactroban® Cream (Mupirocin Calcium Cream, 2%) and Compare Both Active Treatments to a Vehicle Control in the Treatment of Secondarily Infected Traumatic Skin Lesions.
Target Study Description: #Study Description
Brief Summary
The primary objective of this study is to determine the comparability of the safety and efficacy of Mupirocin Calcium Cream, 2% and Bactroban® Cream in subjects with secondarily infected traumatic skin lesions. It will also be determined whether the efficacy of each of the active treatments is superior to that of the vehicle cream (placebo).
#Intervention
- DRUG : Mupirocin Calcium Cream, 2%
- Mupirocin Calcium Cream, 2% (Taro Pharmaceuticals Inc.) applied topically 3 times per day for 10 consecutive days.
- DRUG : Bactroban® Cream
- Bactroban® Cream (mupirocin calcium cream, 2%) (GlaxoSmithKline) applied topically 3 times per day for 10 consecutive days.
- DRUG : Cream vehicle of test product
- Cream vehicle of test product (Taro Pharmaceuticals Inc.) applied topically 3 times per day for 10 consecutive 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:
* Healthy male or nonpregnant females aged 18 months or older with a secondarily infected traumatic skin lesion such as a laceration, sutured wound, or abrasion.
* The laceration or sutured wound should not exceed 10 cm in length with surrounding erythema not more than 2 cm from the edge of the lesion. An abrasion should not exceed 100 cm2 in total area with surrounding erythema not more than 2 cm from the edge of the abrasion.
* Positive baseline culture for S. aureus and/or S. pyogenes from a sample taken from the secondarily infected traumatic skin lesion.
* Positive Gram stain or Wright stain for confirmation of white blood cells in the pus/exudate from the secondarily infected traumatic skin lesion.
* Skin Infection Rating Scale total score for the secondarily infected traumatic skin lesion of at least 8 at baseline.
* Women of childbearing potential, in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study. Subjects entering the study who are on hormonal contraceptives must have been on the method for at least 90 days prior to the study and continue the method for the duration of the study. Subjects who had used hormonal contraception and stopped must have stopped no less than 90 days prior to the study.
* Subjects 18 years or older must provide Institutional Review Board approved written informed consent. Subjects under the age of 18 years must have parent or legal guardian provide Institutional Review Board approved written consent. An assent form for minors must be completed for subjects under the legal age of consent, depending on the age range required by state laws.
* Subjects must be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, return for the required study visits, comply with therapy prohibitions, and be able to complete the study.
* Subjects must be in good health and free from any clinically significant disease, other than secondarily infected traumatic skin lesions, that might interfere with the study evaluations.
Exclusion Criteria:
* Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
* Any dermatological disorder that may interfere with evaluation of the subject's secondarily infected traumatic skin lesion(s).
* Bacterial skin infection that, because of depth or severity, could not be appropriately treated with a topical antibiotic.
* Secondarily infected bite or puncture wound.
* Systemic signs or symptoms of infection.
* Requirement for surgical intervention for treatment of the infection prior to study entry.
* A subject must not have received any topical corticosteroid, topical antibiotic, or antifungal agent for at least 48 hours (2 days) prior to baseline.
* A subject must not have received any systemic antibiotic or systemic corticosteroid for at least 7 days prior to baseline.
* Primary or secondary immunodeficiency.
* Diabetes.
* Presence of any other medical condition that might adversely affect the safety of the study participants or confound the study results.
* History of hypersensitivity or allergy to mupirocin and/or any of the study medication ingredients.
* Subjects who consume excessive amounts of alcohol, abuse drugs, or have any condition that would compromise compliance with the protocol.
* Treatment with an investigational drug or device within 30 days prior to study entry.
* Previously enrollment in this study.
Sex :
ALL
Ages :
- Minimum Age : 18 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 418 |
Target Study Title: Evaluation of B+ Surface on Early Loading
Target Study Description: #Study Description
Brief Summary
The trial is designed as a consecutive enrollment prospective one-center study. A minimum of 30 patients will be included in the study. At implant installation, the implant will be randomized to one of the groups (Control: conventional loading, 8 weeks; Test: early loading, 4 weeks). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be collected at -14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the impressions are taken.
#Intervention
- PROCEDURE : Early Loading
- The procedure in this group will consist on placing implant-supported restorations over the implants placed 4 weeks earlier. The device (dental implant) is of the same type in both groups.
- PROCEDURE : Conventional Loading
- The procedure in this group will consist on placing implant-supported restorations over the implants placed 8 weeks earlier. The device (dental implant) is of the same type in both groups.
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:
* Patient >18 and <=75 years
* One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal).
Exclusion Criteria:
* One-stage bone augmentation
* Heavy smokers (>10 cigarettes/day)
* Uncontrolled type 1 or 2 diabetes (HgA1c>8)
* Known auto-immune or inflammatory disease
* Severe hematologic disorders, such as hemophilia or leukemia
* Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology)
* Liver or kidney dysfunction/failure
* Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy
* Long-term history of oral bisphosphonates use (i.e., 10 years or more)
* History of intravenous bisphosphonates
* Long-term (>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system
* Severe osseous diseases (e.g., Paget disease of bone)
* Pregnant women or nursing mothers
* Not able or not willing to follow instructions related to the study procedures
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>
| 419 |
Target Study Title: Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Nulliparas at Term
Target Study Description: #Study Description
Brief Summary
To compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for nulliparas at term with an unfavorable cervix
#Intervention
- DRUG : Oxytocin
- DRUG : Dinoprostone
- PROCEDURE : Membrane sweeping
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:
* singleton pregnancy
* Nulliparous women
* gestational age >=37.0 weeks
* Bishop score <=6
* intact amniotic membrane
* absence of labor
* live fetus with vertex presentation
* no previous uterine surgical procedure
Exclusion Criteria:
* Multiple pregnancy
* Placenta previa
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 420 |
Target Study Title: CTN 0064: Assessing Long-term CTN 0049 Outcomes, HCV Prevalence and Progression Along the HCV Care Continuum Among HIV/HCV Co-infected Substance Users in the U.S.
Target Study Description: #Study Description
Brief Summary
Primary Objective: This study will evaluate the effectiveness of an HCV Care Facilitation intervention in moving HIV/HCV co-infected substance users forward along the HCV care continuum (compared with a Control group).
Primary Hypothesis: The number of steps achieved along the HCV care continuum will differ between the two study groups over the 14-month follow-up period.
Secondary Objectives:
Component 1 (Long-term CTN 0049 follow-up):
Using the CTN 0064 baseline data (self-report, medical record abstraction and biological data), the following CTN 0049 primary and secondary outcomes in participants who consented to the CTN 0064 protocol will be re-analyzed to evaluate latent and/or enduring effects of the CTN 0049 interventions:
1. HIV virological suppression
2. HIV primary care visit attendance
3. All-cause mortality
Detailed Description
The CTN 0064 study leverages the existing research infrastructure and cohort of the CTN 0049 (NCT01612169) randomized, controlled trial (RCT). CTN 0049 ('Project HOPE -- Hospital Visit as Opportunity for Prevention and Engagement for HIV-Infected Drug Users') is a three-group RCT that evaluated the most effective strategy to achieve HIV virologic suppression among HIV-infected substance users who were recruited from hospital settings. Between July 2012 and January 2014, a total of 801 HIV-infected hospitalized patients were recruited from 11 participating sites throughout the U.S. and randomized to one of the following three groups: 1) Patient Navigator intervention, 2) Patient Navigator plus Contingency Management intervention, and 3) Treatment as Usual. All CTN 0049 participants provided informed consent and completed baseline computer assisted personal interviews or CAPI (computer assisted personal interview: focusing on drug use, mental health, demographics and socio-economic factors, HIV care and drug treatment history) and blood draws (for HIV viral load and CD4 count). The two intervention groups received up to 11 patient navigation sessions over a 6-month period to actively assist participants in linking to HIV primary care and substance use treatment. Participants in all three groups completed follow-up assessments consisting of CAPI, blood draws, urine collection and breath analysis at approximately 6 and 12 months post-randomization. Medical records were reviewed to document receipt of HIV care and treatment during the study period. CTN 0064 will leverage the CTN 0049 research infrastructure and cohort by utilizing the 11 participating CTN 0049 research teams to recruit their randomized participants into the CTN 0064 study.
CTN 0064 has two main components: Component 1 is the baseline assessment for CTN 0064. It will also serve as a long-term follow-up assessment for CTN 0049 for those who consent to participate in CTN 0064. Participants whose HCV antibody test result is positive in this baseline assessment will be invited to enroll in Component 2. Component 2 is an RCT that will assess the effectiveness of a Care Facilitation intervention (compared to Control) in moving HIV/HCV co-infected substance users forward along the HCV care continuum. The study's primary objective is based on Component 2 and will be operationalized as movement through a series of (potentially non-sequential) pre-defined, clinical steps along the HCV care continuum (including the ultimate step, sustained virologic response to treatment at 12 weeks post treatment completion \[SVR12\]) (AASLD/IDSA/IAS-USA). Secondary objectives will be to assess: 1) success at each step in the HCV care continuum, 2) engagement in HIV care and substance use treatment, and 3) HIV viral suppression as well as 4) to examine other long-term outcomes of the CTN 0049 cohort.
All adults who were randomized into the CTN 0049 study and who provided consent to be contacted about future studies (hereafter, referred to as the 'CTN 0049 cohort') will be invited to enroll in the CTN 0064 study. All participants will provide informed consent and complete Component 1, consisting of: 1) a computer assisted personal interview or CAPI (capturing history of HIV care, HCV testing and care, substance use and substance use treatment; mental health; demographics; and socio-economic factors), 2) HCV antibody screening via rapid HCV test (and, if HCV antibody positive, HCV RNA testing via venipuncture), 3) associated pre-/post-HCV test information and counseling, 4) blood specimen collection via venipuncture, and 5) drug/alcohol toxicology screening (via urine evaluation). The blood specimens of all participants will be assessed for HIV viral load and CD4 count. The blood specimens for the subset of participants who screen as HCV antibody positive will be assessed for HCV RNA to determine if their HCV infection is active.
Participants who screen as HCV antibody positive will be randomized into Component 2 and assigned to one of two groups: 1) HCV Care Facilitation intervention or 2) Control. The Care Facilitation intervention group will receive up to 12 sessions during a 6-month intervention period. Follow-up visits with both groups will be conducted at approximately 6 and 12 months post-randomization. These visits will consist of CAPI, blood specimen collection, and drug/alcohol toxicology screening. Medical records will be reviewed to document HCV testing, receipt and use of HCV clinical evaluation, care and treatment (as applicable); and HIV care and treatment before and during the study period.
#Intervention
- OTHER : Control Group
- After screening HCV antibody positive, participants will receive an appointment and reminder card to return for their HCV RNA results. If HCV RNA positive, study staff will attempt to make an appointment for the participant's next step in the HCV continuum. If a participant attends the 'next step' visit, the participant would be subject to whatever is the local standard of care at that clinic/agency from that point forward.
- BEHAVIORAL : Care Facilitation Group
- The same will occur for intervention participants, yet an HCV care facilitator will motivate them to return for their HCV RNA results; appointment reminders will be made prior to the 'next step' visit; follow-up contact will be made for missed appointments; and the HCV care facilitator will coordinate and link the participant to available community resources (e.g., mental health, housing agencies) by scheduling appointments, arranging transportation, and helping to complete any clinic registration (or other) paperwork that agencies may require to access services.
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:
By virtue of participating individuals being recruited from the CTN-0049 cohort, they will be:
* HIV-infected and
* 18 years or older
* Be able to communicate in English
Additionally, to be eligible for Component 1 they must:
* provide informed consent, which includes being willing to provide sufficient locator information and to be tested for anti-HCV antibodies and, if antibody positive, tested for active HCV infection
* sign a HIPAA form / medical record release form to facilitate medical record abstraction
Finally, to continue on to Component 2, they must:
* provide sufficient locator information
* report living in the vicinity and being able to return for follow-up visits
* complete the baseline assessments
* complete the blood draw
* test as HCV antibody positive via study Component 1 and,
* agree to be randomized in Component 2
Exclusion Criteria:
Individuals will be excluded from participation if they:
* have significant cognitive or developmental impairment
* are terminated via Site Principal Investigator decision/discretion with agreement from study Lead Investigator
* are currently in jail, prison or any inpatient overnight facility as required by court of law or have a pending legal action which may prevent an individual from completing the study
Additionally, individuals may participate in Component 1, but will be excluded from Component 2 if they:
* are currently on HCV therapy/medications at baseline
* have completed a course of HCV medications in the last 12 weeks based on self-report.
It should be noted that pregnancy is not an exclusion criterion. Therefore, sites may enroll pregnant women and/or follow-up with already enrolled women who become pregnant after enrollment in the study provided that they have local IRB approval to do so.
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>
| 421 |
Target Study Title: Cardio-respiratory Events and Inflammatory Response After Primary Immunization in Preterm Infants < 32 Weeks Gestational Age: A Randomized Controlled Study
Target Study Description: #Study Description
Brief Summary
Background: Inflammation may depress respiration in neonates. The aim of this study was to establish a link between post-immunization inflammation and cardio-respiratory events (CRE).
Methods: Randomized double-blind controlled study of infants born \<32 weeks gestation receiving the 2 months vaccine. Infants were randomized into an ibuprofen treatment group and a placebo control group. C-reactive protein (CRP) and prostaglandins E2 (PgE2) levels were assessed before and after immunization. CRE were recorded for 72 hours. Heart rate variability (HRV) was assessed by polysomnography.
Detailed Description
Background: Immunization with the pentavalent vaccine Diphtheria-Tetanus-Acellular pertussis-Inactivated poliomyelitis-Haemophilus influenzae type b (DTPa-IPV-Hib) at two months of age is known to be associated with cardio-respiratory events (CRE), such as apnea and bradycardia, in 11 to 47% of preterm infants \[1,2\]
Methods: This randomized, double blinded, placebo-controlled study was conducted in the neonatal intensive care unit of Sainte-Justine University Hospital (Montreal, QC, Canada) over a period of fourteen months (February 2010 - March 2011). Study was approved by CHU Sainte-Justine institutional Ethics Committee for Clinical Studies. Written informed parental consent was obtained for all infants.
The vaccines administered were: Diphtheria-Tetanus-Acellular pertussis-Inactivated polio-Haemophilus influenzae type B (DTaP-IPV-HIB: Pediacel® 0.5ml) and the pneumococcal conjugate 10-valent vaccine (Synflorix® 0.5ml). The two vaccines were administered by nurses intramuscularly in the anterolateral region of each thigh.
On enrollment, patients were randomized by the pharmacy (investigator blinded) into two groups: the study group received oral ibuprofen (Advil® Pediatric drops for infants \< 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522) 5 mg/kg/dose as recommended by the manufacturer (Ibuprofen; n=28):http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails.
The control group received an oral placebo (Placebo; n=28). The placebo was prepared by the CHU Sainte-Justine pharmacy and was composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg. The drugs were administered by nurses in an opaque syringe 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.
Cardio-respiratory monitoring and recordings were performed in all patients continuously for 72 hours, beginning 24 hours before and continuing until 48 hours after immunization (Figure 1). Monitoring tracings were printed and CRE were extracted and compared to nurses' surveillance noted in a separate sheet. These analyses were performed by two different operators: a medical fellow (WBJ) and a research nurse. The results were discussed and an agreement reached between operators in any instances of discordance. The recorded CRE included: bradycardia (a 33% decrease in baseline heart rate for at least 4 seconds or a heart rate ≤ 80 bpm), desaturations (10% decrease in baseline saturation), and apnea (respiratory pause of at least 20 seconds, or a respiratory pause of 15 seconds associated with a bradycardia).
Total CRE was expressed as the average number of events (desaturation + apneas + bradycardia) / 24 hours. Δ Total CRE / patient / 24 hours was defined as the difference between the average number of events / 24 hours observed before vs. after immunization for each patient. Biographical data, maternal and pregnancy data, and infant medical data (base line heart rate, temperature and ventilation duration) were also collected for each patient.
Two annotated polysomnographies were performed for all patients with an AURA PSG GRASS ambulatory and wireless system. Each polysomnography had a duration of 2.5 hours: the first was conducted on enrolment (the day before immunization), and the second was conducted 18 to 24 hours after immunization. The patients were settled comfortably in an environment with reduced tactile, auditory and luminous stimulation, and the cardiac electrodes, oximeter and abdominal respiration detector were placed. The polysomnographies were annotated by the research nurse or medical fellow (WBJ) for the total duration of the recordings, and analysis was performed by the team of Pr Pladys (Rennes, France).
CRP and prostaglandin E2 were measured as systemic markers of inflammation. Blood samples for CRP levels were taken at the same time (0.5ml/sample in microtube with lithium heparin and gel barrier), and analyzed by immunoturbidimetric dosage (Sainte-Justine University Hospital Biochemistry laboratory). Capillary blood samples (0.5ml/sample) were collected in an EDTA-coated tube 30-60 min prior to the immunization, and 18h after. 10µM indomethacin was added to each tube within 30 min of sampling in order to inhibit ongoing PG synthesis by platelets. After centrifugation, plasma was frozen (-80ºC) until analysis. Plasma PGE2 concentration was determined by ELISA (PGE2 Parameter Assay kit; R and D systems, #KGE004B; intra- and inter-assay variability of 6.7% and 10.6% respectively).
All blood samples were taken following sucrose administration as per routine practice in the NICU. They also were taken at the same time of a routine blood test already planned for the patients. Δ CRP and Δ PGE2 were defined, respectively, as the difference between CRP and PGE2 levels before and after immunization.
Statistical analysis was performed using SPSS (v20.0 for Windows). All variables were tested for normal distribution using the Shapiro-Wilk normality test. When normally distributed (parametric), data were presented as mean ± standard deviation, applying one-way analysis of variance (ANOVA) and Bonferroni post hoc test. Nonparametric data were analyzed using the Kruskall-Wallis with Dunn post-test. HRV parameters were analyzed by paired or unpaired Student's t-test, or Wilcoxon w-test and Mann-Whitney u-test as appropriate. Correlations between non parametric data were analyzed using Spearmen test. The two-sided significance level was set at 0.05.
The sample size calculation (26 patients required in each group) was based on a 40% incidence of CRE post vaccination \[1,2\] and with the hypothesis that the ibuprofen will decrease this incidence from 40% to 15% (α of 0.05 and a power of 80%).
A post-hoc analysis was performed to identify the pre-immunization characteristics of the preterm infants who increased their CRE of more than 1 SD.
#Intervention
- DRUG : Advil® Pediatric drops for infants
- Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants
- Other Names :
- Oral Ibuprofen
- DRUG : Placebo
- Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants
- Other Names :
- Oral placebo:sodium stearate 0.25g+lactose 0.5g+15 ml syrup
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:
* preterm infants less than 32 weeks of gestational age
* Postnatal age more than 7 weeks
* Informed parental consent
Exclusion Criteria:
* anomalies in cardiac conduction
* congenital malformations
* severe intraventricular haemorrhage (grade 3 or 4) or with periventricular leukomalacia
Sex :
ALL
Ages :
- Minimum Age : 7 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 422 |
Target Study Title: Longitudinal Hemostatic Profile After Stopping Estroprogestative Contraceptives: a Prospective Cohort Study
Target Study Description: #Study Description
Brief Summary
This prospective cohort evaluates the longitudinal profile of hemostatic biomarkers during the first 3 months after having stopped a combined oral contraceptive.
Detailed Description
Women using a combined oral contraceptive (COC) and who have decided to stop it or switch it to a non-estrogenic contraceptive are included. At baseline, before the COC is stopped, and at multiple time points during the 3 months of follow-up, blood will be drawn to evaluate the hemostatic profile. Findings are compared with a control group of women without an estrogenic contraceptive, who are also followed for 3 months.
#Intervention
- OTHER : Tests of biological hemostatic profile associated with contraceptives
- Tests of biological hemostatic profile associated with contraceptives will be done before and after having stopped an estrogenic contraceptive (group 1) and during the non-use of an estrogenic contraceptive (group 2)
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
* 18 <= age <= 50 years
* current use (for at least 3 months) of an estrogenic contraceptive with the decision to stop it or replace it with a non-estrogenic contraceptive (estrogen group)
* no current use of an estrogenic contraceptive (control group)
Exclusion Criteria:
* personal history of VTE
* known thrombophilia
* recent medical event (hospitalization, surgery, cancer)
* pregnancy, post-partum period, current breastfeeding
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 423 |
Target Study Title: Phase I Trial of Induction Dasatinib Therapy in Patients With Resectable Malignant Pleural Mesothelioma
Target Study Description: #Study Description
Brief Summary
The goal of this clinical research study is to learn how dasatinib affects biomarker levels in patients with malignant pleural mesothelioma that may be able to be removed by surgery. The safety and effectiveness of this drug will also be studied.
This research study is financially supported by the United States Department of Defense.
Detailed Description
The Study Drug Dasatinib is designed to decrease the activity of one or more proteins that are responsible for the uncontrolled growth of tumor cells. This may cause the tumor cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take 2 dasatinib tablets by mouth 2 times a day for the 4 weeks before surgery (in the morning and 12 hours later). Dasatinib may be taken with or without food, but should be swallowed with at least 1 cup (8 ounces) of water. A light meal is not required, but may help you avoid getting a stomach ache when you take your dose. Tablets must be swallowed whole and may not be broken. If vomiting occurs within 30 minutes of swallowing the tablet(s), you can take another dose. If you miss a dose of dasatinib, take it as soon as you remember on the same day. If you miss taking your dose for 12 hours, take your regular dose the next scheduled day (do not take double your regular dose to make up for the missed dose). You will be given a 'pill diary' to write down when you take the study drug. You will be shown how to fill it out and asked to bring the diary with you to each clinic visit.
Study Visits:
On Days 21 and 28, the following tests and procedures will be performed:
* You will have a physical exam, including measurement of vital signs and weight.
* You will also have a test to check the amount of oxygen in your blood.
* Blood (about 3-4 teaspoons) will be drawn for routine tests.
* You will have a performance status evaluation.
* You will have an ECG.
* Blood (about 1-2 teaspoons) will be drawn to check your how well your blood clots.
* You will have a PET scan to check the status of the disease. This PET scan will be before your surgery, the study doctor will tell you when this will be performed.
Surgery:
After you have taken dasatinib for 28 days, you will have surgery to remove the tumor. You will continue to take the dasatinib until midnight the night before the surgery. Depending on the status of the disease, you will have either a pleurectomy or extrapleural pneumonectomy. You will be given a separate consent for these procedures, which will describe the surgery and any risks in detail.
Pleurectomy is the surgical procedure to remove the parietal pleura (the outermost lining around the lungs).
An extrapleural pneumonectomy is a surgical procedure that removes portions of the lung, the parietal pleura (the lining of the lung), the pericardium (the lining of the heart), and the diaphragm.
During surgery, 5-6 core biopsies, if possible, will be taken from different areas of the tumor for biomarker testing.
For the CT-guided core biopsy of the lung, a tissue sample is withdrawn from an organ or suspected tumor mass using a very thin needle and a syringe. The needle is guided while being viewed by the physician on a CT scan.
Length of Study:
After surgery, your doctor will decide the type of treatment you should receive for your condition. If the disease responded well to the 4 weeks of dasatinib, you may be eligible to continue taking dasatinib once a day starting 4-6 weeks after your surgery. The doctor may also decide that you can take dasatinib once a day starting 4-6 weeks after receiving radiation therapy. You may continue to take dasatinib as long as you are benefitting. You will be taken off study if intolerable side effects occur or the disease gets worse.
Follow-up Visits:
If you continue to receive the study drug after surgery, you will have a physical exam and a PET or CT scan every 8 weeks.
If you are taken off study for any reason, you will continue to be followed by the study team to see how you are doing.
This is an investigational study. Dasatinib is an investigational agent and ongoing clinical trials are using this drug in malignant mesothelioma. However, these studies have only recently started, and there is no information so far that shows the drug is effective in malignant mesothelioma. Dasatinib is FDA approved and commercially available for the treatment of acute lymphoid and chronic myeloid leukemia.
However, its use in this research study is investigational.
Up to 60 participants will take part in this study. All will be enrolled at MD Anderson.
#Intervention
- DRUG : Dasatinib
- 70 mg by mouth twice daily x 28 days, for up to 2 years after surgery.
- Other Names :
- BMS-354825, Sprycel
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 potentially resectable malignant pleural mesothelioma, IMIG stage I-III
* Subject, age >= 18 years
* Any patient who is able to tolerate general anesthesia for the extended surgical staging and the definitive surgical resection.
* No prior chemotherapy for mesothelioma within the last 3 years
* No prior radiation to the area of primary disease. Radiation to chest wall port sites is acceptable.
* No prior targeted biologic therapy (i.e. EGFR inhibitors, VEGF inhibitors) within the last 3 years
* Adequate Organ Function: a) Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN), b) Hepatic enzymes (AST, ALT ) <= 2.5 times the institutional ULN, c) Serum Na, K+, Mg2+, Phosphate and Ca2+>= Lower Limit of Normal (LLN), d) Serum Creatinine < 1.5 time the institutional ULN, e) Hemoglobin, Neutrophil count, Platelets, PT, PTT all Grade 0 <= age <= 1
* Ability to take oral medication (dasatinib must be swallowed whole)
* Women of childbearing potential (WOCBP) must have: A negative serum or urine pregnancy test (sensitivity <= 25IU HCG/L) within 72 hours prior to the start of study drug administration
* Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped
* Signed written informed consent including HIPAA according to institutional guidelines
Exclusion Criteria:
* Malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 3 years.
* Prior therapies to be excluded: any prior chemotherapy or targeted biologic therapy for mesothelioma used within the last 3 years
* Concurrent medical condition which may increase the risk of toxicity, including: a) Clinically-significant coagulation or platelet function disorder (e.g. known von Willebrand's disease) b) Any disease which requires persistent anticoagulation therapy (and the patient may not be taken off the anti-coagulation safely) with coumadin, factor Xa inhibitors, or heparin (low-molecular weight, standard)
* Cardiac Symptoms, consider the following: a) Uncontrolled angina, congestive heart failure or MI within (6 months), b) Diagnosed congenital long QT syndrome: 1. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes), 2. Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec), 3. Subjects with hypokalemia or hypomagnesemia if it cannot be corrected
* History of significant bleeding disorder unrelated to cancer, including: a) Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease), b) Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies), c) Ongoing or recent (<= 3 months) significant gastrointestinal bleeding
* Concomitant Medications, consider the following prohibitions: a) Drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib): A) quinidine, procainamide, disopyramide, B) amiodarone, sotalol, ibutilide, dofetilide, C) erythromycin, clarithromycin, D) chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide E) cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine. F) moxifloxacin, levofloxacin
* The concomitant use of H2 blockers or proton pump inhibitors with dasatinib is not recommended.The use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving dasatinib therapy.a)Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy,b)Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia,c)Patient may not be receiving any prohibited CYP3A4 inhibitors,d)Patient may not be receiving any alternative herbal remedies during the dasatinib treatment period
* Women: a) are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or, b) have a positive pregnancy test at baseline, or c) are pregnant or breastfeeding, d) Sexually active women of childbearing potential (WOCBP) must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized.,
* -continued from exclusion #8-: e) Prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy., f) All WOCBP MUST have a negative pregnancy test prior to first receiving dasatinib. If the pregnancy test is positive, the patient must not receive dasatinib and must not be enrolled in the study.
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
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>
| 424 |
Target Study Title: Real-World Assessment of Clinical Outcomes in Metastatic NSCLC Patients With MET Exon 14 Skipping Mutation and Brain Metastases Treated With Capmatinib
Target Study Description: #Study Description
Brief Summary
This was a retrospective, noninterventional cohort study of patients with a confirmed diagnosis of metastatic NSCLC with MET Exon 14 skipping mutation and brain metastases (BM) who received treatment with capmatinib in real-world practice settings.
The study population consisted of patients with histologically confirmed stage IIIB, IIIC, or IV MET Exon 14 skipping mutated NSCLC with BM. The date of the initiation of therapy with capmatinib after the date of initial BM diagnosis at or after the initial advanced or metastatic NSCLC diagnosis defined the study index date. The 12-month period before the study index date defined the baseline period to assess baseline demographic and clinical characteristics. Study measures were assessed at the index and during the baseline and postindex date periods. The index date needed to occur between 1 May 2020 and the date of data abstraction, provided the selected patients meet the requirement of a minimum of 6 months follow-up time available after capmatinib initiation; the exceptions to this are those patients who died during this period.
#Intervention
- DRUG : Capmatinib
- Patients receiving Capmatinib
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
* Patient was aged >= 18 years at the time of NSCLC diagnosis
* Patient had histologically confirmed stage IIIB, IIIC, or IV NSCLC with MET Exon 14 skipping mutation at the time of initial NSCLC diagnosis
* Patient had >= 1 measurable intracranial lesion after initial diagnosis of BM
* Patient was treated with capmatinib after diagnosis of BM (any line)
Exclusion Criteria
* Patients with characterized Epidermal Growth Factor Receptor (EGFR) and Anaplastic Lymphoma Kinase (ALK) mutations that predict sensitivity to epidermal growth factor receptor therapy, including but not limited to exon 19 deletions and exon 21 mutations
* Patients with other known actionable molecular alterations (such as ROS1 translocation or BRAF mutation) who might be candidates to receive alternative targeted therapies
* Patients who had been treated with METis in any therapy line before or after the study index date
* Patients who had participated in a clinical trial related to treatment for NSCLC at any time before or after the study index date
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>
| 425 |
Target Study Title: Investigation of the Effect on the QT/QTc Interval After Multiple Dose Oral Administration (100 and 200 mg Bid) of CG5503 PR in a Randomised, Double-blind, Double-dummy Placebo- and Moxifloxacin-controlled 4- Way Cross-over Phase I Study in 48 Healthy Male and Female Volunteers
Target Study Description: #Study Description
Brief Summary
The effect of multiple oral administration of two doses of CG5503 PR (prolonged release) compared to placebo on the electrical activity of the heart were investigated. The rationale to perform this study was to exclude any effect of CG5503 on the heart rhythm. This study was a randomised, double-blind, double-dummy, placebo- and moxifloxacin-controlled, 4-way cross-over study. Participants were given a combination of either CG5503 PR and placebo (medication with inactive ingredients which looks like the study drug) or moxifloxacin and placebo. Moxifloxacin was used as a positive control. It has consistently shown that it has an effect on the heart rhythm.
Within 14 days prior to the first dosing, participants had a physical examination, a 12-lead electrocardiogram (ECG) was recorded and haematological, serological, biochemical, and urine analyses took place. A blood sample for optional genotyping of genes responsible for long QT syndrome was taken. During each dosing session, the participants were confined in the evening before baseline assessments were performed and stayed in the clinic until 48 hours after the last dosing. Study medication was administered on Day 1 and 2 in the morning (0.5 hours after breakfast) and in the evening (1.5 hours after dinner), and on Day 3 in the morning (0.5 hours after breakfast). Dosing was separated by at least 7 days between the last dosing of each period and the first dosing of next period. Interim analysis of ECG-data were performed after completion of 24 participants (group 1) with possible subsequent adjustment of sample size for group 2.
#Intervention
- DRUG : 100 mg CG5503 (tapentadol hydrochloride) PR tablet
- 100 mg CG5503 (tapentadol hydrochloride) PR tablet.
- DRUG : Placebo matching CG5503 PR tablet
- Matching placebo tablet to CG5503 PR tablet.
- DRUG : Placebo matching moxifloxacin capsule
- Matching placebo capsule to moxifloxacin capsule.
- DRUG : 400 mg Moxifloxacin tablet (overencapsulated)
- Overencapsulated 400 mg Moxifloxacin tablet.
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 Caucasian participants aged 45 <= age <= 65 years;
* Body mass index (BMI) between 19 and 27 kilograms/square meter inclusive;
* Participants must be in good health as determined by medical history, physical examination, 12-lead electrocardiogram , vital signs, and clinical laboratory parameters (serum/urine biochemistry, serology and haematology). Electrocardiogram (ECG) parameters and vitals signs must be in the ranges given in exclusion criteria 3 <= age <= 8 and 11 <= age <= 14, respectively) Minor deviations of laboratory values from the normal range may be accepted (except potassium and magnesium), if judged by the investigator to have no clinical relevance and if not considered to interfere with the study objectives.
* Negative human immunodeficiency virus (HIV) 1/2 -antibodies, hepatitis B surface (HBs)-antigen, hepatitis B core (HBc)-antibodies and hepatitis C virus (HCV)-antibodies at the prestudy medical examination;
* Negative blood beta-human chorionic gonadotropine (HCG)-test for women of child bearing potential;
* Participants giving written consent to participate within this study;
* Participants giving written consent for blood sampling to be genotyped for genes responsible for long QT syndrome (KCNQ1, human ether-a-go-go-related gene (HERG), SCN5A, KCNE1, KCNE2, KCNJ2).
Exclusion Criteria:
* Regular use of any medication within four weeks prior to commencement of the study (self-medication or prescription except for hormonal contraception and HRT);
* Smoker more than 5 cigarettes per day;
* No regular sinus rhythm;
* ECG interval: QRS complex above 100 millisecond;
* ECG interval: PQ above 200 milliseconds;
* ECG interval: RR above 1333 milliseconds;
* QT/QTc intervals above 450 milliseconds;
* Known family history of sudden cardiac death and arrhythmias;
* Diseases and functional disorders of the gastrointestinal tract, liver, cardiovascular system or kidneys;
* Malignancy;
* History of orthostatic hypotension;
* Resting pulse rate below 45 beats/min or above 90 beats per minute;
* Systolic blood pressure above 160 mmHg or below 100 mmHg;
* Diastolic blood pressure above 95 mmHg or below 50 mmHg;
* History of drug allergy;
* Bronchial asthma;
* Participation in another clinical trial within the last three months before starting this study (exception: characterisation of metaboliser status);
* Blood donation (more than 100 milliliters) in the last three months before the start of the study;
* History or evidence of alcohol or drug abuse;
* Positive drug abuse screening test;
* Extremely unbalanced diet (in the opinion of the investigator);
* Excessive consumption of food or beverages containing caffeine (more than 1000 milliliters of coffee per day or other equivalent amounts of caffeine);
* Known or suspected of not being able to comply with the study protocol;
* Not able to communicate meaningfully with the investigator and staff;
* Neurotic personality, psychiatric illness, or suicide risk;
* History of seizures;
* Known hypersensitivity to opioids or quinolones;
* Pregnancy (for female participants);
Sex :
ALL
Ages :
- Minimum Age : 45 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>
| 426 |
Target Study Title: Modulation of Sensorimotor Measures in Chronically Unstable Ankles
Target Study Description: #Study Description
Brief Summary
This study is evaluating reflex board training to see if it will help people who frequently roll their ankles. We are investigating several tests that evaluate the ability of the neuromuscular system to control ankle movement. This study is in 2 parts:Part 1 looks at changes after 1 day of reflex training; Part 2 looks at changes after 6 weeks of reflex training. It is thought that the reflex training will improve measures of static and dynamic balance as well as spinal reflex measures.
Detailed Description
Research has utilized multiple measures in an effort to detect chronic ankle instability (CAI). Recently, investigations have focused on assessment of sensorimotor function in those who suffer from CAI. These measures have included traditional and functional postural control variables, as well as measures of joint position sense, neuromuscular control and recruitment, and nerve conduction velocity. This study seeks to modulate sensorimotor measures through both short- and long-term reflex training. This information may help to better assess sensorimotor deficits associated with CAI, to focus future research, evaluate rehabilitation protocols and to improve our understanding of this chronic disability.
#Intervention
- PROCEDURE : Checking stability of ankle
- Flexing and walking
- Other Names :
- Flexibility study
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:
* chronically unstable ankles with a history of at least 2 ankle sprains in the past year, M/F 18 <= age <= 30, healthy
Exclusion Criteria:
* ankle sprain within past 6 months, any chronic lower extremity injury or condition, neurological condition, balance-inner ear or vestibular condition, any other condition that would interfere with testing
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>
| 427 |
Target Study Title: A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 162 Administered Subcutaneously to Japanese Postmenopausal Women
Target Study Description: #Study Description
Brief Summary
The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162) after a single subcutaneous administration in Japanese postmenopausal women.
#Intervention
- DRUG : Placebo
- Administered by subcutaneous injection
- BIOLOGICAL : Denosumab
- Administered by subcutaneous injection
- Other Names :
- AMG 162, Prolia
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 women between the ages of 40 and 64 years, inclusive
* postmenopausal, defined as amenorrheic for at least 24 months
* clinically acceptable physical exam
* clinical laboratory tests (complete blood count [CBC], blood chemistries, urinalysis) within normal limits or clinically acceptable to the investigator/sponsor at the time of screening with the exception of aspartate transaminase (AST) and alkaline phosphatase (ALT), which must be < 1.25 times the upper limit of normal, or gamma-glutamyl transpeptidase (GGT), which must be < 1.5 times the upper limit of normal
* normal or clinically acceptable electrocardiogram (ECG) (12-lead reporting ventricular rate and PR, QRS, QT, and QTc intervals)
* body mass index between 17 and 27
* willing to sign an approved informed consent form before any study-specific assessments and oral consultations are performed
Exclusion Criteria:
* administration of medications within 6 months before investigational product administration that are known to effect bone metabolism, including but not limited to the following: calcitonin, parathyroid hormone (or any derivative), supplemental vitamin D (> 1000 IU/day), glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the date of informed consent were allowed), anabolic steroids, calcitriol and available analogues, diuretics
* administration of the following medications within 12 months before study drug administration: bisphosphonates, fluoride for osteoporosis
* diagnosed with any condition that affects bone metabolism
* greatly differing levels of physical activity compared with the 6 months before investigational product administration or constant levels of intense physical activities
* routine alcohol intake of >= 2 drinks/day, on average, within 6 months of investigational product administration
* known sensitivity to any drugs
* positive test results for hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus antigen/antibody, syphilis
* receiving or received any investigational drug (or was currently using an investigational device) within 4 months before receiving investigational product
* donated any amount of blood within 16 weeks, or over 400 mL (Note: not 400 mL but 200 mL, for the subjects who were to be enrolled into cohorts 4 or 5) within 1 year of the start day of screening
* subject had previously entered this study
* any other condition that might have reduced the chance of obtaining data (eg, known poor compliance) required by the protocol or that might have compromised the ability to give truly informed consent
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 428 |
Target Study Title: A Randomized, Wait-list Controlled Trial of a Qigong Intervention Program on Telomerase Activity and Psychological Stress in Abused Chinese Women
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to evaluate the effect of a qigong intervention program on telomerase activity in Chinese women with a history of intimate partner violence.
Detailed Description
Qigong is a mind-body exercise rooted in the paradigm of traditional Chinese medicine, aiming to achieve a harmonious flow of energy (qi) in the body through gentle movements and is thus considered as a holistic health practice towards promoting physical and mental well-being and improving longevity. It was suggested that qigong exercise, as a stress management strategy, could be effective in improving psychological symptoms, as well as enhancing cellular telomerase activity by reducing oxidative stress level and regulating immune response.
The study is to evaluate the effects of a qigong intervention on telomerase activity and pro-inflammation cytokines, perceived stress, perceived coping, and depressive symptoms in Chinese women with a history of intimate partner violence. The study design is a randomized, wait-list controlled design with intervention and wait-list control groups. A total of 240 Chinese abused women will be recruited. The qigong intervention program consists of: (i) a 2-hr group qigong training twice a week for 6 weeks; (ii) weekly group follow-up of a 1-hour group qigong exercise for 4 months; and (iii) self-practice of qigong exercise for 30 minutes each day throughout the intervention period lasting 5.5 months. It is hypothesized that the participants in the intervention group will have higher levels of telomerase activity and perceived coping, and lower levels of pro-inflammation cytokines, perceived stress, and depressive symptoms, on completion of a qigong intervention program, compared to abused Chinese women in the wait-list control group.
#Intervention
- BEHAVIORAL : Qigong training
- a total of 103 hours over a period of 5.5 months, consisting of:
* Group learning and practice: a 2-hour qigong exercise training session will be provided by a qigong master twice a week for six consecutive weeks (24 hours),
* Weekly group follow-up: a 1-hour qigong exercise will be conducted with reinforcement of learning and remedial teaching by a qigong master once a week for four consecutive months (16 hours) after the group learning and practice, and
* Self-practice: participant will engage in qigong exercise for 30 minutes every day for the whole intervention period lasting 5.5 months (63 hours).
- OTHER : Wait-list control- Health talks
- Monthly health education talks unrelated to qigong will be provided starting from the point when the intervention group starts the qigong weekly follow-up.Once the intervention group has completed the qigong intervention program, the wait-list control group will receive the qigong exercise training.
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 or older,
* willing to undertake the qigong intervention program,
* available for all testing points,
* receptive to random allocation, and
* assessed to be abused by an intimate partner in the preceding year or longer, based on the Chinese Abuse Assessment Screen.
Exclusion Criteria:
* had participated in qigong training or other mind body intervention within the previous 6 months, or
* have serious medical conditions that might limit their participation in qigong exercise (based on our previous experience, such conditions include cancer, severe obesity, narcolepsy, major depressive disorder, schizophrenia), or
* have psychiatric disorders, or
* use medication or other psychological intervention for stress, or
* are abused by someone who is not their intimate partner.
Sex :
FEMALE
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>
| 429 |
Target Study Title: Development of Online Store for Testing Regulatory Food and Nutrition Policies in Brazil
Target Study Description: #Study Description
Brief Summary
The purpose of this randomized controlled trial is to assess the impact of different nutrient profiles for magnifying glass front-of-package labels (FOPLs) on consumer choices in an online grocery store. Participants will be adults residing in Brazil recruited through a survey research firm. Participants will be randomly assigned to one of three shopping environments in an online grocery store. Participants will complete a shopping task (selecting items from a pre-specified shopping list) in the online grocery store. After completing the shopping task, participants will be rerouted to a computer survey. The survey will include standard behavior and label perception questions, as well as demographic items.
Detailed Description
Among noncommunicable disease, cardiovascular-related diseases are the leading cause of death worldwide and contribute to almost one-third of deaths in Brazil. Cardiovascular disease has become the leading cause of death in Brazil since 1960 due in part to poor eating habits, obesity, and insufficient physical activity. Consumption of high levels of sodium, added sugar, and saturated fat is a major driver of the development of cardiovascular disease. In this context, nutrition policies and interventions, such as the use of warning labels, are an important tool for reducing risk of diet-related diseases. The Brazilian Ministry of Health has recently announced efforts to combat the country's growing burden of diet-related noncommunicable diseases, and Brazil's National Health Surveillance Agency (ANVISA) has approved a more transparent and accessible system for communicating nutrition information for foods and beverages. The proposal will require labeling with a magnifying glass symbol on the front of products' packages to inform consumers about excess nutrients (i.e., sodium, sugar, saturated fat). Similar interventions have been implemented across Latin America, including Chile, Peru, and Mexico. A recent study in Chile demonstrated a reduction in purchases of food and drink items displaying warning labels.
This study seeks to test the effectiveness of different nutrient profiles to determine which products should carry the new labels in Brazil (i.e., the Pan-American Health Organization's profile or Brazil's National Health Surveillance Agency's proposed profile). Additionally, it seeks to assess whether the inclusion of information about products' ultra-processed nature further impacts consumers' product perceptions. The study will provide critical information for the Brazilian Ministry of Health on the effectiveness of the new label proposal and on strategies to inform Brazilians of product healthfulness.
Participants will be initially redirected from Cint (an online panel company). Following online consent and completion of a screening survey, participants will be redirected to an experimental online grocery store (Saruê), given a shopping list, and asked to shop for the items on the list as if in a real store. Upon redirection from Cint, participants will be randomly assigned into three arms: 1) control (no FOPLs); 2) FOPLs applied to products based on Brazil's National Health Surveillance Agency (ANVISA)'s nutrient profile model; or 3) front-of-package labels applied to products based on the Pan-American Health Organization (PAHO)'s nutrient profile model. After participants select products and check out, they will answer a survey about their perceptions about the labels and products carrying them. These questions will include self-reported responses to the content (e.g., elaboration, beliefs). After data collection, data on participants' selected products in the online grocery store will be analyzed to determine which nutrient profile was the most effective in decreasing participants' consumption of key nutrients.
Setting: The trial will take place in Saruê, an experimental online grocery store created for researchers to examine how front-of-package labels influence consumer purchases in a controlled but realistic environment. The online store reflects real-world prices and is modeled after Pão de Açúcar, a Brazilian online grocery store .
Recruitment: Participants will be recruited through Cint, a survey research firm. The eligibility criteria are residing in Brazil, being 18 years or older, and being responsible for at least half of the grocery shopping for one's household. Participants are ineligible if they were involved in any pre-testing related to the survey. Experiments conducted using online convenience samples, such as those recruited by Cint, largely replicate findings from studies conducted via probability-based samples. Cint will screen for eligibility and recruit participants from their pool of 8 million participants in Brazil. Approximately 3,000 participants will be recruited. As compensation, participants will receive incentives or points that can be redeemed for gift cards or goods per Cint's protocols.
Informed Consent: Participants will sign an informed consent form that follows a structure that is customary in Brazil.
Randomization: After the participant has signed the consent form, they will be randomly assigned to one of the three study arms. Randomization order will be determined a priori. Participants will have an equal chance of being randomized to each trial arm.
#Intervention
- BEHAVIORAL : ANVISA
- Products carrying front-of-package labels based on Brazil's Health Regulatory Agency (ANVISA's) nutrient profile model
- BEHAVIORAL : PAHO
- Products carrying front-of-package labels based on the Pan-American Health Organization (PAHO's) nutrient profile model
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
* Resides in Brazil
* Does at least half of the grocery shopping for their household
Exclusion Criteria:
* Involved in any pre-testing
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>
| 430 |
Target Study Title: Is Pediatric Anesthesia Associated With Long-term Hippocampal Dysfunction?
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine whether pediatric anesthesia is associated with long-term hippocampal dysfunction
Detailed Description
Contrary to a longstanding belief, anesthesia has lasting effects on the neonatal brain. In rats anesthesia causes death of brain cells, ill-timed conversion of stem cells to nerve cells and a certain kind of brain defect up to 8 months later. This brain defect is called a hippocampal deficit because it resembles the type of defect that people have when a structure in the brain called the hippocampus has been injured, removed or is no longer functioning. However, to date it is unknown if anesthesia given to human infants causes a lasting hippocampal deficit, which might manifest itself as memory problems and academic failure despite normal intelligence. The investigators will test the hypothesis that anesthesia for more than 2h given to children of less than 2 years of age without coexisting diseases of the brain or the heart causes long-term impairment of hippocampal function. Using state of the art hippocampal and general brain function testing the investigators will compare hippocampal dependent and hippocampal independent memory as well as general cognitive function and emotional state in 10 year-old children that underwent at least a 2h anesthetic at less than 2 years with that of a matched control group that did not undergo an anesthetic.
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:
* Anesthesia at less than 2 years
* Anesthetic time greater than 2 hours
* ASA I or II
* Induction with Propofol or Sevoflurane +/- N2O
* Maintenance with a volatile agent (sevoflurane, isoflurane, desflurane) +/- N2O
Exclusion Criteria:
* Neurosurgery
* Known genetic syndrome
* Any other anesthetic agents (ketamine, meperidine, barbiturates, etomidate, methoxyflurane, methadone, lorazepam)
* Low birthweight (<25%ile)
* Gestational age , 36 weeks
* color blindness
* h/o CNS disease
* cancer
* head trauma
* congenital heart disease
* ASA III or IV
* intra-operative hypotension (<30% baseline for > 5 min)
* Bradycardia (<30% baseline for > 5 min)
* Hypoxemia (Blood Oxygen Saturation <93% for > 5 min)
* Hypercarbia (pCO2 > 60 mm Hg > 5 min)
* Dysthermia (deviation from 36.5 deg C by > 1.5 deg C at any time)
* Puberty
Sex :
ALL
Ages :
- Minimum Age : 6 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 431 |
Target Study Title: Impact of Donor and Recipient CYP3A5 Genetic Polymorphism on Tacrolimus Exposure in Patients With Hepatic Transplant
Target Study Description: #Study Description
Brief Summary
The choice of an immunosuppressant after hepatic transplant is now more difficult than before because of the increasing number of drugs available.
Pharmacokinetic, pharmacodynamic and pharmacogenetic information can help to choose the best treatment and the best dose for each patient. The genetic polymorphism of enzymes metabolizing treatments can affect their efficacy and safety. Concerning tacrolimus, CYP3A5 activity is a major determinant of the dose needed to reach target concentrations. This study is aimed at evaluating the impact of both donor and recipient CYP3A5 genetic polymorphisms on tacrolimus exposure in patients with hepatic transplant.
Detailed Description
Pharmacogenetics is a recent tool which could help to choose the best immunosuppressive therapy in patients with hepatic transplant. Indeed, the CYP3A5 gene has many polymorphisms and one of them, g.6986 A\>G, is the major determinant of the variability of expression of this protein. The allele \*1 (g6986A) leads to normal protein expression while the allele \*3 (g.6986G) causes lack of protein expression, and their different combinations induce a great variability in tacrolimus concentrations. As cytochromes are present in the liver and intestine, in hepatic transplant, tacrolimus exposure results from both recipient (enterocytes) and donor (liver) enzymes. Recent studies demonstrated a significant role of the genotype recipient on the dose/concentration relationship and on the dose needed to reach target concentrations. However, these studies were insufficient to analyze more precisely all impacts of this polymorphism because they did not include enough patients. The purpose of the investigators study is to evaluate the impact of donor and recipient CYP3A5 genetic polymorphism on tacrolimus exposure in patients with hepatic transplant after the first administration of tacrolimus and at 7 days post transplantation, when the dose has been adapted to avoid too high blood levels and to limit serious adverse reactions.
#Intervention
- OTHER : Tacrolimus pharmacokinetics
- tacrolimus pharmacokinetics over 12 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:
* Adults (>18 years) of Caucasian origin,
* with hepatic transplant,
* who are going to be treated by tacrolimus, and
* who gave free, well-informed and written consent.
Non-inclusion Criteria:
* Participation to another protocol incompatible with the study,
* HIV patients with antiretroviral treatment,
* Patients with legal guardianship or deprived of freedom.
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>
| 432 |
Target Study Title: A Randomized, Open-Label, Single-Dose, Crossover Study to Compare Pharmacokinetic Properties and Safety of HCP1704 and HGP1810 in Healthy Adults
Target Study Description: #Study Description
Brief Summary
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HCP1704 in healthy subjects.
#Intervention
- DRUG : HGP1810
- HGP1810: Vildagliptin/Metformin
- DRUG : HCP1704
- HCP1704: Vildagliptin/Metformin
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 19~55 years in healthy volunteers
* BMI is more than 18.5 kg/m^2 , no more than 24.9 kg/m^2
* Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
Exclusion Criteria:
* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 433 |
Target Study Title: Exploring Computerised Cognitive Training for People With Huntington's Disease
Target Study Description: #Study Description
Brief Summary
Cognitive impairments, especially deficits of executive function, have been well documented as a core and early feature in Huntington's disease (HD). Cognitive impairments can be considerably burdensome and devastating for people and families affected by HD. Computerised cognitive training interventions that focus on improving executive function present a potentially exciting non-pharmacological treatment option. Novel work conducted in mouse models of HD, has demonstrated that cognitive training, administered from an early stage in the disease, can improve motor performance at an older age, even in the absence of further training in the intervening time. This represents proof of principle in an animal model of HD that cognitive training can improve HD disease symptoms.
Improvements associated with executive function training have also been reported in a clinical setting in a variety of neurodegenerative diseases. For example, cognitive training, can improve executive function as people age, and training specifically focused on tasks of executive function has been shown to improve both cognitive and motor outcomes in neurodegenerative diseases such as Parkinson's disease (PD) and Alzheimer's disease (AD). Therefore, this study is a feasibility study which aims to establish proof of principle for using computerised cognitive training in people with HD. The investigators propose to determine the feasibility, acceptability and gather preliminary evidence of the effectiveness of a cognitive training intervention programme, targeted for people with HD. The investigators will also aim to investigate the most appropriate outcome measures to use in this study and gather feedback on the cognitive training intervention. The investigators will also establish proof of concept via the study of brain structure and function, using MRI scanning techniques.
The computerised cognitive training software and the associated outcome measures will be investigated, taking into account the views of people and families who are affected by HD. A randomised feasibility study of computerised cognitive training for people with HD will then be conducted. Participants who are randomised to the cognitive training intervention group will be asked to complete a cognitive training intervention utilising 'HAPPYneuron' software. Participants in the intervention group will be asked to complete the cognitive training programme for a minimum of 30 minutes, 3 times a week for the 12 week study duration. Participants in the control group will not receive any cognitive training and will be asked to continue as normal, however they will have home visits to control for the confounding effect of social interaction. Additional monitoring and prompting for the intervention group, will be conducted via email, text or telephone reminders (as preferred by the participant) and home visits. The motor and cognitive function of participants will be assessed at the beginning and end of the study, using a range of motor and cognitive assessments. Additional cognitive measurements will be recorded as part of the HAPPYneuron programme throughout the cognitive training intervention, such as accuracy and response time measures of particular computer games. MRI scans (optional) will be conducted at the beginning and end of the study to identify any structural changes in the brain that may be associated with the cognitive training intervention. As part of the feasibility and acceptability assessment, participants, family members and carers will be invited to complete a semi-structured interview at the end of the study, if consent is obtained, focusing on using this type of software as a home based therapeutic intervention.
Detailed Description
Due to space constraints a more extensive description of the research study can be found in the study protocol.
1. Background and Rationale Huntington's disease (HD) is caused by a CAG repeat trinucleotide expansion within the first exon of the huntingtin gene and causes a range of symptoms including motor, cognitive and psychiatric disturbances, which significantly affect daily activities, independence and quality of life, even during the early stages of the disease. Cognitive dysfunctions from early on in the HD disease process have been well documented and can include specific problems with attention, cognitive flexibility and memory. Indeed, difficulty sharing attention between more than one task has been demonstrated to be a specific and core deficit in HD.
Cognitive training interventions, which focus on executive function, present a potentially exciting non-pharmacological treatment option for neurodegenerative diseases including HD. Studies in HD mice have previously demonstrated executive function impairments, including deficits in attention and subsequent studies have shown that cognitive training can benefit HD mice and prevent the onset of cognitive and motor disease symptoms. This work suggests that an early cognitive training intervention can have significant and long-lasting beneficial effects on HD symptoms. Although further systematic studies in mouse models of HD are required to inform the translational aspects of cognitive training interventions, these results provide important proof of principle evidence that cognitive training can provide benefit in mouse models of HD.
Studies in human populations suggest that cognitive training, via repeatedly conducting tasks that require specific aspects of executive function such as attention, reasoning and memory, can improve cognitive function as people age. Computerised cognitive training studies have also been conducted in a number of neurodegenerative diseases including Parkinson's disease (PD) and Alzheimer's disease (AD). These studies have found that computerised cognitive training that can improve cognition in PD and AD. However, a systematic literature review of Europe PubMed Central using the keywords, 'Huntington's disease' and 'cognitive training' or 'cognitive therapy' or 'brain training' or 'executive function training' conducted from the years 1950 to 2015, produced 2 results. A review on cognitive burden in HD and a paper on exercise in a mouse model of HD benefiting cognitive symptoms. Thus, the use of cognitive training in HD is a considerably under researched area and to our knowledge cognitive training is yet to be explored in HD. Therefore, feasibility studies, such as the one proposed in this application are crucial in trialing novel potential therapeutic interventions.
The outcome measures used to determine patient benefit in cognitive training studies can vary significantly between studies. Furthermore, this is the first time that such an intervention has been used in people with HD. Therefore, the outcome measures used in cognitive training studies to determine patient benefit need to be carefully explored and defined prior to beginning the study. The candidate outcome measures for use in this study have been chosen to include both cognitive and motor measures specific to people with HD to best evaluate the outcome of the intervention. Difficulty sharing attention has been shown to be a specific problem in HD. Attentional sharing can be measured clinically using dual tasks where participants are required to do two tasks at the same time. The two tasks can be from the same modality such as walking and carrying a tray, or from different modalities such as walking combined with a cognitive component such as counting. Dual task studies have shown that people with HD have reduced attentional sharing capacity, particularly when the dual task has a cognitive element. As the ability to complete dual tasks and increasing attentional demand are key skills in everyday life, deficits in such tasks can severely affect independence, increase the risk of falls and reduce quality of life. The proposed study will use dual task performance to assess feasibility, acceptability and to gather preliminary efficacy data on the effect of cognitive training interventions in people with HD.
Environmental enrichment has been shown to improve disease symptoms in HD mice and a retrospective study regarding lifestyle of people with HD suggests that a passive or sedentary lifestyle, lacking in enriching activities, may contribute to earlier onset of disease symptoms. There is also preliminary evidence that motor training can produce functional benefits in HD and accumulating evidence of feasibility and functional improvements from both in- and out-patient exercise and rehabilitation programmes. Motor training exercise studies have shown that multi-modal exercise interventions are well tolerated and associated with improvements in movement, cognition and mood alongside increases in health related quality of life. Work is now ongoing to develop methods to support and enhance adherence to home exercise in HD. Furthermore, the investigators now have preliminary evidence that an intervention with both motor and cognitive components (a training regimen in which patients' train to drum increasingly complex rhythms to music) can produce improvements on the symbol digit modalities, a test of executive function, with accompanying changes on MRI tractography. Brain imaging studies are hugely important in greater understanding the biological mechanisms which may underpin any intervention in a neurodegenerative disease.
Strategies for conducting cognitive training can vary between research studies. Some use taught exercises or puzzles which participants learn and then repeat. However, the utilisation of computerised cognitive training strategies provides several advantages over repeating practical tasks. Computerised cognitive training strategies are automated and can be completed by participants at their convenience, they provide automated tasks which require comparatively little movement to complete and provide several objective outcome measures. Furthermore, the specific HAPPYneuron cognitive training software that the investigators are using in this study provides an interface for the researcher to observe the progress of study participants and it can be made available in different languages to allow for consistent training globally. However, as this is a feasibility study, the computerised cognitive training intervention will be optimised taking into account the feedback and views of people with HD.
2. Study Aims The primary aim of this study is to determine if computerised cognitive training, is feasible and acceptable for people with HD. The researchers will investigate the familiarity of participants with the computerised cognitive training programme, its usability and determine key outcome measures for use in cognitive training studies, before conducting a randomised feasibility study. The randomised feasibility study will also explore the biological underpinnings of any observed behavioral changes using MRI scanning, this is an optional component of the study. During this study, important parameters will be established, which will allow us to develop the intervention programme for use in a larger patient cohort.
2.1. Specific Objectives
The objectives of the proposed study are to:
(i) investigate the familiarity of participants ad usability of computerised cognitive training programmes and determine key outcome measures for use in cognitive training studies.
(ii) assess the feasibility of delivering a home based computerised cognitive training programme for people with HD, considering:
* The willingness of eligible participants to receive the intervention and participate in a feasibility study (including the feasibility of randomisation)
* Potential barriers to recruitment or completion of the study
* Response rates and adherence to the cognitive training programme (iii) determine any behavioural changes which may occur during the intervention or comparable control arm.
(iv) use brain imaging techniques to explore the biological underpinnings of any observed behavioral change (optional).
(v) evaluate the intervention using participant and family member/carer feedback to future use in this patient population.
3. Study Design Participants will be recruited from the Cardiff Huntington's disease Centre. Participants will be asked to complete a range of computer and paper based cognitive tasks, motor tasks and interviews in their first research visit, which may coincide with their ENROLL-HD visit. Participants will then be invited back to complete baseline assessments for the feasibility study within the next 4 weeks. After randomisation, those allocated to the intervention group will receive the 12-week home-based cognitive training intervention, supported by home visits and email or telephone reminders, as preferred. Those allocated to the control group will be asked to continue as normal although they will also receive home visits. At 6 weeks an optional MRI scan will be conducted in addition to cognitive tasks. 12 weeks after completing baseline assessments, participants will be invited back to complete the final outcome assessments.
4. Participant Selection The Cardiff HD Centre is an Enroll-HD (previously Registry) site and many patients attending the clinic are enrolled in this study (REC no. 04/WSE05/89). Patients already enrolled to a global Enroll-HD observational study will be invited to take part in this study. The progression of symptoms in these Enroll-HD participants are monitored longitudinally. One of the optional components within the Enroll-HD study is the giving of permission by participants to be contacted about other additional and affiliated HD research studies, and for their coded data to be accessed by researchers conducting HD related research. As such, a full clinical data set including full medical and medication history will be available for each research participant and this data may be used during the study. In addition, the investigators would like to gather the views of family members, friends and carers. Participants will be asked to provide consent so that the investigators can talk to their family member, friend or carer, who may be attending research visits with the participant, about their involvement in the study. If informed consent is obtained, via a participant dated consent form, the family member, friend or carer will be invited to be interviewed about the study.
5. Recruitment 5.1. Number of Participants This is an initial proof of principle study; thus no formal sample size calculations have been completed. The investigators will aim to recruit 50 participants with a target of randomising 40 participants. The suggested numbers are based on previous literature regarding cognitive training in other diseases and considering that MRI is an optional component of the study. The study team have funds for the MRI scanning of 16 participants during the study, scanning will be conducted on a first come first served basis and once the funds for scanning are used no further participants will be able to be scanned. This study is an essential step towards a larger systematic study of cognitive training and will inform the design and delivery of such a trial, as well as providing data to inform a power calculation to estimate sample size in the future.
5.2. Recruitment Process Potential participants, who have already consented to participate in ENROLL-HD may be approached during their clinical visits and will be informed of the study. Potential participants will receive an information sheet about this study and be will be given sufficient time to ask questions and discuss the study with the researcher. If required, potential participants can take the information sheets home and discuss the study with their family and friends. Potential participants who wish to consent will be reminded that they can change their mind or withdraw without reason at any time. If the potential participant is willing to proceed with the study, they will be asked to sign a consent form and the study assessments will begin.
5.3. Informed Consent The participant will be allowed as much time as needed to consider the Participant Information Sheet (PIS) and the opportunity to question the research team or independent parties to decide whether he/she will participate in the study. All participants will have the procedures explained in detail, including that the study design is randomised, that MRI scanning is an optional component and that they can withdraw at any time. Informed consent will then be obtained by means of participant dated signature and dated signature of the person who presented and obtained the informed consent. The original signed form will be retained at the study site. After informed consent has been received the first study visit will take place. Participants will be reminded that they can withdraw from the study at any time, without the need to give a reason and this will not affect their current or future care. Participants will be asked during the consent process if their family member or carer can be asked their opinions of cognitive training interventions, this is an optional component of the consent form. If consent is provided to ask family members, friends or carers that attend the clinic with the participant, they will be asked to read a separate information sheet. If they agree to participate, they will be asked to sign a consent form and they will then be interviewed regarding the study.
5.4. Health Checks/Screening Required for Magnetic Resonance Imaging (MRI) Scanning MRI scanning is an optional component of the study. Thus, as part of the pre-screening process, all participants will be screened for contraindications to MRI. In addition, comprehensive screening for MRI contraindications will be completed immediately before each MRI scan by the researcher and the MRI operator before the participant is allowed into the scanning room.
5.5. Randomisation Procedures As the study includes an intervention and control group, randomisation will be performed using a minimisation procedure and programme to ensure balance between the groups for categorical variables of age and cognitive function. Minimisation will be performed by the researcher, considering age and cognitive results of the most recently published global ENROLL-HD study data. Age and cognitive function will be given the same weighting during the minimisation procedure. Age will be classified into two categories: 1) \< 45 years and 2) \> 45 years. The total cognitive score of the participant in the Categorical Verbal Fluency Test, will be used to classify participants into two categories. The randomisation procedure will be carefully explained to all potential research participants and is specifically outlined in both the PIS and CF. Randomisation will only be performed after the participant has signed the CF and completed the initial and baseline assessments. Participants allocated to the control group will be asked to carry on as normal. Once allocated to a group, participants will receive an allocation letter detailing the group that they have been randomised to. Unfortunately, due to licencing restrictions those allocated to the control group will only be able to use the cognitive training software in the first research visit and during the baseline and outcome assessments of the second and third research visits. It will be made clear to all potential participants at the end of the study, they will have to stop using the cognitive training software as their access to the login system will expire.
6. Study Procedures
6.1 The 12-week Cognitive Training Intervention The 12-week cognitive training intervention will be completed in participant homes. The intervention will be supported by email, text and telephone reminders (as preferred by the participant and detailed in the Case Report Form) and home visits. Home visits will be conducted for both the active and control groups. Although additional home visits may be necessary if a participant is concerned about using the software. During the research visits, for the active group, the researcher will ensure that the participant is comfortable with the software, offering support and guidance and a battery of cognitive assessments will be performed. For the control group during home visits the researcher will complete the cognitive test battery and talk to the participant about their day. The intervention is designed to be conducted with minimal supervision and this is something that will be explored during participant and friend, family member or carer interviews. When completing home visits, the researcher will comply with the Lone Workers Policy in existence at the Cardiff HD Centre and will discuss visits with the research team prior to completing them to ensure that safety is not compromised at any time. Participants will be asked to complete the training programme provided using HAPPYneuron software for a minimum of 30 minutes 3 times a week for 12 weeks. After the participant completes the 30 minute training programme they will be free to complete any other of the 'games' available on the HAPPYneuron computerised cognitive training software. Completion of the cognitive training programme will be monitored and supported using email or telephone reminders (as preferred by the participant) and home visits by the researcher. This will allow patient adherence with the cognitive intervention programme to be monitored and therefore the feasibility and acceptability of the programme by the participant to be explored. Each participant will be provided with a unique log in. The software provides an interface that allows the researcher to track the regularity of use and progress of all study participants. Therefore, the investigators will be able to remotely determine how often and for how long participants are using the software and can analyse participant performance on each cognitive task. Furthermore, the performance of participants for each specific task, during each cognitive training session is measured and can be used to determine improvements in specific cognitive tasks, for example in response accuracy or response time, throughout the study. Participants will be made aware that the researcher is able to see their training activity throughout the study.
The cognitive training software the investigators plan to use in this study is easy to use, is automated, provides non-biased data recording, provides an interface which allows the researcher to track compliance remotely. It has previously been validated in both healthy controls and patients with depression, and has shown patient benefit including improved cognition and functionality. At the end of the study the participant login details will expire and they will no longer be able to access the cognitive training software, this is made clear in the PIS. The intervention is designed to be completed independently, although in this feasibility study, with the agreement of the participant, the investigators will be specifically exploring the involvement of any friends, family members of carers using semi-structured interviews at the beginning and end of the study.
6.2. Magnetic Resonance Imaging (MRI) Scanning Cardiff University has a world leading brain imaging research centre (CUBRIC) which provides access to state of the art research facilities and equipment. Therefore, MRI scanning will be used in this study, as an optional component, to greater explore the biological effects if any, that the cognitive training programme may have. Prior to consent, potential participants will be screened for any contradictions to MRI. Further screening will be conducted prior to any MRI scanning procedures. MRI scanning is an optional component of the feasibility study, therefore if participants cannot or do not want to undergo the MRI scanning procedures, they will still be able to take part in the study. Participants will also be made aware that they are free to withdraw from the MRI scanning component of the study at any time, without the need to give a reason and this will not affect the care that they receive.
If a participant consents to MRI, the MRI scanning procedure will be carefully explained and discussed with the participant and the participant will have the opportunity to experience the 'mock' MRI scanner, if they feel this may be helpful. The MRI scan will be conducted at a research visit 6 weeks into the intervention. An MRI scan will then be conducted by a fully trained MR Operator with the help of a researcher who is MR safety trained. The scan will be acquired on a 3T Siemens Prisma scanner with 32 head coils. The MRI scanning protocol will include scans to assess a structural scan to assess gross macrostructure, microstructural scans to assess white matter and myelination changes as well as quantitative fMRI to measure resting cerebral blood flow. The complete scanning protocol is expected to last no longer than 90 minutes, but will be led by the participant to ensure that they are comfortable throughout the scanning procedure.
7. Data Collection For the majority of assessment procedures, data will be collected on paper data collection forms and the results of the tests subsequently transferred to a secure online database. The data in the online database will be verified against the paper form to ensure data integrity. Original data collection sheets will be filed and stored securely in the TMF.
For the semi-structured interviews, questions will be asked orally by the researcher, audio recorded and transcribed verbatim. Although some flexibility may be necessary to avoid the need for protocol amendments. A list of topics to be included in the interview schedule for participants and family members, friends or carers who attend the research visit with the participant include:
* How the intervention is perceived/was received?
* Expected or perceived impact on daily routine
* Expected or perceived impact on family members/ carers
* Overall expectations
* Expected or perceived acceptability (support or help required)
* Thoughts and views on the randomisation procedure
* Potential barriers to completing the intervention
* General views or comments on the cognitive training intervention
8. Data Analysis As the proposed study is a feasibility study for the use of computerised cognitive training for people with HD, the study is not formally powered. The primary aim is that of feasibility, so eligibility, recruitment and acceptability of the study will all be evaluated. Adherence to the proposed cognitive training intervention and any adverse effects will also be reported. Therefore, crucial inferences will be made which will allow an estimation of parameters that can inform definitive and future trials in this specific patient population.
8.1. Statistical Analyses Summary statistics of demographics (age, gender, height and weight) and disease burden scores will be reported. Descriptive data will include an evaluation of eligibility, recruitment, retention rates and acceptability of, and adherence to the intervention, with 95% confidence intervals. The completion of outcome measures and assessments will also be reported. Graphical illustration will be used to check distributions of outcome data.
Successful adherence to the intervention will be defined as having completed 12 weeks of the computerised cognitive training for a minimum of 3, 30 minute sessions per week. This is a feasibility study; thus an estimation of retention rates may be difficult with such as small sample size. Therefore, it is suggested that if retention rates are greater than 75%, the investigators will consider this intervention to be feasible. If the proportion retained is less than this but greater than 65%, the investigators will consider adjusting the intervention to increase this in future investigations. The qualitative work will help to establish why retention rates are as they are at the end of the study. A retention rate lower than this would require substantial changes to the intervention and therefore would require further piloting and feasibility studies. Changes in the outcome assessments in will be analyzed using analysis of covariance (ANCOVA) with the baseline score of that variable in addition to the balancing variables (age and UHDRS TMS) as covariates.
Data collection will be performed via HAPPYneuron software systems and initially on data collection forms before transfer to a database. Data completeness will be monitored at the point of collection; therefore, the investigators do not expect large amounts of missing data. As it is our intention to inform future confirmatory trials, the investigators will explore the feasibility of outcomes as applied in this trial and this population. The investigators will consider internal reliability of all outcome measures, as some have not been previously used in HD or applied to computerised cognitive training interventions.
9. Dissemination The research team are committed to disseminating the research findings to the general public and patient groups and will seek to present the results at patient open days, engagement events and outreach activities. Dissemination is a particular passion of the CI. Furthermore, in order to communicate the research widely, the results may be disseminated via social media, through newsletters and other patient engagement outlets in appropriate language and format for the general public to understand. If a participant indicates that they would like to be informed of the results of the trial a report of the findings will be sent to them at trial closure. Where results are presented, they will always be presented in such a way that data from individual participants cannot be identified. In addition to the significant public and patient outreach dissemination, the research findings will be written up for publication in a scientific journal. The results may also be presented at scientific meetings, or in talks at academic institutions.
10. Data Storage, Handling, Retention and Confidentiality All data will be stored within a firewall and password-protected computer system within a swipe-card secured building. Researchers associated with the study will have confidential access to files, which allow the matching of recorded data to participants. No data, whether paper or electronic, will leave Cardiff University sites without being completely anonymised, i.e., all identifiable data will be removed from the dataset. Any electronic files or disks will be stored on Cardiff University sites and electronically on Cardiff University systems. At the conclusion of the study identifiable data will be destroyed and non-identifiable data will be archived, although it will still be accessible to the study team. Data will be archived for 15 years, in line with Cardiff University policies and procedures. Study data may be shared with the organisation funding the study. Where data leaves Cardiff University it will be strictly anonymised. Anonymised data may be shared with researchers at other organisations in the UK or overseas and it may be made publicly available for future research use. In the case of the data generated using HAPPYneuron systems, this data is captured centrally and stored outside of the Cardiff University systems and is therefore subject to HAPPYneuron's policies and procedures. However, a subset of this data will be extracted for use in the study and transferred on to Cardiff University systems as described above.
All participant identification and referral procedures as well as procedures for data storage, processing and management will comply with the Data Protection Act 1998. Data will be kept for 15 years in line with Cardiff University's Research Governance Framework Regulations for clinical research. This data will be stored confidentially on password protected servers maintained on the Cardiff University Network. Data will be stored in locked cabinets and/or on secured computer hard-drives (password protected) in an access controlled building and will be retained indefinitely. This is in compliance with the guidelines set by the Cardiff University Research Governance Framework. The confidentiality of participants will be preserved in accordance with the Data Protection Act 1998. All participants will be allocated an Enroll-HD unique study number identifier and in the case of family members, friends or carers, they will be allocated a unique study number in relation to the participant. All data collected will be held in a linked anonymised form.
11. Study Closure Definition The end of study is the date of the last visit of the last research participant.
12. Indemnity Cardiff University will provide indemnity and compensation in the event of a claim by, or on behalf of participants, for negligent harm as a result of the study design and/or in respect of the protocol authors/research team. Cardiff University does not provide compensation for non-negligent harm.
13. Sponsorship Cardiff University will act as sponsor for this study.
14. Funding
The study is funded by two research grants:
1. 18 month research grant from the Jacque and Gloria Gossweiler Foundation, awarded to Dr. Emma Yhnell (Lead Applicant), Prof. Anne Rosser, Prof. Monica Busse and Dr. Claudia Metzler-Baddeley. 'Exploring cognitive training as a non-pharmaceutical therapeutic intervention for people with Huntington's disease.' (funding start date: 1st April 2016, study end date: 30th September 2017).
2. 36 month fellowship award to Dr. Emma Yhnell from Health and Care Research Wales. 'Using computer based cognitive training to provide a personalised therapeutic intervention for people with Huntington's disease.' (funding start date: 1st October 2016, study end date: 30th September 2019).
15. Study Management The project will be managed by the CI Dr. Emma Yhnell, with the support of colleagues from the Cardiff HD Centre, including Ms. Hannah Furby, Prof. Monica Busse (SEWTU), Prof. Anne Rosser (Clinical Responsible for Care) and Dr. Claudia Metzler-Baddeley (CUBRIC). In addition the CI will receive advisory support from members of SEWTU, in the form of monthly research meetings and email support for the duration of the project. The SEWTU advisory board includes: Dr Rachel Breen, Dr. Rebecca Playle, Mr. Gareth Watson and Dr. Lucy Brookes-Howells.
#Intervention
- BEHAVIORAL : Computerised cognitive training
- Computerised cognitive training regime
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:
* Confirmed HD diagnosis by genetic test.
* Over 18 years.
* Enrolled in the EHDN Registry/Enroll-HD study.
* Stable medication regime 4 weeks prior to recruitment (and not anticipated to change medications during the study period).
Exclusion Criteria:
* Inability to provide consent.
* Any known neurological condition (other than HD).
* Currently actively involved in any other interventional trial (i.e. have begun the intervention) or within four weeks of completing the final assessments of an interventional trial.
* Currently regularly completing computerised brain training programme.
* MRI contraindications (e.g. a pacemaker) as established using standard screening procedures (optional).
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>
| 434 |
Target Study Title: A Feasibility Study of Direct Access to a Newly Developed Abdominal ´Yes-No´ Pathway for Primary Care Patients With Vague and Non-specific Abdominal Symptoms
Target Study Description: #Study Description
Brief Summary
Background To optimise cancer outcome in Denmark, cancer diagnostic pathways should, beside cancer patient pathways (CPP) for alarm symptoms, also include a pathway for patients with vague and non-specific symptoms. Research has demonstrated that 50% of all cancers do not qualify for specific CPPs, although the majority of patients initially present symptoms in general practice.
Hypothesis Direct access to an abdominal 'yes-no' pathway is feasible in general practice. Aim The aim of this study is to assess the implementation and clinical implications of direct access to an abdominal 'yes-no' pathway for primary care patients with vague and non-specific abdominal symptoms Materials and methods The study is a feasibility study in which all general practitioners (GPs) in the municipality of Silkeborg in Central Denmark Region are offered direct access to a newly developed abdominal ´yes-no´ pathway for both men and women aged 30 years or above, who present vague and non-specific abdominal symptoms in primary care. The abdominal ´yes-no´ pathway consists of: 1) Medical and objective examination, 2) Selected blood samples and a Fecal Immunochemical test (FIT), and 3) Abdominal ultrasound (US) and transvaginal US (TVUS) (for women).
Perspectives This study will provide important knowledge on how to improve abdominal cancer diagnostics in general practice.
Detailed Description
Background Danish cancer patients have poorer cancer outcome compared to other European cancer patients. Earlier cancer diagnosis is a pivotal step to improve the prognosis, and there seems to be opportunity for improvement, as e.g. colon cancer is more often diagnosed at an advanced stage in Denmark than in other countries.
In Denmark, more than 11,500 abdominal cancers are registered yearly, which corresponds to 31% of all newly diagnosed cancers. The majority (75-85%) of cancer patients initially present symptoms to their GP. But only half of the patients present an alarm symptom, while 20% present serious non-specific symptoms, and 30% present vague non-specific symptoms. Site-specific CPPs for alarm symptoms were implemented in Denmark in 2008/2009 to optimise the diagnostic route for cancer. In 2012, a new Danish CPP was implemented to target patients with serious non-specific symptoms and signs of cancer (NSSC-CPP). No pathway exists for patients with vague abdominal symptoms.
Presenting in general practice with abdominal symptoms is very common. Most abdominal symptoms presented in general practice can be signs of serious disease in the abdomen and the pelvic region. However, in most cases, the symptoms are benign, self-limiting and harmless. Still, more than ten different cancer types can cause these symptoms, but clinically it is often difficult to distinguish between the symptoms.
For patients presenting vague symptoms to the GP, the ideal strategy could be easy and direct access to relevant investigations rather than a wait-and-see approach or referral to a CPP.
Aim The study sets out to investigate the need for an abdominal 'yes-no' pathway for primary care patients with vague and non-specific abdominal symptoms, how it could be clinically organised and integrated, and whether such pathway is feasible.
Material and methods Prior to the current intervention, a developmental part was conducted in 2018. It consisted of focus group meetings with 16 selected specialist, with expertise regarding patients with abdominal symptoms in general practice and abdominal cancers and other abdominal diseases.
The investigators assembled two focus groups during autumn 2017, each comprising the following experts: two GPs, a physician with expertise in gastroenterology, an abdominal surgeon, a radiologist, a gynecologist, a microbiologist and a physician in clinical biochemistry. The focus groups aimed to develop and agree on an abdominal 'yes-no' pathway using the following criteria: 1) reduce the time to diagnosis, 2) avoid unnecessary tests, 3) increase patient safety and minimise missed opportunities, 4) order the specific investigations temporally, 5) place responsibility and develop a structure and 6) illustrate an optimal pathway.
From January to September 2018, the investigators completed two meetings in each focus group, after which the investigators compared the results and gathered the groups in a common session. From the literature and the preliminary results of an yet unpublished register study, the investigators were able to present the clinical challenges to the participants during the meetings. Moreover, the possible access to investigations was presented (laboratory tests, imaging, endoscopies and access to specialist advice). Based on discussions during the meetings, the investigators developed an abdominal ´yes-no´ pathway. The abdominal ´yes-no´ pathway consists of three steps; 1) Medical and objective examination, 2) Selected blood samples and a FIT, and 3) Abdominal US and TVUS. The GP continues to hold responsibility for follow-up, while hospital examinations are performed on an outpatient basis with direct access from general practice. After finished investigation, the results from the tests will all return electronically to the referring GP.
The intervention is planned to initiate as a feasibility study at Silkeborg Regional Hospital from 1 April 2019. Agreements have been made with the hospital management, and an information meeting has taken place in March 2019 at the hospital. All GPs in the municipality of Silkeborg were invited to participate. An illustration, to hand out for involved GPs has been developed. Prior to investigation, all patients referred to the abdominal ´yes-no´ pathway will receive a consent form with information of the study. The inclusion period is 6 months from 1 April 2019 to 30 September 2019, after which the investigators will monitor the patients for up to 6 months.
The study has been approved and is registered in the Record of Processing Activities at the Research Unit of General Practice in Aarhus in accordance with the provisions of the General Data Protection Regulation (GDPR). The Central Denmark Region Committees on Health Research Ethics has concluded that the study can be conducted without an approval from the Committees (Request 16/2019). Further, The committee on multi-practice studies under the Danish College of General Practitioners (DSAM) and the Organisation of General Practitioners in Denmark (PLO) have been asked to recommend GPs to participate in the study.
The analyses will be descriptive with frequencies and incidence rates of use of the pathway corrected for practice population. An overview of all findings in the abdominal 'yes-no' pathway will be provided, and possible side effects will be assessed.
Perspectives The study will provide new important knowledge of patients with vague and non-specific abdominal symptoms, who do not fulfil access criteria for the CPPs, but for whom the diagnosis of an abdominal cancer should not be missed. This may improve the diagnostics of abdominal cancers or other serious abdominal disease in the future, aiming to reduce time to diagnosis.
#Intervention
- DIAGNOSTIC_TEST : Abdominal ´yes-no´ pathway
- A set of blood samples, a FIT, and an abdominal US (and a TVUS in women)
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:
* GPs in the municipality of Silkeborg can refer patients with the following criteria to Silkeborg Regional Hospital:
Men and women >=30 years presenting with vague and non-specific abdominal symptoms for at least 3 <= age <= 4 weeks
Exclusion Criteria:
* Men or women who fulfil access criteria for the CPPs.
Sex :
ALL
Ages :
- Minimum Age : 30 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 435 |
Target Study Title: A Comparative Study of Incentive Spirometer Versus Inspiratory Muscle Trainer on Pulmonary Function in Patients With Parkinsonism
Target Study Description: #Study Description
Brief Summary
Patients suffering from parkinsonism have respiratory function abnormalities. This study compared the effects of incentive spirometer and inspiratory muscle trainer on pulmonary functions in patients with parkinsonism.
Detailed Description
The participants were recruited according to the inclusion and exclusion criteria. Participants were divided into two groups - incentive spirometer and inspiratory muscle trainer. These trainings were performed for 6 weeks duration. Several outcome measures related to pulmonary function tests were measured before and after the intervention.
#Intervention
- OTHER : Inspiratory muscle training
- Threshold inspiratory muscle training was performed for 6 weeks with device.
- OTHER : Incentive Spirometry
- Incentive spirometry was performed for 6 weeks with device.
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 diagnosed as having Parkinsonism Disease by the Neuro physician.
* Duration of Parkinson's Disease >= 5 years.
* Patients with the age of 65 <= age <= 80.
* Hoen and Yahr classification within 1 to 3.
* Both males and females were included.
* Patients who were able to comprehend the commands.
* Patients who were willing to participate.
Exclusion Criteria:
* Patients having any cardiovascular and pulmonary disorders.
* History of smoking currently or in the past.
* Psychological Impairment.
* Insufficient verbal/intellectual understanding.
* Patients with unstable vital parameters.
* Those unable to perform pulmonary function tests (PFT) because of anatomical abnormalities or clinical signs of dementia.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Maximum Age : 75 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 436 |
Target Study Title: Phase II Trial of Perifosine in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Target Study Description: #Study Description
Brief Summary
Perifosine inhibits the AKT pathway (a way cells communicate with each other). This pathway is felt to be important in the development of several types of cancers including chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). It is thought perifosine may be able to block this pathway and lead to an improvement in the CLL or SLL. The purpose of this trial is to see if perifosine is an effective treatment for relapsed or refractory CLL or SLL. Another purpose of this study is to look at the effect perifosine has on cells.
Detailed Description
Chronic lymphocytic leukemia and small B-cell lymphocytic lymphoma represent different manifestations of the same disease. CLL/SLL (hereafter denoted by CLL) is a clonal disorder of small B lymphocytes expressing a characteristic morphology and immunophenotype. The B cells express CD19, dim CD 20, dim CD 5, CD 23, CD 43, CD 79a, and weakly express surface immunoglobin. CLL can present asymptomatically in 25% of patients when diagnosed on a complete blood count. It also can present with diffuse painless lymphadenopathy and, in a smaller number of patients, B symptoms.
CLL is characterized by accumulation of circulating B cells predominantly in the G0 phase of the cell cycle. These cells are resistant to apoptosis. CLL has been found to have aberrant signaling in several pathways including NF-kB, Akt/PI3K, and JNK/STAT pathways. Akt is important in promoting CLL survival and viability, as seen in in vitro experiments where blocking its activity results in apoptosis. Thus an AKT inhibitor may lead to increased apoptosis and may have a role in the treatment of this disease.
Treatment options for CLL range from a watch and wait approach to high dose chemotherapy with stem cell support. Currently, there is no consensus on the best treatment regimen, since no treatment has been shown to improve survival in randomized prospective clinical trials. New approaches to treatment, especially those with lower toxicity rates, are needed.
Perifosine has been shown to inhibit or otherwise modify signaling through a number of different signal transduction pathways, including Akt, MAPK, and JNK. These pathways are involved in the development of cancers and resistance to chemotherapy. Perifosine is of particular interest, especially due to the difficulty in discovery of drugs that inhibit these pathways with minimal toxicity. The effect of perifosine on CLL cells has been tested in the laboratory and has been shown to be an active agent against primary CLL cells in vitro.
#Intervention
- DRUG : perifosine
- Perifosine 50 mg will be taken orally twice a day for a maximum of six 28-day cycles
- Other Names :
- D-21266
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 diagnosis of CLL or SLL based on iwCLL diagnostic criteria.
* Prior therapy for CLL (no limit on number of prior regimens).
* Patients requiring therapy, based on at least one of the iwCLL criteria.
* 18 years or older.
* Performance status ECOG 0, 1, or 2.
* An estimated or measured creatinine clearance >=30 ml/min at study enrollment.
* AST, ALT, and total bilirubin <= 2.5 times the upper limit of normal, unless due to CLL/SLL.
* Female subject who is either post-menopausal or surgically sterilized or male or female subject willing to use an acceptable method of birth control for the duration of the study therapy and for 2 weeks after study therapy completion.
Exclusion Criteria:
* Female subject is pregnant or lactating.
* Patient has received other investigational drugs for this disease within 14 days of enrollment.
* Patient with known HIV prior to enrollment.
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
* Patients with another malignancy within the last three years (from documentation of remission) other than basal or squamous cell skin cancer or CIS of the cervix or early stage prostate cancer not requiring systemic treatment.
* Patients who underwent allogeneic stem cell transplant and have at least 2% donor cells engrafted will be excluded.
* Significant cardiac or vascular events within 6 months: acute MI, unstable angina, severe peripheral vascular disease (ischemic pain at rest class 3 or worse, non-healing ulcers/wounds, congestive heart failure (NHYA class >= 2), uncontrolled cardiac arrhythmias.
* Known severe hypersensitivity to perifosine or any component of the formulation.
* Life expectancy less than six months due to co-morbid illness
* Active autoimmune hemolytic anemia or immune thrombocytopenia, requiring current steroid therapy.
* De novo prolymphocytic leukemia (PLL) or PLL arising from CLL (>= 55% prolymphocytes).
* Richter's transformation
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>
| 437 |
Target Study Title: Evaluate Immunogenicity,Safety & Reactogenicity of a Booster Dose of Hib-MenC Conjugate Vaccine When Given to Healthy Subjects Aged 13-14 Months Who Were Primed With 3 Doses of Hib-MenC vs a Booster Dose of Infanrix Hexa Given to Subjects Primed With 3 Doses of Infanrix Hexa and Meningitec
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC conjugate vaccine when given to healthy subjects aged 13 to 14 months who were primed with three doses of Hib-MenC compared to a booster dose of Infanrix hexa given to subjects primed with three doses of Infanrix hexa and Meningitec.
Detailed Description
The study is open and Infanrix hexa will serve as active control. Subjects will receive one vaccine dose of either Hib-MenC or Infanrix hexa, and will have 2 blood samples taken: before and one month after vaccination. Subjects who will receive a booster dose of Hib-MenC were primed with 3 doses of Infanrix penta + Hib-MenC or 2 doses of NeisVac-C and Infanrix hexa / Infanrix IPV/Hib.
#Intervention
- BIOLOGICAL : Haemophilus influenzae type b- and meningococcal (vaccine)
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 between, and including, 13 and 14 months of age
* Having participated in the primary vaccination study 217744/097.
Exclusion criteria:
* Previous vaccination against OR history of OR known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b (Hib) and/or meningococcal serogroup C disease except if within the framework of study 217744/097
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
* A family history of congenital or hereditary immunodeficiency
* History of any neurologic disorders or seizures
Sex :
ALL
Ages :
- Minimum Age : 13 Months
- Maximum Age : 14 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 438 |
Target Study Title: The Effect of Pelvic Floor Muscle Training With or Without Kaatsu Training for Women With Stress Urinary Incontinence
Target Study Description: #Study Description
Brief Summary
This study examines the effect of adding so called Kaatsu training to pelvic floor muscle training. Half the participants will perform Kaatsu training on their thigh muscles followed by pelvic floor muscle training. The other half will receive pelvic floor muscle training alone.
Detailed Description
Stress urinary incontinence (SU) is a common problem among adult women . Pelvic floor muscle training (PFMT) is recommended as first line treatment but PFMT is not always efficient and some women cannot comply with the intensive PFMT needed to obtain effect because of weakened or damaged muscles caused by vaginal delivery and age related changes.
Hypothetically alternative methods could be used to enhance the effect of a strength-training program. A low intensity training program with a simultaneous partial occlusion of the blood supply for the training muscle, so called 'Kaatsu' training has been found to increase muscle strength faster than ordinary strength training but with much less effort. It seems difficult to make occlusion of the pelvic floor muscles during PFMT but a study found that low intensity training of the quadriceps femoris with partial occlusion of the blood supply did not only increase muscle strength of the quadriceps femoris muscle but also of the biceps humeri muscle if that muscle was trained with low-load training and no occlusion in the same training session. The specific reason for this this 'cross-transfer effect' could not be fully explained but it was believed to be caused by a systemic effect caused by growth hormones. The aim of this study is therefore to examine if Kaatsu training offered in relation to a low-load PFMT program can increase the effect of PFMT in women with SUI
#Intervention
- BEHAVIORAL : Pelvic floor muscle training and Kaatsu
- The intervention includes three outpatient visits (weeks 0, 6 and 12) and between visits the participants perform PFMT and Kaatsu training as home training
- BEHAVIORAL : Pelvic floor muscle training
- The intervention includes three outpatient visits (weeks 0, 6 and 12) and between visits the participants perform PFMT as home training
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:
* ICIQ-SF >= 12
* Urinary stress incontinence
* Ability to contract pelvic floor muscles
* Normal bladder capacity and normal flow during micturition with at least one micturition of > 350 ml
Exclusion Criteria:
* Urgency urinary incontinence
* Cognitive problems
* Physical inability to perform Kaatsu program
* Inability to understand and read Danish
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>
| 439 |
Target Study Title: Morbidity and Functional Outcome of Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM in Obstructed Defecation
Target Study Description: #Study Description
Brief Summary
The stapled transanal rectal resection (STARR procedure) is an effective treatment for obstructed defecation syndrome (ODS) caused by intussusception and rectocele. Recently a new technique has been developed using the new Contour® TranstarTM stapler, which was specifically designed to facilitate the STARR procedure. The investigators would like to evaluate the morbidity and quality of life.
#Intervention
- PROCEDURE : Stapled transanal rectum resection
- Contour Transtar-STR5G (Ethicon EndoSurgery Inc., Cincinnati, OH).The circular anal dilator is fixed to perianal skin.Rectal intussusception is evidenced with a swab.The first stitch is placed superficial on top of the intussusception. The procedure is performed 5to6 times counterclockwise.A final stitch for first radial cut at 3 o'clock.The device is introduced into the rectum. This cut opens the prolapse. Check with a finger the vagina. The device is then closed and fired. After replacing the cartridge, the device is introduced in the rectum, placed parallel to the circular anal dilator and moved counter clockwise with 4to6firings to complete the resection. Additional stitches across the staple line to assure haemostasis.
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:
* Rectocele
* Intussusception
Exclusion Criteria:
* Non operability
* inflammatory bowel disease
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 440 |
Target Study Title: A Phase IIa Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Pulmonary Embolism
Target Study Description: #Study Description
Brief Summary
This trial is being conducted to assess the efficacy and safety of recombinant Human Prourokinase in the acute pulmonary embolism.
#Intervention
- DRUG : Recombinant Human Prourokinase
- The drug is used for intravenous thrombolysis therapy
- Other Names :
- rhPro-UK
- DRUG : Alteplase
- The drug is used for intravenous thrombolysis therapy
- Other Names :
- Actilyse, rtPA
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 <= age <= 75 years（Include the critical value）AND
* High-risk PE or medium high-risk PE AND
* PE symptom duration <=14 days AND
* PLT>=100×10^9/L，ALT and AST<=2.5ULN，TBIL<ULN，Cr within the normal range AND
* Informed consent can be obtained from subject or Legally Authorized Representative
Exclusion Criteria:
* Hemorrhagic or unexplained stroke history
* Ischemic stroke or transient ischemic attack (TIA) within 6 months
* The existence of the central nervous system injury or tumor
* Severe trauma，major surgery or head injury within 3 weeks
* Active bleeding within 1 month
* Clinician deems high-risk for bleeding
* Using anticoagulants (after a washout period can be randomized)
* Pregnancy or delivery within 1 week
* Vascular puncture which can not be oppressed
* Cardiopulmonary resuscitation within 10 days
* Systolic blood pressure above 180 mmHg or diastolic blood pressure above 100mmHg
* Severe liver dysfunction
* Infective endocarditis
* Arterial aneurysm or arteriovenous malformation or suspected aortic dissection
* left atrial thrombus
* Neurosurgery or eye surgery within 1 month
* Hemorrhagic diabetic retinopathy
* Serious cardiac insufficiency
* ventricular arrhythmias
* Known allergic to prourokinase，urokinase，recombinant tissue-type plasminogen activator，contrast agent or any drug in the trial
* Do not allow for 30 days' study
* Any disease or condition is not suitable for intravenous thrombolysis
* Lactating women or plan to pregnant women during the trial，or don't want to during the study period using effective contraception or abstinence of male and female patients with possibility of fertility
* Clinician thinks patient doesn't fit to participate in the test of other diseases or conditions
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>
| 441 |
Target Study Title: A 72-week, Prospective, Parallel-group, Partially Blinded, Controlled Phase IIIb Study Evaluating the Impact of Specific Lp(a) Apheresis on Atherosclerotic Disease Burden in Coronary Heart Disease Patients With High Lipoprotein(a) Level.
Target Study Description: #Study Description
Brief Summary
To evaluate whether specific lipoprotein(a) apheresis on the top of optimal medical therapy could affect atherosclerotic disease burden in coronary and carotid arteries of coronary heart disease patients with elevated Lp(a) levels.
Detailed Description
Following the hypothesis that if Lp(a) excess has a pathogenic role in atherogenesis, then specific elimination of circulating Lp(a) should affect plaque growth and stability, we evaluated the efficacy of Lp(a) apheresis on changes in coronary plaque volume and composition and carotid intima-media thickness in patients with CHD on the background of optimal medical treatment.
#Intervention
- PROCEDURE : Specific Lp(a) apheresis
- Specific Lp(a) apheresis procedures were carried out weekly with 'Lp(a) Lipopak' columns (POCARD Ltd., Moscow, Russia) according to the standard protocol
- Other Names :
- "Lp(a) Lipopak' immunoadsorption columns
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:
* Stable coronary heart disease (CHD) requiring a clinically indicated coronary angiography.
* Lp(a) >=50 mg/dL
* LDL-C <2.6 mmol/L (100 mg/dL)
* Signed written informed consent form to participate in the study
Exclusion Criteria:
* history of acute coronary syndrome or surgical intervention within prior 3 months to inclusion
* chronic infectious and inflammatory diseases
* familial hypercholesterolemia
* TG >=4.5 mmol/L (400 mg/dL)
* Active liver disease (ALT or AST >3 upper limit of normal (ULN), or total bilirubin >1.5 ULN);
* CK >=3 ULN;
* Thyroid dysfunction;
* Renal dysfunction (creatinine clearance (Cockcroft-Gault Equation) <=30 ml/min);
* Uncontrolled diabetes (HbA1c >=7.0%);
* Coagulopathies;
* Lipid-lowering drugs, except statins for the last month
* Known statin or immunoadsorption intolerance
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>
| 442 |
Target Study Title: Multi-Center Evaluation of Post-Operative Recovery in ATTUNE Primary, Cemented Total Knee Arthroplasty
Target Study Description: #Study Description
Brief Summary
This post-marketing investigation will evaluate the rate of recovery of the ATTUNE knee from the time of surgery through the 6 month endpoint in patients with severely painful and/or severely disabling Non-inflammatory Degenerative Joint Disease (NIDJD).
Detailed Description
This study is designed as a prospective, multi-center, non-randomized, non-comparative, non-controlled study. A sample size of N=200 subjects will be implanted at up to 4 sites in the Netherlands. Each site is expected to implant approximately 50 Subjects (50 knees).
This study allows the participating surgeon to choose the type of ATTUNE implant they would ordinarily use in standard practice. Both resurfaced patellae and non-resurfaced patellae are permitted in this investigation; consistent with the surgeons standard of care.
Subjects will receive one of four available implants: cruciate retaining fixed bearing (CR FB), cruciate retaining rotating platform (CR RP), posterior stabilized fixed bearing (PS FB), and posterior stabilized rotating platform (PS RP).
#Intervention
- DEVICE : ATTUNE Primary, Cemented Total Knee Replacement
- Patients will undergo a primary total knee replacement using one of the four implant configurations of the ATTUNE knee ( CR FB, CR RP, PS FB, PS RP).
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 male or female and between the ages of 22 and 80 years at the time of surgery, inclusive.
* Subject was diagnosed with Non-inflammatory Degenerative Joint Disease (NIDJD).
* Subject is a suitable candidate for cemented primary total knee replacement (TKA) using the devices described in this protocol with either resurfaced or non-resurfaced patellae.
* Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to the study Sponsor.
* Subject is currently not bedridden
* Subject, in the opinion of the Investigator, is able to understand this clinical investigation and is willing and able to perform all study procedures and follow- up visits and co-operate with investigational procedures.
* Subject is able to speak, read, and comprehend the Informed Consent Document as well as complete the Patient Reported Outcomes Questionnaires required per the protocol in either Dutch or English translations.
Exclusion Criteria:
* The Subject is a woman who is pregnant or lactating.
* Contralateral knee has already been enrolled in this study .
* Subject had a contralateral amputation.
* Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected knee.
* Subject is currently experiencing radicular pain from the spine that radiates into the limb to receive TKA.
* Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.
* Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
* Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last 5 years) or has a psychological disorder that could affect their ability to complete patient reported questionnaires or be compliant with follow-up requirements.
* Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.
* Subject has a significant neurological or musculoskeletal disorder(s) or disease that may adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis, Charcot disease).
* Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).
* Subject has a medical condition with less than 3 years of life expectancy.
Sex :
ALL
Ages :
- Minimum Age : 22 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>
| 443 |
Target Study Title: Inclusive Invasive Physiological Assessment in Angina Syndromes Registry (ILIAS Registry)
Target Study Description: #Study Description
Brief Summary
This study evaluates the prognostic value and potential therapeutic impact of combined pressure and flow measurements in the evaluation of epicardial coronary stenosis and microvascular function.
Detailed Description
ILIAS registry is a global effort to gather lesion-level data on the diagnostic and prognostic value of combined coronary pressure and flow measurements in clinical practice. Data is gathered from 7 nations (The Netherlands, Korea, Japan, Spain, Italy, Denmark, USA), using either coronary Doppler velocity measurements or coronary thermodilution measurements to obtain invasive coronary flow assessment. Patient treatment was governed by the local clinical practice guidelines at the time of the invasive procedure, but was at the operator's discretion. A standardized data collection sheet was used and all study adopted standardized definition of patient's baseline characteristics, clinical outcomes, and physiologic data. In case of acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction), only non-culprit vessel evaluation was used.
#Intervention
- DIAGNOSTIC_TEST : Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistance
- Calculation of the resting mean distal coronary to aortic pressure ratio (resting Pd/Pa), fractional flow reserve (Pd/Pa at hyperemia), Coronary flow reserve (peak flow/resting flow), microvascular resistance (Pd/flow).
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:
* underwent combined measurements of coronary pressure and flow for at least 1native coronary artery
Exclusion Criteria:
* hemodynamic instability
* culprit vessel of acute coronary syndrome
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>
| 444 |
Target Study Title: A Prospective, Multi-centre Study to Evaluate the Clinical Performance of the GYNECARE PROSIMA* Pelvic Floor Repair System as a Procedure for Pelvic Organ Prolapse
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to is to evaluate the success of the GYNECARE PROSIMA\* system in women with symptoms for pelvic organ prolapse (POP) requiring surgical correction of POP.
(\*TRADEMARK)
Detailed Description
The GYNECARE PROSIMA\* system provides a simplified mesh repair, avoiding the need for dissection outside the pelvic cavity.
#Intervention
- DEVICE : GYNECARE PROSIMA* Pelvic Floor Repair System
- procedure for pelvic organ prolapse
- Other Names :
- mesh pelvic floor repari
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:
* Candidates with symptomatic pelvic organ prolapse of ICS POP-Q Stage II or III, suitable for surgical repair. Vaginal hysterectomy, perineal repair and/or mid urethral sling procedures for incontinence may be performed concurrently.
* Age >= 18 years.
* Agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the Ethics Committee / IRB approved informed consent.
Exclusion Criteria:
* Additional surgical intervention concurrent to the PROSIMA procedure (e.g. sacrocolpopexy, paravaginal repair, tubal sterilisation).
* Previous repair of pelvic organ prolapse involving insertion of mesh.
* Previous hysterectomy within 6 months of scheduled surgery.
* Experimental drug or experimental medical device within 3 months prior to the planned procedure.
* Active genital, urinary or systemic infection at the time of the surgical procedure. Surgery may be delayed in such subjects until the infection is cleared.
* Coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery.
* History of chemotherapy or pelvic radiation therapy.
* Systemic disease known to affect bladder or bowel function (e.g. Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma).
* Current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia).
* Nursing or pregnant or intends future pregnancy.
* In the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
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>
| 445 |
Target Study Title: A Phase II Study of Hyperthermic Peritoneal Perfusion (HIPEC) for Adolescent and Young Adults With Desmoplastic Small Round Cell Tumor and Other Non-Carcinomas
Target Study Description: #Study Description
Brief Summary
The goal of this clinical research study is to learn if heated intra-abdominal cisplatin can help to control abdominal tumors in patients having surgery to remove the tumors. The safety of this drug will also be studied.
Detailed Description
The Study Drugs:
Cisplatin has a platinum atom at its center. The platinum is supposed to poison the cancer cells, which may cause them to die.
Surgery and Study Drug Administration:
If you are found to be eligible, the abdominal surgery will be performed to try to remove as many tumors as possible. The abdominal surgery is not being performed specifically for this research study and would be performed even if you didn't take part in this study. You will be given a separate consent form to sign that explains the details and risks of abdominal surgery in more detail.
During the surgery you will receive sodium thiosulfate by vein. The abdomen will then be temporarily closed. Then the abdominal wash will begin. During the 'abdominal wash,' heated cisplatin will be delivered through plastic tubing that is connected to a pump into the abdomen. The pump pushes the heated cisplatin into the abdomen and then pulls it out and recirculates the cisplatin. The skin of the abdomen is temporarily closed during the abdominal wash. The surgeon will also 'wash' over the closed area of the surgical site. A pump will be used to pump heated cisplatin in and out of the abdomen over 90 minutes while the surgeon gently presses on the abdominal wall so the cisplatin reaches all areas in the abdomen. After 90 minutes, the cisplatin is removed and the abdomen will be 'washed' with saline and all fluid will be removed before the surgeon permanently closes the abdomen with 3 layers of stitches.
Two (2) pea-sized tumor samples will be sent to the laboratory of Dr. Dina Lev for tissue evaluation and extraction of RNA (genetic material). One (1) tumor sample will be removed before the procedure and the other sample will be removed at the end of the procedure. The samples will be examined under a microscope and DNA (the genetic material in cells) will be removed to look for any changes to the DNA. The results of these tests will not be shared with you, nor will they be used for any decisions regarding your treatment. The samples will be destroyed after these tests are complete.
There is a chance that the surgeon may decide during the surgery that the abdominal wash will not be performed, for example if the disease has spread to or attached to certain organs. If this occurs, your doctor will discuss other treatment options with you.
Study Visits:
On Days 1-5, 11, and 14, (Day 1 being the day after surgery):
* Blood (about 1 teaspoon) will be drawn for routine tests.
* You will have a physical exam, including measurement of your weight and vital signs.
Follow-Up Visits:
About 1, 3, and 6 months after the surgery is complete, you will have follow-up visits and the following tests and procedures will be performed:
* You will have a physical exam, including measurement of your weight and vital signs.
* Blood (about 1 teaspoon) will be drawn at the 1 month visit only for routine tests.
* You will have a hearing test at the 1 month visit only.
* Blood (about 3 teaspoons) will be drawn for routine tests at the 3 and 6 month visits only.
* At the 3 and 6 month visits only, you will have a CT scan, positron emission tomography (PET)-CT scan, or MRI scan to check the status of the disease.
Length of Study:
You will remain on study for up to 6 months. You will be taken off study if the disease gets worse.
If the study doctor learns that the disease has come back or gotten worse at the 6 month follow-up visit, you may be eligible for a re-perfusion, which is a repeat of the operation and study drug administration. If you are eligible for a re-perfusion, your participation on this study will end and then you will be given a new consent form to sign in order to be re-enrolled back onto this study.
This is an investigational study. Cisplatin is FDA-approved and commercially available for the treatment of advanced bladder cancer, metastatic testicular cancer, metastatic ovarian cancer, hepatoblastoma, neuroblastoma, metastatic appendiceal cancer, and abdominal mesothelioma. The use of cisplatin in patients with abdominal sarcoma-type tumors is investigational.
Up to 22 patients will take part in this study. All will be enrolled at MD Anderson.
#Intervention
- PROCEDURE : Hyperthermic Peritoneal Perfusion (HIPEC)
- HIPEC, technique for combining hyperthermia and chemotherapeutic agents delivered intraoperatively to the peritoneal and retroperitoneal surface via a recirculating perfusion circuit, performed after cytoreductive surgery and lysis of adhesions.
- DRUG : Cisplatin
- 100 mg/M2 per perfusion catheter. The perfusion is continued for 90 minutes after adding the cisplatin.
- Other Names :
- Platinol-AQ, Platinol, CDDP
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 greater than or equal to 1 years
* Histologically or genetically proven diffuse peritoneal or retroperitoneal tumor from desmoplastic round cell tumor, ovarian germ cell, sarcoma, Wilms' tumor, or other non-carcinoma tumors.
* Radiologic workup must demonstrate that the disease is confined to the abdominal cavity
* Radiologic workup or prior abdominal exploration must be consistent with disease which can be debulked to a residual size of less than or equal to 1 cm thickness per tumor deposit
* Patients must have a minimum expected duration of survival of greater than 6 weeks as determined and documented by the attending surgeon or medical oncologist.
* Patients must not have any systemic illness which precludes them from being an operative candidate as determined by anesthesia preoperative evaluation. This includes but is not limited to, sepsis, liver failure, pregnant or lactating females.
* Patients must have fully intact mental status and normal neurologic abilities. Intact mental status is defined by 'the capacity to identify and recall one's identity and place in time and space.' Assessment of mental status and documentation of fully intact mental status will be completed using physical and mental exam by the referring doctor or oncologist.
* Patients must have adequate renal function (serum creatinine <= 1.5 mg/dl without history dialysis or renal failure or creatinine clearance less than 50 mL/min/1.73M^2 if less than 5 years)
* Patients will be eligible if the white blood cell count (WBC) is >=2000/microliter or absolute neutrophil count (ANC) is >=1,500 and platelets are >= 100,000/mm^3
* Patients will be eligible if serum total bilirubin and liver enzymes are <=2 times the upper limit of normal
* Patients must be recovered from any toxicity from all prior chemotherapy, immunotherapy, or radiotherapy and be at least 14 days past the date of their last treatment
Exclusion Criteria:
* Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
* Patients will be ineligible if they have disease outside of the abdominal cavity which is uncontrolled
* Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater (because of the potential neurotoxicity associated with platinum)
* Patients who have failed previous intraperitoneal platinum therapy will be ineligible
* Patients with Retroperitoneal Liposarcoma will be ineligible.
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 446 |
Target Study Title: The Effect of usıng Breast mılk pacıfıer, Sucrose pacıfıer and pacıfıer ın reducıng the paın That Occurs durıng orogastrıc Tube ınsertıon ın Preterm Newborns
Target Study Description: #Study Description
Brief Summary
The aim of this study is to determine the effectiveness of 3 different methods (breast milk pacifier, sucrose pacifier and pacifier) in reducing pain caused by Orogastric Tube (OGT) insertion in preterm newborns by monitoring behavioral and physiological changes in infants. The study was planned as a randomized controlled experimental study.
Detailed Description
Babies born before the 37th week of pregnancy are defined as preterm. Preterm newborns need Neonatal Intensive Care Unit (NICU) due to their immature characteristics. NICU includes many diagnostic and therapeutic procedures associated with pain. Babies are exposed to many painful procedures during their stay in the NICU. The International Association for the Study of Pain (IASP) defines pain as 'an uncomfortable sensory and emotional experience that develops as a result of existing or potential tissue damage or is described by this damage'.
It is known that pain begins to be felt by the fetus from the intrauterine second trimester. Especially, preterm newborns are more vulnerable to the effects of pain exposure due to their developing central and peripheral nervous systems and are more sensitive to pain due to low pain thresholds. Therefore, developing appropriate pain control strategies, especially for preterm newborns, is both a medical and ethical responsibility. In their study, Zhao et al. defined pain as a complex and multidimensional phenomenon experienced in the NICU for preterm newborns. In a study by Mooney-Leber et al. with 430 newborns, it was stated that approximately 80 painful procedures were performed without specific analgesia. Reducing the pain of term and preterm newborns experiencing pain with effective and safe methods is a fundamental right of all newborns.
The sucking reflex in preterm newborns is 28th in intrauterine life. it begins to develop after 32-34 weeks of gestation. during the gestational week, sucking and swallowing reflexes develop. Preterm newborns admitted to NICU are fed through the orogastric tube (OGT) until they can coordinate their sucking, swallowing, and breathing. A probe inserted through the mouth into the esophagus (esophagus) and from there into the stomach is called an orogastric tube. Measurement of OGT placement in preterm newborns; it is made in such a way that it comes from the baby's earlobe to the middle line of the mouth, and from there to the middle line between the Deciphoid protrusion and the umbilical cord. Taking the black markers on the probe as reference points, the length of the probe is adjusted accordingly, the tip should not be touched so that the tip of the probe is not contaminated. The process is stopped when the OGT reaches the point measured before the operation. The stomach contents are checked. OGT is detected at the edge of the mouth when it is sure of its location.
The placement and use of OGT is one of the most common nursing practices applied as a therapeutic and diagnostic method in NICU . It is used for enteral nutrition, drug administration, drainage of the contents of the stomach/small intestine or for decompression and gastric analysis in hospitalized infants. However, OGT placement is a painful, stressful and troublesome procedure for preterm newborns. In preterm newborns, OGT placement is performed frequently until the development of the sucking and swallowing reflex is completed. The fact that the pain is felt intensely, the application is frequent, causes more pain in preterm newborns. It has been stated that recurrent pain leads to decreased brain oxygenation, causing excitotoxic damage to the developing neurons of newborn babies, increasing anxiety, changing sensitivity to pain, stress-related diseases, hyperactivity, attention deficit and may have negative effects on the development of social abilities.
Atraumatic care, which is included in nursing approaches, is defined as therapeutic care or interventions that eliminate or minimize physical stress factors. In line with atraumatic nursing care, pain management is considered as a basic element of care. Newborn nurses closely testify to pain and stress. For the prevention of pain, it is important to provide individual and holistic nursing care. Accordingly, the knowledge of pharmacological and non-pharmacological methods in the management of pain by the nurse has a positive effect on the evaluation of pain in infants and pain management. The use of non-pharmacological methods that are easy to apply and low in cost by neonatal nurses is important for effective pain management. Non-pharmacological methods; sucking, sucrose or dextrose, breastfeeding (breast milk), kangaroo care (skin-to-skin contact), wrapping, massage, touching the face, positioning (fetal position), acupuncture and music therapy can be listed as non-nutritious or nutritious. When the literature is examined, it is stated that it is more effective to use more than one non-pharmacological method together in the use of non-pharmacological methods instead of their use alone . Given the frequency of OGT administration and the sensitivity of preterm infants, ensuring the management of pain during the OGT process will positively affect the development of the preterm baby. There are studies in the literature that different non-pharmacological methods used in OGT placement are effective in reducing pain in preterm newborns. In this study, a study planned in which the methods of using breast milk pacifiers, sucrose pacifiers, and pacifiers were compared together to reduce the pain caused by orogastric tube insertion in preterm newborns was not found in the literature.
The use of a pacifier (non-nutritious suction), one of the non-pharmacological methods included in the scope of the study, is used in routine practice to improve the ability to suck in preterm newborns. To stimulate sucking in non-nutritious sucking, a warning is given by touching the cheek, lips, tongue, gums, jaw and palate. The purpose of this method is to strengthen sucking by stimulating the oral motor functions of the preterm baby. In this way, coordination between sucking, swallowing and during respiration is supported. It is stated that sucrose, which will be used as another method, is effective in reducing pain in some studies, but there may be problems in terms of cost and access in routine applications. Breast milk is a miraculous food that meets all the needs of the newborn in terms of the components it contains, and it has the property of preventing the transmission of pain sensation by stimulating opioids with the nutrients it contains and blocking the pain fibers. It is evaluated that determining the effects on pain management by comparing the pacifier, breast milk pacifier and sucrose pacifier methods in reducing the pain that will occur during the OGT insertion procedure in preterm newborns, the outcomes will contribute to the literature by guiding the effective pain management during the OGT procedure in preterm newborns hospitalized in the NICU.
Hypotheses Of The Study:
In reducing the pain caused by OGT insertion in preterm infants, Hypothesis 0 (H0): There is no difference between breast mılk pacıfıers, sucrose pacıfıers and pacıfıers methods.
Hypothesis 1.1 (H1.1): The breast mılk pacıfıers method is more effective than the control group.
Hypothesis 1.2 (H1.2): The sucrose pacıfıers method is more effective than the control group.
Hypothesis 1.3 (h.1.3): The pacifier method is more effective than the control group.
Hypothesis 1.4 (H1.4): The breast milk pacifier method is more effective than the sucrose pacifier group.
Hypothesis 1.5 (H1.5): The breast milk pacifier method is more effective than the pacifier group.
Hypothesis 1.6 (H1.6): The sucrose pacıfıers method is more effective than breast milk pacifier group.
Hypothesis 1.7 (H1.7): The sucrose pacıfıers method is more effective than pacifier group.
Hypothesis 1.8 (H1.8): The pacifier method is more effective than the breast milk pacifier group.
Hypothesis 1.9 (H1.9): The pacifier method is more effective than the sucrose pacifier group.
Place And Tıme Of The Study:
The study was planned to be carried out after the necessary ethics committee permissions were obtained from the Human Research Ethics Committee of Ankara University Faculty of Medicine. July 2022- july 2023 will be conducted at Ankara University Neonatal Intensive Care Unit. There are 30 nurses in the Neonatal Intensive Care Unit and 4. It serves up to the step.
Unıverse And Sample Of The Study:
In the analysis of the research hypotheses, it is planned to perform analyzes of two and more than two group comparisons and the highest sample size calculated according to the statistical method to be performed is taken as the basis. In this study, 'G. Using the 'Power-3.1.9.2' program, the sample size was calculated to compare multiple 3 or more groups at a 95% confidence level. As a result of the analysis, α=0.05, the standardized effect size was taken as 0.460461 (high grade) using a similar study conducted in this field earlier, and the minimum sample volume was calculated as 56 with a theoretical strength of 0.80.
#Intervention
- OTHER : The effect of usıng breast mılk pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns
- 5 Minutes before the OGT insertion, the camera recording will be started and the preterm newborn will be given a breast milk pacifier. After the breast milk pacifier in the OGT intervention group is placed in the mouth as a leak from the edge of the given baby's mouth, the baby's esophagus will be placed by advancing from there to the stomach with the swallowing reflex. It will be checked whether the OGT is in the right place. Registration will be stopped after the evaluation period is completed and the baby is provided with comfort. But the recording will continue so that there are no time restrictions for tracking the crying time of the baby who continues to cry during placement. In terms of the reliability of the research results, nothing should be given orally to a preterm newborn at least 30 minutes before the procedure.
- Other Names :
- Sucrose Pacifiers Group, Pacifiers Group
- OTHER : The effect of usıng sucrose pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns
- The camera recording will be started 5 minutes before the OGT insertion procedure and the newborn will be given a sucrose-sweetened pacifier. After the sucrose-sweetened pacifier in the OGT intervention group is placed in the mouth as a leak from the edge of the given baby's mouth, the baby's esophagus will be placed by advancing from there to the stomach with a swallowing reflex. It will be checked whether the OGT is in the right place. Registration will be stopped after the evaluation period is completed and the baby is provided with comfort. But the recording will be continued so that there are no time restrictions for tracking the crying time of the baby who continues to cry during placement. In terms of the reliability of the research results, nothing should be given orally to a preterm newborn at least 30 minutes before the procedure.
- Other Names :
- Breast Milk Pacifiers Group, Pacifiers Group
- OTHER : The effect of usıng pacıfıer ın reducıng the paın that occurs durıng orogastrıc tube ınsertıon ın preterm newborns
- The camera recording will be started 5 minutes before the OGT insertion procedure and the newborn will be given a pacifier. After the pacifier in the OGT intervention group is placed in the mouth as a leak from the edge of the given baby's mouth, the baby's swallowing reflex will be placed by moving the esophagus from there to the stomach. It will be checked whether the OGT is in the right place. Registration will be stopped after the evaluation period is completed and the baby is provided with comfort. But the recording will be continued so that there are no time restrictions for tracking the crying time of the baby who continues to cry during placement.
- Other Names :
- Breast Milk Pacifiers Group, Sucrose Pacifiers Group
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 gestational age of 30 <= age <= 34 weeks ,
* Having his mother's milk
* Stable state of health
* The fact that the preterm baby has not previously had an orogastic tube inserted
* Having spontaneous breathing
* Being fed through the orogastric tube
* Not taking opioids or non-opioid analgesics
* He did not receive a painful stimulus until 30 minutes before the intervention,
* Volunteer consent of the parents of the preterm neonate to participate in the study
Exclusion Criteria:
* Have any congenital abnormalities on the face or oral cavity,
* The need for a ventilator,
* Having a congenital and genetic anomaly,
* Use of analgesic / Narcotic analgesic drugs,
* The mother has any substance abuse,
* Receiving continuous sedative therapy,
* Congenital malformation that can cause asphyxia and affect breathing
* Preterm newborns with intracranial hemorrhage formed the exclusion criteria of the study.
Sex :
ALL
Ages :
- Minimum Age : 30 Weeks
- Maximum Age : 34 Weeks
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 447 |
Target Study Title: Acute Care Learning Laboratory-Reducing Threats to Diagnostic Fidelity in Critical Illness
Target Study Description: #Study Description
Brief Summary
Diagnostic error and delay remain a leading cause of preventable harm and death in the United States. Using a learning laboratory structure, researchers will implement mixed-methods research approaches to identify the systemic weaknesses that contribute to diagnostic error and delay in the hospital setting. The knowledge gained from research innovative will allow researchers to design, develop, implement, and refined a suite of human-centered tools that can be deployed to reduce the risk of diagnostic error and delay in both community and academic hospital settings.
Detailed Description
Despite the recognition that diagnostic errors an delays are a major contributor to preventable deaths in the USA, little progress has been made to reduce mortality outcomes from this known killer. An effective strategy leading to meaningful reduction in diagnostic error and delay rates has not made its way into practice. This proposal is unique and novel and combines mixed-methods research approaches with systems engineering research approaches to understand the interplay of the multiple factors contributing to diagnostic error and delay. The knowledge gained from this holistic approach will then be used within the learning laboratory to inform the design, development, evaluation, and refinement of the solutions to diagnostic error and delay. 'Control Tower' will be the staging ground for the in situ learning laboratory and will be built on top of a well-established clinical informatics infrastructure and hospital environment open to innovation and practice change.
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
* For EMR review all adults admitted to the hospital ages 18 and older with research authorization
* For survey-clinicians including physicians, advanced care practitioners
* For focus groups and interviews-clinicians including physicians, advanced care practitioners
Exclusion Criteria
* Age <18 years
* No research authorization
* Refusal to give consent
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:
No
</FORMATTED_CRITERIA>
| 448 |
Target Study Title: Development and Preliminary Examination of Two Brief Personalized Feedback Interventions Focused on Lab-based and EMA Alcohol Cues to Reduce Hazardous Young Adult Alcohol Use
Target Study Description: #Study Description
Brief Summary
This study aims to develop a brief intervention that uses information from a lab-based cue reactivity protocol to create personalized feedback targeting high-risk alcohol use among young adults who drink alcohol. The intervention mainly focuses on providing feedback on individuals' drinking desire, mood, willingness to drink, and alcohol demand by comparing scores before and after viewing and smelling an alcoholic beverage in the lab session. Other psycho-educational alcohol-related content is also provided in the intervention including strategies for decreasing exposure to cues that increase drinking desires and how to cope with increased desire to drink. This brief intervention is used in a randomized controlled trial (RCT) comparing young adults who receive the brief, online intervention to those who did not receive the brief, online intervention. Participants in both groups complete baseline, lab-based cue reactivity protocol, 2-week follow-up and 3-month follow-up.
Detailed Description
The purpose of this study is to develop and test a brief intervention that provides personalized feedback to young adults using participants' responses from a baseline survey and from a lab-based cue reactivity protocol. The aim of the intervention is to increase young adults' awareness of how alcohol cues may affect their desire to drink, mood, willingness to drink, and alcohol demand both in relation to lab-based exposure to an alcohol beverage of their choice and also more broadly in everyday life. The intervention also aims to equip young adults with strategies for reducing exposure to factors that increase their desire to drink, how to cope with an increased desire to drink, and how to reduce potential harms from drinking.
This brief personalized feedback intervention is used in a randomized controlled trial comparing young adults who receive the intervention with those who complete the assessments and lab protocol but do not receive any personalized feedback. Online assessments include an eligibility survey, baseline assessment, and follow-up assessments occurring 2-weeks and 3-months post-intervention. Everyone has one in-person session to complete the lab-based cue reactivity protocol after the baseline assessment has been completed online. The intervention will be examined for its feasibility, acceptability, and its effects in reducing alcohol-related outcomes at the follow-up assessments.
#Intervention
- BEHAVIORAL : Lab-based Cue Reactivity Personalized Feedback Intervention (PFI)
- This is an online personalized feedback intervention that contains information summarizing participants' desire to drink, mood, willingness to drink, and alcohol demand as reported before and after alcohol exposure.
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:
* Between ages 18 <= age <= 24
* Lives in Washington state
* Reports drinking at least two days per week in the last six months
* Reports at least one heavy drinking episode (4+/5+ drinks for women/men) in the past month
* Open to changing drinking behavior
* Must be willing to come to our Seattle study office for session visit
* Provide an email address and phone number for study communication
Exclusion Criteria:
* Actively seeking treatment for alcohol use
* Currently participating in another study in our research center regarding young adult drinking behavior
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 24 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 449 |
Target Study Title: Phase 2 Study: GCRC: Effects of L-arginine Supplementation on Exhaled Nitric Oxide and Clinical Exacerbations in Adults With Moderate to Severe Asthma
Target Study Description: #Study Description
Brief Summary
Nitric oxide is an important marker of airway inflammation in asthma. Nitric oxide may have a protective role in patients with moderate to severe asthma. The investigators believe that a natural amino acid, L-arginine, that augments nitric oxide levels can decrease asthma exacerbations and improve the asthma care of moderate to severe asthma patients.
This study is a randomized, placebo controlled trial in which subjects will receive either 3 months of L-arginine supplementation or a placebo. The investigators will monitor subjects' symptoms, the number of asthma exacerbations, and lung function. In addition, we will draw blood, obtain induced sputum samples and measure exhaled breath nitric oxide levels at each monthly visit.
Detailed Description
The primary objective of this 3 month clinical study is to determine if supplemental L-arginine can decrease the number of asthma exacerbations in patients with severe asthma. L-arginine, a natural amino acid, produces nitric oxide (NO) when it is converted to L-citrulline in the presence of the nitric oxide synthase enzymes. We and others have found that NO can protect against allergic airway inflammation, airway hyperresponsiveness and airway fibrosis in various animal models. In addition, we have found that arginase I expression correlates strongly with the lymphocyte and eosinophil influx into the lung and this enzyme may regulate the airway inflammatory response. Our central hypothesis is that L-arginine will increase NO levels in the lung and decrease the number of acute exacerbations of asthma. It may do this by either decreasing the number of Th2 lymphocytes or down-regulating arginase I expression or both.
Our specific aims are, therefore,
1. To test the hypothesis, in a randomized, double-blinded, placebo controlled trial, that 3 months of L-arginine supplementation will decrease the number of acute asthma exacerbations in severe asthmatic patients,
2. To determine whether L-arginine decreases the ratio of peripheral blood Th2 to Th1 lymphocytes and
3. To determine whether L-arginine will modulate serum arginase I/II levels and their downstream products.
Patients will be recruited primarily from the UC Davis Asthma Network (UCAN) clinics, which focus on the care of severe asthmatics, and the study will be performed at the UC Davis/VA General Clinical Research Center.
#Intervention
- DRUG : L-arginine
- subjects will take matching 0.01 g/kg/day of L-arginine in divided doses for thre months.
- Other Names :
- Arginine 1000
- DRUG : Placebo
- Placebo tablets that match the L-arginine intervention tablets will be given for three months
- Other Names :
- Matching placebo tablets
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:
* Moderate to severe persistent asthma
* Subject is stable on same asthma medications for at least one month
* If the subject is a woman of child-bearing age, a negative pregnancy test
Exclusion Criteria:
* Less than 18 yrs/ age
* Baseline Forced Expiratory Volume in 1 second (FEV1) <40% predicted
* Known or suspected allergy to L-arginine
* Pregnant women, nursing women, or women actively trying to achieve pregnancy
* Current smokers
* Subjects with more than a 15 pack-year history of smoking
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>
| 450 |
Target Study Title: A Phase 2, Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of MRX-I Versus Linezolid in Adult Subjects With Acute Bacterial Skin and Skin Structure Infection
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine whether MRX-I is as safe and effective as Linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections
#Intervention
- DRUG : MRX-I
- Oral MRX-I 800mg given twice a day for 10 days
- DRUG : Linezolid
- Oral linezolid 600mg given twice a day for 10 days
- Other Names :
- Zyvox
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 systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI)
* Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections
Exclusion Criteria:
* Uncomplicated skin infections
* Severe sepsis or septic shock
* ABSSSI solely due to gram-negative pathogens
* Prior systemic antibiotics within 96 hours of randomization
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>
| 451 |
Target Study Title: The Effectiveness of Cancer Pain Management Including Early Pain Intervention, Early Multi Modality Treatment and Closed Follow up in Siriraj Outpatient Pain Clinic
Target Study Description: #Study Description
Brief Summary
-Background: Cancer is one of the most common cause of death. Cancer pain is often cited as one of the most feared in cancer patients. Although, WHO guidelines have been provided to improve pain outcome, the results are still unsatisfied. In order to improve cancer pain management we consider to contribute a new guideline which includes interdisciplinary approach, early doing the pain interventions, breakthrough pain, education, high quality of pain assessment and contribute the effectiveness follow-up system
Detailed Description
* Objectives:Primary outcome is study the effectiveness of new approach and closed follow up system by relief pain intensity 30% at 3 month up to 80% of all new cancer pain patients in OPD setting Secondary outcomes are quality of life (BPI,ESAS), side effect of treatments and the contributing factors that impact on the outcomes
* Study design:A prospective observational study
* Sample size : 150
* Data collection: General information: age, gender, body weight, height, religion, residence, care giver, occupation, income, education, medical problem Clinical pain information: primary diagnosis, staging, cancer site, current medications Clinical assessment: at three study time points: baseline (initial assessment) and the three subsequent follow-ups (FU1, FU2 and FU3)
#Intervention
- OTHER : follow up system and multimodality approach
- To provide a new service system for cancer pain in pain clinic by early detecting red flag sign to consult other departments, early alleviating severe pain, following patients intensively by telephone call and giving pain education
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:
* Cancer pain patients
* more than 18 years
Exclusion Criteria:
* Clinical instability
* Cannot read and write
* Do not know the diagnosis
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>
| 452 |
Target Study Title: Evaluating Wearable Robotic Assistance on Gait Mechanics and Energetics in Individuals With Neurological Impairment
Target Study Description: #Study Description
Brief Summary
The overarching goal of this study is to improve mobility in individuals with movement disorders through advances in wearable assistance (i.e. powered orthoses).
Detailed Description
Individuals with cerebral palsy completed high frequency over-ground gait training (4x/week for 1 week) with ankle exoskeleton assistance, and then, after a 1 year washout period, the same participants will complete low frequency over-ground gait training (2x/week for 2 weeks).
#Intervention
- DEVICE : powered orthosis
- Novel powered leg brace to provide assistance during walking.
- Other Names :
- exoskeleton
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 5 and 35 years, inclusive.
* Either a healthy volunteer or a diagnosis of a neurologically-based walking disorder due to stroke, spinal cord injury, Parkinson's disease, or cerebral palsy.
* Must be able to understand and follow simple directions based on parent report and clinical observation during the history and physical examination.
* Able to provide verbal assent, if appropriate. If the participant is non-verbal, parental interpretation of gesticulation for assent will be used.
* The ability to read and understand English.
* Able to walk at least 30 feet with or without a walking aid (GMFCS Level I-III for individuals with cerebral palsy)
Exclusion Criteria:
* Any neurological, musculoskeletal or cardiorespiratory injury, health condition ( including pregnancy), or diagnosis other than stroke, spinal cord injury, Parkinson's disease or cerebral palsy that would affect the ability to walk as directed for short periods of time.
Sex :
ALL
Ages :
- Minimum Age : 5 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 453 |
Target Study Title: Screening and Intervention Reducing Anxiety in Patients With Implanted Cardioverter Defibrillator (ICD) - Screen-ICD
Target Study Description: #Study Description
Brief Summary
The hypothesis is that there is a significant difference in anxiety scores between intervention and usual care group after intervention.
The aim of this randomised trial is (I) to determine the type of anxiety in ICD patients and (ii) to investigate the effect of screening followed by randomisation to intervention with consultations based on cognitive therapeutic principals to reduce anxiety in patients with ICD or usual care.
Detailed Description
Screen-ICD is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, including two university hospitals, with 1:1 randomisation to cognitive therapy plus usual care or usual care alone.
The intervention: all patients receive usual care. Patients in the intervention group will receive an intervention based on cognitive behavioral therapy. The intervention consists of three steps: 1. The intervention begins with a consultation with a nurse aiming at uncovering anxiety using the Hamilton anxiety scale and exploring how life with an ICD is perceived, 2. Based on the pre-specified protocols for each type of anxiety, cognitive therapy is provided and 3. After each session participants are asked to fill out the HADS questionnaire. When the patient scores below the cut-off value two times in a row, sessions will end. Each patient can have a maximum of 15 sessions.
#Intervention
- BEHAVIORAL : Cognitive 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:
* Over 18 years
* Have had ICD implantation
* Speaks and understands Danish
* Scores 8 or more in the HADS-A questionnaire
* Gives written informed consent
Exclusion Criteria:
* Scores 11 or more in the HADS-D questionnaire and the depression score exceeds the anxiety score.
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>
| 454 |
Target Study Title: Effect of Bright Light on Sex Hormones and Ovulation in Humans
Target Study Description: #Study Description
Brief Summary
The study investigated whether bright artificial light may influence menstrual cycle and ovulation conclusively, and what underlying hormonal changes for this effect are.
Detailed Description
Several studies have shown a shortening of the menstrual cycle following light therapy in women with abnormally long menstrual cycles or with winter depression, which suggests that bright light may influence sex hormones and ovulation. The study was designed to investigate this possibility. Twenty-two women with slightly lengthened menstrual cycles and without clinically evident endocrine abnormalities completed a study lasting for two menstrual cycles separated by an off-protocol episode of at least 1 menstrual cycle. Bright light therapy was administered for a week at home during one experimental cycle, and dim light during another cycle (placebo-controlled, crossover, counter-balanced order). Daytime blood sampling and ultrasound scan were performed before and after a week of light therapy, on the \~7th and 14th days after menstruation onset. Ultrasound examination was repeated further to document ovulation. Serum was assayed for thyroid-stimulating hormone, prolactin, luteinizing hormone, follicle-stimulating hormone, and estradiol. The preliminary results were reported at the SLTBR meeting in June, 2005.
#Intervention
- PROCEDURE : Light 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:
* Age 19 <= age <= 40 years
* Mean menstrual cycle 28 <= age <= 38 days
* Good general health
* Generally normal sleep-wake regimen
* Motivated for free participation
Exclusion Criteria:
* Low cooperation
* Medications known to interfere with hormone release
* Clinically evident endocrine abnormalities including the signs of
* Hyperandrogenism
* Travel over several time zones during two months prior the study
Sex :
FEMALE
Ages :
- Minimum Age : 19 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 455 |
Target Study Title: Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic
Target Study Description: #Study Description
Brief Summary
The objective of the study is to develop and validate a molecular diagnostic strategy (RT-ddPCR multiplex) of COVID-19 based on a saliva sample and alternative to the RT-qPCR method, in order to :
1. to compensate for the risk of a shortage of diagnostic kits, reagents and materials necessary for molecular diagnosis;
2. to increase the molecular diagnostic capacity of COVID-19 at the Rouen University Hospital;
3. and to have a method compatible with screening extended to populations at risk.
#Intervention
- DIAGNOSTIC_TEST : Saliva collection
- Saliva collection will be done in addition to standard diagnosis collection (nasopharyngeal collection using swab)
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:
* Person aged > 18 years presenting to the COVID-19 consultation of the Rouen University Hospital for screening
* Person affiliated to a social security scheme
Exclusion Criteria:
* Person objecting to participation in the research after reading information
* Person under the protection of justice,
* Person deprived of their liberty by administrative or judicial decision (guardianship, curatorship, etc.)
* Patient under guardianship or curatorship
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>
| 456 |
Target Study Title: EFFECT OF SOMATOSTTIN ON EARLY DIASTOLIC LEFT VENTRICULAR FUNCTION IN AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE: A MATCHED-COHORT, SPECKLE-TRACKING ECHOCARDIOGRAPHIC STUDY
Target Study Description: #Study Description
Brief Summary
Autosomal dominant polycystic kidney disease (ADPKD) is associated with early onset hypertension and left ventricular (LV) hypertrophy. Since LV hypertrophy is associated with LV diastolic function impairment, we aimed to assess the changes over time of LV diastolic function in ADPKD patients and whether they were affected by the treatment with the somatostatin analogue, octreotide.
35 ADPKD patients (14 males) aged 34±8 years (mean glomerular filtration rate 82±26 mL/min/1.73m2) were randomly assigned to 36 month treatment with placebo (n=18) or octreotide (n=17). Clinical and echocardiography parameters were evaluated at baseline and study end. LV mass (M) and ejection fraction (EF) were calculated according to Devereux formula and biplane Simpson's algorithm, respectively. LV filling was assessed by mitral and pulmonary vein flow velocity curves and mitral annulus early diastolic velocity peak (Ea) by tissue Doppler imaging.
#Intervention
- DRUG : Octeotride
- 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:
* diagnosis of autosomal dominant polycystic kidney disease
* glomerular filtration rate grater than 40 ml/min
Exclusion Criteria:
* diabetes mellitus
* proteinuria greater than 1 g/24 hours
* significant glomerular disease
* urinary tract lithiasis and infections
* symptomatic gallstones
* biliary sludge
* cancer
* pregnant women
* lactanting women
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>
| 457 |
Target Study Title: Early Childhood Caries in Jordanian Children: Prevalence, Risk Factors and Prevention Using Silver Diamine Fluoride
Target Study Description: #Study Description
Brief Summary
In this cross sectional epidemiological study, we aimed to report the prevalence of early childhood caries (ECC) in children attending kindergartens in Jordan, and its associated risk factors. We also, aimed to determine the effectiveness of silver diamine fluoride as a caries control material and its acceptance among parents of children with ECC. Children (n=887) with mean age 4.64 ± 1.56 were examined. Among this sample there was a number of children (n=159) who were enrolled in a randomized controlled trial to study silver diamine fluoride efficacy in caries control. The sample consisted of two groups; the study group (children who received single spot application of 38% SDF) and control group (children who were examined only).
Detailed Description
Background: Early childhood caries is a well-known international public health challenge amongst young children.
Aims: To report the prevalence of early childhood caries in children attending kindergartens in Jordan, and its associated risk factors. To determine the effectiveness of silver diamine fluoride as a caries control material and its acceptance among parents of children with ECC.
Methods: This is a cross sectional epidemiological study comprised of children (n=887) with mean age 4.64 ± 1.56 who attended kindergartens of different cities in Jordan, this sample received questionnaires to fill data related to their demographic, socioeconomic, oral hygiene, oral health, nursing and nutritional habits. These children were also examined to determine early childhood caries prevalence in Jordan. Among this sample there was a number of children (n=159) with the mean age 4.8 ± 0.85 who were planned to be involved in a sample of a randomized controlled trial to study silver diamine fluoride efficacy in caries control. The sample consisted of two groups; the study group (children who received single spot application of 38% SDF) and control group (children who were examined only). Application of SDF started after distribution and receiving back approval letters from children's parents accompanied with questionnaires for data related to the approval/disapproval of the application. The sample were followed up for 1 year.
#Intervention
- DRUG : Silver Diamine Fluoride
- A colourless solution known with its alkaline nature; it simply consists of a union of silver, fluoride and ammonia. It can be applied on caries cavities using a micro-brush.
- Other Names :
- SDF
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:
* Children with early childhood caries involving anterior and/or posterior primary teeth
* Children with with cavitated lesions with active caries
* Children with no clinical signs of pulp involvement
Exclusion criteria:
* Children with grossly broken down teeth
* Children with teeth with more than one third of the crown missing
* Children with pulpally involved teeth (with pulp exposure, presence of an abscess or a sinus) Children with obvious discoloration, and abnormal mobility
Sex :
ALL
Ages :
- Minimum Age : 3 Years
- Maximum Age : 5 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 458 |
Target Study Title: Can Non-invasive Sampling Determine the Inflammatory Status of the Intra-uterine Environment?
Target Study Description: #Study Description
Brief Summary
Preterm birth (birth before 37 weeks gestation) is a large problem in the United States and is a major cause of neonatal morbidity and mortality and childhood neurological disability. Despite significant advances in the care of pregnant mothers, the incidence of preterm labor is on the rise. There is growing recognition that cytokines and inflammatory mediators present at amniotic fluid and placenta play a fundamental role in regulating labor.
Cytokines are chemicals in the fluid that tell the body's immune system what to do. These (and other biomarkers) can be measured with a small amount (a few drops) of amniotic fluid. The researchers have previously shown that people at risk for preterm labor have higher cytokine levels. However, understanding the in-utero environment currently requires invasive sampling, such as amniocentesis, to determine cytokine concentrations. This procedure has inherent risks, causes patient discomfort and anxiety, and thus does not avail itself to routine use or repeated sampling, especially in non-high risk patients. Therefore, the researchers are looking for non-invasive sampling that can predict the in-utero environment.
To date, no studies have simultaneously evaluated different maternal-fetal compartments to determine the relationship of these markers among the compartments. Therefore, the purpose of this pilot study is to determine the differential expression of inflammatory mediators in various maternal-fetal compartments; specifically, vaginal fluid, cervical secretions, placenta, cord blood (arterial and venous), amniotic fluid, maternal serum, maternal urine, and maternal saliva.
The researchers seek to obtain fluid samples from nine maternal-fetal compartments and determine the inflammatory mediator expression in each. The timing of collection, location, and proposed studies for each of the samples is outlined in Table 1. In this pilot study, we plan to enroll 20 patients undergoing cesarean delivery.
After consent, the samples will be collected and given a unique Study ID number. No protected health information will be collected. In addition, there will be no link between the Study ID and patient identifiers. Therefore, we are not seeking HIPAA authorization at the time of consent. While none of these samples would routinely be collected as part of the standard of care, the collection procedures meet the criteria for minimal risk.
#Intervention
- OTHER : Specimen Collection
- We will compare mediators from non-invasive samples (blood, urine, saliva, vaginal or cervical secretions) with traditional gold-standard invasive samples (amniotic fluid and placenta samples).
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:
* Undergoing cesarean delivery
* Able to provide informed consent, including permission of storage of specimens
* No apparent major fetal abnormality
Exclusion Criteria:
* Major Fetal Malformation
* Rupture of membranes
Sex :
FEMALE
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>
| 459 |
Target Study Title: In Vivo Experience With NRT to Increase Adherence and Smoking Abstinence
Target Study Description: #Study Description
Brief Summary
This is a study to determine the efficacy of a smoking cessation intervention (nicotine replacement therapy (NRT) and counseling) done in a systematized manner with participants recruited from the UAB Substance Abuse Program. The definition of In Vivo experience is: use of the NRT medication during the session using specialized counseling focused around their experience of using NRT, including how the use of NRT may help them quit smoking, side effects, and smoking cessation expectancies. In this study those in the In Vivo group will put the patch on during Session 1 and given nicotine gum in Session 2 and will discuss the experience of wearing the patch or chewing the gum while they are in session. The control group will not put on the patch or chew gum during the sessions but will be given standard counseling regarding quitting smoking.
Detailed Description
Aim 1: Compare the efficacy of an In Vivo experiential intervention to a standard treatment control group for smoking cessation. The goal of this aim will be to compare the rates of point prevalence abstinence at the 6 month post-intervention follow-up. It is expected that smokers who receive the behavioral experience of the NRT In Vivo intervention will have higher rates of abstinence at the 6 month follow-up compared to the control group. Aim 2: Compare medication adherence between groups over the 12 week intervention. The goal of this aim is to determine the impact of the In Vivo behavioral experience intervention on promoting medication adherence to NRT. It is expected that individuals in the In Vivo NRT group will have better medication adherence relative to control participants. Exploratory: Examine moderators and mediators of the experimental intervention on smoking abstinence. The goal of this aim is to explore whether demographic and smoking characteristics (e.g., sex, race, nicotine dependence, motivational status, legal charges) moderate the effect of treatment on abstinence after 12 weeks of treatment and 6-month follow-up. In addition, we will look at changes in expectancies about NRT, medication adherence, and withdrawal symptoms to determine if these changes mediate the relationship between the experimental intervention and smoking abstinence.
#Intervention
- BEHAVIORAL : In vivo counseling
- Participants in the intervention group will receive 4 in session nicotine replacement therapy and counseling focused on their experience of using NRT, including positive experiences, side effects and smoking cessation expectancies. They will also received nicotine replacement therapy (nicotine lozenge and patch) to use for smoking cessation.
- BEHAVIORAL : Standard Smoking Cessation Counseling
- Participants will receive 4 sessions of standard behavioral counseling to address their smoking. In addition, participants will received nicotine replacement therapy (Nicotine lozenge and patch) to use for smoking cessation.
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:
* At least 18 years,
* Under criminal justice supervision and expecting to remain under supervision for 9 months,
* Smoked at least 5 cigarettes per day for the last 12 months,
* Expire carbon dioxide (CO)> 10 ppm.
* Must be able to read and speak English.
* Women of child-bearing potential must be using adequate birth control.
Exclusion Criteria:
* Pregnant or breastfeeding women,
* Non-English speaking,
* Living in an restricted environment that does not allow smoking,
* Known sensitivity to nicotine replacement or allergy to adhesive used in nicotine patches,
* Cognitive impairment or major untreated mental illness that interferes with the informed consent process,
* Within 6 months post-myocardial infarction or untreated severe angina,
* Latex allergy,
* Daily or exclusive use of other tobacco products (e.g. cigars, e-cigarettes).
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>
| 460 |
Target Study Title: Assessing Feasibility and Program Effectiveness of Home Fortification of Complementary Foods in Bihar: A Cluster Randomized Community Pilot
Target Study Description: #Study Description
Brief Summary
This study evaluates the program effectiveness of home fortification along with infant and young child feeding (IYCF) counseling as a strategy to address anemia and complementary feedings gaps in a program setting of the Integrated Family Health Initiative being implemented by CARE India (a non-profit organization) in partnership with the Government of Bihar. The study also seeks to assess the field level worker experience with counseling and dissemination of home fortification products.
Detailed Description
This study evaluates the program effectiveness of home fortification along with infant and young child feeding (IYCF) counseling as a strategy to address anemia and complementary feedings gaps in a program setting of the Integrated Family Health Initiative being implemented by CARE India (a non-profit organization) in partnership with the Government of Bihar.The key objectives of this study are to examine acceptability and utilization by target population, assess impact on infant and young child feeding (IYCF) practices, evaluate impact on child growth, evaluate impact on hemoglobin concentration, and assess front line worker experience and motivation to disseminate enhanced counseling and home fortification products.
#Intervention
- DIETARY_SUPPLEMENT : Home Fortification Product (HFP)
- The home fortification product (HFP) is a sachet containing multiple vitamins and nutrients as follows:
Iron (Ferrous Fumarate) 12.5 mg Zinc (Zinc Gluconate) 5 mg Folic Acid 0.160 mg Vitamin-A (Vit-A Acetate) 0.30 mg Vitamin-C (Ascorbic Acid) 30 mg Vitamin-B12 0.9 mcg Iodine 90 mcg Maltodextrin (Base)
- OTHER : Infant and Young Child Feeding (IYCF) Practices Counseling
- Infant and Young Child Feeding (IYCF) Practices Counseling provides direction on breast milk and milk feeding, food variety, and frequency for caregivers of children aged 6 to 18 months. Participants will be visited at least monthly by a field line worker for IYCF counseling and educational materials distribution.
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:
* Randomly selected children living within Health-Sub Centers (HSC) in West Champaran Bihar
Exclusion Criteria:
* Children less than six months of age
* Children greater than eighteen months of age
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 18 Months
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 461 |
Target Study Title: Bioavailability and Pharmacokinetic Parameters of Watermelon (Rind, Flesh and Seeds) Polyphenols in Human Plasma: A Pilot Study to Investigate Relationship to Endothelial Function.
Target Study Description: #Study Description
Brief Summary
The primary objectives of the study are outlined below:
1. To investigate the relative bioavailability and absorption/kinetic profile of polyphenols after consumption of watermelon rind, flesh and seeds, respectively in an acute pilot study.
2. To study the effects of watermelon intake on endothelial function using the FMD technique and to understand the relationship between plasma metabolites, including L-citrulline and arginine, and FMD responses.
Detailed Description
The proposed trial will be a randomized, 4 arm, placebo controlled, within-subject crossover, study design. It is a pilot trial to establish methods and collect the preliminary data (N=6). Subjects meeting eligibility criteria (see eligibility criteria) will participate in 4 study visits where they will receive one serving (equivalent to 100 kcal) of 1 of 4 treatments: watermelon rind, watermelon flesh, watermelon seeds or placebo.
Qualified subjects from the screening visit will be randomized into the study and provided with a standard breakfast consisting of a high carbohydrate and moderate fat western-type meal 3 hours after the treatment. Each subject will be asked to come for one screening visit, a pre-study visit, and four dinner pick-ups on the day before each of the four test visits. The study day visit will last for approximately 9 h with a follow up visit the next day (24 h) for blood collection to allow for the characterization of target watermelon polyphenols and metabolites in plasma. Subjects will be instructed not to alter their usual diet or fluid intake during the study periods. Seven days prior to each study day visit, subjects will be advised not to consume fruits and vegetables rich in polyphenols and carotenoids or other high phytochemical foods (watermelon and products, arugula, spinach, tea, berries, grapes, carrots, tomatoes, sweet potatoes etc.).
Each study visit will involve with blood samples collection at time points 0 (fasting), 0.5, 1, 2, 3, 4, 5, 6, 7, 8 h and 24 hour (h). An assigned test treatment will be provided immediately after the 0 h blood collection, a breakfast meal will be provided immediately after the 2 h blood collection, and lunch after 6 h blood collection. FMD will be measured at 0 (fasting), 1, 3, 5, and 7h.
#Intervention
- DIETARY_SUPPLEMENT : Watermelon Rind
- watermelon rind
- DIETARY_SUPPLEMENT : Watermelon Flesh
- watermelon flesh
- DIETARY_SUPPLEMENT : Watermelon Seeds
- watermelon seeds
- DIETARY_SUPPLEMENT : Placebo
- Control Comparator
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 or women, 20 <= age <= 45 years with body mass index (BMI) in range from 27.5 <= age <= 32 kg/m2
* Nonsmokers (Past smokers can be allowed if they have abstinence for minimum of 2 years)
* No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
* Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, dietary supplements especially arginine and L-citrulline, etc.
* Able to provide informed consent
* Able to comply and perform the procedures requested by the protocol (including dietary restrictions, consumption of study treatments, records of food diary and questionnaire, and study visit schedule)
Exclusion Criteria:
*
* Men and women who smoke
* Men and women with known or suspected intolerance, allergies or hypersensitivity to study foods or treatments
* Men and women who consume > 2 servings of watermelons per day
* Men and women known to have/diagnosed with diabetes mellitus
* Men and women who have fasting blood glucose concentrations > 125 mg/dL
* Men and women who have uncontrolled blood pressure >140 mmHg (systolic)/90 mmHg (diastolic)
* Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries, etc. that, in the opinion of the investigator, could interfere with the interpretation of the study results
* Men and women with cancer other than non-melanoma skin cancer in previous 5 years
* Men and women diagnosed with chronic constipation, diarrhea or other chronic gastrointestinal complaint (e.g. irritable bowel syndrome)
* Women who are known to be pregnant or who are intending to become pregnant over the course of the study
* Women who are lactating
* Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication, blood pressure lowering medication, etc... Subjects may choose to go off dietary supplements (requires 30 days washout); e.g., fish oil, probiotics, etc...
* Men and women who have donated blood within 3 months of the Screening Visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
* Men and women who are vegans or vegetarian
* History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional
* Substance (alcohol or drug) abuse within the last 2 years
* Excessive coffee and tea consumers (> 5 cups/d)
* Men and women who do excessive exercise regularly or an athlete
* Unstable weight: gained or lost weight +/- 5 kg (11 lbs) in previous 2 months
* Women who are taking unstable dose of hormonal contraceptives and/or stable dose for less than 6 months
* Unusual working hours i.e., working overnight (e.g. 3rd shift)
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>
| 462 |
Target Study Title: A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of pGA2/JS7 DNA Vaccine and Recombinant Modified Vaccinia Ankara/HIV62 Vaccine in Healthy, HIV-1-Uninfected Adult Participants
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine the safety of and immune response to a DNA HIV vaccine, pGA2/JS7, followed by a modified vaccinia (smallpox) HIV vaccine, MVA/HIV62, in HIV uninfected adults.
Detailed Description
The worldwide HIV/AIDS epidemic may only be controlled through a safe and effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct, easily produced in large quantities, and stable for long periods of time. Recombinant modified vaccinia Ankara vaccines have been shown to be safe in humans, and immunogenicity after administration of both vaccines has been encouraging. When used together, a more robust immunologic response was associated with DNA HIV vaccine administration followed by modified vaccinia vaccine administration, compared to using either DNA or vaccinia vaccine alone. This study will evaluate the safety and immunogenicity of an experimental DNA HIV vaccine prime, pGA/JS7, followed by a similarly structured modified vaccinia boost, MVA/HIV62, in HIV uninfected adults. Participants in this study will be recruited only in the United States.
This study will be divided into 2 parts. Each participant will be involved with their part of study for 1 year. Participants in Part 1 will be randomly assigned to one of two different vaccination groups. Group 1A participants will be randomly assigned to receive either placebo or 2 lower doses of the DNA HIV vaccine (DNA) at study entry and Month 2, followed by 2 lower doses of the modified vaccinia vaccine (MVA) at Months 4 and 6. Group 1B will not enroll until safety and immunogenicity data from Group 1A have been evaluated. Group 1B participants will receive either placebo or two higher doses of DNA at study entry and Month 2, followed by two higher doses of MVA at Months 4 and 6.
Enrollment into Part 2 will begin only after safety data from Part 1 are reviewed. In Part 2, participants will be randomly assigned to one of two different vaccination groups. Within each group, participants will be randomly assigned to receive some series of vaccines or placebo. Group 2A participants will receive either placebo or the maximum tolerated dose (MTD) from Part 1 of DNA at study entry and MTD of MVA at Months 2 and 6. Group 2B participants will receive MTD of MVA at study entry and Months 2 and 6.
There will be 12 study visits over 12 months for Groups 1 and 2. There will be 11 study visits over 12 months for Groups 3 and 4. Medication history, a physical exam, an interview, HIV and pregnancy prevention counseling, and adverse events reporting will occur at all visits. Blood and urine collection and an electrocardiogram (ECG) will occur at selected visits.
#Intervention
- BIOLOGICAL : pGA2/JS7 DNA
- DNA Vaccine
- BIOLOGICAL : Modified vaccinia Ankara/HIV62
- Recombinant Modified Ankara Vaccine
- Other Names :
- MVA
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 uninfected
* Has access to a participating HIV Vaccine Trials Unit (HVTU) and is willing to be followed for the duration of the study
* Understands vaccination procedure
* Willing to receive HIV test results
* Good general health
* Willing to use acceptable forms of contraception
Exclusion Criteria:
* Received HIV vaccines in prior HIV vaccine trial
* Received vaccinia vaccine. More information on this criterion can be found in the protocol.
* Recreational cocaine or methamphetamine use within 12 months prior to study entry
* Immunosuppressive medications within 168 days prior to first study vaccine administration. Participants who use corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for mild, uncomplicated dermatitis are not excluded.
* Blood products within 120 days prior to first study vaccine administration
* Immunoglobulin within 60 days prior to first study vaccine administration
* Live attenuated vaccines within 30 days prior to first study vaccine administration
* Investigational research agents within 30 days prior to first study vaccine administration
* Subunit or killed vaccines within 14 days (for influenza or pneumococcal vaccines) or 30 days (for allergy treatment with antigen injections) prior to first study vaccine administration
* Current tuberculosis prophylaxis or therapy
* Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
* Any medical, psychiatric, or social condition that would interfere with the study. More information about this criterion can be found in the protocol.
* Any job-related responsibility that would interfere with the study
* Allergy to egg products
* Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
* History of or known active cardiac disease. More information on this criterion can be found in the protocol.
* Electrocardiogram (ECG) with clinically significant findings OR features that would interfere with assessments for myocarditis or pericarditis. More information on this criterion can be found in the protocol.
* Two or more of the following cardiac risk factors: elevated blood cholesterol (defined as fasting low density lipoprotein [LDL] of greater than 160 mg/dl); first-degree relative (e.g., mother, father, brother, sister) who had coronary artery disease before the age of 50; current smoker; or body mass index (BMI) greater than 35
* Autoimmune disease or immunodeficiency
* Active syphilis infection. Participants whose syphilis infection was fully treated at least 6 months prior to study entry are not excluded.
* Severe and unstable asthma
* Diabetes mellitus type 1 or 2
* Thyroid disease requiring treatment
* Serious angioedema within the past 2 years
* Uncontrolled hypertension OR systolic blood pressure (BP) of 150 mmHg or greater or diastolic BP of 100 mmHg or greater
* BMI greater than 40
* Bleeding disorder
* Cancer. If a participant has had surgery to remove the cancer and, in the opinion of the investigator, the cancer is not likely to recur during the study period, the participant is not excluded.
* Seizure disorder
* Asplenia
* Mental illness that would interfere with compliance with the protocol
* Other conditions that, in the judgment of the investigator, would interfere with the study
* Pregnancy or breastfeeding, or plans to become pregnant
Sex :
ALL
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>
| 463 |
Target Study Title: The EFFect of hIgh Dose ClopIdogrel treatmENT in Patients With Clopidogrel Resistance
Target Study Description: #Study Description
Brief Summary
Continuing high dose clopidogrel treatment after elective PCI decreased adverse cardiac events in patients with clopidogrel resistance
Detailed Description
Aim:
Primary objective:
* To evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac events after elective PCI in patients with clopidogrel resistance
Secondary objective:
* To evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac events after elective PCI
* To evaluate the effect of continuing high dose clopidogrel treatment on bleeding complications after elective PCI
* To evaluate the clinical effect of VerifyNow which use as a clopidogrel resistance kit.
Study central:
Bursa Postgraduate Hospital, Cardiology Clinic
Study population:
we planned to enrol 180 patients. 50% of patients without clopidogrel resistance (control group: 90 patients) 50% have clopidogrel resistance. Than we randomise the patients (with clopidogrel resistance) in two groups (group 1:45 patients (75mg/day), group 2:45 patients (150mg/day))
inclusion criteria:
* The patients; who have planned elective PCI and have had written informed consent for participation to study.
* Age\>18 year-old,
* The native coronary artery;lesion with narrowing \>=70%
Exclusion criteria:
* Patients have allergy for ASA, Clopidogrel and heparin
* Patients who performed primary PCI
* Patients with acute coronary syndrome
* Patients with have a history of PCI and use clopidogrel
* Patients on warfarin therapy
* Patients who have bleeding diathesis, or have high risk for bleeding.
Study works:
* Write case report form for all patients
* Control for inclusion criteria.
* Evaluate the clopidogrel and ASA resistance with VerifyNow kit. Than randomised the patients.
* Demographic data (age, gender)
* Height, weight, BMI and GFR
* Risk factors
* laboratory data (biochemical and hematologic)
* Medication history
* Echocardiographic data
* Angiographic data
* PCI data(vessel diameter, stent diameter, lesion and stent length, performed PTCA or not, etc)
* Note complication (MACE, bleeding, hematoma etc)
4 weeks later note the first control data and re assess the clopidogrel resistance with VerifyNow kit in patients groups 1 and 2.
Six months later note the second control data.
#Intervention
- DRUG : Clopidogrel
- high dose clopidogrel continuing after percutaneous coronary 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:
* The patients; who have planned elective PCI and have had written informed consent for participation to study.
* Age>18 year-old,
* The native coronary artery;lesion with narrowing >=70%
Exclusion Criteria:
* Patients have allergy for ASA, Clopidogrel and heparin
* Patients who performed primary PCI
* Patients with acute coronary syndrome
* Patients with have a history of PCI and use clopidogrel
* Patients on warfarin therapy
* Patients who have bleeding diathesis, or have high risk for bleeding.
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>
| 464 |
Target Study Title: An Exploratory 16 Week, Double Blind, Placebo-Controlled Single Center Mechanistic Study to Determine the Effect of Rhumab-E25 on Phenotype and Function of IgE Mediated Antigen Presentation by Dendritic Cells in Subjects With Atopic Dermatitis.
Target Study Description: #Study Description
Brief Summary
Elevated levels of immunoglobuline E in blood are said to promote the occurence of atopic dermatitis; in fact, many patients with atopic dermatitis have high IgE levels. This study tried to explore whether the depletion of IgE from blood and skin might result in a change of immunological parameters and might alter the clinical course of the disease.
#Intervention
- DRUG : Omalizumab
- 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:
* aged between 12 and 60 years
* clinical diagnosis of AD (criteria of Hanifin and Rajka, 1980)
* serum IgE between 30 and 1,300 IU/ml
* at least one significantly positive RAST
* a positive skin prick test of the same specificity as the RAST
* an Investigator's Global Assessment Score of 2 or more at randomization
* stable AD, as defined as active AD (IGA 2 or more) for > 9 months per year
* signed informed consent.
Exclusion Criteria:
* pregnant or nursing females or women of childbearing potential who did not use a reliable contraceptive method
* treatment with omalizumab within the last 12 months before study treatment
* known hypersensitivity to any ingredients of omalizumab or omalizumab- related drugs
* elevated serum IgE levels for reasons other than atopy
* ongoing immunotherapy
* use of long-acting antihistamine astemizol within 3 months prior to visit1
* use of medium-acting antihistamines (e.g. loratadine, cetirizine) within 5 days prior to visit 1
* use of short-acting antihistamines (e.g. diphenhydramin, terfenadine) within 3 days prior to visit 1
* use of zafirlukast or other leukotriene receptor inhibitors and zileuton or other 5-lipoxygenase enzyme inhibitors within 3 days prior to visit 1
* use of phototherapy or systemic therapy that is known or suspected to have had an effect on AD within 1 month prior to first application of study medication
* treatment with topical therapy (other than hydrocortisone 1%) that is known or suspected to have had an effect on AD within 14 days prior to first application of study medication
* use of systemic steroids (oral, intravenous, including intraarticular and rectal) within one month prior to first application of study medication. (Patients on a stable maintenance dose of inhaled steroids were allowed to participate)
* use of systemic antibiotics within 2 weeks prior to first application of study medication
* use of tranquilizers, hypnotic agents or tricyclic antidepressants within 2 weeks prior to the start of the study
* immunocompromised patients or patients having a history of malignant disease
* concurrent skin diseases
* active bacterial, viral or fungal infections that required treatment with a prohibited medication
* a history of recurrent herpes simplex infection having active lesions at baseline
* tinea corporis / tinea cruris
* clinically significant laboratory abnormalities
* a history of noncompliance to medical regimens and patients who were considered potentially unreliable
* evidence of drug or alcohol abuse or other factors limiting ability to fully cooperate
* any condition or prior/continuing treatment which, in the opinion of the investigator, should have rendered the patient ineligible for the study.
Sex :
ALL
Ages :
- Minimum Age : 12 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 465 |
Target Study Title: The Caregiver's Burden in Cerebral Palsy
Target Study Description: #Study Description
Brief Summary
Cerebral palsy (CP) results from damage to the developing brain of the fetus or infant. These non-progressive lesions cause a set of permanent movement and posture disorders, responsible for activity limitations. These disorders are often accompanied by sensory, perceptual, cognitive impairments, communication and behavioral disorders, and sometimes epilepsy and/or secondary musculoskeletal problems. It is the leading cause of motor disability in childhood and affects 200 newborns per year in Belgium.
Cerebral palsy affects two to three people in every 1,000 of the world's population. The prevalence, incidence and most common causes have varied over time due to significant changes in obstetric care and pediatric care. In 75% of all cases of cerebral palsy, the lesions occurred before childbirth.
The population of adults diagnosed with cerebral palsy is increasing as the survival rate of children born with a disability increases. This population requires adapted and expert care services for the continuous monitoring and management of their condition. In addition, the development of additional health problems in adulthood increases the need for permanent access to care structures. Adults with CP have a higher rate of chronic health problems (ischemic heart disease) and a deterioration in their functional status. They would also have difficulty having a social and professional life which negatively impacts their quality of life.
A large number of adults with CP cannot access appropriate care or medico-social structures. This results in a significant involvement of caregivers (family environment or close entourage).
The role of caregiver is at the origin of a significant physical and psychological burden, whether for underage patients or adult patients. The study of this burden is well known in certain neurological pathologies (head trauma, multiple sclerosis, brain tumors). In the field of cerebral palsy, a study showed that the primary caregivers of children with CP had higher levels of psychological and physical disorders than the control group studied (caregivers of healthy children).
Currently, there are very few studies assessing the burden of caregivers of adults with cerebral palsy. The objective of this study is to analyze, through various specific questionnaires, the quality of life and the presence of depressive symptoms linked to the burden of caregivers of adults and children with cerebral palsy, taking into account socio-economic and environmental data.
#Intervention
- OTHER : Questionnaire
- Questionnaires in French on the quality of life, the burden of caregiving and a screening for depressive symptoms, completed during specific interviews.
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 subjects, aged 18 to 75, caring for relatives of adults and children with cerebral palsy, with a good understanding of the French language.
Exclusion Criteria:
* Subjects under 18 or over 75, presenting a language barrier (interview guide written in French), subjects with a known history of psychiatric pathologies.
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>
| 466 |
Target Study Title: Renal Effects of Remote Ischemic Preconditioning in Patients After Total Arch Replacement
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.
Detailed Description
Acute kidney injury (AKI) is a well-recognized complication after cardio-thoracic surgeries and is associated with increased morbidity and mortality. Total arch replacement is reported with a relatively high incidence of post-operative AKI. In addition, few effective preventive or therapeutic interventions for AKI have been identified. A number of studies have now addressed renal protection as a primary outcome following RIPC. Because the mechanism of I/R injury are similar to those proposed for AKI after CPB, the purpose of this study is to test the hypothesis that remote ischemic preconditioning prevents acute kidney injury and improves clinical outcomes in patients undergoing total arch replacement.
#Intervention
- OTHER : remote ischemic preconditioning
- Remote ischemic preconditioning (RIPC) will be induced after the general anesthesia prior to the cardiopulmonary bypass by four cycles of right limber ischemia (5-min blood pressure cuff inflation to a pressure of 200mmHg or a pressure that is 50 mmHg higher than SAP and 5-min cuff deflation)
- OTHER : Control
- Four cycles of right upper limb pseudo ischemia and reperfusion, which will be induced by 5-minute blood pressure cuff inflation to a low pressure of 20 mmHg followed by 5-minute cuff deflated.
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 scheduled for total arch replacement
* written informed consent
Exclusion Criteria:
* pre-existing AKI
* peripheral vascular disease affecting the upper limbs
* hybrid total arch replacement
* the history of kidney transplantation
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>
| 467 |
Target Study Title: A Randomized Controlled Trial of Systemic and Topical Treatments for Rash Secondary to Erlotinib in Advanced Stage IIIB or IV Non-Small Cell Lung Cancer
Target Study Description: #Study Description
Brief Summary
The purpose of this trial is to determine if rash caused by erlotinib can be successfully treated and if so to determine the optimal treatment approach.
Hypothesis:
Hypothesis 1: If the incidence of rash is 50% while on erlotinib, prophylactic monotherapy with minocycline can prevent occurrence in 50% of these patients.
Hypothesis 2: Treatment of rash is successful in improving rash by at least one Grade in 80% of patients.
Hypothesis 3: In patients with untreated rash, the rash will be self-limiting in 25% of patients, and 65% will be grade 1, 2A, and 2b. Ten percent will be grade 3 requiring treatment with monotherapy intervention.
Detailed Description
Erlotinib has been shown to prolong survival in NSCLC patients who are no longer candidates for further chemotherapy. In July 2005, erlotinib was approved in Canada for the treatment of patients with locally advanced or metastatic NSCLC, following failure of first or second-line chemotherapy.
Erlotinib's side effect profile includes rash. The incidence of rash in clinical trials has been reported to be approximately 50 - 75%, and has been hypothesised to parallel tumour response (20).
The treatment of rash is controversial and many oncologists believe it is untreatable and self-limiting. The cause of the rash is not well understood but is felt to be a systemic event. Clinical experience of the investigators has suggested that minocycline 100 mg orally given twice-daily for 4 weeks and clindamycin 2% and hydrocortisone 1% topical cream for moderate to severe rash is a successful treatment.
The objectives of this trial are to better delineate the rash and its features and to describe an optimal treatment. Since the rash is often facial in distribution and can therefore lead to physical and psychological distress to the patient, a dermatology life quality index will also be completed throughout the study.
#Intervention
- DRUG : Minocycline
- Patients will receive prophylactic treatment with minocycline 100 mg orally twice-daily for at least 4 weeks on the initiation of erlotinib therapy. If rash occurs during the 4 week period of minocycline prophylaxis, the minocycline prophylaxis will continue and additional treatment by grade of rash will be according to the Treatment Arm 2 schedule. If rash occurs after the completion of the 4 week prophylaxis period, treatment by grade of rash will be according to the Treatment Arm 2 schedule.
- Other Names :
- Dynacin, Minocin, Minocin PAC, Solodyn, Vectrin, Myrac
- DRUG : Clindamycin 2% in hydrocortisone 1% lotion
- Appropriate amounts of clindamycin and hydrocortisone powder are mixed with corresponding amount of Nutraderm® lotion for this mixture.
If preferred, the appropriate amount of clindamycin powder can be mixed with Emo-Cort® lotion (already contains hydrocortisone 1%), available in 60 mL bottles.
- DRUG : Erlotinib
- Erlotinib will be given on an outpatient basis at a fixed dose of either 150 or 100 mg as a single daily oral dose.
- Other Names :
- Tarceva
- DRUG : Topical clindamycin 2%, triamcinolone acetonide 0.1% soln
- Clindamycin 2% in Triamcinolone acetonide 0.1% solution in equal parts propylene glycol and water
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 or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (stage IIIB or stage IV) non-small cell lung cancer.
* Evidence of disease (measurable disease is not mandatory).
* 18 years or older.
* ECOG performance status of 0 - 3.
* Written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Exclusion Criteria:
* A history of another cancer other than basal cell carcinoma or cervical cancer in situ within the past 3 years
* Prior therapy with any type of cancer growth factor inhibitor (EGFR inhibitor or agent targeting this family of growth factor receptors)
* Life expectancy of less than 12 weeks.
* Ongoing toxic effects from prior chemotherapy.
* Pregnant or lactating women.
* Females of childbearing potential who have a positive or no pregnancy test (pregnancy tests must be obtained within 72 hours before starting therapy). (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
* Male or female patients with reproductive potential who are unwilling to use effective and reliable contraceptive methods throughout the course of the study and for 90 days after the last dose of study medication.
* Ongoing treatment with any inhibitors or inducers of CYP3A4 activity
* Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
* Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions.
* Unwilling or unable to comply with the protocol for the duration of the study.
* Patients who have experienced prior hypersensitivity reaction to active ingredients or excipients of the following compounds: erlotinib, minocycline, tetracycline, doxycycline or clindamycin.
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>
| 468 |
Target Study Title: Characterising Early Response to Neoadjuvant Chemotherapy With Quantitative Breast MRI
Target Study Description: #Study Description
Brief Summary
Firstly, the investigators aim to show that breast tumour blood flow, measured as part of a standard MRI examination, decreases at the earliest stage of neoadjuvant chemotherapy in those patients who go on to respond to treatment. Importantly, the investigators will also show that blood flow does not decrease in those patients who fail to respond.
Secondly, the investigators will test whether the decrease in tumour blood flow over the whole course of neoadjuvant chemotherapy can predict the response of the tumour measured at the time of surgery.
Detailed Description
i) Background. In a recent pilot study of 18 patients undergoing neoadjuvant chemotherapy (NAC), the investigators demonstrated for the first time that it was feasible to measure breast tumour blood flow (TBF) as part of a standard clinical MRI exam. TBF decreased dramatically in clinical responders and when compared with similar results obtained by others using \[15-O\] H2O positron emission tomography, the data led the investigators to hypothesise that TBF will decrease after only 1 cycle of NAC in responders. The data also suggested that changes in TBF over the course of NAC might predict pathological response.
ii) Aims. The primary aim is to assess response to first line NAC non-invasively after only 1 cycle of treatment. A secondary aim is to predict pathological response based upon changes measured over the course of NAC.
iii) Techniques and Methodology. The investigators will measure TBF using a novel MRI approach in 40 patients studied before, following 1 cycle, at the mid-point and the end of a fixed course of NAC. The MRI data will be compared with histological and molecular markers, obtained from biopsies at baseline and after 1 cycle of NAC and from specimens obtained during surgery at the end of NAC, to assess mechanisms of response to chemotherapy. In a sub-study of 10 patients imaged twice at baseline the investigators will assess the reproducibility of the TBF measures.
iv) Impact on breast cancer research. These techniques will provide absolute measures of tumour function during therapy which will particularly benefit non-responders to first line NAC allowing clear and objective decisions to be made about possible early changes in their treatment.
#Intervention
- OTHER : magnetic resonance imaging
- early MRI
- Other Names :
- MRI
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 large but operable invasive carcinoma of the breast. All molecular subtypes are eligible and incidentally detected small volume metastatic disease is NOT an exclusion criterion.
* Clinical indication for NAC as determined by the Breast Therapeutic MDT.
* Sufficient biopsy material taken at diagnosis to measure the standard molecular markers.
* Participant is willing and able to give informed consent for participation in the study.
* Female, aged 18 years or above.
* Histologically or cytologically confirmed invasive carcinoma of the breast and having received no prior treatment for this.
* Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
* Participant has adequate renal function (estimated glomerular filtration rate >= 30 ml/min).
* In the Investigator's opinion, is able and willing to comply with all study requirements.
Exclusion Criteria:
* Previous breast cancer treated with radiotherapy or chemotherapy or recurrent breast cancer.
* Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
* Significant renal impairment (estimated glomerular filtration rate < 30 ml/min).
* Contraindication to MRI.
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>
| 469 |
Target Study Title: Respiratory Impact of Local Anaesthetic Volume for an Interscalene Brachial Plexus Block With an Extrafascial Approach.
Target Study Description: #Study Description
Brief Summary
The hypothesis of this study is that a reduced extrafascial volume of local anesthetic for an interscalene brachial plexus block is associated with a lower incidence of diaphragmatic hemiparalysis after an arthroscopic surgery of the shoulder, without any reduction of the analgesic efficacy.
Detailed Description
The hypothesis of this study is that a reduced extrafascial volume of local anesthetic for an interscalene brachial plexus block is associated with a lower incidence of diaphragmatic hemiparalysis after an arthroscopic surgery of the shoulder, without any reduction of the analgesic efficacy.
Our prospective randomized controlled trial will include two parallel groups: a group will receive a volume of 20 mls of ropivacaine 0.75%, while the other group will receive a volume of 10 mls.
All participants will have a preoperative ultrasound-guided interscalene brachial plexus with an extrafascial injection of 10 or 20 mls of ropivacaine 0.75%. In both groups, participants will have an examination of the hemidiaphgragm with the ultrasound, before and 30 min after the block. The respiratory function will also be assessed with a bedside spirometer before and after the block, and at 12 and 24 postoperative hours. During surgery all participants will receive multimodal analgesia inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 milligram kg\^2, iv ketorolac 30 milligrams, and iv acetaminophen 1000 milligrams, according to the current practice in our institution. In the postoperative period, Participants will be prescribed an IV pca of morphine.
Assignment to one of these two groups will be done according to a computer-generated list of random numbers, and the sealed envelopes method will be used.
#Intervention
- DRUG : Ropivacaine 0.75% Injectable Solution
- 10 ml extrafascial interscalene brachial plexus block
- DRUG : Ropivacaine 0.75% Injectable Solution
- 20 ml extrafascial interscalene brachial plexus block
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:
* arthroscopic surgery of the shoulder
* ASA class 1 to 3
* age more than 18 years
Exclusion Criteria:
* patient refusal or inability to understand and/or sign the inform consent
* contraindication for perineural block (allergy to local anesthetics, infection of puncture site, major coagulopathy, sensitive or motor deficiency on the operative side arm
* chronic alcool abuse
* opioid drug abuse or under substitution treatment
* patients known for allergies to paracetamol, non steroidal anti inflammatory drugs, dexamethasone, sulfate magnesium, ondansetron, droperidol, and omeprazole;
* patients under chronic corticotherapy
* patients known for malignant hyperthermia;
* patients with chronic kidney failure (Glomerular Filtration Rate < 20 ml/min)
* patients with severe pulmonary disease
* patients with history of neck surgery or radiotherapy on the operative side;
* pregnancy
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>
| 470 |
Target Study Title: A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination With Platinum-based Chemotherapy in Completely Resected Stage II-III NSCLC (MERMAID-1)
Target Study Description: #Study Description
Brief Summary
This is a Phase III, randomized, parallel-arm, placebo controlled, double blind, multicenter study assessing the efficacy and safety of durvalumab versus placebo following SoC chemotherapy in patients with completely resected stage II-III NSCLC who are MRD+ post surgery
Detailed Description
Patients who have no evidence of disease recurrence confirmed by CT and/or MRI and are confirmed to meet all eligibility criteria will be randomized 1:1 to durvalumab + Standard of care (SoC) chemotherapy or placebo + Standard of care (SoC) chemotherapy arm.
The primary objective of this study is to assess the efficacy of durvalumab +SoC chemotherapy compared to placebo+ SoC chemotherapy as measured by DFS in all patients.
#Intervention
- DRUG : Durvalumab + SoC chemotherapy
- Experimental Treatment
- Other Names :
- MEDI4736
- OTHER : Placebo + SoC chemotherapy
- Placebo Comparator
- Other Names :
- 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 must be capable of giving signed informed consent, which includes a mandatory genetic informed consent and compliance with the requirements and restrictions listed in the informed consent forms (ICFs) and in this protocol. Provision of signed and dated, written ICFs must occur prior to any mandatory study-specific procedures, sampling, and analyses.
In addition to ICF1 and ICF2, patients will provide signed and dated written optional genetic informed consent prior to collection of a sample for optional genetic analysis at the time of second screening (Table 2). This is different from the genetic samples and testing covered by ICF1, which are mandatory for participation in this study.
Criteria and procedures initiated with the signing of ICF1
* ICF1 must be signed and dated prior to any study procedures and prior to the planned surgical resection of the primary NSCLC, with the exceptions noted below. This consent will cover the study-specific first screening procedures outlined in Table 1.
Exception: Patients will be permitted to sign ICF1 up to Week 3 (Day 21) postsurgery. Patients identified after Week 3 post-surgery but prior to Week 5 (Day 35) post-surgery may be allowed to sign ICF1 depending on the outcome of the discussion with the study physician. In these cases, a whole blood sample and resected tumor tissue must be collected and sent to the diagnostic lab as soon as possible after ICF1 is signed for development of the personalized panel. A plasma sample must still be collected at Week 3 <= age <= 5 (Day 21 <= age <= 35) post-surgery, even if creation of the personalized panel for MRD detection is delayed.
Age
* Age >=18 years at the time of screening. Sex
* Male and/or female. Type of patient and disease characteristics
* Individuals who have diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable (stage II-III) disease (according to IASLC Staging Manual in Thoracic Oncology v8.0). Select (ie, T3N2 or T4N2) stage IIIB patients will be eligible, provided that they are upstaged to T3N2 or T4N2 based on confirmed pathology. Patients who are staged asT3N2 or T4N2 prior to surgery are not eligible.
* A contrast-enhanced CT or MRI scan of the chest must have been done for surgical planning prior to surgery. It is recommended that patients undergo combined FDG-PET (18F-Fluoro-deoxyglucose positron emission tomography) and CT scan (contrastenhanced or low-dose CT component) in order to rule out detectable extrathoracic, extracranial metastasis and to assess for potential mediastinal lymph node involvement prior to surgery. In the absence of pre-operative FDG-PET CT imaging, pre-operative contrast-enhanced CT imaging or MRI scan must cover liver and adrenal glands. If only CT is available, or FDG-PET reveals suspicious lymph node mediastinal involvement, it is recommended that invasive pre-operative mediastinal staging is performed according to the algorithm of the European Society of Thoracic Surgeons guidelines (algorithm to follow for primary mediastinal staging if only pre-operative CT is available [De Leyn et al 2007], algorithm to follow for primary mediastinal staging when PET-CT is available [De Leyn et al 2014]). It is preferred that imaging occurs within 6 weeks prior to surgery. Brain MRI (preferred) or brain CT with IV contrast is required for complete staging of the tumor.
* Complete resection of the primary NSCLC is mandatory. The primary tumor must be deemed resectable by a multidisciplinary evaluation that must include a thoracic surgeon certified or trained according to local standards and who performs lung cancer surgery as a significant part of their practice. Surgical resection of the primary NSCLC can occur by open thoracotomy or by video-assisted thoracic surgery (VATS) and resection can be achieved by segmentectomy, lobectomy, sleeve resection, bilobectomy, or pneumonectomy. Patients undergoing wedge resection are not eligible for this study. Note: Patients undergoing segmentectomy must have tumors less than 2 cm in maximum diameter. Where a resection has been extended by means of a wedge resection of an adjacent lobe to ensure complete resection of a tumor at or crossing a fissure between lobes, this is acceptable if surgical margins are clear of disease. Where the resection of a second tumor nodule (eg, a T4 lesion) is undertaken by means of a wedge resection of a separate lobe, then the patient is not eligible.
At a minimum, the following parameters should be met for a tumor to be declared completely resected:
1. The surgeon performing the resection should remove all gross disease by the end of surgery. All surgical margins of resection must be macroscopically negative for tumor.
2. Pathology and/or operative reports must include the examination of at least 2 different mediastinal lymph node (N2) levels, one of which is the subcarinal node-group (level 7) and the second of which is lobe-specific (defined below).
Note: In the uncommon clinical situation where the surgeon thoroughly examines a mediastinal lymph node level and does not find any lymph nodes, that mediastinal lymph node level may be counted among the minimum 2 required levels. However, the surgeon must clearly document in the operative report or in a separate written statement that the lymph node level was explored and no lymph nodes were present. Normal appearing lymph nodes, if present, must be biopsied or removed. Exploration of nodes must clearly be documented in medical file if not recorded in operative report.
Note: Lobe-specific lymph node stations are classified based on the location of the primary tumor as follows (based on IASLC 2009 lymph node map terminology [Rusch et al 2009]): Stations 2R and 4R for right upper lobe or middle lobe tumors, stations 4L, 5, and 6 for left upper lobe tumors, stations 8 and 9 for lower lobe tumors of both sides (Adachi et al 2017, Rami-Porta et al 2005).
3. No extracapsular nodal extension of the tumor is observed in resected mediastinal N2 lymph nodes.
Note: Extracapsular nodal extension in resected N1 nodes is permitted. Note: The highest mediastinal node resected can be positive for malignancy. Note: Carcinoma-in-situ can be present at the bronchial margin.
* All patients who enrol in the study prior to surgery must have a pre-surgical plasma sample collected for MRD evaluation. Patients will not be excluded from randomization based on the results of analysing the pre-surgical plasma samples.
The following criteria must be met prior to signing ICF2:
* Confirmation of suitable samples of resected tumor tissue and whole blood for WES of tumor and germline DNA, respectively, and creation of Sponsor-approved personalized panel for MRD detection. Tumor tissue and whole blood samples must be provided to the diagnostic laboratory for development of the personalized panel as soon as possible.
Germline sequencing of whole blood is mandatory. Note: If a patient's tumor has less than the requisite 50 tumor-specific variants, a panel cannot be built and the patient will no longer be able to participate in the study.
* Established MRD status (MRD+ or MRD-) based on Sponsor-approved personalized assay of a plasma sample collected at Week 3 <= age <= 5 (Day 21 <= age <= 35) post-surgery.
* Known tumor PD-L1 status determined at a central reference laboratory testing service using a validated Ventana SP263 PD-L1 immunohistochemistry (IHC) assay prior randomization. Patients with unknown PD-L1 status are not eligible for the study.
Criteria and procedures initiated with the signing of ICF2
* Post-operative CT scan of the chest (including liver and adrenal glands) performed within 28 days + 7 days prior to randomization. If clinically indicated, additional scans (such as brain MRI [preferred] or brain CT with IV contrast) should be performed to confirm no evidence of metastasis.
* ICF2 must be signed and dated after MRD status is determined and prior to initiation of any study-specific procedures, sampling, and analyses outlined in SoAs in Table 2 and Table 3. Randomization must occur within the 12 weeks (+ 7 days) following surgery.
* WHO/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Complete postoperative wound healing must have occurred prior to randomization; patients must have recovered from all acute, reversible toxic effects from prior treatments (excluding alopecia) that could potentially adversely impact further administration of durvalumab/placebo or chemotherapy according to the Investigator's judgment.
* Eligible to tolerate 4 cycles of platinum-based adjuvant chemotherapy
* Adequate organ and marrow function as described in the protocol. 17 Must have a life expectancy of at least 12 weeks Weight 18 Body weight >30 kg
Exclusion criteria:
Diagnostic assessments
* Post-operative imaging demonstrating unequivocal evidence of disease recurrence or tissue biopsy-proven disease recurrence. In the event of lymphadenopathy on imaging that would lead to exclusion, histopathological confirmation of lymph node metastasis should be obtained prior to excluding a patient from the study. If pathological confirmation of lymph-node metastasis is not technically feasible and imaging appearance are deemed unequivocal for relapse, the patient will be excluded.
* EGFR-mutant and/or ALK-translocation-positive, as assessed either from a pre-surgical biopsy sample (preferred) or the resected tumor tissue (if biopsy was not evaluable or available). Any of the following scenarios are acceptable for this study:
Where EGFR/ALK results are obtained from a pre-surgical tissue biopsy as part of standard local practice, the patient must be confirmed EGFR/ALK wild-type prior to enrolling in the study.
Results obtained from testing the patient's primary tumor tissue during screening for another AstraZeneca study may be used in this study.
Results from local testing of a pre-surgical biopsy. All local EGFR/ALK testing performed locally must be performed using a well-validated, local regulatory-approved test. EGFR/ALK may be tested centrally if local testing is unavailable. Patients will still be allowed to continue with first screening procedures while testing is ongoing but will not be able to continue into second screening if their tumor tests positive for EGFR mutations and/or ALK translocations.
* Mixed small cell and NSCLC histology.
* Require re-resection or are deemed to have unresectable NSCLC by a multidisciplinary evaluation that must include a thoracic surgeon who performs lung cancer surgery as a significant part of their practice.
* Patients who are candidates to undergo only wedge resections. Medical conditions
* History of allogeneic organ or bone marrow transplantation.
* Non-leukocyte-depleted whole blood transfusion within 120 days of genetic sample collection. Note: This exclusion criterion only relates to whole blood and does not include other blood products (eg, packed red blood cells).
* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
* Patients with vitiligo or alopecia
* Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
* Any chronic skin condition that does not require systemic therapy
* Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician
* Patients with celiac disease controlled by diet alone
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ILD, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, 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
* 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
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
* Adequately treated carcinoma-in-situ without evidence of disease
* History of active primary immunodeficiency
* Active infection, including tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (HBV; known positive HBV surface antigen [HBsAg] result), hepatitis C (HCV), or human immunodeficiency virus infection (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
* Known allergy or hypersensitivity to any of the IPs or any of the IP excipients.
* Any medical contraindication to treatment with platinum-based doublet chemotherapy as listed in the local labeling.
Prior/concomitant therapy
* Received any prior adjuvant therapy for NSCLC or any prior exposure to durvalumab.
* Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable.
* Radiotherapy treatment for NSCLC in the neoadjuvant setting. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP.
* Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine while receiving IP and up to 30 days after the last dose of IP.
* Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab/placebo. The following are exceptions to this criterion:
* Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)
* Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
* Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication) Prior/concurrent clinical study experience
* Participation in another clinical study with an IP administered since completion of surgery.
* Previous IP assignment in the present study.
* Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study, or during the follow-up period of an interventional study.
* Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment group assignment.
Other exclusions
* Patients who are never-smokers; defined as no more than 100 cigarettes or its equivalent in his/her lifetime.
* 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/placebo.
* Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 130 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 471 |
Target Study Title: Neoveil® Versus TachoSil® for the Treatment of Pulmonary Air Leaks Following Lung Operation
Target Study Description: #Study Description
Brief Summary
Postoperative prolonged air leak (PAL), referring to the passage of air from the lung parenchyma into the pleural space, is one of the most frequent postoperative complications after lung resection. To control air leak, there are two different products certified since years: TachoSil® and Neoveil®. This study is to investigate the difference of TachoSil® and Neoveil® in patients with PAL.
#Intervention
- OTHER : TachoSil®
- topical absorbable fibrin sealant patch applied directly on the lung area with air fistula.
- OTHER : Neoveil®
- bioabsorbable soft-tissue reinforcement material applied on the normal shape of the lung at the end of the operation.
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 pulmonary air leak following open lung surgery, regardless of whether an anatomical or atypical resection was performed
* Patients who are able to decide for themselves whether to participate in the study or not ( for example due to language problems, mental disorders, dementia of the participant)
* Patients who are not family member or employee of the investigator
Exclusion Criteria:
* Inability to follow the procedures of the study, for example, due to language problems, mental disorders, dementia of the participant
* Enrolment of the investigator, his/her family members, employees and other dependent persons
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>
| 472 |
Target Study Title: Safety Phase I Evaluation of MaaT033, a Lyophilized Full-ecosystem Gut Microbiota Delayed-release Capsule, In HeMatOlogy Malignant Patients Under iNtensive Chemotherapy (CIMON)
Target Study Description: #Study Description
Brief Summary
Richness and diversity of gut microbiota are increasingly found to be associated with cancer outcomes. Moreover, an adequately responsive immune system seems to rely on the existence of a functioning gut ecosystem that includes the microbiota and its natural environment.
Cancer by itself, but also cancer treatments - in particular chemotherapy - induce gut dysbiosis, impair the constant reparation mechanisms of the gut epithelium, disrupt immune homeostasis, and stunt immune responsiveness.
The objective of MaaT033 is to (1) prevent the decay of the gut ecosystem (dysbiosis) to preserve immune homeostasis, (2) restore and optimize the gut ecosystem to full functionality including its role in repairing the gut epithelium and healthy gut barrier, and (3) maintain a restored gut ecosystem and fully functional immune homeostasis.
Restoring the full gut ecosystem and its associated microbiota could become an important therapeutic option to improve clinical outcomes and control adverse events of conventional approaches, including immunotherapy in cancer patients.
As a first step, MaaT033 capsules containing lyophilized, pooled, full-ecosystem microbiota in its natural environment are to be tested for their safety and tolerability in hematological malignant patients, who are exposed to intensive rounds of chemotherapy and antibiotics.
#Intervention
- DRUG : MaaT033 capsule
- Oral capsule
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
* Age >= 18 years
* Patients diagnosed with AML defined according to WHO 2016 criteria with >=20% leukemic blasts in the bone marrow or with high- risk myelodysplastic syndrome, receiving intensive chemotherapy
* Patients healthy enough to likely receive their consolidation or second cycle of chemotherapy after induction chemotherapy
* Patients healthy enough to likely receive HSCT
* Informed written consent
* Patient recovered from neutropenia
Exclusion Criteria:
* Acute promyelocytic leukemia (AML-M3)
* AML secondary to myeloproliferative disorder or chronic myelomonocytic leukemia (CMML)
* Acute myeloid leukemia BCR-ABL1+
* Active CNS leukemia
* Patients with a life expectancy of <70 days according to investigator's opinion, or subject to therapeutic limitations
* Confirmed or suspected intestinal ischemia
* Confirmed or suspected toxic megacolon or gastrointestinal perforation
* Active uncontrolled infection according to the attending physician
* Any gastro-intestinal bleeding in the past 3 months
* Any history of gastro-intestinal surgery in the past 3 months
* Any history of inflammatory bowel disease
* Any counter-indication to swallow capsules
* Enrollment in another trial that may interfere with this study
* Known allergy or intolerance to trehalose, maltodextrin or PEG
* Women of childbearing potential without efficient contraceptive protection
* Pregnant or breastfeeding
* Patients with EBV-negative serology
* Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
* Exclusion period of a previous study
* Administrative or legal supervision
* Confirmed positive result to SARS-CoV-2 nasopharyngeal test at screening
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>
| 473 |
Target Study Title: Use of Topical Lidocaine (Lidoderm 5% Patch) to Reduce Pain in Patients With Diabetic Neuropathy: Does the Density and Subtype of Sodium Channels Affect Response?
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to see if an investigational drug known as the lidocaine 5% patch is safe and effective in reducing the symptoms of diabetic neuropathy, to examine how topical lidocaine affects the nerve endings, and to determine whether treatment with the lidocaine patch can prevent the potential progression to chronic diabetic neuropathy pain in subjects who did not report pain at the start of the study.
#Intervention
- PROCEDURE : Skin biopsy
- Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.
- DRUG : Lidocaine 5% patches
- Subject will apply patches to affected area QD for 12 hours then remove.
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:
* Group 1: 18 <= age <= 70 years, non-diabetic with no nervous system disease (healthy control group)
* Group 2: 18 <= age <= 70 years with Type I or Type II diabetes with significantly painful diabetic neuropathy (VAS > 40mm at Baseline)
* Group 3: 18 <= age <= 70 years with Type I or Type II diabetes with non- painful or insignificantly painful diabetic neuropathy (VAS < 40mm at Baseline)
Exclusion Criteria:
* History of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator
* Allergy to lidocaine
* Unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study
* Women who are pregnant, breastfeeding or trying to become pregnant
* History of slow-healing diabetic foot ulcers
* Current skin or soft tissue lesions on the foot that will interfere with application of the lidocaine patch and or skin biopsies
* Subjects taking Class I antiarrhythmics
* HgA1c > 11%
* Active cancer within the previous two years except treated basal cell carcinoma of the skin
* Co-morbidities that can produce neuropathy
* Subjects taking sodium channel blockers within one week of study treatment and throughout the study
* Subjects taking any other experimental drugs within 30 days prior to Screening Visit (Visit 1)
* Application of lidocaine patch to either foot within two weeks of Screening Visit (Visit 1)
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>
| 474 |
Target Study Title: A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity (in a Subset) Following a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects Who Received Either One or the Other Vaccine One Year Before in the V58P4 Study.
Target Study Description: #Study Description
Brief Summary
The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.
#Intervention
- BIOLOGICAL : Cell culture derived influenza vaccine
- as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
- BIOLOGICAL : egg-derived influenza subunit vaccine
- as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
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 to < 61 years (first age group) OR 61 years and older (second age group) at enrolment in V58P4
* Mentally competent to understand the nature, the scope and the consequences of the study
* Able and willing to give written informed consent prior to study entry
* Available for all the visits scheduled in the study
* in good health as determined by:
1. Medical history related to the previous six months,
2. Physical examination,
3. Clinical judgment of the investigator.
Exclusion Criteria:
* Unwilling or unable to give written informed consent to participate in the study
* Currently experiencing an acute infectious disease
* Any serious disease such as, for example:
1. Cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy)
2. Autoimmune disease (including rheumatoid arthritis)
3. Advanced arteriosclerotic disease or complicated diabetes mellitus
4. Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy
5. Acute or progressive hepatic disease
6. Acute or progressive renal disease
7. Congestive heart failure
* Surgery planned during the study period
* Bleeding diathesis
* History of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
* Known or suspected impairment/alteration of immune function resulting from:
1. Receipt of immunosuppressive therapy (any cortical steroid or cancer chemotherapy)
2. Receipt of immunostimulants
3. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study
4. High risk for developing an immunocompromising disease
* History of drug or alcohol abuse
* Laboratory confirmed influenza disease in the past 6 months
* Received influenza vaccine within the past 6 months
* Received another vaccine or any investigational agent within the past 60 days, or expect to receive another vaccine within 3 weeks following the study vaccination
* Participation in another clinical trial within 90 days prior to enrollment and throughout the full length of the study
* Any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever _ 38°C within the past 5 days
* Pregnant/ breast feeding women or women who refuse to use a reliable contraceptive method during the first three weeks after vaccination
* Any condition which, in the opinion of the investigator, might interfere with the evaluation of 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:
Yes
</FORMATTED_CRITERIA>
| 475 |
Target Study Title: Effect of DDD Pacing Titrated by Stepwise Changing of AVD on Aortic dP/dt
Target Study Description: #Study Description
Brief Summary
The maximum value of rate of left ventricular pressure increase, denoted by left ventricular peak dP/dt value (dP/dt max), corresponds to the highest point on the curve of first derivative of ventricular pressure curve with respect to time. It is one of the important systolic performance parameters, which is primarily determined by ventricular contractility, and emerges in isovolumetric contraction phase when aortic valves are closed. Thus it is not influenced by parameters beyond ventricle such as aortic valve area, aortic elastance and peripheral resistance. Despite these unique advantageous, the main reason for its limited usage in assessing ventricular systolic performance instead of commonly used ejection fraction is the difficulties in its calculation, which requires incessant intraventricular pressure recordings.
The maximum value of acceleration rate of aortic pressure increase can be named as aortic peak dP/dt. It, likewise, corresponds to the maximum value of first derivative of pressure curve with respect to time.
Since it is one of the principal determining factors of aortic peak dP/dt, changing left ventricular contractility thereby left ventricular peak dP/dt value is expected to change aortic peak dP/dt in the same direction since all other variables being unchanged. Yet to conclude the extent of this association and magnitude of change, measuring these parameters for various contractility levels is necessary. In addition, impact of decreasing left ventricular peak dP/dt by gradually lowering ventricular contractility upon aortic peak dP/dt has not been investigated in previous studies.
In the present study, changes in left ventricular and aortic peak dP/dt values in response to gradual reduction in LV contractility with stepwise changing (decremental shortening) atrio-ventricular delay (AVD) by dual chamber pacing will be investigated in patients without systolic dysfunction.
Detailed Description
The maximum value of rate of left ventricular pressure increase, denoted by left ventricular peak dP/dt value (dP/dt max), corresponds to the highest point on the curve of first derivative of ventricular pressure curve with respect to time. It is one of the important systolic performance parameters, which is primarily determined by ventricular contractility, and emerges in isovolumetric contraction phase when aortic valves are closed. Thus it is not influenced by parameters beyond ventricle such as aortic valve area, aortic elastance and peripheral resistance. Despite these unique advantageous, the main reason for its limited usage in assessing ventricular systolic performance instead of commonly used ejection fraction is the difficulties in its calculation, which requires incessant intraventricular pressure recordings.
The maximum value of acceleration rate of aortic pressure increase can be named as aortic peak dP/dt. It, likewise, corresponds to the maximum value of first derivative of pressure curve with respect to time. Unlike left ventricular peak dP/dt, it emerges after aortic valve opens in early systolic ejection phase and thus is influenced by parameters beyond ventricle in addition to left ventricular contractility such as aortic elastance and compliance, vascular resistance, interference of forward and backward propagating pressure waves, stroke volume and its ejection rate (dV/dt). Notably, aortic peak dP/dt can be expected to be one of principal determinants in pressure-related damages in the vascular system. In structures exposed to variable pressures, the extent of damage depends on the magnitude and rate of acceleration of applied pressure in addition to susceptibility of the structures. Whether this mechanism, which has numerous implications from the real world, operates in the organism as well can be exemplified by the pulse pressure, which is an independent risk factor for adverse cardiovascular events apart from systolic and diastolic blood pressure levels. A wide pulse pressure suggests an accelerated rate of pressure increase. Therefore applications lowering left ventricular and aortic peak dP/dt values may open a new therapeutic avenue in management of pressure-related vascular damages such as aortic aneurisms. However, aortic peak dP/dt concept is seldom found a place even in research articles.
Since it is one of the principal determining factors of aortic peak dP/dt, changing left ventricular contractility thereby left ventricular peak dP/dt value is expected to change aortic peak dP/dt in the same direction since all other variables being unchanged. Yet to conclude the extent of this association and magnitude of change, measuring these parameters for various contractility levels is necessary. In this context, it has been demonstrated that narrowing of the QRS complex by cardiac resynchronization therapy (CRT) was shown to increase left ventricular peak dP/dt value. This finding strongly suggests that widening of the QRS complex, on the contrary, will decrease left ventricular peak dP/dt value. However, impact of decreasing left ventricular peak dP/dt by gradually lowering ventricular contractility upon aortic peak dP/dt has not been investigated in previous studies.
In the present study, changes in left ventricular and aortic peak dP/dt values in response to gradual reduction in left ventricular (LV) contractility with stepwise changing (decremental shortening) atrio-ventricular delay (AVD) by dual chamber pacing will be investigated in patients without LV systolic dysfunction.
#Intervention
- DEVICE : Temporary DDD pacing
- Measurements will be performed in patients otherwise undergoing invasive catheterization procedure. Baseline ventricular and aortic hemodynamic parameters (continuous pressure recordings) will be recorded. Thereafter, DDD pacing with stepwise changing of the AV delay will be performed. During each pacing steps left ventricular and aortic pressures at different aortic levels will be continuously recorded. From these hemodynamic data, left ventricular and aortic dP/dt values will be calculated off line.
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:
* Normal left ventricular systolic function
Exclusion Criteria:
* Abnormal left ventricular systolic function with ejection fraction < 50%
* Presence of severe coronary artery disease
* Presence of valvular heart disease
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:
Yes
</FORMATTED_CRITERIA>
| 476 |
Target Study Title: Promoting Self-efficacy and Social Support to Enable Women to Reduce the Risks of Pelvic Organ Prolapse Related to Heavy Lifting in a Non-randomized Controlled Trial With a 3-arm Parallel Intervention Group Design in Rural Nepal
Target Study Description: #Study Description
Brief Summary
The Women Lift Safely! Intervention study aims to increase safe carrying behavior to reduce health risks of heavy lifting in a rural area of Nepal (i.e. reducing weight and using safe lifting techniques).
The study's specific aims are to:
1) Test whether a psychological intervention that promotes self-efficacy can promote women's use of safe carrying behavior effectively compared to an information only control condition.
(2) Test whether including a social partner in the intervention is more effective than an individual psychological intervention.
Detailed Description
Background
The frequent carrying of heavy loads bears health risks for women in low- and middle-income countries, such as Nepal (Geere et al. 2018,2020; Koyucu et al., 2021; Walker \& Gunasekera, 2011).
To prevent the physical health impacts of carrying heavy loads, e.g. pelvic organ prolapse, research has shown that preventive behaviors in terms of applying safe carrying behaviors can enable women to minimize adverse health outcomes:
1. Reducing the carried load, especially during pregnancy and postpartum (Darshan, 2009; Koyucu et al., 2021; MacDonald et al., 2013; Oxford University Hospitals, 2016; Sharma, 2012; SUVA, the Swiss National Accident Insurance Fund, 2019)
2. Using safe lifting techniques (exhale, tighten pelvic floor and use a safe body posture when lifting load) (Caagbay et al., 2020; Hagins et al., 2004)
In a preliminary study, the investigators identified low self-efficacy (belief in the own capability to engage in healthy behavior) and insufficient social support (emotional, practical or informational assistance by social partner) as reasons for risky carrying behavior (Tomberge et al., 2021).
Study design
A 3-arm parallel non-randomized controlled trial will be conducted in three rural villages in the Kavre and Sindhupalanchowk districts of Nepal. The villages will be randomly assigned to one of the three groups: (1) individual promotion of self-efficacy, (2) promotion of self-efficacy + social support (3) active control group to test the effect of promoting self-efficacy and the additional effect of social support on safe carrying behavior against an information only control group. The latter, in the sense of a waiting list control group, will receive the most effective intervention after completing the study. The assignment of groups to the villages will be random (drawing lots by a person not included in the research team). All participants from one village will receive the same intervention. This village-based allocation of interventions prevents the transfer of information within the village (spillover effect, Benjamin-Chung et al., 2018).
Recruitment and informed consent procedure:
The villages included were already part of the prestudy in 2019. 100 women from each of the three villages and a self-selected social partner from the same or neighboring household (e.g. husband, mother-in-law) having experience in carrying loads will be included (N = 600). Households / Participants within the villages will be selected using the random route method (Hoffmeyer-Zlotnik, 2003). Due to their acute vulnerability, women who are pregnant or who have delivered in the last month will be approached specifically.
Arriving at the households, trained local research assistants will present themselves and briefly inform about the study purpose and procedures in Nepali language. The respondents willing to participate will be provided with more detailed explanation of the study both verbally and with participant information sheets. Respondents will also be provided with information and consent forms written in easy language and will be informed that the participation will be voluntary.
Since all the participants will be interviewed in personal communication with enumerators with a professional background in health science the informed consent will be fully read out to the participants and can be explained more deeply in case of any dubiety. After explaining the content of the study the participant will ask the woman if she and also a self-selected social partner are willing to participate in the study. If the women and the social partner agree and all their doubts and questions are answered, they will be requested to sign the informed consent sheet either by signature or thumbprint.
Study procedure:
Training: Before the beginning of the study, the local team (practitioners graduated in nursing sciences or physiotherapy and research assistants graduated in health/social Sciences) will be trained in interviewing techniques and data collection tools. Additionally, a pelvic physiotherapist will train them in instructing and assessing safe lifting techniques.
The training will last one week, 2 pretests in villages not part of the analyses included.
Baseline Survey and Intervention:
The research assistants will conduct baseline interviews in one village. They will collect quantitative data in computer-assisted, structured face-to-face interviews with women and their social partners and conduct structured behavioral observations of the women while carrying a water-filled container. A local field coordinator will monitor the quality of data during the data collection during fieldwork to reduce interviewer bias.
After the baseline interview, the households will be visited again by the health practitioners in order to receive one of the three interventions to promote safe carrying behaviors (information only control, individual promotion of self-efficacy, promotion of self-efficacy + social support) for which the study participants will be blinded. The study team cannot be blinded to condition, but the specific intervention assignment is concealed until the arrival at the intervention site. The intervention will be delivered via household visits.
Follow-Up:
The follow-up survey to test intervention effects will be conducted 8 weeks after baseline. In a debriefing after the follow up survey, the allocated intervention group will be revealed to the participants.
Hypotheses:
The main research questions and hypotheses of this study are:
1. Does the promotion of self-efficacy lead to more safe carrying behavior in women?
H1a: Women in the two intervention groups with self-efficacy promotion indicate increased reduction of carried weight compared to the control group.
H1b: Women in the two intervention groups with self-efficacy promotion indicate increased use of safe lifting techniques compared to the control group.
2. Can adding social support by a social partner increase safe carrying behavior additionally?
H2a: Women in the group with self-efficacy + social support indicate increased reduction of carried weight compared to the group with individual self-efficacy promotion.
H2b: Women in the group with self-efficacy + social support indicate increased use of safe lifting techniques compared to the group with individual self-efficacy promotion.
3. Can the intervention effects on safe carrying behavior be explained by increased self-efficacy?
H3a: The intervention effect on carried weight of the two intervention groups with self-efficacy promotion compared to controls is explained by increased self-efficacy.
H3b: The intervention effect on the use of safe lifting techniques in the two intervention groups with self-efficacy promotion compared to controls is explained by increased self-efficacy.
H3c: The increased reduction of carried weight of the group self-efficacy + social support compared to the group with individual self-efficacy promotion is explained by increased self-efficacy.
H3d: The increased use of safe lifting techniques in the group self-efficacy + social support compared to the group with individual self-efficacy promotion is explained by increased self-efficacy.
4. Can the intervention effects be explained by increased received social support? H4a: The increased reduction of carried weight of the group self-efficacy + social support compared to the group with individual self-efficacy promotion is explained by increased social support.
H4b: The increased use of safe lifting techniques in the group self-efficacy + social support compared to the group with individual self-efficacy promotion is explained by increased social support.
H4c: The increased self-efficacy in the group self-efficacy + social support compared to the group with individual self-efficacy promotion is explained by increased received social support.
Additionally, the investigators will investigate the following exploratory research questions:
5. Can the interventions increase women's self-efficacy and intention to reduce carried weight in future pregnancies and postpartum?
6. Is the reduction of carried weight related to an increased carrying frequency?
7. Does the intervention have an impact on other psychosocial determinants of carrying behavior?
8. Can the interventions improve women's quality of life, and reduce strain during lifting, pain, symptoms of incontinence and pelvic organ prolapse, and perceived personal control over symptoms?
9. Do the interventions have an impact on relationship quality with the social partner and/ or the social partners' behavior and attitudes towards safe carrying behavior?
Statistics:
An a priori power analysis with a desired power of \> 95%, a significance level of α = 0.05 and the assumption of medium effects (based on a study by Ernsting et al.,(2015)) resulted in a required sample size of N = 251 to detect a significant difference between the three groups when using repeated-measures ANCOVA (Faul et al., 2009). This analysis is based on including six covariates (Outcome at baseline, age, socioeconomic status, ethnicity, education and pregnancy status). Due to an expected dropout rate of up to 20% from baseline to follow-up (Wood et al., 2004) we will recruit 100 women in each of the three villages.
Planned analyses:
Summary of descriptive statistics
All primary and secondary outcomes will be presented. For the evaluation of the intervention effects, repeated measures covariance analyses (ANCOVA) with the two measurement points (pre/ post) will be calculated using the intervention groups as independent variables and reduced weight and use of safe lifting techniques as well as self-efficacy and social support as dependent variables. Further secondary outcomes, e.g. effects of the intervention on psychological wellbeing and physical health symptoms, will be calculated additionally.
Mediation analyses will be carried out for self-efficacy and social support as mediators.
Research Team:
Jennifer Inauen \& Vica Tomberge (University of Bern, Institute of Psychology, Health Psychology and Behavioural Medicine), Akina Shrestha (Kathmandu University Hospital; Kathmandu University School of Medical Sciences), Regula Meierhofer (Eawag, Swiss Federal Institute of Aquatic Science and Technology; Department of Sanitation, Water and Solid Waste for Development), Helena Luginbühl (Bern University of Applied Sciences, Department of Health Professions, Division of Physiotherapy)
#Intervention
- BEHAVIORAL : Information about benefits of the behavior
- The women will be informed that the safe carrying behaviors can reduce pelvic strain. She is informed about the benefits reducing pelvic strain may imply \[5.1; 5.3.,5.6 Information about health; environmental; social; and emotional consequences, (Michie et al., 2013)\]
- BEHAVIORAL : Instruction on how to perform a behavior
- For the target behavior 'reduce carried weight' information on recommended weight limits will be given. The women will be encouraged, that even if these limits may not be feasible for them, any reduction of weight can still reduce the strain on the pelvic floor.
For the target behavior 'safe lifting techniques', instructions to learn the correct behavior (how to perform safe lifting techniques?) based on leaflets developed and validated by Caagbay et al., (2017, 2020) \[4.1 Instruction on how to perform a behavior (Michie et al., 2013)\]
- BEHAVIORAL : Self-efficacy
- Self-efficacy will be promoted by the four sources of self-efficacy (Bandura, 1977): 1) Mastery Experiences (experience that one is able to successfully apply the behavior), vicarious experience (observing successful others performing the safe carrying behavior), verbal persuasion (receiving positive feedback when performing the behavior and encouraging messages to do so) and emotional state (e.g. being in a positive emotional state when performing the behavior). \[6.1 Demonstration of the behavior; 8.1 Behavioral practice/rehearsal; 15.1 Verbal persuasion about capability; 15.2 Mental rehearsal of successful performance; 15.3 Focus on past success;15.4 Self-talk; 5.4 Monitoring of emotional consequences (Michie et al., 2013)\]
- BEHAVIORAL : Social Support
- A self-selected social partner from the same or neighboring household (e.g. husband, mother-in-law) will be involved in the learning process (observational learning, feedback). The partner will participate in the intervention activities and will be instructed to provide emotional social support and practical informational support. \[3.2 practical support, 3.3 emotional support; 6.3 Information about others' approval (Michie et al., 2013).\]
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 informed consent
* Gender: female
* Being adult and in reproductive age (18 <= age <= 49 years)
* Having experience in carrying loads
* Having a social partner with experience in carrying loads
* Residing in the targeted community
Exclusion criteria:
* If the women themselves or a household member presents covid symptoms they need to be excluded to avoid any risk of contamination of the research team.
* Women without a possible social partner will be excluded from the survey since this intervention is designed to include support of a social partner. They will receive the information only control intervention for ethical reasons when approached as a household in random selection.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 49 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 477 |
Target Study Title: Pericapsular Nerve Group Block: An Imaging Study for Determination of the Spread of the Injectate Using 3-D CT Scan
Target Study Description: #Study Description
Brief Summary
Over the last 20 years, different interventional regional analgesia techniques have been proposed to treat pain after hip surgeries.
The most commonly used techniques are the fascia iliaca and femoral nerve blocks, resulting in reduced pain scores, opioid-sparing effects, and opioid-related adverse effects. However, these interventional analgesia techniques result in a motor block and muscle weakness of the quadriceps muscle, impeding early ambulation and rehabilitation.
Recently, the pericapsular nerve group (PENG) block has been proposed as an effective choice for analgesia after hip surgeries while sparing the motor function of the lower extremities. The aim of this technique is to inject local anesthetic to target the more distal sensory branches innervating the anterior aspect of the hip joint.
Detailed Description
Ten patients scheduled for hip surgery were included after Ethical Committee approval and informed consent were obtained.
Preoperatively, patients received an ultrasound-guided pericapsular nerve group block. The injections were performed preoperatively using a Canon US Applio 700 with a linear transducer (14 to 6 MHz), and a 21-gauge, 80 mm stimulating needle (SonoPlex Stim, Pajunk ® ️ GmbH, Germany). After confirmation of the correct needle tip position with 2 mL of sodium chloride 0.9%, 20 mL of injectate containing 18 mL ropivacaine 0.5% with 2 mL of radiopaque contrast (Iomeron 300: 61.24% w/v of Iomeprol equivalent to 30% iodine or 300 mg iodine/mL (Bracco UK Limited)) was injected.
After surgery, high-definition CT scans (Siemens) were obtained to determine the distribution patterns of the injectates.
#Intervention
- PROCEDURE : Pericapsular nerve group block
- Ultrasound-guided injection of local anesthetic mixed with contrast agent underneath the iliopsoas muscle, lateral to the iliopsoas tendon.
- DRUG : 18 mL ropivacaine 0.5% + 2 mL radiopaque contrast
- 20 mL of injectate: 18 mL ropivacaine 0.5% + 2 mL radiopaque contrast (Iomeron 300: 61.24% w/v of iomeprol equivalent to 30% iodine or 300 mg iodine/mL)
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 indication for PENG blocks for postoperative pain management
* American Society of Anesthesiologists (ASA) physical status I or II
* at least 18 years, and able to understand the purpose and risks of the study
Exclusion Criteria:
* pregnancy
* body mass index above 35 kg/m2
* hepatic or renal insufficiency
* history of allergic or adverse reactions to local anesthetics or contrast agents.
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>
| 478 |
Target Study Title: A Three-Month Bleeding-Model Clinical Study
Target Study Description: #Study Description
Brief Summary
The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.
#Intervention
- DRUG : 0.454% stannous fluoride
- Brush two times daily
- DRUG : 0.76% sodium monofluorophosphate
- Brush two times daily
- DRUG : 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM
- Brush two times daily
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:
* Be at least 18 years;
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
* Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial;
* Have at least 20 gradable teeth;
* Have established gingivitis with 10 <= age <= 70% bleeding sites;
* Agree to return for scheduled visits and follow the study procedures;
* Agree to refrain from use of any non-study oral hygiene products for the duration of the study;
* Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study.
Exclusion Criteria:
* Having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the Baseline Visit;
* Having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease;
* Having known hypersensitivity to the test products;
* Having removable oral appliances;
* Having fixed facial or lingual orthodontic appliances;
* Self-reported pregnancy or lactation;
* Having any diseases or condition that might interfere with the safe participation in the study;
* Having an inability to undergo study procedures.
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>
| 479 |
Target Study Title: P-pVAC-SARS-CoV-2: Phase I Single-center Safety and Immunogenicity Trial of Multi-peptide Vaccination to Prevent COVID-19 Infection in Adults
Target Study Description: #Study Description
Brief Summary
Part I:
12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study IMP (CoVac-1). No more than one subject per day will be enrolled. 28 days following vaccination of the 12th volunteer, there will be an interim analysis of safety and a safety review by the data safety monitoring board (DSMB) as well as an amendment to the regulatory authorities (Paul-Ehrlich Institute and Ethics Committee) before proceeding to Part II.
Part II:
12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study investigational medicinal product (IMP) (CoVac-1). 28 days following vaccination of the 12th volunteer, there will be an interim analysis of safety and a safety review by the DSMB whether to proceed to next Part III.
Part III:
12 subjects will receive an open-label 500 µl subcutaneous injection via needle and syringe of the study IMP (CoVac-1).
The aim of the clinical is to evaluate the safety and immunogenicity of a single use of a SARS-CoV-2-derived multi-peptide vaccine in combination with the toll like receptor (TLR)1/2 ligand XS15 in adults
Detailed Description
SARS-CoV-2 peptide vaccine The aim of this study is to investigate the safety and immunogenicity of a peptide vaccine consisting of SARS-CoV-2 specific HLA class II peptides in volunteers without prior or current SARS-CoV-2 infection.
The identification and characterization of T cell epitopes is a long-standing and unparalleled expertise of the Department of Immunology. This unique approach is based on i) the prediction of HLA binding sequences for HLA class I and class II alleles using the world's first prediction tool (www.syfpeithi.de) and newer, more refined methods, all based on SYFPEITHI (database for MHC ligands), ii) the identification of naturally presented HLA class I and class II ligands, iii) the synthesis of synthetic peptides, and iv) the characterization of T-cell epitopes and peptide-specific cluster of differentiation (CD)4+ and CD8+ T cell responses. This strategy has been successfully applied in recent years to define and characterize T-cell epitopes derived from various viruses such as cytomegalovirus (CMV),Epstein-Barr virus (EBV), adenovirus (ADV) and influenza as well as tumor-associated antigens of various solid and hematological malignancies.
Based on this work, the results were translated into therapeutic vaccination and T cell transfer studies in cancer patients (e.g. NCT02802943) and viral infections. This direct translation is made possible by the Wirkstoffpeptidlabor (Prof. Dr. rer. nat. Stefan Stevanović) of the Department of Immunology and the good manufacturing practice (GMP) facility for individualized drugs at the University Hospital Tuebingen as well as our immune monitoring platform equipped with state-of-the-art, validated T-cell assays and methods.
The existing experience and logistics can be directly used for the treatment and prevention of COVID-19 disease. In preliminary work for this study, CD4+ T cell epitopes have already been characterized in a large cohort of SARS-CoV-2 infected donors validating their high relevance in the natural course of COVID-19. The vaccination cocktail in the study will consist of eight promiscuous HLA class II peptides from the different proteins of the SARS-CoV-2 virus, predicted to bind to several HLA class II allotypes. Furthermore, especially those peptides were selected that contain embedded HLA class I sequences in order to induce CD4+ T cell responses and CD8+ T cell responses simultaneously. Furthermore, especially for peptides derived from virus surface proteins, only sequences were selected that do not represent antibody epitopes. This should prevent the formation of antibodies against the vaccinated peptides, which could possibly have a deteriorative effect on COVID-19. Immunogenicity was proven for all HLA class II peptides included in the peptide cocktail in a large cohort of SARS-CoV-2 convalescent donors as well as for single peptides in a first vaccination of a healthy volunteer.
A further prerequisite for successful peptide vaccination, besides selection of optimal antigen targets, is the use of a suitable adjuvant, which is able to induce potent and long-lasting immune responses. Among the most effective approaches tested in humans is the subcutaneous injection of peptides emulsified in Montanide ISA 51 VG, a water-in-oil-emulsion, combined with the TLR9 ligand CpG.However, CpG is not available for clinical trials, and a peptide/antigen vaccine emulsified in Montanide without any additional adjuvant induces no or only weak immune responses. In the P-pVac-SARS-CoV-2 trial, the novel TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG will be employed as adjuvant, applied subcutaneously together with the peptide vaccine. XS15 is a water-soluble derivative of the TLR1/2 ligand Pam3Cys and induced a strong CD8+ and Th1CD4+ T-cell response against free short peptides in Montanide ISA 51 VG after a single s.c. injection in a healthy volunteer as well as in cancer patients.Immune responses could be induced against viral peptides (including SARS-CoV-2 derived peptides), neo-epitopes derived from cancer-specific mutations as well as tumor-associated self-peptides. XS15 results in granuloma formation on the vaccination site, where the vaccinated peptides persist for at least 7 weeks. Peptide-specific T cells were detected at the granuloma site, however, with a lower frequency than in peripheral blood, which rules out the risk of T cell sequestration, dysfunction or deletion at the vaccination site due to the use of XS15 in Montanide ISA 51 VG. Strikingly, the induced immune responses were found to persist for more than 1.5 years.
With regard to the planned study we could also show that this vaccination method is able to induce potent SARS-CoV-2 specific T-cell responses in a human volunteer.
#Intervention
- BIOLOGICAL : multipeptide cocktail
- Three groups of participant will be administered the multipeptide cocktail
1. Part I: Age 18-55 at the time of screening
2. Part II: Age 56-74 years at the time of screening
3. Part III: Age ≥ 75 years at the time of screening
- Other Names :
- Vaccination
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 male or non-pregnant, non-lactating female
* Part I: Age 18 <= age <= 55 at the time of screening 2. Part II: Age 56 <= age <= 74 years at the time of screening 3. Part III: Age >= 75 years at the time of screening 2. Pre-existing medical condition
* Part I and II: Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening 3. Ability to understand and voluntarily sign the informed consent form. 4. Ability to adhere to the study visit schedule and other protocol requirements.
* female with child bearing potential (FCBP) and male volunteers with partners of childbearing potential, who are sexually active must agree to the use of two effective forms (at least one highly effective method) of contraception. This should be started from the signing of the informed consent and continue until three months after vaccination 6. Postmenopausal or evidence of non-childbearing status. For women of childbearing potential: negative urine or serum pregnancy test within 7 days prior to study treatment. Postmenopausal or evidence of non-childbearing status is defined as:
* Amenorrhoea for 1 year or more following cessation of exogenous hormonal treatments
* Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50 7. Be willing to minimize blood and body fluid exposure of others for 7 days after vaccination
* Use of effective barrier prophylaxis, such as latex condoms, during sexual intercourse
* Avoiding the sharing of needles, razors, or toothbrushes
* Avoiding open-mouth kissing
* Refrain from blood donation during the course of the study
Exclusion Criteria:
* Pregnant or lactating females.
* Participation in any clinical study with intake of any investigational drug interfering with the study primary endpoint
* Any concomitant disease affecting the effect of the therapeutic vaccine or interfering with the study primary endpoint
* Any immunosuppressive treatment except low dose corticosteroids (<=10mg prednisolone/day)
* Prior or current infection with SARS-CoV-2 tested serologically or by throat/nose swab (PCR)
* History of Guillain-Barré Syndrome
* Positive serological HIV, hepatitis B or C test. In case of positive HBsAg, volunteer must provide prove of hepatitis B vaccination, otherwise volunteer must be excluded.
* History of relevant central nervous system (CNS) pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder, excluding febrile seizures as child)
* Baseline laboratory with lymphocyte count <= 1000/µl
* Only Part I and II:
- Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the Investigator based on medical history, physical exam, and/or laboratory screening test
* All parts of the clinical trial
* Diabetes mellitus Typ II requiring drug treatment
* Chronic lung disease requiring drug treatment
* Any chronic liver disease or unknown liver abnormalities defined as:
* Alanin-aminotransferase (ALT) and Aspartat-aminotransferase (AST) <= 2.5 x ULN (upper limit of normal)
* Gamma-glutamyl-transferase (γ-GT) <= 2.5 x ULN
* Chronic renal failure defined as glomerular filtration rate (GFR) < 40 ml/min/1,73m2
* Serious pre-existing cardiovascular disease such as New York Heart Association (NYHA) >= II, coronary heart disease requiring coronary surgery or known peripheral arterial disease (pAVK) >= grade 2
* Sickle cell anemia
* Obesity (body mass index >= 30kg/m2)
* Hospitalization at study inclusion
* Administration of immunoglobulins and/or any blood products within 120 days preceding study entry or planned administration during the study period
* History of blood donation within 30 days of enrolment or planned donations within the study period
* Known hypersensitivity to any of the components included in the CoVac-1 vaccine
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>
| 480 |
Target Study Title: A Randomized, Open-label, Single Dose, Replicate Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YH22162 in Healthy Volunteers
Target Study Description: #Study Description
Brief Summary
This is a phase 1, randomized, open label, single-dose, replicate crossover clinical trial to compare the safety and pharmacokinetics of YH22162 in healthy male volunteers.
Hypothesis: Study drug and comparator drug are showing equal pharmacokinetics.
Detailed Description
In ARM1, 32 subjects will be assigned and the subjects will be administered 'comparator drug' at Day1/Day43 and 'study drug' at Day22/64.
In ARM2, 32 subjects will be assigned and the subjects will be administered 'study drug' at Day1/Day43 and 'comparator drug' at Day22/64.
#Intervention
- DRUG : Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg
- White colored oval three-layer tablet
- Other Names :
- Study drug
- DRUG : Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg
- White and pink colored oval two-layer tablet
- Other Names :
- Comparator drug
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 with body mass index(BMI) between 18.5 and 30 kg/m2
* Who has not suffered from clinically significant disease
* Provision of signed written informed consent
Exclusion Criteria:
* History of and clinically significant disease
* Administration of other investigational products within 3 months prior to the first dosing
* Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
Sex :
MALE
Ages :
- Minimum Age : 19 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 481 |
Target Study Title: Anti-FLEX: Flexed Levering of Gluteal Vessels on OR Table May Lead to Extreme Danger During Gluteal Augmentation With Lipoaspirate, a Radio-graphically Studied Position of Superior and Inferior Gluteal Vessels During Flexion of OR Table or 'Jack-knife' Position, Danger Zone.
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to evaluate the effect of the gluteal vasculature in the prone and jackknife positions.
Detailed Description
This is a prospective collection of contrast-enhanced CT images of healthy female volunteers in prone and jackknife positions in order to determine if position impacts gluteal venous vasculature.
#Intervention
- DIAGNOSTIC_TEST : CT imaging
- Contrast-enhanced CT imaging of the pelvis in prone and jackknife positions
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:
* Females age 20 - 50 years
* BMI between 20 - 35 kg/m2
* Willingness and ability to provide written informed consent
* Willingness and ability to comply with all study procedures
* Interested or planning to have a gluteal augmentation
Exclusion Criteria:
* Males
* Females age < 20 or >= 51 years
* BMI between < 20 or > 35 kg/m2
* Prior gluteal augmentation surgery
* Any prior gluteal soft tissue filler
* Known or suspected history of immediate or delayed hypersensitivity (including but not limited to hives, anaphylactoid or cardiovascular reactions, laryngeal edema, and bronchospasm) to iodine or any iodinated contrast medium
* Documented history of chronic kidney disease that contraindicates the use of contrast dye
* Pregnant
* Currently breast-feeding
* Any reason (in addition to those listed above) that, in the opinion of the principal investigator, precludes full participation in the study
Sex :
FEMALE
Ages :
- Minimum Age : 20 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 482 |
Target Study Title: Prevalence of Sarcopenia and Its Geriatric Features
Target Study Description: #Study Description
Brief Summary
The goal of this study is to determine the prevalence of sarcopenia in a geriatric hospital ward.
Sarcopenia is defined by a loss of muscle mass, loss of muscle strength and loss of muscle quality. It is a geriatric syndrome that, to this date, is not systematically tracked in clinical practice.
In order to detect sarcopenia, the investigators will use the operational definition proposed by the European Working Group (EWGSOP) involving the measure of three parameters, namely the speed of walking, the muscle strength and the measurement of the muscular mass.
#Intervention
- OTHER : Sarcopenia detection
- The assessment of sarcopenia is performed according to the recommendations of the EWGSOP (European Working Group on Sarcopenia in Older people). Three measurements are made:
* Muscle mass measurement by dual energy X-ray absorptiometry (DEXA).
* Walking speed measurement
* Hand grip test
A diagnosis of sarcopenia is established if the walking speed is inferior to 0.8 m/sec, the muscular strength is low and the muscular mass is low.
Data regarding the geriatric characteristics of this sarcopenic population will be collected.
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 admitted in the unit 83 of the Geriatric Departement of the CHU Brugmann hospital, from 10/01/2016 till 30/03/2017.
Exclusion Criteria:
* Patients unable to consent or without representatives
* Patients unable to perform the hand- grip test, the walk test or measurement of the body components by DEXA
* Patients in severe pain
* Bedridden patients
* Patients for which a clear therapeutic abstention has been established
* Language barriere that cannot be overcome
* Patients unable to walk without the help of a third person
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>
| 483 |
Target Study Title: Facilitating Anemia Treatment Risk Communication for Patients With Kidney Disease: Decision Aid Trial
Target Study Description: #Study Description
Brief Summary
Anemia is a common complication of chronic kidney disease (CKD). In anemia of chronic kidney disease, patients suffer from low hemoglobin levels, which contribute to feelings of malaise and fatigue. The current accepted practice is often to administer erythropoietin-stimulating agents (ESAs), which act like the body's natural hormones to stimulate the production of red blood cells from bone marrow. Although ESAs are widely used in CKD, recent evidence suggests that they are not as safe as previously thought. In this study, we seek to test a decision aid to be used when a patient visits his or her nephrologist at Vanderbilt. The objective of the decision aid is to reduce patient confusion, improve their satisfaction with their care, improve their knowledge of kidney disease, and ultimately bring more clarity to patients about a controversial but ubiquitous drug.
The decision aid will be about 1 page long and will include questions and information that might help the patient be more active and informed regarding the choice of a course of ESA therapy. We will ask patients to answer questions before and after their clinic visits regarding their satisfaction and confidence in their treatment and their knowledge of kidney disease; we will ask some of the same questions 3 months after the clinic visit. We will compare patients who are counseled using the decision aid to patients who are not. We anticipate total experiment running time to be approximately 5 months to recruit and follow up on all patients.
#Intervention
- BEHAVIORAL : interactive educational intervention
- Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.
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:
* Has Chronic Kidney Disease or End Stage Renal Disease
* Over 18, under 80 years
* Currently receiving care in the Vanderbilt Nephrology or Dialysis Clinics
* Receiving ESAs for anemia
* Speaks and can read English (no previous use of interpreter services)
* No significant visual impairment documented in medical record
Exclusion Criteria:
* Diagnosed cognitive disability
* Stated inability to converse and read fluently in English, or prior use of translation services
* Poor visual acuity
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>
| 484 |
Target Study Title: Neo-adjuvant Pembrolizumab in dMMR/ POLE-EDM Uterine Cancer Patients: a Feasibility Study
Target Study Description: #Study Description
Brief Summary
In this feasibility study the investigators intend to treat patients with high mutational uterine cancer with two cycles immune checkpoint inhibition before standard-of-care hysterectomy.
Detailed Description
Objective:
The investigators aim to establish proof-of-concept for use of immune checkpoint blockade (ICB) as novel neo-adjuvant therapy in (deficient mismatch repair) dMMR and (Polymerase ε mutation)POLE-EDM uterine cancer (UC). When ICB proves to be feasible as defined in the primary endpoint, a follow-up with a larger multicenter studies to determine clinical efficacy, such as postponing standard-of-care surgery or randomized studies to standard-of-care.
Study design:
The investigators planned a window-of-opportunity study of ICB in primary dMMR UC (n=10) and primary POLE-EDM UC (n=10) patients. ICB (pembrolizumab; anti-PD1) will be administered in two cycles of 3 weeks between diagnosis and standard-of-care hysterectomy.
Tumor responses to pembrolizumab will be assessed 3 weeks after the second cycle of pembrolizumab by a pathologist (primary endpoint) and MRI (secondary endpoint).After treatment with immun checkpoint blockade a hysterectomy will take place (standard-of care). Peripheral blood and tumor samples will be used to evaluate immune responses.
Study population:
Primary dMMR/ POLE-EDM UC patients of any stage and/or grade who are intended to be treated with a hysterectomy recruited from the North-Netherlands oncological region.
Intervention: Pembrolizumab, 200mg IV Q3W for a total of 2 administrations per patient, integrated into standard-of-care protocol prior to surgery. Based on the well-established time lines, the interval between diagnosis and standard of care hysterectomy is sufficient to treat patients with two cycles of pembrolizumab without interfering with standard of care.
Main study endpoints:
The primary endpoint is the response rate of the tumor assessed by pathology in uterine cancer patients treated with neo-adjuvant pembrolizumab. The secondary endpoint is the objective response rate of the tumor by MRI using RECIST. Exploratory objectives are immunogenicity, safety and the value of a pipelle biopsy as a predictor for response.
#Intervention
- DRUG : Pembrolizumab (Keytruda)
- Pembrolizumab (Keytruda), 200mg IV Q3W for a total of 2 administrations per patient, integrated into standard-of-care protocol prior to surgery. Based on the well-established time lines, the interval between diagnosis and standard of care hysterectomy is sufficient to treat patients with two cycles of pembrolizumab without interfering with standard of care.
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:
* Female participants who are at least 18 years on the day of signing informed consent with histologically confirmed primary diagnosis of dMMR/POLE-EDM uterine cancer who are intended to be treated with hysterectomy will be enrolled in this study.
* Have measurable disease based on RECIST 1.1 on MRI.
* A female participant is eligible to participate if she is not pregnant, not breastfeeding, is not a woman of childbearing potential (WOCBP) or agrees to follow the contraceptive guidance in section 5.2 during the treatment period and at least until standard-of-care hysterectomy.
* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial
Exclusion Criteria:
* A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks [could consider shorter interval for kinase inhibitors or other short half-life drugs] prior to allocation.
Note: Participants must have recovered from all AEs due to previous therapies to <=Grade 1 or baseline. Participants with <=Grade 2 neuropathy may be eligible.
Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
* Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (<=2 weeks of radiotherapy) to non-CNS disease.
* Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
* Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
* Has severe hypersensitivity (>=Grade 3) to pembrolizumab and/or any of its excipients.
* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
* Has an active infection requiring systemic therapy.
* Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.
* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.
* 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 pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
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>
| 485 |
Target Study Title: Phase II Study on Safety and Activity of a Short Term Intensified Chemo-immunotherapy Combination in HIV-positive Patients Affected by Burkitt Lymphoma
Target Study Description: #Study Description
Brief Summary
This is a multicenter,open-label trial to evaluate activity and safety of the investigational intensive in HIV+ patients with Burkitt's lymphoma.
Experimental treatment consists of an induction phase followed by a consolidation or intensified phase according to tumor response.
Until recently, the immuno-compromised state of patients with concomitant HIV/AIDS and BL was thought to limit the ability to administer intensive chemotherapeutic regimens due to infection rate. However, the advent of highly active antiretroviral therapy (HAART) and evidence in diffuse large B-cell lymphomas that HIV-positive patients can tolerate standard chemotherapeutic regimens with improved outcomes have led investigators to treat HIV-positive patients with the same intensive chemotherapy regimens used to treat immuno-competent patients. Data suggest that these current approaches, along with supportive care, may result in improved patient outcomes, similar to those in the immuno-competent patient population.
Detailed Description
The activity of feasibility of the proposed program will be assessed in HIV+ patients with Burkitt lymphoma with the aim to improve tolerability, minimize source consuming and supporting treatment and redu ce late sequels. Available combinations in this setting are really source demanding and toxic combinations showing high rates of septic complication and a treatment-related mortality of near 20%.
#Intervention
- DRUG : Induction Phase
- * dd -2 to 1: Methylprednisolone
* dd 0-1, Cyclophosphamide, associated on day 0 with Vincristine
* dd 2, Rituximab
* dd 7, Methotrexate
* dd 14, Rituximab
* dd 15, Etoposide
* dd 21, Methotrexate
* dd 29, Rituximab and Doxorubicin
* dd 36, Rituximab and VCR
At the end of this induction phase, subsequent treatment will be performed according to the objective response:
1. pts in CR: consolidation phase followed by bulky site irradiation
2. pts in PR: consolidation phase followed by BEAM conditioning regimen supported by ASCT and bulky irradiation
3. pts with SD after induction or PD during or after induction: intensification phase followed by BEAM conditioning regimen supported by ASCT and bulky irradiation
- Other Names :
- Short-term intensive sequential chemoimmunotherapy
- DRUG : Consolidation Phase (on day +50)
- * dd 1-2: cytarabine twice a day
* dd 3 and 11: rituximab
* dd 11-13: leukapheresis for PBPC collection.
- Other Names :
- high-dose cytarabine; consolidation phase
- DRUG : Intensification phase
- 1. One or two courses of R-IVAC or R-ICE chemoimmunotherapy regimen, every three weeks as debulking.
2. CTX (dd 1) associated with rituximab on dd 3 and 10, followed by PBPC collection (dd 11-13);
3. AraC every 12 hours for four days (dd -5 to -2) supported by reinfusion of CD34+ cells (dd 0), rituximab infusion (dd -1 and +11) and second in-vivo purged PBPC collection (if needed).
- Other Names :
- unresponsive patients, refractory disease
- DRUG : BEAM conditioning
- BCNU on dd 1; VP-16 every 12 hours on dd 2-5 and araC every 12 hours on dd 2-5; melphalan on dd 6, followed by the reinfusion of CD34+ cells
- Other Names :
- Conditioning regimen, autologous transplantation
- RADIATION : Consolidation radiotherapy
- At the end of the whole program, patients will be evaluated for involved-field irradiation with 6-10 MeV photons and a dose of 36 Gy (2 Gy/d, five fractions a week). Three subgroups of patients will be considered for radiotherapy
- Other Names :
- bulky irradiation; residual lesion
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:
* Histologic diagnosis of Burkitt's lymphoma (WHO 2008)
* HIV sero-positivity
* Age >=18 and <=60 years
* ECOG-PS <=3
Exclusion Criteria:
* CNS parenchymal involvement
* Absolute neutrophil count <1.000 cells/μL and platelets count <75 × 109/L (Burkitt unrelated)
* Creatinine >1,5N (Burkitt unrelated)
* SGOT and/or SGTP >2,5N (Burkitt unrelated)
* Bilirubin >2N (Burkitt unrelated)
* Severe psychiatric illness or any other clinical, social or psychological condition that could interfere with patient's adherence and compliance
* Significant cardiac disease or acute myocardial infarction in the last 12 months
* Severe active infection (except for HBV and/or HCV co-infection)
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>
| 486 |
Target Study Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Nalmefene HCl in the Treatment of Pathological Gambling
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine if nalmefene is safe and effective in the treatment of pathological gambling.
Detailed Description
Randomized, double-blind, placebo-controlled, parallel-group, multi-centered, outpatient study to assess the efficacy, safety and tolerability of two doses of nalmefene in patients with current diagnosis of pathological gambling.
#Intervention
- DRUG : nalmefene HCl
- Nalmefene HCl film-coated tablets, 20 or 40 mg, administered orally once daily for 10 weeks.
- OTHER : Placebo
- Placebo tablet
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:
* Current diagnosis of pathological gambling as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
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>
| 487 |
Target Study Title: A Phase 1, Open-Label, Randomized, 3-Way Crossover Study In Healthy Subjects To Estimate The Pharmacokinetics Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State
Target Study Description: #Study Description
Brief Summary
This study will test two different formulations. The results will be used to select formulation for phase 3.
#Intervention
- DRUG : Pharmacokinetics
- Single dose of 750 mg PF-00868554 as a solution and tablets.
- Other Names :
- pharmacokintics
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.
Exclusion Criteria:
* Standard for healthy volunteers.
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>
| 488 |
Target Study Title: The Mysterious on/Off Itch and Erythema During Whole Body Vibration Exercise
Target Study Description: #Study Description
Brief Summary
Intense itch on the legs sometimes associated with redness can be adverse effects of whole body vibration (WBV) according to own observations and numerous posts in non-professional online-blogs. To the investigators' knowledge, the appearance of itch and/or a rash during WBV exercise has not yet been described.
The research objectives are:
1. To determine the effect of WBV on itch rating and its unpleasantness and on skin changes.
2. To determine the effect of WBV on immunoglobulin E (IgE) and serum tryptase
Detailed Description
Objectives Intense itch on the legs sometimes associated with redness can be adverse effects of WBV according to the investigators observations and numerous posts in non-professional online-blogs. To the investigators knowledge, the appearance of itch and/or a rash during WBV exercise has not yet been described.
The objectives of this study are:
1. to determine the effect of WBV on itch rating and its unpleasantness and on skin changes.
2. to determine the effect of WBV on serum tryptase.
Hypothesis The working hypothesis is that repeated WBV leads to an increase of itching and erythema. Further investigators hypothesize that repeated WBV does not lead to an increase in serum tryptase.
Inclusion and exclusion criteria will be evaluated. Subjects will be instructed to not shave their legs one week before the intervention day and to shave only the left leg from the ankle to the knee on the day prior to the intervention day.
On the intervention day, subjects will be informed in detail about the study protocol and written informed consent will be collected. If a pregnancy cannot be excluded (days from last menstruation) subjects are instructed to do a pregnancy test. Then, a blood sample will be taken. Subsequently, subjects will be instructed to stand on the vibration plate (Galileo 900) in a slightly crouched position with their hands loosely resting on the rail. Subjects will complete ten 1-minute WBV repetitions interspaced by 1-minute breaks in seated position. During each break, subjects will rate the itch intensity, and skin changes will be captured. Sixty minutes after the last WBV repetition, another blood sample will be taken. Subjects will rest until itch and erythema return to baseline. During resting phase subjects will fill in the Eppendorf itch questionnaire and the Erlanger atopy score.
#Intervention
- OTHER : Whole body vibration training
- 10 x 1 min whole body vibration exposure
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 <= 35 years
* female
* Informed Consent as documented by signature (Appendix Informed Consent Form)
Exclusion Criteria:
* itchy skin diseases
* hay fever
* asthma
* chronic venous insufficiency
* peripheral artery disease
* musculoskeletal diseases or injuries affecting the legs, hips and pelvis
* BMI < 17 and > 35 kg/m2
* pregnancy
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:
Yes
</FORMATTED_CRITERIA>
| 489 |
Target Study Title: Endoscopic Sclerotherapy and/or Ligation Versus Portacaval Shunt for Bleeding
Target Study Description: #Study Description
Brief Summary
In unselected cirrhotic patients with bleeding gastric varices to compare the influence on mortality rate, duration of life, control of bleeding, quality of life, and economic costs of treatment of: portacaval shunt, endoscopic variceal sclerotherapy and/or variceal ligation.
Detailed Description
BACKGROUND: In patients with cirrhosis, bleeding gastric varices (BGV) are associated with a high mortality rate, but have received much less investigation than bleeding esophageal varices. Various therapeutic measures have been used to treat BGV, including endoscopic, radiographic, and surgical procedures, but there have been few prospective evaluations of therapy involving sizable groups of patients that have received acceptable follow-up. Management of this serious disorder has been uncertain and often unsuccessful. Herein is a prospective randomized controlled trial in unselected cirrhotic patients with BGV that compared the effectiveness of endoscopic therapy (ET) and portacaval shunt (PCS) during follow-up for more than 5 years or until death.
STUDY DESIGN: 518 unselected patients with cirrhosis and BGV were randomized to ET or PCS performed as an emergency in 220 and electively in 298. All patients received the same diagnostic workup, initial therapy, post-treatment therapy, and rigorous follow-up. One-, 5-, 10-, and 15-year follow-up rates were 100%, 97%, 97%, and 92%, respectively. ET consisted of repetitive sessions of intravariceal injection sclerotherapy and/or variceal band ligation aimed at variceal obliteration. PCS consisted of a direct anastomosis, side to side in 95%. ET and PCS were compared specifically with regard to control of bleeding, survival rate, and quality of life.
#Intervention
- PROCEDURE : Portacaval shunt
- Subject taken to the operating room and undergoes portacaval shunt surgery
- PROCEDURE : Sclerotherapy
- Subject taken to Endoscopy Suite and undergoes endoscopic sclerotherapy
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:
* All patients with upper gastrointestinal bleeding (blood in the upper gastrointestinal tract) of a magnitude that required 2 or more units of blood transfusion and entered the emergency room directly, or were referred from an area hospital, or developed bleeding while in the hospital, and were shown to have cirrhosis of the liver, and were shown by endoscopy to have bleeding gastric varices, absence of bleeding from esophageal varices, and absence of any other lesion that could reasonably account for the bleeding were included ('all comers').
Exclusion Criteria:
* None
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 490 |
Target Study Title: Nalbuphine/Dexmedetomidine Versus Nalbuphine/Propofol Conscious Sedation for Cataract Extraction Under Topical Anaesthesia: A Double-Blind Randomized Trial
Target Study Description: #Study Description
Brief Summary
Topical anaesthesia of the eye for ophthalmologic procedures avoids pain and discomfort of local anaesthetic injection in the peribulbar or retrobulbar block so that patient comfortability is achieved. Sedation during topical anaesthesia of the eye is mostly required to achieve anxiolysis, amnesia and keeping the patient calm all through the procedure. In the present study, the investigators will investigate the effect of nalbuphine/dexmedetomidine versus nalbuphine/propofol on the sedation as a primary outcome, intra-operative, postoperative analgesia, vital signs, patient and surgeon satisfaction and side effects as secondary outcomes
Detailed Description
In both groups, the patients will receive i.v. nalbuphine 50 μg/kg. Patients in group D, will receive an i.v. loading dose of dexmedetomidine 1 μg/kg over 10 min followed by a maintenance infusion of 0.5 μg/kg/h. Patients in group P, will receive a bolus i.v. dose of propofol 0.5 mg/kg followed by an infusion started at 0.025 mg/kg/min .If sedation score was \<3, rescue sedation with boluses of midazolam 0.01 mg/kg will be given. If the patient complained of pain (Numerical verbal pain rating scale ≥3) during the surgery, i.v. fentanyl 50 μg will be given as an intra-operative rescue analgesic and the surgeon will be instructed to use additional topical local anaesthetic eye drops if appropriate. After the completion of surgery, all infusions will be stopped, and the patients will be shifted to the postanaesthetic care unit (PACU) to be monitored for 2 hours before discharge.
#Intervention
- DRUG : Nalbuphine
- i.v. nalbuphine bolus of 50 μg/kg.
- Other Names :
- Nalbuphine bolus
- DRUG : Propofol
- A bolus i.v. dose of propofol 0.5 mg/kg followed by an infusion of 0.025 mg/kg/min
- Other Names :
- propofol infusion
- DRUG : Dexmedetomidine
- i.v. loading dose of dexmedetomidine 1 μg/kg over 10 min followed by a maintenance infusion of 0.5 μg/kg/h.
- Other Names :
- Dexmedetomidine infusion
- DRUG : Benoxinate Hydrochloride 0.4% Eye Drops
- Benoxinate hydrochloride 0.4% eye drops instilled twice, 5 minutes apart.
- Other Names :
- Topical anaesthesia of the eye
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:
* Both genders,
* 20 and 65 years,
* American Society of Anesthesiologists (ASA) physical status I and II,
* Scheduled for cataract extraction surgery under topical anaesthesia.
Exclusion Criteria:
* Known allergy to local anaesthetics,
* Allergy to study drugs,
* Second or third-degree heart block,
* Alcohol or drug abuse
* Morbid obesity, pregnant and lactating females,
* Patients with severe cardiac, renal and hepatic disorders.
Sex :
ALL
Ages :
- Minimum Age : 20 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>
| 491 |
Target Study Title: The Role of Turbinectomy in Rhinoseptoplasty: a Randomized Clinical Trial With Evaluation of Quality of Life
Target Study Description: #Study Description
Brief Summary
Research Question: Performing partial turbinectomy associated with rhinoseptoplasty is responsible for an increase in quality of life related to nasal obstruction when compared to no intervention in rhinoseptoplasty inferior turbinate?
* Population: patients eligible for functional rhinoseptoplasty and / or aesthetic
* Intervention: surgery, turbinectomy of inferior turbinates
* Comparison: the absence of intervention in inferior turbinates
* Primary endpoint: Quality of life related to nasal obstruction
#Intervention
- PROCEDURE : Rhinoseptoplasty
- Rhinoseptoplasty without turbinectomy procedure
- PROCEDURE : Partial turbinectomy
- After medial dislocation of the inferior turbinate, proceed partial resection of the inferior turbinate in all its inferior extension in range. Possible bleeding is cauterized.
- Other Names :
- Turbinectomy
- PROCEDURE : Endoscopic partial turbinectomy
- Endoscopy to medial dislocation of the inferior turbinate with instrument
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:
* Eligible patients to rhinoseptoplasty
* Patients who agreed to participate
Exclusion Criteria:
* Presence of symptoms of nasal obstruction in the absence of septal deviation, poor support of the nasal tip or clamping of the nasal valve;
* Presence of hypertrophic and obstructive inferior turbinates;
* Presence of sinonasal tumors;
* Patients undergoing treatment of other concomitant rhinoplasty entities such as inflammatory sinus pathology, adenoid hypertrophy, septal perforation, otoplasty and blepharoplasty.
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 90 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 492 |
Target Study Title: The Effectiveness of Speech Therapy and Repetitive Transcranial Magnetic Stimulation Therapy in Patients With Post-stroke Anomic Aphasia
Target Study Description: #Study Description
Brief Summary
The aim of the study is to observe the effects of speech therapy and transcranial magnetic stimulation therapy in patients who develop anomic aphasia after stroke. Patients meeting the inclusion criteria will be randomly divided into groups. In the repetitive transcranial magnetic stimulation (rTMS) treatment group, a total of 10 sessions, 1 session per day, will be applied to the right inferior frontal gyrus area with a frequency of 1 Hz for 20 minutes. The control group patients will be given speech therapy in the same way, but no active magnetic stimulation will be given in rTMS sessions (sham application). Speech therapy will be given to each patient by the same physiotherapist, and the treatment will last a total of 10 days, 60 minutes a day. Minimental test (MMT), Ege aphasia test, aphasia quality of life scale (SAQOL-39) will be filled in to the patients before and after the treatment.
#Intervention
- DEVICE : Repetitive transcranial magnetic stimulation
- Transcranial Magnetic Stimulation(TMS) has been used for diagnostic and therapeutic purposes in the treatment of many neurological and psychiatric diseases such as stroke, multiple sclerosis, myelopathy, amyotrophic lateral sclerosis, movement disorders, epilepsy, and depression. It is a way to stimulate the targeted areas in the cerebral cortex without invasive methods. The application of TMS in the aphasia usually consists of repetitive stimulations, in order to activate or deactivate the target area.
In this study, 10 sessions of 1-Hz low frequency rTMS for 20 minutes will be applied to the inferior frontal gyrus of the right frontal lobe.
- OTHER : Speech therapy
- Speech therapy will be given to each patient by the same therapist, and the treatment will last 10 days, 60 minutes a day. It will consist of exercises to improve the articulation and comprehension.
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:
* Stroke diagnosed with cranial MR examination causing unilateral hemiplegia
* Post-stroke patients with anomic aphasia
* 40 <= age <= 70 years
* Being able to read the basic instructions
* Medically and neurologically stable patients
Exclusion Criteria:
* Clinical condition that will constitute a contraindication to TMS (metallic implant, Cardiac pacemaker, pregnancy, breastfeeding, epilepsy, head trauma...)
* Having previously had TMS treatment
* Presence of Life-threatening disease and/or active systemic disease (chronic disease, malignancy ...)
* Alcohol or drug addiction
* Presence of neurodegenerative or psychiatric disorders
* Pregnancy or breastfeeding status
* Severe cognitive impairment
* Having a history of previous epilepsy
* Visual and auditory impairment
Sex :
ALL
Ages :
- Minimum Age : 40 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>
| 493 |
Target Study Title: Effectiveness of Low Frequency Combined Frontal and Temporal Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Chronic Tinnitus
Target Study Description: #Study Description
Brief Summary
Transcranial Magnetic Stimulation is used to modulate the auditory neural pathways caused by hearing loss and leading to the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus.
Detailed Description
Tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. It is a frequent problem which can interfere significantly with the ability to lead a normal life. Treatment is difficult. Most available therapies focus on habituation rather than treating the cause. Tinnitus is thought to be generated in the brain, as a result of functional reorganization of auditory neural pathways and tonotopic maps in the central auditory system, following damage to the peripheral auditory system. Low-frequency rTMS has been investigated for the treatment of hyperexcitability disorders such as auditory hallucinations and tinnitus. Pilot data indicate that the beneficial effect of low-frequency rTMS can be enhanced by low frequency rTMS of the right dorsolateral prefrontal cortex (DLPFC). In the proposed study we investigate whether low frequency rTMS of the DLPFC improves therapeutic efficacy of low-frequency rTMS on tinnitus in a controlled trial.
#Intervention
- DEVICE : Combined frontal and temporal rTMS
- Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 1000 stimuli of 1Hz rTMS over the right DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold)
- DEVICE : Temporal low frequency rTMS
- Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold)
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 subjective chronic tinnitus
* Duration of tinnitus more than 3 months
Exclusion Criteria:
* Objective tinnitus
* Treatable cause of the tinnitus
* Involvement in other treatments for tinnitus at the same time
* Clinically relevant psychiatric comorbidity
* Clinically relevant unstable internal or neurological comorbidity
* History of or evidence of significant brain malformation or neoplasm, head injury
* Cerebral vascular events
* Neurodegenerative disorder affecting the brain or prior brain surgery;
* Metal objects in and around body that can not be removed
* Pregnancy
* Alcohol or drug abuse
* Prior treatment with TMS
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>
| 494 |
Target Study Title: National Registry Investigating the Effectiveness of Different First-line Treatment Strategies in Patients With Critical Limb Ischemia
Target Study Description: #Study Description
Brief Summary
The principal research question is which treatment modality between open surgical, endovascular and conservative therapy is the most effective in terms of limb salvage, survival and reinterventions in patients with critical limb ischemia
Detailed Description
The target population consists of patients suffering from critical limb ischemia (CLI) lasting more than 2 weeks. CLI is defined as rest pain or tissue loss (Fontaine stages III-IV or Rutherford classes 4 to 6) and/or ankle-brachial index \< 0.40. Patient with acute limb-threatening ischemia, bone fractures in the relevant areas, nonatherosclerotic disease (e.g. arteriitis) and documented hypercoagulable diseases will be excluded from this study. There will be no experimental or control groups. The comparison groups will be:
Group 1: Best endovascular treatment (angioplasty +/- stent) Group 2: Best surgical treatment \[bypass (vein or prosthetic)\] Group 3: Femoral artery patchplasty +/- profundoplasty (+/- endovascular treatment) Group 4: Best conservative treatment
The proposed sample size amounts to 1200 patients.
To be assessed for eligibility (n=1200) To be allocated to trial (n=1000) To be analysed (n=900)
In CRITISCH registry, randomization or blinding is not feasible, because optimized standard care will be performed as established at each participating centre (best medical treatment). Data storage, validation, monitoring, update, backup and analysis will be performed centrally following established procedures. Web-based software will be used to develop a data model representing the data structure. The data validation will include standard data validation techniques such as the manual review of selected variables and the routine check of missing and outlying data points. Regional staff will be instructed and supervised by study nurse, who will perform the study monitoring. Assessment of relevant prognostic factors during the statistical analysis will prevent biased results due to the non-randomized design and the potential structural inequality.
#Intervention
- PROCEDURE : Surgical revascularization
- Other Names :
- Vein, PTFE, Dacron, Femoral artery patchplasty, Profunda patchplasty
- PROCEDURE : Endovascular revascularization
- Other Names :
- Balloon angioplasty, Stent, Drug-eluting balloon, Drug-eluting stent, Lysis
- OTHER : No vascular intervention
- Other Names :
- Major amputation, Minor amputation, Sympatholysis, Conservative treatment
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:
* Rest pain or tissue loss (Fontaine stages III-IV or Rutherford classes 4 to 6) and/or ankle-brachial index < 0.40
Exclusion Criteria:
* Acute limb-threatening ischemia
* Bone fractures in the relevant areas
* Non-atherosclerotic disease (e.g. arteriitis)
* Documented hypercoagulable diseases
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>
| 495 |
Target Study Title: Evaluation Concerning the Influence of Myo-inositol Therapy on the Dynamics of Embryo Development in Patients Suffering From PCOS Undergoing ICSI Treatment
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to analyse the activity of myo-inositol on pregnancy rate, embryo development dynamics and oestradiol and progesterone concentration in blood serum and Superoxide Dismutase (SOD) and catalase concentration in follicular fluid of patients with Polycystic Ovary Syndrome (PCOS) undergoing Intracytoplasmic Sperm Injection (ICSI).
#Intervention
- DIETARY_SUPPLEMENT : Inofolic: myo-inositol and folic acid
- 4000 mg of myo-inositol and 0,4 mg of folic acid for 3 months preceding the ICSI procedure
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:
ICSI treatment due to infertility
PCOS patients enrolled according to the criteria established by representatives of the American Society of Reproductive Medicine (ASRM) and the European Society of Human Reproduction and Embryology (ESHRE)
Exclusion Criteria:
Severe endometriosis BMI <17 and >30 Metabolic diseases Lowered ovarian reserve
Sex :
FEMALE
Ages :
- Minimum Age : 27 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 496 |
Target Study Title: An Association Study of Characterizing Cognitive Decline and Functional Cardiac Senescence Profile Through the Association of Biomarkers and Clinical Outcomes in Healthy Middle Aged and Elderly Korean Volunteers
Target Study Description: #Study Description
Brief Summary
* Although aging process appears to be generally characterized, investigators have been paid much attention to the specific target molecules, which leads to discover the clinical markers of the senescence. The present study is to investigate the clinical and biological profile of cognitive decline and functional cardiac senescence in healthy middle aged and elderly Korean volunteers.
* This study was conducted as a cross-sectional, single-center, comparative clinical study.
* Each volunteer was given informed consent for checking cognition and cardiac function. Blood and urine samples were collected to analyze genome, proteome, and metabolome to assess cognition and cardiac function of its muscle enzymes.
Detailed Description
* The protocol of this study was developed as the first assessment of the three to four series of clinical research on senescence.
* This design of the study is a non-interventional, single-center, single-visit design for investigating the cognitive decline and cardiac function including heart muscle enzyme activity, which have been considered one of the key points in aging process.
* Volunteers visit the study site during the screening period, informed consent for study participation and blood draw are given respectively, then, the eligibilities are met, participants visit the study site just once within two weeks.
* The participants undergo the following five procedures for 2-3 hours; out-patient visit,
1. additional demographic interview including covariate factors (depression status, marital status
2. vital sign check
3. the questionnaire for cognitive function
4. blood draw for genomic, proteomic, and metabolomic analyses (10 milli Liter), urine collection (20 milli Liter)
5. electrocardiogram (ECG), then they are discharged.
* Their safety follow-up is monitored in a week (± 1 day) by a phone-call from the study associates.
* To evaluate cognitive function, several cognitive batteries were used, 3MSE (Modified-Mini Mental State Examination), ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale); for cognitive biomarkers, Apolipoprotein E, Type-3 metabotropic glutamate receptors.
* To evaluate cardiac function including its enzyme activity: HRV (heart rate variability), CRP (c-reactive protein); Cardiac Troponin T.
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 subjects >= 45 and <= 80 years
* who understands the study procedures signs informed consent forms
Exclusion Criteria:
* who > 150 mmHg in systolic or < 95 mmHg in diastolic blood pressure
* who > 110 mg/dl in fast glucose level
* Smoking > 20 cigarettes/day
* Alcohol > 3 units/day (1 unit = pure alcohol 10 milli Liter)
* Caffeine > 5 cups of coffee or tea/day
Sex :
ALL
Ages :
- Minimum Age : 45 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>
| 497 |
Target Study Title: Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma
Target Study Description: #Study Description
Brief Summary
The study investigates the performance of a new adhesive with regard to the skin condition
#Intervention
- DEVICE : Test Product A
- The test product is a newly developed ostomy product
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:
* Have given written informed consent
* Have an ileostomy or a colostomy with liquid* output (as their usual output)
* Be at least 18 years and have full legal capacity
* Have had their stoma for at least three months
* Be able to use products with max cut size 45 mm
* Have self-reported problems with leakage** (three times within 14 days)
* Handle the Clinical App, test product and comparator product themselves
* Use a flat SenSura® Mio or a flat SenSura® with standard adhesive as their current product
* Minimum change of baseplate at least once every 3rd day
* Are willing and suitable (determined by investigator/study nurse) to use the test product and comparator without using a paste/mouldable ring during the investigation
* Are willing and suitable (determined by investigator/study nurse) to use a 1-piece product during the investigation
Exclusion Criteria:
* Are currently receiving or have within the past two months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
* Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (e.g. lotion or spray) or systemic treatment* (e.g. injection or tablets).
* Get a positive result of a pregnancy test for women of childbearing age/fertile (**clarified in section 6.3.2)
* Are breast feeding
* Are participating in other interventional clinical investigations or have previously participated in this investigation
Exception:
Participation in other Coloplast in-house clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP300) protocol.
* Have known hypersensitivity towards any of the products used in the investigation
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>
| 498 |
Target Study Title: Exploratory Study of Frailty Evaluation in Elderly Population With Cancer
Target Study Description: #Study Description
Brief Summary
The Comprehensive Geriatric Assessment (CGA) is, still today, barely established in the standard practice. Although the different scientific societies recommend a CGA in elderly population affected with cancer at first visit, the evidence regarding its transcendence is limited. On the other hand, the components of this evaluation and the translation of their findings in changes in the clinical practice are not stablished. This project intends to implement a CGA in a group of patients to compare this group with an historical cohort that reflects the standard practice, to evaluate the differences between both approaches. The study also evaluate the feasibility and utility of this CGA. All these questions aims to support the hypothesis that CGA impacts on the cancer treatment for elderly population affected with cancer.
Detailed Description
This study compares two groups of elderly patients affected with stage IV non-small lung cancer (NSCLC), stage III colon cancer and stage IV colorectal cancer (CRC): a prospective experimental cohort and an historic control cohort. The sample size is 60 patients, 30 prospective and 30 retrospective. Of each cohort, 10 patients have stage IV NSCLC, 10 have stage III colon cancer and 10 have stage IV CRC. Prospective patients will be recruited longitudinally from January 2013 and retrospective patients are recorded longitudinally backward in time from December 2012. Both groups are patients of Medical Oncology Service of Hospital General Universitario de Elche, and both groups sign an informed consent form.
A CGA is performed in the experimental group after the first visit with oncologist and prior to therapeutic decision. This CGA includes:
* Nutritional Assessment: Mini Nutritional Assessment (MNA)
* Functional Assessment: Get up and Go, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Karnofsky Scale, Walking one Block, Number of Falls in last 6 months and Hearing Loss.
* Cognitive Assessment: Mini-Mental State Examination (MMSE-30)
* Psychological status: Geriatric Depression Scale (GDS)
* Social Support: Medical Outcomes Study Social Support Survey (MOS-SSS)
* Comorbidity and Severity of Comorbidities: Charlson Comorbidity Index and Adult Comorbidity Evaluation (ACE-27)
The evaluation includes too age, haemoglobin, Creatinine Clearance (CrCl) and presence of geriatric syndromes.
The results of this evaluation allow to calculate:
* Early mortality risk according to Soubeyran et al (JCO 2012, 30: 1829-1834) (MNA and Get up and Go):
* risk of early mortality
* no risk of early mortality.
* Toxicity to chemotherapy according to Hurria et al. (J Clin Oncol 2011, 29: 3457-3465) (age, type of cancer, dose and number of chemotherapy drugs, haemoglobin, CrCl, hearing loss, number of falls in last 6 months, ability to take medication without help (IADL), walking one block and social support (MOS-SSS):
* low risk
* medium risk
* high risk.
* Frailty group according Köhne et al (The Oncologist 2008, 13: 390-402) (ADL, IADL, comorbidity and severity of comorbidities and presence of geriatric syndromes). This information dictates the therapeutic strategy for each experimental patient:
* Group 1: standard treatment.
* Group 2: modified treatment
* Group 3: no treatment
Experimental patients will be followed for six months from CGA and their toxicity and its severity, occurrence of treatment modifications, number of hospitalizations and reasons for hospitalizations and mortality and reason of mortality will be compared with the same items of historic controls, followed too for six months from the moment the physician made the therapeutic decision.
Other data to record for both groups: sex, age, origin, leucocytes, platelets, LDH, albumin, CEA, Cr Cl, haemoglobin, subjective weight loss, corporal mass index, comorbidities, primary tumor: stage, metastases location, treatment intent: adjuvant, palliative, number of drugs, number of concomitant medications, PS according to ECOG and Karnofsky (some data are expected to be missing for historic group).
Only for historic controls, physicians should answer one question : In wich category would include the treatment recommendation? according to Köhne, The Oncologist 2008: Balducci, The Oncologist 2000; J Clin Oncol 2012:
* standard treatment
* modified treatment
* no treatment despite treatment is recommended
* no treatment
Only for historic controls two more questions should be answered:
* Has a Geriatric Evaluation been performed? Yes or No
* What sort of evaluation?
The trial records too how long does it take each test and how long does it take to complete CGA.
All information is recorded in a database with anonymous code for each subject.
Statistical analysis will consist of a descriptive analysis of sociodemographic and clinical characteristics of both cohorts. It will be performed also non-parametric analysis comparing this characteristics between the experimental groups. A descriptive analysis of daily life characteristics in experimental group will be performed, and also a non-parametric analysis comparing these variables between the experimental groups.
Changes due to CGA incorporation will be evaluated and the variables measuring the toxicity and early mortality should be correlated to the coincidence or not of the treatment performed with the one concluded by the geriatric evaluation.
Contribution of the different elements of CGA will be evaluated. A multiple regression will be performed in order to carry out an evaluation of the degree of contribution of each of the elements of the CGA.
A significance 'p' less than 0.05 will be considered significant.
There are some study limitations: size, missing data for historic patients, monocentric study.
#Intervention
- DIAGNOSTIC_TEST : Comprehensive Geriatric Assessment (CGA)
- CGA includes a set of evaluations to determine therapeutic decision based on mortality risk, toxicity risk and frailty group. Evaluations includes:
* Nutritional Assessment: Mini Nutritional Assessment (MNA)
* Functional Assessment: Get up and Go, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Karnofsky Scale, Walking one Block, Number of Falls in last 6 months and Hearing Loss.
* Cognitive Assessment: Mini-Mental State Examination (MMSE-30)
* Psychological status: Geriatric Depression Scale (GDS)
* Social Support: Medical Outcomes Study Social Support Survey (MOS-SSS)
* Comorbidity and Severity of Comorbidities: Charlson Comorbidity Index and Adult Comorbidity Evaluation (ACE-27)
* Age
* Haemoglobin
* CrCl
* Presence of geriatric syndromes
- Other Names :
- Frailty Evaluation
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 more than 70 years
* Outpatients
* Patients diagnosed with stage III colon cancer, stage IV colorectal cancer or stage IV NSCLC
* No previous diagnosis of cancer.
* No previous chemotherapy for current diagnosis of cancer
* Signed informed consent
Exclusion Criteria:
* Not fulfilling inclusion criteria
Sex :
ALL
Ages :
- Minimum Age : 70 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 499 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.