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Target Study Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Effects of PN2034 in Insulin-Dependent Patients With Type 2 Diabetes
Target Study Description: #Study Description
Brief Summary
This study is designed to evaluate the safety and efficacy of PN2034 in insulin-dependent type 2 diabetics as measured by the change in average daily insulin dose from baseline to week 12. The effects of PN2034 on HbA1c, fasting plasma glucose (FPG), and lipid levels will also be measured.
#Intervention
- DRUG : PN2034
- DRUG : Insulin
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 type 2 diabetes mellitus
* 21 <= age <= 65 of age
* on stable doses of insulin (>= 40 units/day) alone or with metformin for at least 3 months
* HbA1c level of >=7.5% but <=10.0%
* fasting blood sugar level >= 125 mg/dL but <= 279 mg/dL
* BMI 26 <= age <= 43 kg/m2
* direct bilirubin < 1.5x the upper limit of normal (ULN)
* serum creatinine < 1.5 mg/dL (males) or < 1.4 mg/dL (females)
* blood urea nitrogen (BUN)<=40 mg/dL
* all other clinical laboratory parameters (hematology, serum chemistry, and urinalysis) within normal limits or not clinically significant
* ECG normal, or abnormalities not clinically significant
* surgically sterile,postmenopausal,or using adequate contraception and have a negative pregnancy test at Screening
* able to perform daily self-monitoring of blood glucose (SMBG) tests
* willing and able to sign an informed consent form
Exclusion Criteria:
* diagnosed with type 1 diabetes mellitus or has a history of ketoacidosis
* treatment with TZDs or any other oral antidiabetic (excluding metformin) within 3 months prior to screening or during study treatment
* change in lipid-lowering medication within 2 months of screening
* taken systemic corticosteroids within 1 month prior to screening or during study treatment
* history of or current/active cardiovascular disease
* significant current pulmonary conditions
* significant thyroid disease
* CPK value > 3x ULN
* a female who is pregnant or lactating
* systolic BP > 160 mm Hg or a diastolic BP > 90 mm Hg at screening
* previous or current history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin, that has not been in remission within 5 years prior to randomization
* liver function tests (ALT, AST, ALP) > 2 times ULN, or active liver disease at screening
* history of positive HIV
* positive hepatitis B test at screening
* weight loss or gain >= 15 lbs within 3 months of screening
* history of substance abuse (including alcohol abuse) within 2 years prior to screening
* donated and/or received any blood or blood products within 3 months prior to randomization
* taken an investigational study medication within 30 days prior to screening or during the study
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 600 |
Target Study Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
Target Study Description: #Study Description
Brief Summary
This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.
#Intervention
- DRUG : ombitasvir/paritaprevir/ritonavir and dasabuvir
- Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
- Other Names :
- Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333
- DRUG : Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir
- Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir
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:
* Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and Taiwanese parentage
* Chronic hepatitis C virus (HCV) infection prior to study enrollment.
* Screening laboratory result indicating HCV subtype 1b (GT1b) infection.
* Per local standard practice, documented absence of cirrhosis.
* Participant has never received antiviral treatment (including interferon [IFN]-based therapy [alpha, beta or pegylated (peg)IFN] with or without RBV) for HCV infection (treatment-naïve participant) or participant must have documentation that they met the definition of one of the following categories (treatment experienced participant): Non-responder or Relapser
* Participant has plasma HCV RNA level > 10,000 IU/mL at Screening.
Exclusion Criteria:
* HCV genotype performed during screening indicating unable to genotype or infection with any HCV genotype other than GT1b.
* Positive test result at Screening for hepatitis B surface antigen (HBsAg), or hepatitis B virus DNA (HBV-DNA) > Lower Limit of Quantification (LLOQ) if HBsAg negative, or anti-human immunodeficiency virus antibody (HIV Ab) positive.
* Any current or past clinical evidence of cirrhosis.
* Any primary cause of liver disease other than chronic HCV infection.
* Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic function.
* Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of cytochrome P450 3A (CYP2C8) within 2 weeks or within 10 half-lives, whichever is longer, of the respective medication/supplement prior to study drug administration.
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>
| 601 |
Target Study Title: Hydroxychloroquine Efficacy and Safety in Preventing SARS-CoV-2 Infection and COVID-19 Disease Severity During Pregnancy and Postpartum
Target Study Description: #Study Description
Brief Summary
It still unclear how SARS-CoV-2 affects pregnant women and their offspring, as well as which factors may influence obstetrical disease and outcomes, including the timing of maternal viral exposure by gestational age, the effects of parity, age, host immune responses, coexisting medical and obstetrical conditions and the effects of treatment regimens. While further information is gathered, based on the existing evidence from other infections causing pneumonia, pregnant women should be considered to be at high risk for developing severe infection during the current COVID-19 epidemic. Results from clinical trials with HCQ in nonpregnant adults may not be directly extrapolated to pregnant women given the special features of the pregnancy status. Thus, clinical research is urgently needed to improve the care and reduce the risk of poor pregnancy outcomes of women in this and in future epidemics.
Detailed Description
This is a randomized, double blinded, placebo-controlled multicenter clinical trial including 714 pregnant women (200 SARS-CoV-2 infected -100 symptomatic with mild disease and 100 asymptomatic- pregnant women and 514 SARS-CoV-2 uninfected pregnant women who are contacts with a SARS-CoV-2 case) with the main objectives of assessing the safety and efficacy of oral hydroxychloroquine (HCQ) in reducing maternal viral shedding by PCR, and preventing incident SARS-CoV-2 infection and disease severity. Pregnant women undergoing antenatal follow up at five maternity hospitals, presenting at least one sign and/or one mild suggestive symptoms and a positive SARS-CoV-2 PCR test, or who are contacts of a suspected or confirmed case, will be recruited and randomized 1:1 to receive HCQ orally (400 mg/day for 3 days, followed by 200 mg/day for 11 days) or placebo. Women will be followed up for the duration of the intervention. One week after intervention completion, a SARS-CoV-2 PCR test will be repeated. At delivery, the pregnancy outcome will be registered, and a cord blood sample will be collected to measure for IgG and IgM of SARS-CoV-2. A neonatal nasopharyngeal aspirate will be collected to perform PCR SARS-CoV-2 testing.
#Intervention
- DRUG : Hydroxychloroquine
- Participants will receive a bottle containing 19 tablets of study medication. They will be instructed to take two tablets for the first three days and one tablet for the following 11 days. (400 mg/day for three days, followed by 200 mg/day for 11 days).
- Other Names :
- Dolquine
- DRUG : Placebo
- Participants will receive a bottle containing 19 tablets of placebo. They will be instructed to take two tablets for the first three days and one tablet for the following 11 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:
* Presenting with fever (>=37.5ºC) and/or one mild symptom suggestive of COVID-19 disease (cough, dyspnoea, chills, odynophagia, diarrhoea, muscle pain, anosmia, taste disorder, headache) OR contact of a SARS-CoV-2 confirmed or suspected case in the past 14 days
* More than 12 weeks of gestation (dated by ultrasonography)
* Agreement to deliver in the study hospitals
Exclusion Criteria:
* Known hypersensitivity to HCQ or other 4-aminoquinoline compounds
* History of retinopathy of any aetiology
* Concomitant use of digoxin, cyclosporine, cimetidine
* Known liver disease
* Clinical history of cardiac pathology including known long QT syndrome
* Unable to cooperate with the requirements of the study
* Participating in other intervention studies
* Delivery onset (characterized by painful uterine contractions and variable changes of the cervix, including some degree of effacement and slower progression of dilatation up to 5 cm for first and subsequent labours)
Sex :
FEMALE
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 602 |
Target Study Title: The Effect of Gum Acacia on Satiety, Glycemic Response and Gastrointestinal Tolerance
Target Study Description: #Study Description
Brief Summary
This study will provide needed insight on the satiety and blood glucose and l effects of the soluble fiber gum acacia at 20g and 40g doses.
Detailed Description
This is a randomized, single-blind, crossover, intervention study testing the satiety and blood glucose effects of the soluble fiber gum acacia.
#Intervention
- OTHER : Low Fiber
- 20 g of acacia gum will be added to orange juice
- OTHER : High Fiber
- 40 g of acacia gum will be added to orange juice
- OTHER : Placebo/Control
- No acacia gum will be added to orange juice.
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: BMI between 18 and 29 kg/m2
Exclusion Criteria:
* distaste for bagels and cream cheese, orange juice or cheese pizza;
* current smoker;
* restrained eating habits;
* recent weight change;
* any history of disease or significant past medical history;
* are vegetarian;
* do not normally eat breakfast or lunch;
* pregnant or lactating;
* irregular menstrual cycles.
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>
| 603 |
Target Study Title: Voiding Log and Fluid Intake Habits Among Young Healthy Population
Target Study Description: #Study Description
Brief Summary
Health practitioners usually instruct patients with complaints of urinary incontinence and urinary tract infection regarding voiding and fluid intake habits. However poor drinking habits develop early in life, even prior to the symptoms presentation. Little is known about the voiding habits and fluid intake routine among healthy young population. The current study aims to assess the habits of drinking and voiding log among such population.
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 male and female Adolescent healthy population
Exclusion Criteria:
* History of incontinence Symptoms of urinary tract infection History of any pelvic floor disorder
Sex :
ALL
Ages :
- Minimum Age : 24 Years
- Maximum Age : 38 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 604 |
Target Study Title: Persistance of Anti-HPV After a Single Dose of Gardasil and the Effect of a Dose of Gardasil-9 When Administered 3-8 Years Later
Target Study Description: #Study Description
Brief Summary
This study will assess the immunogenicity of one dose of Gardasil and one dose of Gardasil-9
Detailed Description
This is a one group exploratory study.
The main objective of this study is to assess the persistance of anti-HPV after a single dose Gardasil and the effect of one dose of Gardasil-9 when administered 3-8 years later.
#Intervention
- BIOLOGICAL : Gardasil and Gardasil-9
- All subjects will receive one dose of Gardasil-9. Blodd samples for serological testing will be collected just before and one month post Gardasil-9 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: Have received a single dose of Gardasil 3 <= age <= 8 years before recruitement.
*
Exclusion Criteria: Immunossupressed or blood coagulation problems
*
Sex :
FEMALE
Ages :
- Minimum Age : 12 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 605 |
Target Study Title: A Patient Portal Intervention to Address Diabetes Care Gaps: A Usability Study
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to evaluate the usability of a novel patient portal intervention designed to: (a) notify patients when selected, clinically meaningful, evidence-based diabetes monitoring \& preventative care (e.g., annual diabetes eye exam) become due and (b) allow patients to initiate orders for the care. In addition, the investigators will assess pre-post change on secondary psychosocial outcomes (e.g., self-efficacy).
Detailed Description
Up to 60 adult patients with type 1 or 2 diabetes mellitus will be enrolled and given access to a new feature within the patient portal at Vanderbilt University Medical Center. The new feature will be available via the patient portal native app (i.e., My Health at Vanderbilt (MHAV) app) for mobile devices (smartphone or tablet). The new feature will allow patients to: (1) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (2) initiate an order for the care.
Study participants will complete questionnaires electronically via email at three time points: baseline (T0), immediately after first use of the intervention (T1), and three-month follow-up (T2) to as assess study outcomes including usability and pre-post change in secondary psychosocial outcomes.
#Intervention
- OTHER : Diabetes Care Gaps Patient Portal Intervention
- The Diabetes Care Gaps Patient Portal Intervention involves a new feature embedded with the My Health At Vanderbilt (MHAV) native app (on Epic's MyChart platform) for mobile devices that allows patients to: (a) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (b) initiate an order for the care. Automated notifications will be sent to patients if, according to the evidence-based guidelines, the patients are due for a hemoglobin A1C blood test, microalbumin urine test, diabetes eye exam, or pneumonia vaccination. Once notified patients can initiate orders for the care within the MHAV app. The patient will receive confirmation when the order has been processed and will be provided instructions to receive the relevant 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:
* Established patient at participating primary care clinic
* Type 1 or 2 diabetes mellitus
* Able to speak and read in English
* Age 18 <= age <= 75 old
* Mobile device (smartphone or tablet) with internet access
* Active MHAV account and willing and able to use the MHAV native app on a mobile device
* Due (based on evidence-based guidelines) for any of the following: hemoglobin A1C, urine microalbumin, diabetes eye exam, and/or pneumococcal vaccination.
Exclusion Criteria:
* Known cognitive deficits or functional impairment preventing the use of a mobile device
* Pregnant or planning to become pregnant during the study period
* Severe difficulty seeing
* Severe difficulty hearing
* Medical condition that make it hard for people to understand what they are saying
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>
| 606 |
Target Study Title: A Dyadic Telehealth Program to Support Alzheimer's Disease Patients and Their Caregivers During COVID-19
Target Study Description: #Study Description
Brief Summary
This study aims to refine and evaluate feasibility of a telehealth intervention for persons with Alzheimer's disease and their caregivers. The intervention will use evidence-based techniques for decreasing symptoms of depression, anxiety, and poor sleep, that are commonly reported among this vulnerable group during the COVID-19 pandemic. Improved symptoms among this group may improve their other health outcomes and quality of life and furthermore the quality of care that caregivers provide for persons with Alzheimer's disease during this challenging time.
#Intervention
- BEHAVIORAL : sleep education program
- A multicomponent behavioral sleep program, consisting of sleep hygiene, stimulus control, sleep compression, pleasurable activity, daily walking, and light 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:
Inclusion criteria for patients
* Have a diagnosis of AD (probable or possible), other related dementia, or mild cognitive impairment as documented in electronic medical record
* Community-dwelling
* Aged > 50 years
* Have no previously diagnosed sleep disorders (e.g., sleep apnea, restless legs syndrome)
* Able to ambulate with or without assistive devices (i.e., dyads will be excluded if the care recipient is bedbound)
* Have an eligible caregiver
Inclusion criteria for caregivers
* Aged >18 years
* Live with the eligible patient
* Have regularly assisted the care recipient with >1 of 7 basic activities of daily living (ADLs; i.e., eating, dressing/undressing, grooming, walking across a room, getting in and out of bed, bathing, toileting) or >1 of 7 Instrumental ADL (IADLs; i.e., using the telephone, getting to places beyond walking distance, shopping, preparing meals, doing housework, taking medicine, handling money) for the past 6 months
* Have no history of cognitive impairment
* Can communicate in English.
Exclusion Criteria:
*Professional caregivers will be excluded. Patients will be excluded if they are bedbound. If the eligibility criteria for either a patient or a caregiver are not met, their dyads will be excluded for this study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 607 |
Target Study Title: Effectiveness Evaluation of Alcohol Hand Gel Use in Mbale Regional Referral Hospital, Rural Eastern Uganda
Target Study Description: #Study Description
Brief Summary
Ministry of Health through the National Medical Stores has supplied alcohol-based handgels to the different health facilities in Uganda for the health care providers to use during clinical care. However, constant stock-outs and or limited supplies remains the main constraint faced by the hospitals. Thus the handgels are generally used by a few of the senior health care providers.
The promotion of bedside, antiseptic handrubs largely contributes to the increase in compliance and sustained improvement of hand hygiene compliance reduces Health care acquired infections (HCAIs), but it is not yet established how cost- effective the intervention is in a a rural Ugandan hospital where funds are severely rationed and, which serves over 4 million people in over 15 districts in Uganda. An evaluation of an intervention's cost-effectiveness is a crucial factor in whether the government will be prepared to fund the intervention and sustain it.
This WardGel study thus aims to assess the cost-benefit of providing hand gel for all health care workers in Mbale Regional Referral Hospital.
Detailed Description
The WardGel Study aims to assess the cost- effectiveness of providing handgel for all health care workers in selected wards of Mbale regional Referral Hospital in rural Eastern Uganda.
The WardGel study seeks to address the following specific objectives:-
1. To determine the incidence of new infections following hospital admission among in-patients
2. To assess the hand hygiene compliance among the health care providers (HCPs) as the usual practice and with handgel
3. To determine the effectiveness of handgel in reduction of new infections after hospital admission
4. To determine the additional costs associated with development of new infections after hospital stay
This study will compare infection rates before (pre-intervention phase) and after implementation of the hand gel for use by health care providers (intervention phase). The study will also assess hand-hygiene compliance amongst health workers and additional costs associated with management of new acquired infections amongst inpatients while at the hospital.
The pre-intervention phase lasting for 12 weeks will involve baseline evaluation of the current hand hygiene practices on each of the study wards, ascertaining how frequently HCPs washed their hands or used handgel.
At the end of 12 weeks, the Intervention will begin and last for 12 weeks. Alcohol-based hand gels will be introduced and provided to health care providers (HCPs) for use before and after each patient care episode.
In ward Training will be provided for all HCPs, including student trainees of clinical medicine and nursing prior to introduction of the hand gels on its use and any promotion messages for example, displaying posters in each hand washing area in the respective wards. Any other training will be arranged and conducted accordingly. 1-Litre handgel bottles will be fitted in the holders fixed to the walls on the wards, and other free bottles placed on the trolleys for using while conducting ward rounds, others on the reception area during the registration of inpatient, and treatment area while administering patients' treatment.
Also 40ml hand-sized bottles will be availed to health care providers. Additional stocks of the hand gel will be available in the staff areas and one central pharmacy area. Compliance with the intervention will be assessed by direct observation by the research assistants on each ward based on the WHO assessment tools and by volume of gel use.
In both phases, the following will be crosscutting: -
* The study shall adopt the WHO hand hygiene tools (the WHO 5-Moment Tool and hand hygiene compliance tool) to assess the hand hygiene compliance (WHO 2009).
* Prospective data will also be collected daily from all recruited inpatients on the wards prior to and during the implementation of the intervention to document the frequency of infections on admission and the rate of new acquired infections during their hospital stay.
The new infections definitions acquired after admission of the patients and applied in this WardGel study have been developed and modified from the CDC/NHSN Surveillance definitions for specific infections \[CDC 2014\].
* Individual patients data collected from patient interviews will be augmented by a review of their case files.
* Research assistants will interview all recruited patients and or their carers diagnosed with a new infection to assess the exact extra care costs incurred from patients' perspective. Meanwhile, hospital records shall help to establish the extra costs incurred for antibiotics, and health workers extra time. Other costs will be related hand gel supplies, training and start-up costs.
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 is admitted for at least 24 hours
* Any health care provider, including students
Exclusion Criteria:
* Patients discharged before 24 hours
Sex :
ALL
Ages :
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 608 |
Target Study Title: A Placebo-controlled, Single Blind, Randomized Two Part Study Toinvestigate the Tolerability, Pharmacokinetics, and brainDopamine D3 Receptor Occupancy of Increasing Repeat Doses ofGSK618334 for up to 21 Days in Healthy Volunteers.
Target Study Description: #Study Description
Brief Summary
The proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers.
Detailed Description
GSK618334 strongly binds to dopamine type 3 receptors in the human brain and is being developed as an innovative treatment for substance dependence. This study will evaluate the safety, tolerability, blood concentrations and effect following repeated oral doses of GSK618334 in healthy male and female volunteers. The effect of food on a single oral dose of GSK618334 will also be evaluated. Another portion of this study will investigate dopamine type 3 receptor binding in the human brain by PET scan before and after repeated doses of GSK618334.
#Intervention
- DRUG : GSK618334 Low Dose
- GSK618334 low dose
- DRUG : GSK618334 PET subjects
- PET subjects
- DRUG : GSK618334 Medium Dose
- Medium Dose
- DRUG : GSK618334 High Dose
- GSK618334 High Dose
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Healthy Males and Females between the ages of 18 <= age <= 50 years
* Male and Female subjects must agree to use protocol specified contraceptive methods.
* Male subjects only in PET parts of the study.
* Capable of providing written informed consent.
Exclusion Criteria:
* A positive test for Hepatitis B or Hepatitis C within 3 months of screening.
* Current or chronic history of liver disease, or known liver/bile/gallbladder abnormalities.
* Personal or family history of heart disease (such as irregular heart beats, a history of sudden unexplained death in a first degree relative, or unexplained fainting).
* Screening ECG parameters outside the protocol specified parameters.
* Pulse rate <50 or >100 bpm OR a systolic blood pressure >140 or <95 mmHg OR a diastolic blood pressure >90 or <50 mmHg at screening and/or baseline.
* Pregnant or lactating females.
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
* Previous inclusion in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden.
* Significant suicidal risk.
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>
| 609 |
Target Study Title: A Multi-Center, Randomized, Subject and Evaluator Blind, Split-Face Comparative Medical Device Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus to Restylane® Sub-Q for Correction of Nasolabial Folds
Target Study Description: #Study Description
Brief Summary
This study is to verify that Dermalax Implant Plus is not inferior to the reference device, Restylane® Sub-Q, in terms of efficacy and safety in the correction of nasolabial folds
#Intervention
- DEVICE : Dermalax Implant Plus
- Dermalax implant plus injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.
- DEVICE : Restylane Sub-Q
- Restylane Sub-Q injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.
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 subjects no younger than 30 and no more than 75 years.
* Subjects who scored 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) and want to improve the appearance of their nasolabial folds (the subject does not need to have the same score on both sides.*)
*The scores need not to be same on both sides, but the two nasolabial folds should have symmetry in the range of 3 <= age <= 4.
* Subjects who have symmetric nasolabial folds.
Exclusion Criteria:
* Subjects who received an antithrombotic agent within 2 weeks prior to screening (with the exception of low dose Aspirin less than 300 mg/day)
* Subjects who have a history of bleeding disorder.
* Subjects who have received calcium hydroxyapatite, CaHA injection in nasolabial area.
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>
| 610 |
Target Study Title: Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent Nausea and Vomiting Induced by Cisplatin-Based Doublet Chemotherapy: A Non-inferiority, Prospective, Multi-Centered, Randomized, Controlled, Phase III Clinical Trial
Target Study Description: #Study Description
Brief Summary
Chemotherapy-induced nausea and vomiting is a common side effect of cancer treatments, and dexamethasone offers a clear advantage over placebo for protection against chemotherapy-induced emesis in both acute and delayed phases. However, its side effects such as moderate to severe insomnia, hyperglycemia, dyspepsia, upper abdominal discomfort, irritability, increased appetite, weight gain and acne are gathering increasing concerns. Several clinical trials have shown that olanzapine plays an important role in treating delayed, refractory, breakthrough nausea and vomiting. Its side effects mainly include sedation and weight gaining. At present, the NCCN guidelines have recommended olanzapine-containing three-drug regimen for Highly Emetogenic Chemotherapy (HEC) and moderate emetic chemotherapy (MEC) to prevent vomiting, but its data in the Chinese population is limited. Hence, we initiated this prospective, multi-center, phase III study to validate the dexamethasone-free protocol: applying olanzapine to prevent CINV instead of dexamethasone.
#Intervention
- DRUG : Olanzapine+NK-1 RA+5-HT3 RA
- On day 1-4, Olanzapine (5mg) is delivered orally after dinner.
- DRUG : Dexamethasone+NK-1 RA+5-HT3 RA
- On first day, dexamethasone (12 mg) is given orally/intravenously within 30 minutes before cisplatin administrated, and on day 2-4, the given dose of dexamethasone is 8 mg.
- Other Names :
- Acidocont, Deronil, Dexacortal, Desameton, Fluprednisolone, (11β，16α）-9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
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 are eligible to be included in the study only if they meet all of the following criteria):
* Cancer patients, age >= 18 years and <=75 years, ECOG score 0 <= age <= 2 points, receiving cisplatin-containing doublet chemotherapy such as cisplatin + gemcitabine / albumin paclitaxel / etoposide /fluorouracil / irinotecan / temozolomide as first line treatment;
* Life expectancy >= 3 months;
* Leucocytes>=3,000/uL;
* AST<=2.5 × upper limit of normal;
* Bilirubin <=1.5 × upper limit of normal;
* Serum creatinine <= 1.5 × upper limit of normal.
Exclusion Criteria (Patients will be excluded if any of the following criteria is met):
* History of CNS disease, such as brain metastases or epilepsy;
* Use of other antipsychotic drugs (such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone, or such treatment is under scheduling during the study) within 30 days before enrollment; long-term use of phenothiazine as an antipsychotic agent;
* Concurrent use of pharyngeal or abdominal radiotherapy;
* Concurrent use of quinolone antibiotics;
* Chronic alcoholism;
* Known hypersensitivity to olanzapine;
* Know arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within 6 months;
* Known uncontrolled diabetes mellitus;
* Vomiting or retching 24 hours before chemotherapy;
* Use of anti-emesis drugs 48 hours before chemotherapy;
* Concurrent use of amifostine;
* Concurrent use of corticosteroids and the only anti-allergic choice is corticosteroids
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>
| 611 |
Target Study Title: Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy
Target Study Description: #Study Description
Brief Summary
Hypothesis: Ropivacaine, morphine and ketorolac injected after knee arthroscopy is as effective as this solution plus ropivacaine administered intra-articularly for twenty-four hours.
Three groups were assigned random patients, each group provided a different method of pain medication in order to determine the effectiveness of each treatment.
Detailed Description
Arthroscopic knee patients were randomized to 1 of 3 groups. A) 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; B) an identical solution plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour; C) an identical solution and no pain pump. Pain level, the amount of pain medication used and time to discharge were recorded. Clinical and radiographic evaluation was performed at nine months after surgery.
#Intervention
- DEVICE : pain pump containing ropivacaine
- 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour
- Other Names :
- ropivacaine, pain, pump
- DEVICE : saline pain pump with injectable medication
- 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
- Other Names :
- ketorolac, saline
- DRUG : ropivacaine, ketorolac , morphine sulfate
- 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
- Other Names :
- morphine, sulfate
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 subjects who underwent:
* knee arthroscopy + synovectomy
* knee arthroscopy + partial or complete meniscectomy
* knee arthroscopy + chondroplasty
* knee arthroscopy + microfracture
* knee arthroscopy + autologous osteoarticular transplantation
Exclusion Criteria:
* A surgical procedure that required an incision other then an arthroscopic portal
* A surgical procedure within the same joint within ninety days
* A acute or chronic knee infection
* Any diagnosis of complex regional pain syndrome
* A known allergy to one of the study drugs
* A documented history of narcotic use
* A score of less than two standard deviation on the SF-12 mental component
* Any major systemic or cardiac illness (heart failure, uncontrolled angina, bifascicular blocks, renal insufficiency, or liver disease)
* Under the age of eighteen years
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>
| 612 |
Target Study Title: The Pharmacokinetic Parameters of Tenofovir (TFV) in Maternal Blood and Breast Milk in Women Treated With Daily Tenofovir Disoproxil Fumarate (TDF; 300mg) for Prevention of Mother to Child Transmission (PMTCT) of Hepatitis B Virus (HBV) Mono-infection
Target Study Description: #Study Description
Brief Summary
Hepatitis B virus (HBV) can be asymptomatic for years but can also lead to chronic hepatitis, hepatocellular carcinoma, and liver failure and death and cannot be eradicated with the current therapy. Chronic maternal HBV infection is an important source of perinatal transmission in regions of high HBV prevalence. In antenatal clinics at Shoklo Malaria Research Unit (SMRU), the Hepatitis B (HB) surface antigen (sAg) prevalence is 8.3% with a HB e-antigen (HBeAg) prevalence of 32.7% in those positive for HBsAg in 2012-2014. Perinatal infection occurs in 70-90% of women with HBeAg positive chronic HBV compared with 0-30% in those with HBeAg negative chronic HBV (inactive carriers). These infection rates reflect, in part, the failure of maternal and child health programs to prevent perinatal transmission with hepatitis B immunoglobulin (HBIG) and HB vaccines. Prevention of mother to child transmission (PMTCT) fails in an estimated 8-32% of cases with adequate preventive techniques. Antiretrovirals, like tenofovir (TFV) that is administered as the prodrug Tenofovir Disoproxil Fumarate (TDF), are active against HBV and may reduce the risk of HBV transmission at birth if offered at the right time in pregnancy.
One of the major gaps in implementing this strategy is adequate pharmacokinetic (PK) data in pregnant women that informs correct dosing. One recently published population PK study in 154 women who provided maternal blood samples (32 and 36 weeks of pregnancy, at delivery, and at 1 and 2 months post-partum) reported a tenofovir area under curve (AUC) 0-24 that was estimated to be 20% (95% CI, 19-21%) lower during pregnancy than during post-partum suggesting no dose adjustments are needed in 3rd trimester. Most PK studies for TDF in pregnancy have been for Human Immunodeficiency Virus type 1 (HIV-1) infections. However, these patients often receive additional antiretroviral medications, preventing conclusions on PK parameters of Tenofovir (TFV) alone. Doses that are optimal for HIV may not be appropriate for HBV.
When TDF is administered during pregnancy and potentially during lactation, it is important to establish the infant drug exposure. Previous human studies have shown that antiretrovirals administered to lactating mothers are present in the breast milk and have detected a low TDF breast milk concentration representing 0.03% or less of the proposed infant dosage. However, there is no data on this subject in therapeutic treatment of HBV infected women. In resource poor settings TDF administration will be ceased after 1 month post-partum. While there is some understanding of what happens to viral load post cessation in non-pregnant individuals, post-partum TDF cessation is less well understood and may be affected by differences in immunity. With breastmilk as the primary source of nutrition for babies in resource limited settings, it is important to know the viral exposure from breastmilk, if any, as these settings may also have problems achieving birth dose, HBIG and completion of the recommended three doses of vaccine.
The investigators propose a dense PK study of once daily TDF 300 mg during pregnancy given for PMTCT of HBV mono-infection. Tenofovir PK will be measured in maternal blood samples in steady-state, in the 2nd and 3rd trimesters and post-partum. The presence of HBV DNA in blood and breast milk will also be explored in women after cessation of treatment until 6 months post-partum.
Detailed Description
Participants with HBV mono infection and a measurable HBV DNA viral load attending SMRU antenatal clinics (ANC) on the Myanmar-Thailand border will be invited if they have a gestational age of at least 20 weeks. A total of 24 women: 12 participants enrolled in 2nd trimester (EGA 20-\<24 weeks) and 12 enrolled in 3rd trimester (EGA 28-\<36) with complete samples are required.
Women, identified by routine antenatal care screening for HBV will be invited to participate if they are HBsAg positive and meet the inclusion and exclusion criteria. Participants will be provided TDF 300mg daily and will continue TDF treatment until one month after delivery. The TFV concentrations will be measured monthly before delivery, at delivery, in cord blood and 1 and 2 months postpartum. Additional dense PK blood sampling will be done in the second and third trimester and postpartum. Breast milk samples timed with mother blood and infant blood samples will be included to measure drug concentrations in breastmilk as possible presence of HBV DNA viral in breastmilk following cessation of TDF.
The dense sampling for pharmacokinetics assessments will occur at least after 2 weeks of TDF treatment in second trimester between 22-26 weeks gestation, in third trimester between 30-38 weeks gestation, and 4 weeks postpartum. The dense sampling will entail twelve blood samples in a 24 hour period (24ml of blood in total). Women will be counseled about the importance of adherence. Direct Observed Treatment (DOT) in the 3 days prior to the dense blood sampling will be performed. The woman can choose to be admitted for these days or if a home visitor lives close enough be supervised at home.
The follow-up for women will be until 6 months post-partum, to check for flares. TFV concentrations will be collected by venous blood testing but an indwelling catheter can be used during the rich sampling 24 hour period. Infants will be followed up from delivery, and at 1, 2, 4 and 6 months of age for vaccination and growth. Infant drug exposure is measured at month 1 and HBV DNA will be measured at birth from cord blood and HBsAg by venepuncture at 2 months of age.
Funder \& grant reference number: iTPA Award (grant ref. no. WT-iTP-2019/006)
#Intervention
- DRUG : Tenofovir Disoproxil Fumarate
- Tenofovir Disoproxil Fumarate 300 mg once daily and will continue until one month after delivery
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:
* Single viable pregnancy at enrollment day
* Estimated Gestational Age (EGA) 20-<24 weeks for 2nd trimester or EGA 28-<34 for 3rd trimester
* Willing and able to give informed consent for participation in the study
* Hepatitis B infected (HBsAg and HBeAg confirmed positive or HBsAg confirmed positive and HBV DNA detected in HBeAg negative)
* Burmese and Karen female, 16 <= age <= 49 years (inclusive)
* Willing to take TDF daily during pregnancy
* Plans to deliver at SMRU clinics
Exclusion Criteria:
* Undetectable HBV DNA in HBeAg negative women
* HIV infected or other chronic illness incompatible with the study requirements or receiving Immunosuppressive therapy
* Creatinine at screening >1 mg/dL
* Serum phosphate <2.4 mg/dL
* History of chronic kidney disease
Sex :
FEMALE
Ages :
- Minimum Age : 16 Years
- Maximum Age : 49 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 613 |
Target Study Title: The Use of Methylphenidate to Improve Clinical Outcomes in Geriatric Depression: A Double-blind Placebo-Controlled Trial of Methylphenidate (Ritalin) Augmentation of Citalopram (Celexa) in Depressed Elderly Patients
Target Study Description: #Study Description
Brief Summary
This study will evaluate the safety and effectiveness of methylphenidate in improving cognition and function in older adults with depression.
Detailed Description
Less than 50% of older adults with depression achieve remission and functional recovery in response to first-line antidepressant treatment. Most are left with significant residual symptoms, putting them at risk for illness relapse, frailty, and suicide. Improved understanding of the neurobiology of depression in older adults and mechanisms of treatment response may lead to better clinical management of depression. Methylphenidate (MPH) has long been used in the elderly and the medically ill to provide rapid improvement in depression, apathy, and fatigue. However, its potential beneficial effects on cognitive and functional outcomes in older adults with depression have not been studied. Combining MPH with the serotonergic antidepressant citalopram may result in better clinical outcomes than would using citalopram alone. This study will compare the safety and effectiveness of MPH combined with citalopram, MPH combined with placebo, and citalopram combined with placebo in improving thinking, memory, and speed of recovery in older adults with depression. The study will also evaluate selected dopamine- and serotonin-related gene relationships with mood, cognitive symptoms, and treatment response to MPH and citalopram.
Participation in this double-blind study will last 16 weeks. All potential participants will initially undergo comprehensive medical, neuropsychiatric, and cognitive assessments and genetic testing. These initial assessments will include questionnaires about depressive symptoms, a medical history, an electrocardiogram (ECG), and a blood draw for the genetic testing. Eligible participants will then be randomly assigned to one of three groups: MPH and citalopram, MPH and placebo, or citalopram and placebo. All participants will receive 16 weeks of treatment with their assigned medications. Study visits will occur weekly for the first 6 weeks of treatment and bi-weekly for the remainder of the study. During study visits, participants will undergo vital sign and weight measurements, answer questionnaires, and report any medication side effects. Blood will again be drawn at Visits 4 and 10, and the ECG will be repeated at Visit 10 if any cardiac symptoms occur. Most initial assessments will be repeated on Visit 13, the last study visit. Participants will also be contacted weekly by phone throughout the study to answer questions on how they are feeling and any possible side effects.
#Intervention
- DRUG : Citalopram
- Citalopram dosage will be 20 to 60 mg a day prior to FDA warning limiting it to 20-40 mg in 2011. Participants will begin taking one 20-mg capsule once per day for 4 weeks, and this dosage may be increased or decreased depending on the participant's response to the medication or side-effect profile. Participants will continue on their assigned dosage of citalopram that will be titrated up after week 4 if clinical global impressions (CGI) scores were \> 2 until treatment completion.
- Other Names :
- Celexa
- DRUG : Methylphenidate (MPH)
- MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule (2.5 mg) twice per day, which will be increased to a maximum up to 8 x 2.5 mg capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
- Other Names :
- Ritalin
- DRUG : Placebo
- Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day matching methylphenidate, and 1-3 capsules matching citalopram. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.
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:
* Meets Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for major depressive disorder (recurrent and nonrecurrent course will be identified)
* Score of 16 or higher on the 24-item Hamilton Depression Rating Scale (HDRS) at study entry
* Score of 26 or higher on the Mini-Mental State Exam (MMSE)
Exclusion Criteria:
* History of psychiatric illness or a substance abuse disorder other than unipolar depression, diagnosed prior to the onset of the first depressive episode
* Presence of psychotic symptoms
* Severe or acute medical illness (e.g., major surgery, metastatic cancer, stroke, heart attack) 6 months prior to study entry
* Acute suicidal or violent behavior or history of suicide attempt within the year prior to study entry
* Presence of delirium, neurodegenerative dementia, Parkinson's disease, or any other central nervous system (CNS) diseases
* Toxic or metabolic abnormalities on laboratory examination
* Medications taken or medical illnesses present that could account for depression
* Active heart failure categorized as Class III or greater according to New York Heart Association criteria
* Heart attack or crescendo angina within the 3 months prior to study entry
* Symptomatic cardiac arrhythmias or symptomatic, hemodynamically significant mitral or aortic valvular disease
* Resting heart rate less than 50 beats per minute and a corrected QT (QTc) interval greater than 0.45 seconds
* Second or third degree atrioventricular block
* Systolic blood pressure greater than 180 mmHg or less than 90 mmHg and diastolic blood pressure greater than 105 mmHg or less than 50 mmHg at study entry
* Treated with depot neuroleptic therapy within 6 months prior to study entry
* Treated with any neuroleptic, antidepressant, anxiolytic medication (other than lorazepam), or over-the-counter CNS-active medications used for treatment of depression (e.g, St. John's Wort, kava-kava, melatonin) within 2 weeks (4 weeks for fluoxetine or monoamine-oxidase inhibitors (MAOIs)) prior to the first administration of study medication
* Known allergy to citalopram or MPH or history of ineffective treatment with citalopram or MPH for current depressive episode
* Requires concomitant therapy with any prescription or over-the-counter medications that have potentially dangerous interactions with either citalopram or MPH
* Requires electroconvulsive therapy (ECT) or received ECT within 3 months prior to study entry
* Initiated psychotherapy within 3 months prior to study entry or will be initiating or terminating psychotherapy during the study
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 614 |
Target Study Title: A Study to Evaluate the Single-Dose and Steady-State Pharmacokinetics/Dynamics of 1592U89 and Its Active Moiety, 1144U88 5'-Triphosphate (1144U88-TP) Following Six Different Dosing Regimens of 1592U89 in HIV-1 Infected Subjects
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to see if it is safe to give 1592U89 to HIV-infected patients. This study also examines the effect 1592U89 has on plasma viral load (the level of HIV in the blood).
Detailed Description
Cohorts of 8 patients are entered sequentially into 1 of 6 1592U89 dosing regimens. All patients receive 12 weeks of monotherapy during the initial 12-week treatment phase.
On completion of the treatment phase, patients are offered continuation therapy with 1592U89 for a minimum of 12 weeks.
#Intervention
- DRUG : Abacavir sulfate
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
Prophylaxis for opportunistic infections.
Patients must have:
* HIV-1 infection.
* CD4 cell count 100 - 500 cells/mm3 within 3 to 5 weeks prior to study drug administration.
* No active diagnosis of AIDS (other than non-visceral Kaposi's sarcoma) according to the 1993 CDC AIDS surveillance definition.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and symptoms are excluded:
* Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption.
* Chronic disease such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that in the opinion of the investigator, would compromise the safety of the patient.
Concurrent Medication:
Excluded:
* Immunomodulating agents.
* Chemotherapeutic agents.
* Antiretroviral therapy. NOTE:
* Patients who elect to continue study treatment into the extended phase may, after consultation with their primary physician, combine 1592U89 at a recommended dose of 300 mg bid with other licensed antiretroviral drugs.
Concurrent Treatment:
Excluded:
Radiation therapy.
Patients with the following prior conditions are excluded:
* History of clinically relevant hepatitis or pancreatitis within 6 months prior to study drug administration.
* History of hypersensitivity, anaphylactic, or idiosyncratic reaction to nucleoside analogs.
Prior Medication:
Excluded:
* Treatment with immunomodulating or cytotoxic chemotherapeutic agents within six weeks prior to study drug administration.
* Antiretroviral therapy within 2 weeks prior to administration of study drugs.
Prior Treatment:
Excluded:
Radiation therapy within six weeks prior to study drug administration. Current alcohol or illicit controlled substance use that in the opinion of the investigator, may interfere with the patient's ability to complete 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>
| 615 |
Target Study Title: A Long-Term, Randomized, Double-Blind Study of the Safety, Tolerability and Efficacy of Aclidinium Bromide At Two Dosage Levels When Administered to Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.
#Intervention
- DRUG : Aclidinium Bromide 200 µg
- aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
- DRUG : Aclidinium Bromide 400 µg
- aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of 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:
* A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2010; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 >= 30% and < 80% predicted
* Current or former cigarette smokers
Exclusion Criteria:
* Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
* Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
* Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
* History or presence of asthma verified from medical records
* Chronic use of oxygen therapy greater than or equal to 15 hours per day
* Patient with uncontrolled infection due to HIV and/or active hepatitis
* Patients with a history of hypersensitivity reaction to inhaled anticholinergics
* Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 616 |
Target Study Title: Assessment of Patient-reported Goal Attainment in the Treatment of Female Overactive Bladder (Phase Ⅳ)
Target Study Description: #Study Description
Brief Summary
For many years, antimuscarinics have been first-line pharmacological treatment for OAB. A recent meta-analysis of randomised, controlled trials on antimuscarinic treatment of OAB concluded that the drugs provide significant improvements in OAB symptoms compared with placebo but that the benefits are of limited clinical significance. The analysis questioned the clinical significance of the trial results, one reason for which was the lack of data on the use of sensitive patient-driven criteria. Traditional symptomatic and urodynamic measures of treatment success may be meaningful to clinicians but often have little meaning to patients. Therefore, patient-reported outcomes (PROs), which provide a subjective measure of a patient's response to treatment, are useful. Recently, clinicians treating OAB have begun to recognize the value of PROs but still overlook the treatment efficacy in terms of patient-reported goal achievement (PGA).
Patients with OAB have combination of symptoms and the extent to which individual OAB symptoms affect patients varies. Also each patient can have different goal for the treatment. Therefore, assessing the degree of goal achievement in each patient can provide a new aspect of treatment benefit.
This controlled study will advance the understanding of OAB in terms of patient-centered treatments goals and goal achievement and will provide a new aspect of treatment benefit.
Detailed Description
1. Objectives
1. Primary objective: To explore the 'Patient-reported Goal Attainment (PGA)' after 12 weeks of treatment with tolterodine extended-release (ER) 4mg in female overactive bladder (OAB) patients.
2. Secondary objective: To explore the patient-reported treatment goals and the efficacy of tolterodine on the patient-reported outcomes (PROs), micturition diary parameters, and safety parameters from baseline to 12 weeks of treatment in female OAB patients.
2. Specific aim
: To compare the efficacy of tolterodine ER 4mg with that of placebo, on PROs in terms of PGA after 12 weeks of treatment in female OAB patients.
3. Experimental/research design
1. 12-week randomized, placebo-controlled, double-blind, parallel-group, prospective study in Korean women with symptoms of OAB
2. Treatment: Each patient will receive tolterodine ER (4 mg, qd) or placebo (randomized in the ratio of 1:1) for 12 weeks.
3. Time schedule Start date: 01/Jan/2009 Finish date: 01/Sep/2009 Duration of washout: 7 days Duration of run-in: 7 days Duration of enrollment period: 5 months Duration of treatment period: 12 weeks Completion of analysis: 6 weeks
#Intervention
- DRUG : Tolterodine extended-release (ER) 4mg
- Tolterodine extended-release (ER) 4mg once daily for 12 weeks
- Other Names :
- Detrusitol ER 4mg
- DRUG : Placebo
- Identical Placebo once 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:
* Female aged >= 18 and <= 80 years
* Symptoms of OAB as verified by the screening 3 day micturition diary, defined by:
Mean urinary frequency >=8 times/24 hours Mean number of urgency episodes >= 2 episode/24 hours
* Symptoms of OAB for >= 3 months.
* Ability and willingness to correctly complete the micturition diary and questionnaire
* Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits
Exclusion Criteria:
* Subjects with stress incontinence or mixed stress/urge incontinence where stress incontinence is the predominant component based on prior history.
* Significant hepatic or renal disease, defined as having twice the upper limit of the reference range for serum concentrations of aspartate amino- transferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), alkaline phosphatase or creatinine.
* Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
* Symptomatic acute urinary tract infection (UTI) during the run-in period
* Recurrent UTI defined as having been treated for symptomatic UTI > 4 times in the last year
* Diagnosed or suspected interstitial cystitis
* Clinically significant bladder outlet obstruction or poor detrusor function defined by clinical symptoms and investigator's opinion according to local standard of care
* Previous history of major urethral and/or bladder surgery
* History of radiation treatment (external or interstitial) to pelvic organs or external genitalia for any reason.
* Subjects with neuropathology that could affect the lower urinary tract or nerve supply
* Patients with marked cystocele or other clinically significant pelvic prolapse.
* Subjects with current (within 2 years) urogenital neoplasms or malignancies including bladder, uterine or cervical cancer
* Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with: Any anticholinergic drugs other than trial drug Any drug treatment for overactive bladder
* On an unstable dosage of any drug with anticholinergic side effects, or expected to start such treatment during the study
* Subjects currently taking tricyclic antidepressants, diuretics or alpha blockers who have not been on a stable dose of these medications for at least one month
* Current administration of a selective serotonin reuptake inhibitor (SSRI) and has not been on a stable dose for at least three months
* Receipt of any electrostimulation or bladder training within the 14 days before randomization, or expected to start such treatment during the study
* An indwelling catheter or practicing intermittent self-catheterization
* Use of any investigational drug within 1 months preceding the start of the study
* Patients with chronic constipation or history of severe constipation
* Pregnant or nursing women
* Sexually active females of childbearing potential not using reliable contraception for at least 1 month prior to study start and not agreeing to use such methods during the entire study period and for at least 1 month thereafter *Reliable contraceptive methods are defined as intrauterine devices (IUDs), combination type contraceptive pills, hormonal implants, double barrier method, injectable contraceptives and surgical procedures (tubal ligation or vasectomy).
* Any other condition which makes the patient unsuitable for inclusion.
Sex :
FEMALE
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>
| 617 |
Target Study Title: Use of Virtual Reality for Procedural Planning of Transcatheter Aortic Valve Replacement (TAVR)
Target Study Description: #Study Description
Brief Summary
This study sought to evaluate the impact of Virtual Reality (VR) tools in procedural planning of transcatheter aortic valve replacement (TAVR).
Detailed Description
A prospective study involving 11 patients referred for TAVR was conducted. A multidetector computed tomography (MDCT) was used to acquire and segment the anatomy of the access route and landing zone. From the information obtained with the MDCT in DICOM format, the investigators built a virtual platform (VisuaMed, Teacher Team. Valencia. Spain) that contains all the clinical information of the patients and a virtualized model of their anatomy. Wearing VR devices, the professional was able to 'walk inside ' the anatomy in an interactive and immersive way. Decisions after the evaluation of routine clinical images were compared with those after experience with VR models and intraprocedural findings.
#Intervention
- DIAGNOSTIC_TEST : TAVR planning
- TAVR planning without VR vs after VR
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:
* Severe aortic stenosis considered for TAVR procedure at a single Institution
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>
| 618 |
Target Study Title: A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy (Paclitaxel And Carboplatin) Vs. Chemotherapy Alone For The Treatment Of Advanced Stage Non-Small Cell Lung Cancer.
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase inhibitor when given in combination with chemotherapy (carboplatin and paclitaxel) is effective in the treatment of advanced stage non-small cell lung cancer.
#Intervention
- DRUG : CP-547,632
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 cytologically confirmed stage IIIB (inicluding those with pleural effusion), IV or recurrent non-small cell lung cancer (nsclc).
* Bidimensionally measurable disease >2cm x 1 cm by conventional CT Scan or >1 cm x 1cm by spiral CT Scan.
Exclusion Criteria:
* No tumors in close proximity to major veins or arteries.
* No sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease.
* No evidence or history brain metastases.
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>
| 619 |
Target Study Title: Functional Neuroimaging of Alcoholism Vulnerability: Glutamate, Reward, Impulsivity and Pavlovian-to-Instrumental Transfer (PIT)
Target Study Description: #Study Description
Brief Summary
This project compares Family History Positive (FHP) for alcoholism subjects to matched Family History Negative (FHN) subjects derived from the project Principal Investigator's National Institute on Alcohol Abuse and Alcoholism-funded longitudinal study of drinking behavior in a 2000 college freshman population (known as the Brain and Alcohol Research in College Students study (BARCS)). The age of these subjects is a valuable one at which to capture the transition from harmful use to abuse/dependence. This project explores the effects of memantine in a double-blind, randomized, counterbalanced manner on alcoholism risk-relevant tasks. More specifically, this project studies functional MRI tasks related to different aspects of reward and/or impulsivity-related behavior in different contexts, compares the underlying neural circuitry across tasks, and uses a pharmacologic probe of the glutamatergic system to examine NMDA/DA interactions. The combined measures provide the opportunity to advance our understanding of specific aspects of brain function related to familial alcoholism vulnerability in an already well-characterized population as some members evolve into alcohol abuse. In addition to conventional within-task analyses, functional network connectivity and allied approaches will be used to examine brain networks across tasks.
The investigators will study adult male and female subjects in equal numbers who are either offspring of an alcoholic parent or are FHN matched controls. The investigators will recruit and assess a total of 84 (42 FHP and 42 matched FHN) subjects between the ages of 18-21 years on initial BARCS contact. The investigators will use 4 cognitive tasks during the functional MRI (fMRI) which include: 1) a Monetary Incentive Delay Task that distinguishes networks engaged in motivational (anticipation) and consummatory (outcome) components of reward processing; 2) a Go/No-Go Task that measures the ability to inhibit response to a pre-potent stimulus; 3) an Alcohol Cue Reactivity Task that examines Nucleus Accumbens response to alcohol-related versus matched soft drink stimuli; and 4) a Pavlovian-to-Instrumental Transfer (PIT) Task that dissects a component of the Monetary Incentive Delay (MID) Task, and provides an imaging assay of a transfer-like process that can be related to real-world drinking behavior, thus informing upon and extending the key findings from CTNA-2.
#Intervention
- DRUG : Memantine
- Memantine is a low-side-effect NMDA receptor antagonist usually administered therapeutically to elderly persons with moderately severe Alzheimer's disease in typical doses of 10-20 mg daily. In this study, single doses of 40 mg are administered.
- DRUG : Placebo
- Identically appearing sugar pill, given orally
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Biological father with a history of Alcoholism
* A least 1 other first- or second-degree relative with a history of Alcoholism.
Exclusion Criteria:
* Cannot be an only child
* A diagnosis of DSM-IV-TR Axis I psychotic disorders screened with the Mini International Neuropsychiatric Interview (MINI), done in the BARCS study (with the exception of Alcohol Abuse)
* Report of psychotic disorder in a 1º relative
* Prenatal exposure to alcohol (mother reported to drink 3 or more drinks on an occasion or more than 3 times per month during pregnancy
* Not speaking English fluently or being a non-native English speaker, or being educated in a primary language other than English >grade 1
* Mental retardation (Full Scale IQ<70)
* Traumatic brain injury with loss of consciousness > 30 minutes or concussion in last 30 days
* Presence or history of any medical/neurologic illness that may affect brain physiology (e.g., epilepsy, Multiple Sclerosis), including focal brain lesion seen on structural MRI (all structural scans are read by a licensed radiologist)
* Current pregnancy (all females will be tested with urine screens on the day of MRI)
* Any positive alcohol screen will result in exclusion
* Inability to comprehend the consent form appropriately
* Other specific fMRI exclusions include metal devices, clips or fragments in body (orbital x-ray performed if needed)
* Female participants under 125 pounds will be excluded from participating due to the strength and side effects in this segment of the population.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 35 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 620 |
Target Study Title: The Role of Lactate From Viral to Bacterial Infection
Target Study Description: #Study Description
Brief Summary
Acute upper respiratory tract infection(AURI) is common in children, and viral infection is the main cause. However, several children with viral infection are easy to suffer from secondary bacterial infection, and the mechanism is unclear.
Detailed Description
Lactate is an important molecule in the spread and metastasis of tumor by suppressing the innate immune response. As is known, the immune system is not mature in children and it is reverse related to the age of children. An reasonable hypothesis is that the lactate is a independent risk factor in the children with viral infection progress to bacterial infection. Here, our aim is to test the hypothesis.
#Intervention
- OTHER : viral infection
- a child is infected by virus only
- OTHER : viral and bacterial infection
- a child is infected by virus and progress to bacterial infection
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:
* child's age is from 0 <= age <= 18
* a child is at least diagnosed with viral infection
Exclusion Criteria:
one of the following conditions appeared:
* congenital heart disease or other abnormalities
* respiratory failure
* hereditary and/or metabolic disease
Sex :
ALL
Ages :
- Minimum Age : 1 Minute
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 621 |
Target Study Title: Actions for Collaborative Community Engaged Strategies for HPV (ACCESS-HPV)
Target Study Description: #Study Description
Brief Summary
In the current pilot study, Actions for Collaborative Community-Engaged Strategies for HPV (ACCESS-HPV), investigators will use participatory crowdsourcing methods to drive HPV prevention among mother-daughter dyads. Crowdsourcing open calls will allow us to identify locally relevant messages and dissemination techniques to increase uptake of HPV prevention. Then, participatory learning communities will build capacity for community led implementation of selected strategies. Informed by social learning theory and the PEN-3 cultural model, our multi-disciplinary research team proposes the following specific aims: (1) to develop a new combined campaign to increase HPV vaccination for young girls (ages 9-14) and HPV self-collection for mothers (ages 30-65) using crowdsourcing open calls and participatory learning communities; and (2) to determine the preliminary effectiveness of, seven crowdsourced campaign on uptake of HPV vaccination among young girls/women and HPV self-collection among their mothers. Our primary outcome will be HPV vaccine uptake (ascertained by clinic records of vaccine uptake) among young girls and HPV self-collection (ascertained by laboratory receipt of specimens) among their mothers. The strong support of the Nigerian Institute for Medical Research (NIMR) alongside national HPV programs creates a rich research infrastructure and increases the likelihood of successful implementation. Our multi-disciplinary research team has experience organizing implementation research focused on crowdsourcing and community participation in Nigeria. This pilot study will enhance our understanding of HPV prevention in resource-constrained settings.
Detailed Description
Step 1: Health facilities training. For the purposes of this research study, the Nigerian Institute of Medical Research team would provide training to health centers currently working with the Nigerian Institute of Medical Research .The training would be to ensure that these health facilities are trained to provide follow up services to participants who be referred. Following the training, the NIMR research team would in charge of collecting data to record participants HPV self-collection uptake and HPV vaccination uptake.
Step 2: Participant enrollment. This will involve recruiting women and girls to participate in the pilot study. Participant recruitment strategies will include: social media, online, event- and venue based, participant referral, and walk-ins at study clinics. Participant enrollment will be completed by study team.
Step 3: Baseline data collection. After enrollment, study team will collect baseline data on HPV self-collection and cervical cancer screening history, knowledge of cervical cancer, HPV screening, determine the role of intersectional stigma on barriers and facilitators of HPV-related service delivery (HPV vaccination/HPV self-collection) among Nigerian girls and women, assess the feasibility, acceptability, and preliminary impact of three asset-based mother-daughter interventions that address intersectional stigma and HPV service uptake among Nigerian girls and women and other related outcomes will be collected from recruited participants. Participants mobile phone numbers will also be collected as tracking information for follow-up and retention in a coupon format. The mobile phone numbers would be used to contact study participants through text messages and phone calls. These contacts would serve as reminders for participants to participate in follow-up data collection. The mobile phone service charge would be covered by the research. No other personal identifiers will be collected and no biological specimens will be collected at baseline. The investigators will obtain informed consent before proceeding with any data collection.
Step 4: Intervention implementation. Following participant recruitment and enrollment in the study as well as completion of baseline study, participants will be assigned to one of the seven mother-daughter interventions focused on expanding the uptake of HPV self-sampling, HPV vaccination and addressing stigma associated with HPV prevention services uptake among Nigerian women and girls.The pilot intervention implementation would occur for 30 days. Nigerian Institute of Medical Research (NMIR) will provide local training on HPV prevention to the seven participatory interventions following their existing guidelines. The participatory interventions will be conducted in the locations of the seven teams who emerged as winners from the innovation boot-camp. These participatory interventions will only provide HPV self-sampling and vaccination and instructions of how to perform the test to participants. They will also provide referral coupons to women who test positive or participants who have any adverse effects. The referral coupons are intended to provide study participants information on health facilities and specialists that are involved with the research. The intervention only provide participants with the HPV self-collection and vaccination kits and does not involve monitoring HPV self-collection procedure, the investigators will only be asking for self-reported HPV self-collection and vaccination uptake
Step 5: Follow up surveys at 8 weeks. At 8 weeks post intervention implementation, study team will collect similar baseline data from study participants. The follow-up survey will assess HPV self-testing, HPV vaccination assess the feasibility, acceptability, and preliminary impact of 7 mother-daughter interventions focused on expanding the uptake of HPV self-sampling, HPV vaccination and addressing stigma associated with HPV prevention services uptake among Nigerian women and girls.
#Intervention
- BEHAVIORAL : Heroes for Her
- Market outreach intervention- daily awareness creation through public market announcements, and distribution of educational fliers in local dialects. Community women will also be involved in the spread awareness through door to door approach. Thee will be repeated radio jingles to promote awareness. Interested women and girls will be provided with screening and vaccination services at a designated community health facility. All samples will be returned to the facility by the women and sent to a designated laboratory for testing. Participants contact information will be collected for follow up
- BEHAVIORAL : The Reach Initiative
- School based intervention-The Reach Initiative involves the organisation of the Mother-Daughter Day (MDD) by Mother-Daughter Planning Committee (MDPC) who are volunteer young school girls and their mothers and provision of a Key-Card which is a cervical cancer awareness card attached to a key chain for awareness creation. HPV vaccination and HPV -self sampling will be carried out in private rooms within the venue of the intervention and all samples will be sent to designated laboratory for testing. Participants contact information will be collected for follow up and communication of results
- BEHAVIORAL : W.H.I.T.E project
- Community based intervention- This will involve the engagement of women's trade unions and organisations in the community to create awareness and women and girls interested in the uptake of HPV prevention services will be directed to receive these services at a designated community facility accessible to women and girls in the community. Participants contact details will be collected for follow uo and communication of results
- BEHAVIORAL : Project Shield
- Utilization of community based structures (pharmacy and health center)- The intervention will involve the creation of a branded self-sampling kit for HPV screening and a free vaccination voucher to encourage mother-daughter uptake of cervical cancer prevention measures. Awareness will be raised through banners at the points of access of the vaccines and kits, use of jingles, and the involvement of the Community Development Association (CDA) to help mobilize girls, women and the men. Women and girls will be referred to community health centers to receive the HPV vaccination and carry out the screening
- BEHAVIORAL : Project SHADE
- Community-based approach- health education of girls and women. The use of a uniquely designed bag 'Eno Iban' to package and distribute the self-collection tool, vaccination of the adolescent girls. Screening and HPV will be provided at designated areas within the community for women and girls. A simple app (d-SHADE) will be used to collect data of the girls and women by the health professionals and volunteers, as well as send the reminders for next screening dates and test results
- BEHAVIORAL : Operation Reach Her (ORH) program
- Faith based approach- Awareness programs would be conducted in the chosen religious centres to educate women and girls about their health, cervical cancer, its prevention, and the benefits of screening and HPV vaccination. This would be achieved by organizing a ' Health Day ' for free health check-ups for all members of the congregation. The self-sampling kit would be distributed to women aged 30-65 in mobile tents stationed in churches in Akoka and HPV vaccinations would be administered to girls aged 9-14 in mobile tents stationed at churches and mosques in Akoka, Lagos
- BEHAVIORAL : Project Care
- Community pharmacy intervention-Trained community volunteers will be involved in creating awareness of HPV prevention services and cervical cancer. There will be distribution of cervical cancer self-sampling kits to community pharmacies which will serve as service points for screening (self-collection point) and vaccination point for girls in the community,
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
* Both the mothers'/caregivers' (between ages 30 <= age <= 65 years) and daughters' (Between 9 <= age <= 14) willingness to participate in the study
* All participants must agree to an informed consent in English
* Parental guardian's cell phone number for follow-up and/or retention
Exclusion Criteria:
Inability to comply with study protocol
* Illness, cognitive impairment or threatening behavior with acute risk to self or others
* No informed consent or cell phone
Sex :
FEMALE
Ages :
- Minimum Age : 9 Years
- Maximum Age : 65 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT, CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 622 |
Target Study Title: Post-authorization, Observational Study to Evaluate the Effectiveness of Adalimumab (HUMIRA®) on Moderate-severe Psoriasis Under Conditions of Routine Clinical Practice in Spain.
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of adalimumab as used in routine clinical practice in adult patients with moderate to severe chronic plaque psoriasis in Spain.
Detailed Description
PROMISE is a 2 year post-authorization study of patients taking adalimumab for Psoriasis. Patients who volunteer to participate will be asked to provide information about their medical history and experiences with adalimumab. No study specific testing will be performed. Patients will be asked to provide data on their experiences with adalimumab approximately every 6 months, or as determined by the study doctor. No drug will be provided as a result of participation in the registry. All treatment decisions are independent of participation in the registry. A total of 547 subjects were enrolled: 532 in the ITT population were analyzed for efficacy (excluding 15 for lack of follow-up visits (n=8), non-fulfillment of the criteria of moderate to severe PS (n=6) and failure to initiate treatment at the baseline visit (n=1)); 542 were analyzed for safety (excluding 5 due to lack of evaluable safety data).
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 years or older.
* Patient diagnosed with moderate to severe chronic plaque PS beginning treatment with adalimumab in accordance with the authorized conditions of use.
* Patient gives informed consent in writing.
Exclusion Criteria:
* Patients who cannot be treated in accordance with the local product label
* Patient participating or going to participate in a clinical trial during the study follow-up
* Patient with difficulties for adequately reading, understanding and completing a questionnaire
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>
| 623 |
Target Study Title: Asthma, Smoking, Emotional Deficits
Target Study Description: #Study Description
Brief Summary
The objective of the study is to determine whether poor control of asthma is related to an emotional deficit such as alexithymia. The hypothesis is that there is a correlation between the severity of asthma, its control, and the degree of emotional deficits.
#Intervention
- OTHER : Interview and tests of drawing.
- The intervention will take place with patients followed for asthma at the Croix Rousse hospital. Patients agreeing to participate in the study will come to the hospital for one hour and a half. They will answer questionnaires and tests of drawing. Results Restitution Session (optional) is proposed to patients within the next 4 weeks during a routine consultation.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Men and women (> 18 years).
* Asthma (mild, moderate, severe).
* Beneficiary of social security
Exclusion Criteria:
* Pregnant women
* Patients who oppose their participation in the study
* Multiple drug users (psychoactive substances).
* Patients with severe psychiatric antecedents and comorbidities.
* Patients with cancer
* Patients with cognitive impairment
* Patients with speech, hearing, visual, and praxic disorders.
* Any chronic and especially respiratory pathology other than asthma (COPD, bronchiectasis), which can alter the study.
* Patients not speaking French
* Persons protected by law
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>
| 624 |
Target Study Title: Incentives for Primary Care Use: A Randomized Controlled Trial in a Safety Net Setting
Target Study Description: #Study Description
Brief Summary
A randomized controlled trial (RCT) of incentives for an initial primary care visit within 6 months of enrollment in a health care coverage program. Study subjects are drawn from a low-income adult population that gains coverage and access to community-based primary care services under a program administered by an academic safety-net hospital. The investigators will offer financial incentives to encourage an initial primary care visit within 6 months of enrollment and evaluate whether the primary care visit altered subsequent health seeking behavior and influenced patient satisfaction and other outcomes such as self-reported health status.
Detailed Description
A randomized controlled trial (RCT) of incentives for an initial primary care visit within 6 months of enrollment in a health care coverage program. Study subjects are drawn from a low-income adult population that gains coverage and access to community-based primary care services under a program administered by an academic safety-net hospital. The investigators will offer financial incentives to encourage an initial primary care visit within 6 months of enrollment and evaluate whether the primary care visit altered subsequent health seeking behavior and influenced patient satisfaction and other outcomes such as self-reported health status.
Incentives should steer patients in their decision to seek primary care, reduce barriers to care, and ultimately improve patient health and reduce utilization and costs through their relationship with a PCP. This study is the first of its kind to incentivize low-income patients. This population has the greatest need for health care and exerts the greatest pressure on the United States' safety net system. Furthermore, the safety net population is the target of policies such as Medicaid eligibility expansions, yet urban safety net patients are largely understudied. These patients are rarely given the opportunity to participate in research, and when they are the subjects of measures to reduce health care utilization, they are the subject of policies using negative incentives such as those that introduce cost sharing for using ED services.1 Alternatively, safety net providers invest in case management systems to reduce utilization. The proposed study is a departure from prior measures to reduce utilization among low-income patients by focusing on patients and using positive incentives. The study borrows from the principles of behavioral economics to motivate patients towards primary care utilization. Once in the primary care system, The investigators will test whether primary care contact reduces more expensive forms (e.g., inpatient, ED) of health care.
The investigators will compare outcomes of patients assigned in the highest incentive group ($50) to patients assigned to the modest incentive group ($25) and to patients assigned to usual care (no incentive, but assignment to a PCP). The investigators will also compare incentive patients ($50, $25) to a contemporaneous group of patients that enroll in the safety net clinic at the same time.
#Intervention
- BEHAVIORAL : 0 dollars group
- Those assigned to the $0 group will not receive an incentive for visiting their PCP.
- BEHAVIORAL : 50 dollars group
- Those assigned to the $50 group will receive $50 if they visit their PCP within 6 months of study enrollment.
- BEHAVIORAL : 25 dollars group
- Those assigned to the $25 group will receive $25 if they visit their PCP within 6 months of study enrollment.
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 between ages 21 <= age <= 64 years
* No prior enrollment in VCC for the past 12 months
* English or Spanish speaking, and
* Can be contacted by mail and telephone (preferably) or willing to be interviewed in person.
Exclusion Criteria:
* Unable to be contacted by phone/mail
* Cannot provide consent
* No longer located in catchment area
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 625 |
Target Study Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication
Target Study Description: #Study Description
Brief Summary
This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ('high' or 'low') or placebo, administered as subcutaneous (SC) injection every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. Participants who were assigned to placebo during the placebo-controlled period of the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams (mg) or 125 mg every 4 weeks from Weeks 53 to 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.
#Intervention
- DRUG : Lebrikizumab
- Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
- Other Names :
- RO5490255
- DRUG : Placebo
- Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Asthma diagnosis for greater than equal to (>=) 12 months at Visit 1
* Bronchodilator response at Visit 1, 2, or 3
* Pre-bronchodilator FEV1 of 40 percent (%) - 80% predicted at both Visits 2 and 3
* On ICS therapy at a total daily dose of 500 <= age <= 2000 microgram (mcg) of fluticasone propionate dry powder inhaler (DPI) or equivalent for >= 6 months prior to Visit 1
* On an eligible second controller medication (long-acting Beta-agonist [LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], or theophylline) for 6 months prior to Visit 1
* Uncontrolled asthma at Visit 1 and/or Visit 2, and at Visit 3
* Chest X-ray or computed tomography (CT) scan within 3 months prior to Visit 1 or chest X-ray during the screening period (prior to Visit 3) confirming the absence of other clinically significant lung disease
* Demonstrated adherence with controller medication during the screening period
Exclusion Criteria:
* History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
* Maintenance oral corticosteroid therapy within 3 months of Visit 1
* Treatment with systemic (oral, intravenous [IV], or intramuscular [IM]) corticosteroids within 4 weeks prior to Visit 1 or during the screening period
* Treatment with intra-articular corticosteroids within 4 weeks prior to Visit 1 or during the screening period or anticipated need for intra-articular corticosteroids during the course of the study
* Infection requiring hospital admission for >=24 hours or requiring treatment with IV or IM antibiotics within 4 weeks prior to Visit 1 or during screening; Upper or lower respiratory tract infection within 4 weeks prior to Visit 1 or during screening; Active parasitic infection or Listeria monocytogenes infection within 6 months prior to Visit 1 or during screening
* Active tuberculosis requiring treatment within 12 months prior to Visit 1
* Known immunodeficiency, including, but not limited to, human immunodeficiency virus (HIV) infection
* Evidence of acute or chronic hepatitis or known liver cirrhosis
* History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma
* Known current malignancy or current evaluation for potential malignancy
* Current smoker or former smoker with a history of greater than (>) 10 pack-years
* History of alcohol or drug abuse
* Past and/or current use of any anti-interleukin (IL)-13 or anti-IL-4/IL-13 therapy, including lebrikizumab; use of other monoclonal antibody therapy, including omalizumab, within 6 months or 5 drug half-lives prior to Visit 1 (whichever is longer) or during screening
* Initiation of or change in allergen immunotherapy within 3 months prior to Visit 1 or during screening
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>
| 626 |
Target Study Title: Comparative Effects of A1 Versus A2®Cow Milk Based Formula and Breast Feeding on Alimentation and Gastrointestinal Digestion for the Infant: a Pilot Double-blinded, Randomized, Controlled Parallel Study
Target Study Description: #Study Description
Brief Summary
This pilot study primarily aimed to compare effects of breast feeding, A1 versus A2®cow milk based formula on alimentation and gastrointestinal digestion. The impact of the study products on fecal myeloperoxidase (MPO), short-chain fatty acid (SCFA), secretory immunoglobulin A (sIgA) concentration, gastrointestinal tolerance, defecating habit and infant growth were also evaluated.
#Intervention
- DIETARY_SUPPLEMENT : Oral consumption of Nutricia Aptamil Stage 1 formula
- Daily oral consumption of Nutricia Aptamil Stage 1 formula
- DIETARY_SUPPLEMENT : Oral consumption of a2® Platinum Stage 1 formula
- Daily oral consumption of a2® Platinum Stage 1 formula
- DIETARY_SUPPLEMENT : Oral consumption of breast milk
- Daily oral consumption of breast milk
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:
* Willing to formula feeding and consume 600ml or more of IF each day;
* Have normal electrocardiograms (ECG) and blood pressure during quiet respiration.
* Agree not to take any medication, supplements, nutrition or other dairy products including acidophilus milk;
* Parent(s) or legal guardian's consent to the study and willing to comply with study procedures;
* Parent(s) or guardian of infant agrees not to enroll infant another clinical study while participating in this study;
* Fully understand the nature, objective, benefit and the potential risks and side effects of the study.
Exclusion Criteria:
* Twins, multiple birth, low birth weight children, over birth weight children or early birth children with gestational age less than 37 weeks;
* During pregnancy, the mothers had pregnancy complications or other disease that may affect the results;
* Having serious diseases that may affect study interventions, such as neonatal sepsis, pneumonia (associated with respiratory failure), heart failure and other disease;
* Having neonatal diarrhea or acute respiratory infections within 48hours before enrollment;
* Having potential metabolic diseases, chronic diseases, congenital malformations, central nervous system disorders, neuromuscular disorders or diseases affecting bone metabolism that may affect growth or the study results;
* Having taken any food containing prebiotics or probiotics tithing 15 days of enrollment;
* Body weight-to-height Z-value <-3 according to the standard of the World Health Organization (WHO);
* Receiving hormone therapy and intravenous nutrition;
* Lactose intolerance or allergic to ingredients of study product;
* Have history of faecal impaction;
* Have participated in similar dairy or probiotics-containing product's clinical trials within 3 months before the screening;
* Currently taking medicines for cardiovascular or metabolic disease ;
* Currently suffering from any gastrointestinal disorders or gastrointestinal disease , including but not limited to: irritable bowel syndrome, colitis, ulcerative colitis, celiac disease, irritable bowel syndrome(IBS);
* Had hospitalizations within 3 months before screening;
* According to investigator's judgment, current frequent users of drugs which may affect the gastrointestinal function or immune system;
* Unable to comply the study schedule.
Sex :
ALL
Ages :
- Minimum Age : 40 Days
- Maximum Age : 60 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 627 |
Target Study Title: Treating HIV-infected Elite Controllers as a Model of HIV Remission
Target Study Description: #Study Description
Brief Summary
Although highly active antiretroviral therapy (HAART) decreases HIV-associated mortality, it does not to completely restore health. Patients doing well on otherwise effective HAART remain at risk for cancer, cardiovascular/liver disease, osteopenia, and other 'non-AIDS-defining' events. While complete eradication may never be feasible, a 'functional cure' in which patients are able to maintain undetectable viral loads indefinitely without therapy may be possible. The best evidence for this are the so-called 'elite' controllers, whom we define as individuals who are HIV-seropositive, with plasma HIV RNA levels below the level of conventional detection without treatment. Controllers may be conceptualized as a naturally occurring model of a functional cure (or 'HIV remission'), and are ideal patients in which to study HIV persistence and the possibility of eradication.
We propose to conduct a pilot study to better characterize the reservoirs that lead to viral persistence in a group of well-characterized controllers. We propose two specific aims: 1) to characterize the dynamics of viral production in blood and gut-associated lymphoid tissue (GALT) in controllers; and 2) to prospectively treat 10 controllers with raltegravir, tenofovir/emtricitabine for 24 weeks and study the effects of HAART on viral dynamics and host inflammatory responses.
Our primary hypotheses are: 1) viral replication is ongoing in untreated controllers, 2) HAART will reduce viral replication in blood and GALT and decrease immune activation, and 3) higher levels of immune activation are associated with greater measures of microbial translocation and distribution of virus to more differentiated T cell subsets.
#Intervention
- DRUG : Raltegravir, tenofovir/emtricitabine
- 16 controllers will be treated with open-label raltegravir/tenofovir/emtricitabine for 24 weeks.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Age >=18 years, and
* HIV infection, and
* Antiretroviral-naïve, and
* CD4+ T cell count >350 cells/mm3, and
* 'Controllers': antiretroviral untreated with 50 <= age <= 1000 copies/mL viral load for at least 12 months
Exclusion criteria:
* Persons with known rheumatologic conditions (e.g., systemic lupus erythematosus), because of their predilection for biologic false-positive testing on HIV antibody tests.
* Screening absolute neutrophil count <1,000 cells/mm3, platelet count <70,000 cells/mm3, hemoglobin < 8 mg/dL, estimated creatinine clearance <40 mL/minute, aspartate aminotransferase >100 units/L, alanine aminotransferase >100 units/L.
* Screening genotype resistance testing showing resistance to tenofovir or emtricitabine.
* Known kidney disease.
* Known bone disease, including pathologic fractures.
* Patients with chronic Hepatitis B infection, because of the risk of liver abnormalities after starting and stopping tenofovir/emtricitabine.
* Concurrent treatment with lamivudine, adefovir, entecavir, or telbivudine.
* Serious illness requiring hospitalization or parental antibiotics within the preceding 3 months.
* Any vaccination 2 weeks prior to baseline (Day 0) visit and throughout the study period. NOTE: Because the study will most likely be actively recruiting during the influenza season, all subjects will be encouraged to receive their annual influenza vaccine at the screening visit (4 weeks prior to baseline [Day 0] visit) if they have not already been vaccinated for the 2009 <= age <= 10 season and if it is medically indicated.
* Concurrent treatment with immunomodulatory drugs, or exposure to any immunomodulatory drug in the preceding 16 weeks (e.g. corticosteroid therapy equal to or exceeding a dose of 15 mg/day of prednisone for more than 10 days, IL-2, interferon-alpha, methotrexate, cancer chemotherapy). NOTE: Use of inhaled or nasal steroid use is not exclusionary.
* Concurrent treatment with phenobarbital, phenytoin, or rifampin.
* Pregnant or breastfeeding women. Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
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>
| 628 |
Target Study Title: Prevention of Glucocorticoid-Induced Osteoporosis in Patients With Rheumatic Diseases. The STOP-Study: a Randomized Placebo Controlled Trial With Alendronate Versus Alfacalcidol.
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine wich treatment is the most effective in prevention of glucocorticoid-induced osteoporosis in patients with rheumatic diseases. The STOP-study: a randomized placebo controlled trial with alendronate versus alfacalcidol.
Detailed Description
Treatment with glucocorticoids (GCs) is associated with bone loss initiated already early in therapy, causing increased (vertebral) fracture risk. Bone loss is caused by inhibition of bone formation by GCs. Active vitamin D analogues like alfacalcidol directly stimulate osteoblasts leading to an increase in bone formation. Bisphosphonates like alendronate induce apoptosis of osteoclasts leading to inhibition of bone resorption.
We performed a randomized, double-placebo, double-blind clinical trial of 18 months duration in patients with a rheumatic disease, starting GCs in a dosage of 7.5 mg prednisone equivalent daily or higher. Two hundred one patients were allocated to receive either alendronate 10 mg and alfacalcidol-placebo daily or alfacalcidol 1 microgram and alendronate-placebo daily. Primary outcome was change in bone mineral density of the lumbar spine in 18 months, secondary outcome incidence of (symptomatic) morphometric vertebral deformities.
#Intervention
- DRUG : Alendronate versus alfacalcidol (1-alpha OH vitamin D)
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 rheumatic disease.
* Starting treatment with glucocorticoids in a dosage of 7.5 mg prednisone equivalent daily or higher.
* All ethnic groups and races.
Exclusion Criteria:
* Glucocorticoid treatment in the past 12 months (except for 12 weeks preceding the study)
* Primary hyperparathyroidism, hyperthyroidism or hypothyroidism in last year
* Metabolic bone disease
* Creatinine clearance of < 50 ml/min
* Documented hypercalcemia or hypercalciuria, nephrolithiasis in the last 5 years
* Pregnancy or lactation
* Treatment in the last 12 months with hormone-replacement therapy
* Anabolic steroids, calcitonin, active vitamin D3 analogues, fluoride or bisphosphonates.
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>
| 629 |
Target Study Title: Phase I/II Study of Anti-HIV Cellular Therapy Based on Dendritic Cells Pulsed With Chemically Inactivated Virus
Target Study Description: #Study Description
Brief Summary
The aim of this study was to assess tolerability and safety of three different formulations of an anti-HIV immunotherapy based on autologous dendritic cells (DCs) pulsed with HIV chemically inactivated with Aldrithiol™-2 (AT-2). Patients were chronically infected with HIV, naïve for antiretroviral drugs. A possible immunological and virological favorable impact was also assessed.
#Intervention
- BIOLOGICAL : DC
- Autologous dendritic cells (3x10e7)
- BIOLOGICAL : DC10e6+HIV-AT2
- Autologous dendritic cells (3x10e6), pulsed with chemically inactive autologous HIV
- BIOLOGICAL : DC10e7+HIV-AT2
- Autologous dendritic cells (3x10e7), pulsed with chemically inactive autologous HIV
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 HIV infection;
* absence of antiretroviral therapy, antineoplastic therapy or the use of corticosteroids for at least six months prior to study entry;
* plasma viral load >= 1,000 copies / mL, stable (ie no variation > 0.5 log) in the six months before the start of the study;
* blood CD4+ T cells >= 350 /mL, stable (ie no variation > 25%) in the six months before the start of the study.
Exclusion Criteria:
* individuals without proper venous access for blood and apheresis collection procedure.
* use of drugs, alcohol, psychiatric disorder or any condition that interferes with the ability of patients to follow the requirements of the study;
* history of diagnosis of HIV infection <01 years;
* pregnancy or breast-feeding;
* use of antiviral therapy, in anticancer therapies or corticosteroids six months prior to study start;
* presence of chronic diseases, such as infection with hepatitis B (HBV) and C (HCV), human T-lymphotropic virus (HTLV) I / II or any condition that promotes immune system dysfunction, with the exception of HIV infection.
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>
| 630 |
Target Study Title: Hypofractionated Radiotherapy as Primary Therapy for Prostate Cancer: Randomised Trial Comparing Toxicity Between 2 Different Hypofractionated Schedules
Target Study Description: #Study Description
Brief Summary
External beam radiotherapy (RT) is one of the standard curative treatment options for patients with prostate cancer (PC). Several randomised trials have shown excellent long-term biochemical outcome with higher radiation doses. Nowadays, RT for PC commonly consists of delivering 74-80 Gy in 2 Gy fractions, resulting in an overall treatment time of 7-8 weeks. The sensitivity of different tissues to fractionation changes can be quantified through the α/β ratio in the linear-quadratic model. Dose-response analysis of PC patients treated with both external beam RT and brachytherapy has led to the hypothesis that the α/β ratio of PC is lower than for most other tumors and approaches a value characteristic of late responding tissues. Values between 1.2 and 3.9 Gy have been calculated. If the α/β ratio of PC is indeed low, then hypofractionating RT treatments can theoretically maintain high bioequivalent tumor doses, shorten overall treatment time and decrease late toxicities.The advantages in terms of patient convenience and treatment cost are obvious. There is level I evidence that shows that hypofractionated radiotherapy schedules have at least equivalent biochemical outcome with only a small increase in acute but not late toxicity when compared to conventional fractionation RT schedules.
Results on different hypofractionation schedules have been reported, however the optimal hypofractionation is not clear so far. In this randomised trial we would like to compare 2 different radiotherapyschedules: 16 fractions à rato of 4 fractions a week versus 25 fractions à rato of 5 fractions a week. The incidence on acute toxicity and early late toxicity (i.e. within 2 year post radiotherapy) and the impact on quality of life will be registrated and compared. The study will be performed in 2 stages. For stage 1, sample size was calculated to rule out an upper limit of 40% of patients with RTOG grade 2 or worse bowel (GI) complications with an expected rate of 25%, based on a one-stage Fleming-A'Hern design. A power of 83.0% (alpha level 0.038 one-sided) was obtained when including 72 patients per group (144 patients in total). If 22 or more patients out of 72 had grade 2 or worse GI complications, then the study arm was to be rejected. To allow for a dropout of 10%, 160 patients were included in stage 1. Sample size for stage 2 was calculated analogously allowing ruling out an upper limit of 35% of patients with RTOG grade 2 or worse GI complications with an expected rate of 25%. When including 155 patients per group (310 in total) a power of 85.7% (alpha level 0.049 one-sided) was obtained. If 45 or more patients out of 155 had grade 2 or worse GI complications, then the study arm was to be rejected. The sample size for stage 1 and stage 2 combined was set at 346 (173 per group), with a 10% allowance for dropout.
#Intervention
- RADIATION : hypofractionation
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 T1 <= age <= 4 N0 M0 prostate cancer
Exclusion Criteria:
* other no skin cancer diagnosed within 5 years prior to enrolment
* no informed consent
Sex :
MALE
Ages :
- Minimum Age : 40 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>
| 631 |
Target Study Title: Randomised Investigation to Evaluate Phe Fluctuation in PKU Patients Treated With PKU GOLIKE Versus Standard Amino Acid Protein Substitute.
Target Study Description: #Study Description
Brief Summary
This is a 2 arm, randomised, controlled, cross-over study in 16 children with PKU. Subjects who are currently taking a Phe free/low Phe protein substitute will be recruited for a 31-day trial.
Patients will be randomised to receive:
1. The study product for 7 days as their last dose of protein substitute for the day (at least one sachet with 15g PE) in an amount equivalent to their usual protein substitute PE; or
2. An amino acid protein substitute for all daily doses for 7 days; followed by a 2-week washout period on their usual protein substitute,
and then 7 days of the other study arm.
During this time, patients/caregivers will be asked to:
* Collect 3 finger prick blood spots on days -1, 0, 6, 7, 20, 21, 27 and 28.
* Collect urine sample, second void of the day on days 0, 7, 21 and 28.
* Complete a questionnaire on sleep quality on day 0, 7, 21 and 28.
* Complete a 24 hour food diary on days -1, 0, 6, 7, 20, 21, 27 and 28.
APR will supply the study product for participants free of charge.
Detailed Description
16 children with PKU who currently take a Phe-free/low Phe protein substitute (3 or 4 doses/day) will be recruited. Subjects will replace the last daily dose of their usual protein substitute with the study product for 7 days of the 28 day trial (either days 1-7 or days 22-28 based on random allocation). On the remaining study days, subjects will take an amino acid based protein substitute for all daily doses. There will be a 2 week washout period between study arms where subjects will take their usual protein substitute. The amount of study product prescribed will be calculated to provide the same amount of protein as their usual protein substitute. The last protein substitute (PS) dose of the day (amino acids or study product) will need to be taken between 7-9pm to allow an 8-10 hour fasting period overnight. Three finger prick blood spots will be collected and analysed for phenylalanine, tyrosine and BCAA at 5am, 6am and 7am on days -1, 0, 6, 7, 20, 21, 27 and 28. For all subjects, a second void urine sample will be collected on days 0, 7, 21 and 28 for analysis of urea and creatinine. A quality of sleep questionnaire will be completed by subjects or their carers on days 0, 7, 21 and 28 and a 24 hour food diary on days -1, 0, 6, 7, 20, 21, 27 and 28. A palatability questionnaire will be completed by subjects or their carers on days 7 or 28 (at the end of the period with PKU GOLIKE, if Bars or Krunches are used). Subject visits will be on days -2 (enrolment), 0, 7, 21 and 28 where the research dietitian will collect urine samples, blood spots, questionnaires and diaries.
#Intervention
- DIETARY_SUPPLEMENT : PKU GOLIKE
- AA protein Substitute for the dietary management of PKU, PKU GOLIKE is a food for special medicinal purposes (FSMP) for the dietary management of PKU.
- Other Names :
- PKU GOLIKE is a food for special medicinal purposes (FSMP) for the dietary management of PKU.
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 and female PKU patients >=5 years and <=16 years.
* Patients diagnosed with PKU via new born screening.
* Taking a Phe free/low Phe protein substitute
* On a low phenylalanine diet .
* Absence of neurological deficiencies.
* Adherence with dietary management and protein substitute.
* Able to understand and comply with the requirements of the investigation and sign the Informed Consent Form/Assent form.
Exclusion Criteria:
* Age <5 years and >16 years.
* Patients with mild PKU or HPA.
* On sapropterin therapy.
* Patients with late diagnosis of PKU and neurological problems.
* History of hypersensitivity to any excipients/components of the investigational product.
* Pregnancy or breastfeeding during the study.
* Any moderate to severe acute illness which in the opinion of the Investigator would interfere with the study procedures or study outcome.
* History of poor co-operation, non-adherence with dietary management, or poor adherence to investigation procedures.
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
Sex :
ALL
Ages :
- Minimum Age : 5 Years
- Maximum Age : 16 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 632 |
Target Study Title: A Randomized Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes Who Were Previously Treated by Basal Insulin Glargine With Either Metformin or Metformin and Sulfonylurea
Target Study Description: #Study Description
Brief Summary
The study will compare two combination therapies: 1) Combined Basal Insulin Glargine (once a day), Exenatide (twice a day), and Metformin Therapy; or 2) Combined Basal Insulin Glargine (once a day), Bolus Insulin Lispro (three times a day), and Metformin Therapy, in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control.
#Intervention
- DRUG : exenatide
- subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (26 weeks), twice a day
- Other Names :
- Byetta
- DRUG : insulin lispro
- titrated based on pre-meal glucose level; three times a day
- Other Names :
- Humalog
- DRUG : Metformin
- DRUG : Insulin/ Glargine
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 been taking a basal insulin Glargine, at dose of >= 20 units/day, for at least 3 months prior to study start.
* Have been taking basal insulin Glargine at dose of >= 20 units/day, in combination with 1 of the following oral antidiabetic medication (OAM) regimens, for at least 3 months prior to study start:
* Metformin or immediate-release metformin or extended-release metformin alone at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start; or
* Metformin or immediate-release metformin or extended-release metformin at a maximum tolerated and stable dose with no less than 500 mg/day for at least 6 weeks prior to study start and sulfonylurea at a stable dose for 6 weeks prior to study start.
* Have an HbA1C > 7.0% and <= 10.0%.
* Have a body mass index (BMI) between >= 25 and <= 45 kg/m2.
Exclusion Criteria:
* Are currently taking OAM that is not described above and not allowed with concurrent use of insulin per local product label.
* Have taken more than 1 week within 1 month prior to the study start any glucose-lowering medications not included above either alone or in combination formulations, or have used a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phenylpropanolamine, rimonabant or similar over-the-counter medications).
* Have taken any insulin other than Glargine within the 3 months prior to study start for more than 1 week.
* Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical, intraocular, and inhaled preparations) within 4 weeks prior to the study start.
* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
* Have previously completed or been withdrawn from this study after enrollment.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 633 |
Target Study Title: Usefulness of Measuring Plasma Brain Natriuretic Peptide for Diagnosis and Prognosis in Very Elderly Patients.
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to test the usefulness of measuring plasma brain natriuretic peptide (BNP) for diagnosis and prognosis in very elderly dyspneic patients.
Detailed Description
Measurement of BNP concentration is approved for use in the diagnosis of heart failure (HF) in elderly patients below 80 years of age. The value of plasma BNP assays as diagnostic tools has not been determined in very elderly populations because the plasma BNP increases with age. This large, multicenter, prospective, observational, study in 300 participants is aimed to prospectively test the usefulness of measuring plasma BNP for diagnosis of HF in dyspneic patients aged 80 and older.
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:
* acute dyspnea
* crackles on lung auscultation,
* hypoxemia,
* right-sided signs.
Exclusion Criteria:
* no exclusion criteria
Sex :
ALL
Ages :
- Minimum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 634 |
Target Study Title: The Effect of Nurse-led Motivational Interviewing Based on the Trans-theoretical Model on Promoting Physical Activity in Healthy Older Adults: A Randomised Controlled Trial
Target Study Description: #Study Description
Brief Summary
Older adults constitute the age group that leads the most sedentary life in society and is mostly affected by physical inactivity.
This study was conducted to determine how nurse-led Motivational Interviewing (MI) based on the Trans-Theoretical Model (TTM) affected promoting physical activity in older adults.
A randomised controlled trial. The population of this trial was composed of seniors aged between 65 and74 living in a family health center area in Yozgat, Turkey (N=1630). The study sample, estimated via power analysis (d=0.30; 1-β=0.80; α=0.05), constituted 117 older adults (Intervention Group (IG) n=58; Control Group (CG) n=59) who met the inclusion criteria. The data were gathered via a questionnaire, TTM-Scales, Physical Activity Scale for Elderly (PASE), KATZ-ADL by an independent researcher who was blinded to the study groups. A pedometer (JP-600) for each senior was used to calculate the average weekly step counts. The data were analyzed via IBM-SPSS version 23.0. Descriptive statistics, student's t-test, paired-samples t-test, Mann Whitney-U, the Wilcoxon Sign, Friedman, Pearson chi-square, and Fisher-Freeman-Halton exact tests were used to analyze the data. Cohen's d and dz formulas were used to calculate the effect sizes.
MI sessions were held every two weeks in IG. No intervention was applied in CG. Significant progress was found in the change stages of IG compared to CG. The mean of step counts was significant in favour of IG, and the effect size was d=0.641. PASE total score increased significantly in IG, and the effect size was dz=0.202.
This trial indicated that after the TTM-based MI, the change stages of the older adults improved, and their exercising behaviours promoted. In conclusion, TTM and MI are recommended to be used by the nurses toimprove healthy lifestyle behaviours in older adults, and studies to increase physical activity levels in this population should be conducted for a longer period, and studies with larger sample groups are recommended.
Detailed Description
This randomised controlled study was carried out in a Family Health Centre (FHC) region in Turkey between April and November 2019.
The population of the study consisted of older adults aged 65 to 74 years residing in the related FHC region (n=1630). First, their records were examined, and those (n=881), who were determined to meet the inclusion criteria \[19\] based on these records, were called up and invited to the FHC. The sample size was calculated to be at least 90 individuals (d=0.30; 1-β=0.80; α=0.05). Considering the possibility of the participants' withdrawal from the study, all 117 older adults, who met the inclusion criteria in the population and agreed to participate, were included in the study (Intervention Group n=58; Control Group n=59). Figure 1 shows the Consort Flow Diagram of the study.
After stratifying according to age (65-69, 70-74), gender, and stage of exercise change (contemplation and pre-contemplation stage), the stratified simple randomisation procedure was used. No researcher and participant blindness were performed. The randomisation procedure was conducted via the R programming language version 3.5 (https://cran.r-project.org ) by an independent statistician to prevent selection bias. The data were collected and recorded by an independent researcher who was trained by the researcher and did not know the groups. The statistics were performed by an independent statistician.
The data were collected using the personal information form, the TTM scales (the Exercise Stages of Change Scale, the Exercise Processes of Change Scale, the Decisional BalanceScale for Exercise, and the Exercise Self-efficacy Scale), the PASE, the KATZ Activities of Daily Living (ADL) Scale, and a pedometer.
TTM-based MI and Information Guidelines for Gaining Exercise Behaviour were prepared by the researcher within the scope of the relevant literature.
The guideline was used after consulting five experts in the field of nursing who have research on TTM.
A preliminary application was conducted between September 2018 and January 2019. Filling the forms took about 30 minutes. Preliminary motivational interviews were conducted by the researcher and were recorded. Two experts supervised the records and gave feedback. The individuals who participated in the preliminary session were not included in the study.
An independent research assistant trained by the researcher collected the data in the FHC via the face-to-face interview method, and the researcher conducted motivational interviews (face-to-face and on the phone) between April and November 2019.
In the present study, an effort was made to help the IG to realize the dilemmas of individuals in the precontemplation stage about exercising, and individuals in the contemplation stage to produce their own solutions. In this direction, techniques such as decision balance, importance, and trust technique were applied, thus enabling them to reveal their feelings, thoughts, and reactions regarding the benefits/harms of doing/not doing exercise. They were supported to raise awareness about the consequences and solutions of the causes.
Face-to-face motivational interviews lasted for an average of 30 minutes. After the MI, the exercise information guideline prepared by the researcher and the TTM-based MI guideline according to the stages were given to the older adults. During the MI, a form prepared by the researcher was used to note the content of the interview. At the end of MI, the next appointment was planned. In addition, the older adults were given a chart prepared by the researcher to note their walk.
On the other hand, the phone-based motivation interviews lasted an average of five to seven minutes. Before the telephone interview, it was determined which stage of change the older adult was in. Then a motivational interview was held according to the stage.
The CG was only followed up at the beginning and end of the study, no intervention was made. The CG received standard care. Although the family health staff do not give routine and standard training about the benefits of exercising in the FHC to the elderly, they give information when necessary.
#Intervention
- BEHAVIORAL : Intervention motivational interview group
- Motivational interviewing (MI) a client-centered, goal-oriented method for enhancing intrinsic motivation to change by exploring and resolving ambivalence. Motivational interviewing is underpinned by a series of principles that emphasise a collaborative therapeutic relationship in which the autonomy of the patient is respected and the patient's intrinsic resources for change are elicited by the therapist.
In the present study, an effort was made to help the IG to realize the dilemmas of individuals in the precontemplation stage about exercising, and individuals in the contemplation stage to produce their own solutions. In this direction, techniques such as decision balance, importance, and trust technique were applied, thus enabling them to reveal their feelings, thoughts, and reactions regarding the benefits/harms of doing/not doing exercise. They were supported to raise awareness about the consequences and solutions of the causes.
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:
* 65 <= age <= 74 aged seniors, who will voluntarily participate in the study
* Seniors, at least literate or elementary school graduated
* Seniors, at the pre-contemplation or contemplation stages of exercise behavior change
* No cognitive impairment which affects the interpersonal communication
* No muscle-joint problems to be a barrier for the physical activity
* No neuropsychiatric disorder
Exclusion Criteria:
* Individuals whose age are less than 65 and bigger than 75.
* Seniors whose Mini Mental State Test (MMT) scores under 24 points (Mild Cognitive Impairment)
* Seniors whose Geriatric Depression Scale (GDS) scores above 5 points
* Seniors diagnosed with Cancer, Insulin-dependent Type-2 Diabetes Mellitus, Uncontrolled-Hypertension, Heart Failure, Chronic Obstructive Pulmonary Disease (COPD) and Asthma
Termination Criteria:
* Termination criteria are changing in the mental status of the senior during the follow-ups, requesting for leaving the research at any stage and any situation that requires hospitalization needs of the senior.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Maximum Age : 74 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 635 |
Target Study Title: Deep Sedation and General Anesthesia for Endoscopic Retrograde Cholangiopancreatography
Target Study Description: #Study Description
Brief Summary
Providing the appropriate anesthetic technique for endoscopic retrograde cholangiopancreatography (ERCP) in remote locations can be challenging. The aim of this study was therefore to prospectively assess and compare the feasibility of monitored anesthesia care (MAC) with propofol based deep sedation, standard general anesthesia and general anesthesia without neuromuscular blockade in patients undergoing ERCP.
Detailed Description
ERCP is identified as one of the most invasive endoscopic procedures, during which patients may experience anxiety, discomfort and suffer different degree of pain. So, anesthesia and analgesia are essential for this invasive procedure, especially therapeutic ERCPs. Thus, we compared the efficacy of using monitored anesthesia care (MAC) with deep sedation versus general anesthesia (GA) to perform this procedure and the incidence of complications associated with these methods of anesthesia.
Previous studies have concluded that intubation is possible without the use of neuromuscular blockade. We assume that the use of propofol and adjuvants short-acting opioids may provide adequate conditions for tracheal intubation. It was also hypothesized that it may also be useful in facilitating ERCP under general anesthesia without neuromuscular blockade.
#Intervention
- PROCEDURE : Monitored Anesthesia Care
- MAC was induced and maintained via the continuous infusion of propofol AND remifentanil using a target-controlled infusion (TCI) pump. The appropriate level of sedation was 65 to 80 points on BIS. The adjunctive sedatives (eg, fentanyl, midazolam) was at the discretion of the anesthesia team.
- PROCEDURE : General Anesthesia
- Induction was done with propofol (2 mg/kg) , cis-atracurium (0.15 mg/kg) , and fentanyl (5μg/kg). After orotracheal intubation, general anesthesia was maintained with sevoflurane (1-1.3MAC) , propofol (3mg/kg/h), remifentanil (0.05-0.2 ug/kg/min) and repetitive doses of 0.1mg atracurium per kilogram were administered. After the procedure was completed, neostigmine mixed with atropine was used as a reversal agent for the neuromuscular blockade, and the patient was extubated when the recovery from anesthesia was confirmed.The BIS was 45 to 60 points .
- PROCEDURE : Induction Without Neuromuscular Blockade
- Anaesthesia was induced with propofol (2 mg/kg), remifentanil(3 ug/kg) and 2% lidocaine (1 mg/kg). Nasotracheal intubation was performed 60 s after the administration. After intubation, general anesthesia was sevoflurane (1-1.3MAC) , propofol (3mg/kg/h), remifentanil (0.05-0.2 ug/kg/min). After the procedure was completed, the patient was extubated when the recovery from anesthesia was confirmed.The BIS was 45 to 60 points .
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 <= 70 years
* Grade Ⅰ and Ⅲ according to physical status classification system of the American Society of Anesthesiologists (ASA)
* Coagulation function tests in normal range
Exclusion Criteria:
* Potentially difficult airways
* Administration of sedative or narcotic drugs in the previous 24 hours
* Severe renal or hepatic impairment
* Severe cardiopulmonary comorbidities (defined as American Society of Anesthesiologists physical status IV or greater)
* Contraindications to a nasotracheal intubation
* Coagulopathy
* History of frequent episodes of epistaxis
* Emergent ERCP
* At risk for reflux and aspiration
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>
| 636 |
Target Study Title: Association Between Early Change in PaCO2 After ECMO Initiation and Neurological Outcome in Newborns
Target Study Description: #Study Description
Brief Summary
Investigation of the association between PaCO2 change after extra corporeal membrane oxygenation (ECMO) initiation and neurological outcome and mortality in neonates treated by ECMO for respiratory failure.
Detailed Description
Retrospective analysis of the ELSO database investigating the association between the change of PCO2 value after ECMO start and the risk of acute neurological event under ECMO defined by the onset of cerebral bleeding and/or ischemic stroke and/or clinical or electrical seizure and/or brain death.
#Intervention
- OTHER : ECMO for neonates
- Neonates (\<28 j) supported by ECMO for severe respiratory failure
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 :
* Support by ECMO for respiratory indication
Exclusion Criteria :
* None
Sex :
ALL
Ages :
- Minimum Age : 1 Day
- Maximum Age : 28 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 637 |
Target Study Title: A Phase I Study of INCB024360 (Epacadostat) Alone, INCB024360 in Combination With Pembrolizumab (MK-3475), and INCB024360 and Pembrolizumab in Combination With Chemotherapy in Patients With Advanced Solid Tumors (KEYNOTE-434)
Target Study Description: #Study Description
Brief Summary
This is an open-label, non-randomized, Phase I study of epacadostat (INCB024360) alone and in combination with pembrolizumab with chemotherapy and pembrolizumab without chemotherapy in participants with advanced solid tumors. The primary objective of the trial is to evaluate the safety and tolerability of epacadostat administered alone and in combination with pembrolizumab with and without chemotherapy.
With protocol amendment 02 (26-April-2019), treatment with epacadostat was stopped in the 'Epacad+Pembro+Cisplatin+Pemetrexed', 'Epacad+Pembro+Carboplatin+Pemetrexed', and 'Epacad+Pembro+Carboplatin+Paclitaxel' study arms.
#Intervention
- DRUG : Epacadostat 25 mg
- Oral administration
- Other Names :
- INCB024360
- DRUG : Epacadostat 100 mg
- Oral administration
- Other Names :
- INCB024360
- BIOLOGICAL : pembrolizumab 200 mg
- Intravenous (IV) infusion
- Other Names :
- MK-3475, KEYTRUDA®
- DRUG : Cisplatin 75 mg/m^2
- IV infusion
- Other Names :
- Platinol®, Platinol-AQ®
- DRUG : Carboplatin Area Under the Curve (AUC) 5
- IV infusion
- Other Names :
- Paraplatin®
- DRUG : Pemetrexed 500 mg/m^2
- IV infusion
- Other Names :
- Alimta®
- DRUG : Paclitaxel 200 mg/m^2
- IV infusion
- Other Names :
- Taxol®, Abraxane®, Onxol®
- DRUG : Carboplatin AUC 6
- IV infusion
- Other Names :
- Paraplatin®
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 Part A: Has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
* For Part B: Has a histologically-confirmed or cytologically confirmed diagnosis of non-small cell lung carcinoma (NSCLC) stage IIIB/IV, be naïve to systemic therapy, and have confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated. Cohort 1 and 2 must have a histological or cytological diagnosis of non-squamous cancer.
* Has at least one measurable lesion by computed tomography or magnetic resonance imaging per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
* Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Has a life expectancy of >=3 months
* Females must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start)
* Women of childbearing potential and male participants must agree to use adequate contraception during the study through 120 days after the last dose of study medication
* For Part A: Has provided tissue for programmed cell death ligand 1 (PD-L1)/ Indoleamine 2,3-dioxygenase 1 (IDO1) expression evaluation from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. For Part B submission of tissue is optional.
Exclusion Criteria:
* Has received prior therapy with an anti-Programmed cell death protein (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) agents (including ipilimumab or any other antibody/drug specifically targeting T-cell co-stimulation or checkpoint pathways), or IDO1 inhibitor
* Is currently participating or has participated in a study with an investigational compound or device within 4 weeks, or 5 times half-life of the investigational compound, whichever is longer, of initial dosing on this study
* For Part A: Has had chemotherapy, targeted small molecule therapy, radiotherapy, major surgery, or biological cancer therapy (including monoclonal antibodies) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study medication, or who has not recovered (<= Grade 1 or baseline) from adverse events due to a previously administered treatment
* For Part B: Has received radiotherapy within 7 days of the first dose of trial treatment or radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study medication
* Is expected to require any other form of systemic or localized anti-neoplastic therapy while in study
* Has active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has symptomatic ascites or pleural effusion
* Has an active autoimmune disease that has required systemic treatment
* Is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 1 week prior to the first dose of study medication
* Has an active infection requiring systemic therapy
* Has history of (noninfectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease
* Has received a live vaccine within 4 weeks prior to the first dose of study medication
* Has a known hypersensitivity to the components of the trial treatment or another monoclonal antibody
* For Part B: Has a known sensitivity to any component of cisplatin, carboplatin, paclitaxel, or pemetrexed.
* For Part B: Is on chronic systemic steroids with the exception of use of bronchodilators, inhaled steroids, or local steroid injections
* For Part B cohort 1 and 2: Is unable to interrupt aspirin or other nonsteroidal ant-inflammatory drugs (NSAIDs), other than an aspirin dose <=1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
* For Part B cohort 1 and 2: Is unable or unwilling to take folic acid or vitamin B12 supplementation
* Is Human Immunodeficiency Virus (HIV)-positive (HIV 1/2 antibodies)
* Has known history of or is positive for active Hepatitis B (Hepatitis B surface antigen reactive) or has active Hepatitis C (Hepatitis C virus ribonucleic acid)
* 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 or father children during the study through 120 days after the last dose of study medication
* Has received monoamine oxidase inhibitors (MAOIs) within the 3 weeks before the first dose of study medication
* Has any history of Serotonin Syndrome after receiving serotonergic drugs
* Has presence of a gastrointestinal condition that may affect drug absorption
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 638 |
Target Study Title: Stepped, Reward-exposure Based Therapy vs. PST in Late Life Depression
Target Study Description: #Study Description
Brief Summary
This is a non-inferiority trial of Engage, a new intervention for late-life depression, and problem solving therapy (PST). Patient participants will be randomized to either Engage or PST and receive 9 weeks of either intervention. Interview assessments will be collected at baseline and weeks 2, 4, 6, 8, 9, 26, and 36. Clinician participants, social workers from mental health agencies, will be randomized to receive training and certification in either Engage or PST.
Detailed Description
Policy reports document that evidence-based psychotherapies are rarely employed and sustained in the community. Several causes of this science to service gap have been identified. One cause, specific to behavioral interventions, is the complexity of interventions and the competencies community clinicians must acquire and sustain over time in order to deliver them. A realistic solution is to streamline behavioral interventions and tailor them to the settings and therapist skill level available in the community. In response to this need, we have developed Engage, which: 1) is streamlined on the basis of concepts and findings on the neurobiology of depression; 2) consists of psychotherapeutic and ecosystem management components of known efficacy; 3) has distilled and simplified these components so as they can be accessible to most depressed older patients and taught to larger numbers of clinicians than available therapies, e.g., Problem Solving Therapy (PST); and 4) is personalized through a structured stepped approach focusing on 'reward exposure'. Problem Solving Therapy is an evidenced-based intervention shown to be effective in treating late-life depression.
Three hundred (150 per site) patient participants will be randomly assigned to receive 9 sessions of either Engage or PST. Forty-two clinician participants will be randomly assigned to receive training and certification in either Engage or PST. Once certified, clinicians will be assigned a patient participant and administer their assigned intervention.
#Intervention
- BEHAVIORAL : Problem Solving Therapy
- PST is a behavioral intervention for depression that is delivered by trained therapists over a 9 week period. It consists of a process to help patients understand and then solve the problems in their lives they feel is contributing to their depression.
- BEHAVIORAL : Engage
- Engage is a weekly behavioral intervention that is delivered over a 9 week period of time by trained therapists. The focus of Engage is to help patient reconnect with activities that they have lost interest in pursuing due to depression.
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 participants):
* Age >= 60 years
* unipolar, non-psychotic major depression (by SCID, DSM-IV)
* MADRS >= 20
* MMSE >= 24
* off antidepressants or have been on a stable dose of an antidepressant for 12 weeks and do not intend to change the dose in the next 10 weeks
* English speaking
* capacity to provide written consent
Exclusion Criteria (Patient participants):
* Presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder
* Newly started use of psychotropic drugs (<12wks) or cholinesterase inhibitors other than mild doses of benzodiazepines
* Current active suicidal intent/plan
* Current substance abuse
Sex :
ALL
Ages :
- Minimum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 639 |
Target Study Title: Preventing Acute Kidney Injury and Improving Outcome in Critically Ill Patients Utilising Risk Prediction Score - a Pilot Feasibility Randomized Controlled Trial
Target Study Description: #Study Description
Brief Summary
An interventional controlled trial to test the feasibility of applying risk score based prevention for critically ill patient at high risk to develop acute kidney injury (AKI)
Detailed Description
Background and rationale AKI is common in the intensive care unit .It contributes significantly to mortality and morbidity .the estimated incidence or AKI among critically ill patients is 30-40% and morality is high.
There is a well recognized gap between the optimal care and the delivered care regarding prevention and management of AKI.
The focus over the last few years has been on early detection. A panel of urinary biomarkers have proved helpful for early detection of AKI. However the cost and low specificity make no single one of them solely reliable .using a panel of bio-markers increases their specificity.
The concept of electronic alerts has been recently introduced. Some trials have been testing its impact on the outcome of AKI. The benefit of electronic alerts is still uncertain .A meta-analysis is currently underway to synthesize stronger evidence of electronic alerts benefit.
Another evolving area, is the development of risk score to predict AKI and and hence applying timely preventive measures.
KDIGO recommends applying preventive measures to high risk patients. However no study to date has tested risk scores based interventions
Hypothesis:
We will use the recently validated score to predict AKI in ICU patients. We will then apply preventive measures. To patients at risk .To our knowledge this is the first study to apply preventive interventions based on AKI risk score assessment
#Intervention
- OTHER : Measures to prevent AKI among critically ill patients
- 1. Meticulous optimization of the fluid balance
2. Avoidance of nephrotoxic medications where possible
3. Optimisation of the hemodynamic status
4. Avoidance of blood transfusion unless marked acute blood loss or symptomatic anemia
5. Optimization of the underlying medical condition
6. Seek expert renal advise when necessary
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 adult patients (>=18 year old) admitted to the intensive care unit and do not fulfill the criteria for the diagnosis of AKI by Kidney Disease Improving Global Outcome (KDIGO) definition
Exclusion Criteria:
* Patients who have already developed AKI at the time of intensive care unit ICU admission.
* Patients with insufficient medical records to obtain previous medical history
* Patients who lack mental 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>
| 640 |
Target Study Title: Care for Post-Concussive Symptoms
Target Study Description: #Study Description
Brief Summary
The proposed study is a pilot randomized trial of a stepped collaborative care intervention designed to decrease post-concussive symptoms and improve post-injury functioning among sports-injured youth aged 11-17. Participants with persistent post-concussive symptoms (symptoms persisting at least two months post-injury) will be recruited from Seattle Children's Hospital departments of sports medicine and rehabilitation medicine. Consent and assent will be obtained in-person. Participants will be randomized to receive either the stepped collaborative care intervention, or treatment-as-usual. Participants will be assessed on a range of symptoms and areas of functioning at four time points: 0 months, 1 month, 3 months, and 6 months after enrollment. The primary hypothesis is that the intervention group athletes, when compared to usual care control group athletes, will demonstrate clinically and statistically significant reductions in postconcussive, anxiety, and depressive symptoms over the course of the 6-month study. Secondary analyses will assess the impact of the intervention on functional impairment including missed school days and other academic outcomes. Exploratory analyses will examine MRI findings that are characteristic of postconcussive neuropathology, if available in medical record, as predictors of treatment responses.
#Intervention
- BEHAVIORAL : Stepped Care
- Intervention will include : 1) care management; 2) cognitive-behavioral therapy (CBT); 3) psychiatric medication consultation in addition too receiving standard care through their medical team. Care management will include initial consultation to determine participants' and families' concerns and areas of difficulty, followed by brief interventions to connect them with care providers as needed . If participants do not show adequate symptom reduction, they will be engaged in structured CBT. CBT will be delivered in 4 to 12 structured sessions, each ranging from 30-60 minutes in length. Psychiatric medication consultation will be offered on an as-needed basis for participants not adequately responding to prior stepped care interventions. MD providers with expertise in psychopharmacological treatment of youth will provide consultation for participants' primary care provider regarding the prescription of psychiatric medications.
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 11 and 18
* Have sustained a head impact during sports participation
* Have incurred an onset or increase of at least three post-concussive symptoms following head impact
* Have increased post-concussive symptoms following head impact have continued for at least 4 weeks
* Live with their parents or legal guardians
* Live within commuting distance of Seattle Children's Hospital
* Willing to participate in assessment and treatment
* Have at least one parent/caregiver willing to participate in assessment and treatment
Exclusion Criteria:
* Meet Diagnostic and Statistical Manual of Mental Disorders (DSM - V) criteria for a psychotic disorder or bipolar disorder
* Active suicidality
* Substance dependence
Sex :
ALL
Ages :
- Minimum Age : 11 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 641 |
Target Study Title: Pulsed Electromagnetic Field in Patients With Impingement Shoulder: A Randomized, Placebo-Controlled Clinical Trial
Target Study Description: #Study Description
Brief Summary
In the past many authors have reported the abnormal contact between the rotator cuff and coracoacromial arch, but the exact etiology was not clearly understood. Thus, the objectives of this study relate specifically to improve the symptoms and rehabilitation of shoulder function of the patient:
1. Assess the effectiveness of magnet therapy in the treatment of impingement of the rotator cuff;
2. Assess whether the application of magnetic therapy 3 times a week for three weeks, may be effective as a single treatment of impingement of the rotator cuff;
3. Assess whether the combination of magnetic therapy with therapeutic exercises is more effective than magnetic therapy only;
4. Evaluate the benefits of magnetic therapy associated with therapeutic exercise in the short and long term.
5. Assess the effectiveness of the modulation of pulsed electromagnetic field at 25 Hz and 20 mT in patients with shoulder impingement syndrome.
Detailed Description
1. Randomization of the patients 1.1) Duration of wash-out Having made the proper screening of patients undergoing the study, all pre-selected patients should discontinue any medications that might influence the symptoms of impingement syndrome (such as analgesics, antiinflammatory, chondroprotective, etc.) for a period of 7 days.
1.2) Randomization
The investigators have chosen a total sample of 30 patients undergoing the study. Only one will be treated the shoulders of patients, if there are cases of bilateral impingement syndrome (IS). Patients will be equally distributed in two groups, receiving first place:
Group 1: treatment with magnetic therapy, three times per week lasting 30 minutes each session.
Group 2: placebo of magnet therapy (MT), three times per week lasting 30 minutes each session.
Randomization will be done as follows: initially 10 patients will be selected to be evaluated by a blinded evaluator and by the end of the evaluation, the patient will randomly choose a paper folded into 2 parts, which will be inside a plastic bag. Inside this bag there will be 10 paper folded in the same way and with the same color and size, where in three of them will say 'A', two of them written in 'B', three of them written in 'C' and two of them 'D' . Patients were drawn papers written 'A' and 'D' will be selected for group 1 and patients to raffle papers written 'B' and 'C' will be selected for group 2. After the drawing paper, the same can not be placed back in the bag. Randomization will be done this way so that all patients can also be divided into two groups and for the blind assessor does not know which group the patient was allocated.
2. PLAN OF STUDY 2.1) Assessment 1: Patients selected for study are those referred to our outpatient musculoskeletal physiotherapy with a diagnosis of impingement syndrome grade II and grade III. All will be evaluated by a blinded investigator, who uses the Visual Analogue Scale (VAS), the rating scale of Constant and University of California, Los Angeles (UCLA) shoulder rating scale, and measurement of rotator cuff muscle force (external and internal rotation) and shoulder elevation.
2.2) Assessment 2: After 3 weeks of treatment only with the applications of magneto therapy, a new assessment will be equal to an evaluation made by an assessor blinded, who do not know which patients are exposed to placebo or not. After the third evaluation, all patients will continue with the sessions of magnetic therapy (placebo or not), but now associated with specific therapeutic exercises for the treatment of impingement syndrome of the shoulder. The assessment consists of two re-evaluation of all parameters previously in an evaluation.
2.3) Evaluation 3: The third evaluation will happen after three weeks of treatment with magnetic therapy and exercises over again a blind assessor will evaluate patients in the same manner as in evaluation 1 and 2. After this evaluation, patients receive high treatment and receive a booklet of exercises to help them to practice proper exercises for the shoulder at home.
2.4) Evaluation 4: The fourth review will occur six months after the third evaluation, where the main objective is to evaluate the efficacy of treatment without the guidance of a physiotherapist and without weekly applications of magnetic therapy.
* Application of methods: The investigators have chosen a total sample of 30 patients undergoing the study. Only one will be treated the shoulders of patients, if there are cases of bilateral impingement syndrome. Patients will be equally distributed in two groups, receiving first place: Group 1: treatment with magnetic therapy, three times per week lasting 30 minutes each session. Group 2: placebo of magnet therapy, three times per week lasting 30 minutes each session.After the first 3 weeks of application of magnetic therapy, will begin a program of therapeutic exercises (kinesiotherapy) equally to all patients in both groups. These exercises will be conducted after each application of magnetic therapy and all patients will receive a brochure guiding them to perform exercises at home. The applications of magnetic therapy will continue to be 3 times per week with 30 minutes duration each application, but this time associated with exercise, treatment will be done for another 4 weeks. After these four weeks, patients will be reassessed by the scale of Constant and UCLA to evaluate the overall function of the shoulders that received placebo treatment and the magneto.
#Intervention
- OTHER : Pulsed Electromagnetical Field and Exercise
- G1: MT, three times per week lasting 30' each session. G2: placebo MT, 3 X week lasting 30'each session. After 3 weeks of application of MT, will begin a program of exercises.
- Other Names :
- PEMF, Pulsed Electromagnetical Field, Exercise
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* The patient must have a diagnosis of impingement of the rotator cuff grade II or grade III. For patients with grade III, they must present at least 90 ° of active elevation of the affected shoulder-free. Patients with extensive lesions of the rotator cuff will be deleted.
* The patient must be aged between 30 and 50 years, of both sexes.
* Patients should not use any anti-inflammatory, analgesic and / or chondroprotective by at least one week before the start of treatment.
* The patient must not have been subjected to intra-articular injection of corticosteroids for at least 30 days before the start of treatment.
* The patient can not be being subjected to physical therapy for at least 30 days before the start of treatment.
* Patient must have at least 3 months of discomfort and / or symptoms of impingement syndrome.
Exclusion Criteria:
* Make use of systemic anti-inflammatory medications and / or topics during the study.
* Patient presenting during pregnancy or postpartum.
* A patient with cancer, even if you are treated.
* Having been subjected to surgery on the shoulder to receive the study treatment
* submit inflammatory joint diseases (such as rheumatoid arthritis, lupus, gout, etc.) except for the impingement of the rotator cuff.
* Patients who do not submit high active-free up to 90 degrees (minimum) of the affected shoulder will be deleted. These cases are specific to patients with extensive lesions of the rotator cuff and have no function of this muscle group.
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>
| 642 |
Target Study Title: A Phase 1a/b, Open-Label, Dose-Escalation and Expansion Study of IK-175, an Oral Aryl Hydrocarbon Receptor (AHR) Inhibitor, as a Single Agent and in Combination With Nivolumab, a PD-1 Checkpoint Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma
Target Study Description: #Study Description
Brief Summary
This study will be conducted in adult subjects diagnosed with any form of an advanced or metastatic solid tumors including urothelial carcinoma for which standard therapy is no longer effective or is intolerable. This is a phase 1, multi-center, open label study designed to assess safety and tolerability of IK-175 as a single agent and in combination with nivolumab, to determine the recommended phase 2 dose (RP2D). Disease response, pharmacokinetics (PK), pharmacodynamics, and response biomarkers will also be assessed.
#Intervention
- DRUG : IK-175
- Subjects will be administered IK-175 PO daily for every 21-day treatment cycle during the Single Agent Treatment dose escalation or for every 28-day treatment cycle during the Single Agent dose expansion.
- Other Names :
- KYN-175
- DRUG : IK-175 and nivolumab
- Subjects will be administered IK-175 PO daily and administered a single dose of nivolumab IV on Day 1 for every 28-day treatment cycle during the Combination Treatment dose escalation and expansion.
- Other Names :
- KYN-175 and nivolumab
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Adult patients >=18 years.
* Patients with confirmed solid tumors (including urothelial carcinoma) who have locally recurrent or metastatic disease that has progressed on or following all standard of care therapies or who is not a candidate for standard treatment.
* For patients with urothelial carcinoma to be enrolled in the Combination Treatment arm, patients must have confirmation of urothelial carcinoma and have unresectable locally recurrent or metastatic disease that has progressed on or following all standard of care therapies, or who is not a candidate for standard treatment. Checkpoint inhibitor therapy with anti-PD-1 or anti-PD-L1 does not necessarily need to directly precede the study, but patients must have progressed on or within 3 months of receiving the last infusion/dose anti-PD-(L)1 therapy for inclusion in the Combination Treatment arm only.
* Have measurable disease.
* Accessible tumor that can be safely accessed for multiple core biopsies and patient is willing to provide tissue from newly obtain biopsies before and during treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Adequate organ function.
* Highly effective birth control.
* Time since the last dose of prior therapy to treat underlying malignancy (including other investigational therapy): 9a. Systemic cytotoxic chemotherapy: >= the duration of the most recent cycle of the previous regimen (with a minimum of 2 weeks for all, except 6 weeks for systemic nitrosourea or systemic mitomycin-C). 9b. Biologic therapy (eg, antibodies): >= 3 weeks or their dosing interval if shorter than 3 weeks (e.g. q2w therapy would require a 2-week washout). 9c. Small molecule therapies: >= 5 × half-life. 9d. Investigational Agent: >=4 weeks or >=5 × half-life, whichever is shorter
Exclusion Criteria:
* Untreated symptomatic central nervous system (CNS) tumors or brain metastasis. Patients are eligible if CNS metastases are asymptomatic and do not require immediate treatment or have been treated and patients have neurologically returned to baseline (residual signs or symptoms related to the CNS treatment are permitted). In addition, patients must have been either off corticosteroids, or on a stable or decreasing dose of <=10 mg daily prednisone (or equivalent) for at least 2 weeks prior to entering the Treatment period (Day 1).
* Patients who have not recovered to <= Grade 1 or baseline from all adverse events (AEs) due to previous therapies
* Has an active autoimmune disease that has required systemic treatment in past 2 years with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs; nonsteroidal anti-inflammatory drugs (NSAIDs) are permitted. Patients with type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
* Any condition requiring continuous systemic treatment with either corticosteroids (>10mg daily prednisone equivalents) or other immunosuppressive medications within 2 weeks prior to first dose of study treatment (Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalent are permitted in the absence of active clinically significant [ie, severe] autoimmune disease.).
* Any other concurrent antineoplastic treatment or investigational agent except for allowed local radiation of lesions for palliation and hormone ablation.
* Uncontrolled or life-threatening symptomatic concomitant disease (including known symptomatic human immunodeficiency virus (HIV) positive with an AIDS defining opportunistic infection within the last year, or a current CD4 count <350 cells/uL, symptomatic active hepatitis B or C checked at screening, or active tuberculosis). Patients with HIV are eligible if: 6a. they have received antiretroviral therapy (ART) for at least 4 weeks prior to entering the Treatment period as clinical indicated while enrolled on study; 6b. they continue on ART as clinically indicated while enrolled on study; 6c. CD4 counts and viral load are monitored per standard of care by a local health care provider.
* Patients that have undergone a major surgery within 3 weeks of starting trial treatment or has inadequate healing or recovery from complications of surgery prior to starting trial treatment.
* Prior radiotherapy within 2 weeks of start of study treatment. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had severe radiation pneumonitis. A 1-week washout is permitted for palliative radiation [<= 2 weeks of radiotherapy] to non-CNS disease.
* Prior AHR inhibitor treatment without Sponsor permission.
* Potentially life-threatening second malignancy requiring systemic treatment within the last 3 years or which would impede evaluation of treatment response. Hormone ablation therapy is allowed within the last 3 years. Patients with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible.
* Recent or current significant cardiovascular disease (e.g. stroke, heart attack, heart failure, or arrhythmia).
* Medical issue that limits oral ingestion or impairment of gastrointestinal function that is expected to significantly reduce the absorption of IK-175.
* Clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (>= New York Heart Association Classification Class II), or the presence of any condition that can increase proarrhythmic risk (eg, hypokalemia, bradycardia, heart block) including any new, unstable, or serious cardiac arrhythmia requiring medication, or other baseline arrhythmia that might interfere with interpretation of ECGs on study (eg, bundle branch block). Patients with QTcF >450 msec for males and >470 msec for females on screening ECG are excluded. Any patients with a bundle branch block will be excluded with QTcF >450 msec. Males who are on stable doses of concomitant medication with known prolongation of QTcF (eg, Selective Serotonin Reuptake Inhibitor Antidepressants) will only be excluded for QTcF >470 msec.
* History of life-threatening toxicity related to prior immune therapy (eg. anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (eg. hormone replacement after adrenal crisis).
* Has an active infection requiring systemic therapy.
* Treatment with any live/attenuated vaccine within 30 days of first study treatment.
* A woman of child-bearing potential (WOCBP) who has a positive pregnancy test or is breastfeeding prior to treatment.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 643 |
Target Study Title: Randomized Clinical Trial of Health Information Technology for Problem Solving in Diabetes Management
Target Study Description: #Study Description
Brief Summary
The main hypothesis of this research is that use of an informatics intervention for problem-solving in diabetes management, Mobile Diabetes Detective (MoDD), by individuals with type 2 diabetes will lead to positive improvements on a number of primary and secondary outcomes related to their health and their management of diabetes. The primary outcomes are a reduction in individuals' glycolated hemoglobin (HbA1c), improvement in their problem-solving abilities, and self-care behaviors. Secondary outcomes include a reduction in individuals' fasting blood glucose (BG); improvement in individuals' self-efficacy, and in emotional aspect of living with diabetes. We hypothesize that primary and secondary outcome effects will be sustained at three months and twelve months. Exploratory outcomes include a decrease in individuals' Cardiovascular Risk (Body Mass Index, Blood Pressure, Total, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) Cholesterol levels, and Framingham Cardiovascular Risk Score). We also hypothesize that improvements in clinical outcomes (HbA1c, fasting BG and Cardiovascular Risk) will be mediated by the improvements in problem-solving abilities and self-efficacy.
Detailed Description
Well-developed problem-solving is essential to successful diabetes management results in better diabetes self-care behaviors, and leads to improvements in clinical outcomes. Problem-solving is central to many self-management and behavior change programs; the American Diabetes Association (ADA) includes problem-solving as a critical self-care behavior. Given the importance of problem solving skills, innovative diabetes education programs, such as Discovering Diabetes, have been developed and shown to be effective in fostering independent problem-solving.
At the same time, many care management programs and diabetes education centers struggle with staffing shortages, limited funding, and competitive time demands. As a result, 50 to 80% of individuals with diabetes experience significant knowledge and skill deficits. Health Information Technology (HIT) can make successful interventions available to more diverse populations. At present, however, many HIT interventions target improved patient-clinician communication and logging and monitoring, rather than focusing more specifically on fostering problem-solving skills. Moreover, few HIT interventions have been rigorously evaluated in controlled trials. The main contribution of this research is a theoretically-grounded HIT intervention, Mobile Diabetes Detective (MoDD), that incorporates best practices and current guidelines for supporting and fostering individuals' problem-solving skills in context of diabetes self-management. In our prior work we developed and evaluated a mobile application for reflection and discovery in diabetes management, MAHI (Mobile Access to Health Information). MAHI helped individuals with diabetes capture diabetes-related experiences and reflect on them under a supervision of a diabetes educator. The proposed intervention, MoDD will further extend this prior work, specifically focusing on guided problem-solving through experimentation. The intervention will utilize an open source platform for disease self-management developed by the research team.
If the results are achieved, the project will have significant impact both locally and globally. Locally, diabetes continues to be a major problem in NYC, particularly among disadvantaged populations, many of whom are served by the Health Resources and Services Administration (HRSA) funded Community Health Centers (CHCs) participating in this study. In the past 10 years, the number of people with diabetes in NYC has more than doubled. An estimated 530,000 adult New Yorkers have been diagnosed with diabetes, with another 265,000 having diabetes but are unaware. In the HRSA funded CHCs in New York State, 8% of the adult patients have a diagnosis of diabetes. At the same time, our prior studies showed that despite such barriers as low health literacy or lower socio-economic status, disadvantaged populations in NYC can greatly benefit from informatics interventions that target health and wellness. The proposed research will use HIT to partially assuage the ongoing challenge of control and management of diabetes. The expected improvement in problem-solving skills has been shown to lead to improved self-care behaviors, such as a more careful diet and appropriate level of exercise, and significant reduction in HbA1c7, which in turn has been linked to reduction in diabetes-related complications. Thinking more broadly, this research can provide new insights into facilitating problem-solving in diabetes management with HIT, as an alternative to more traditional staff-intensive interventions.
#Intervention
- BEHAVIORAL : Mobile Diabetes Detective (MoDD)
- MoDD is a web-based application that is designed to help individuals with diabetes identify specific problems related to glycemic control, and engage in problem-solving process. MoDD includes a number of messages that explain its users the nature of various problems related to glycemic control, aspects of individuals' behaviors that might have contributed to these problems, and alternative behaviors that could help to improve glycemic control. In addition to these messages displayed on the MoDD website, study participants may receive SMS messages with reminders to test blood glucose, or to follow the selected new behavior.
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 <= 65 years
* A diagnosis of Type 2 Diabetes with HbA1c >= 8.0. A patient of the health center for at least 6 months
* Has participated in at least one diabetes education session at the participating site in the last 6 months
* Proficient in either English or Spanish
* Must own a basic cell phone
Exclusion Criteria:
* Pregnancy
* Presence of serious illness (e.g. cancer diagnosis with active treatment, advanced stage heart failure, multiple sclerosis)
* Presence of cognitive impairment
* Plans for leaving the community health center (CHC) in the next 12 months
* Does not have a computer and/or Internet access
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>
| 644 |
Target Study Title: One-month Clinical Comparison of Silicone Hydrogel Monthly Lenses in High Lipid Depositors
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to compare AIR OPTIX® plus HydraGlyde (AOHG) contact lenses to ACUVUE® VITA® (VITA) contact lenses for total lipid uptake (total of surface and bulk uptake) after 30 days of wear by high lipid depositors.
#Intervention
- DEVICE : Lotrafilcon B contact lenses
- Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
- Other Names :
- AIR OPTIX® plus HydraGlyde
- DEVICE : Senofilcon C contact lenses
- Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
- Other Names :
- ACUVUE® VITA®
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:
* Sign Informed Consent;
* Best corrected visual acuity (BCVA) of at least 0.1 logarithm of the minimum angle of resolution (logMAR) in each eye at Visit 1;
* Manifest cylinder less than or equal to 0.75 diopter (D) in each eye at Visit 1;
* Successful current wearer (during the past 2 months for a minimum of 5 days per week and 8 hours per day) of monthly replacement silicone hydrogel lenses within the power range of lens powers available for the screening and study lenses;
* Screening lenses worn 10 hours exhibiting high lipid uptake.
Exclusion Criteria:
* Habitual lens used in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) during the past 2 months;
* Habitually wearing AIR OPTIX AQUA, AIR OPTIX plus HydraGlyde, ACUVUE OASYS®, or ACUVUE VITA as contact lenses during the past 2 months;
* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current)
* History of herpetic keratitis, corneal surgery, or irregular cornea;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* Abnormal ocular conditions or findings, as specified in the protocol;
* Known pregnancy and lactation.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 645 |
Target Study Title: The Administration Time Point of Carboprost Methylate and Effects on Perioperative Complications and Cervical Ripening Effect in Artificial Abortion
Target Study Description: #Study Description
Brief Summary
Artificial abortion is the most widely used procedure in termination of first-trimester pregnancy. Cervical ripening before the operation guarantees operative convenience and decreases complications. An overstrained cervical dilation associates with uterine perforation, cervical laceration and cervical incompetence. To address the issue, various mechanical and pharmaceutical methods have been applied to prepare the cervix before transvaginal procedures. Prostaglandin analogues (PGs) play an important role in ripening the cervix or promoting uterine contraction in gynecology and obstetrics. As most tissues express prostaglandin receptors, vomiting, nausea, fever, diarrhea and abdominal pain can hardly be avoided with PGs administration. Longer PGs action contributes to better cervical ripening, but more uncomfortableness at the same time. These annoying symptoms may affect the participants' satisfaction and increase perioperative risks. To balance the safety and effectiveness of the surgery as well as patients' feeling, a proper timing for cervical ripening should be investigated. However, the administration timing of PGs has not reached a broad consensus, ranging from 16 hours to 2 hours before surgery. Carboprost methylate (CM), a PG-F2α analogue, has been used nationwide for cervical ripening in China. To minimize the side effects of PGs without affecting cervical ripening, the investigators intended to explore shortening the action time of CM in cervical preparation before artificial abortion. Thus, the investigators conducted this prospective cohort study and aimed to examine the efficacy of early and delayed vaginal administration of CM before surgery, and optimized both the perioperative safety and participants' convenience. The investigators hypothesize that early vaginal administration of CM would not affect the cervical ripening status, but will greatly reduce the unpleasant complications among the participants.
#Intervention
- DRUG : early vaginal administration of carboprost methylate
- In this group, the administration time point of carboprost methylate is 20 minutes before the surgery.
- DRUG : delayed vaginal administration of carboprost methylate
- In this group, the administration time point of carboprost methylate is usually 110-120 minutes before the surgery.
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 <= 59
* Signed informed consent.
* Admitted to hospital for surgical termination of unplanned pregnancy
* Gestational weeks range between 7 to 10
* Average diameter of the gestational sac was no larger than 4cm
Exclusion Criteria:
* Massive vaginal bleeding
* Severe abdominal pain at admission (numerical rating scale, NRS>3)
* Genital tract infection
* Contraindication of PGs (including uncontrolled hypertension, asthma, glaucoma, severe heart disease or allergy to prostaglandins, etc.)
* Prior history of vaginal delivery
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 59 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 646 |
Target Study Title: The Effect of Ballet Training on Plantar Venous Pump Activity in Ballerinas
Target Study Description: #Study Description
Brief Summary
Classic ballet dance is a demonstration of complex motor skills to be revealed in aesthetic combinations and repetitively, and it demands intensive use of the lower extremities within extreme of range of motion (ROM). Because ballet practice depends on advanced technical skills, it involves intensive physical training and causes an overload on the musculoskeletal system and foot deformities such as pes planus.
Plantar venous pump (PVP) is a network of multiple venous vessels located between the muscles of the foot arch. PVP is considered the first step of venous return and discharges into the posterior tibial vein (PTV). PVP is reported to be active during gait while it is inactive in resting position. There are different views on the mechanisms enabling its activation 1-3. The general view is that during the stance phase of the gait, the flattening of the plantar arch with weight transfer causes the veins in this region to narrow and creates a force that pumps the blood up.
The aim of this study is the investigation what kind of hemodynamic changes ballet training causes in the lower extremity
#Intervention
- OTHER : Navicular drop measurement
- The difference in navicular height between sitting and standing positions was recorded (mm) as the amount of navicular drop.
- OTHER : Measurement of venous return parameters in supine
- Venous return parameters of posterior tibial vein was measured when participant applied force equivalent to their own body weight on plantar surface of their right leg in supine position
- OTHER : Measurement of venous return parameters in standing
- In standing, venous return parameters was measured of posterior tibial vein when participants shift all of their weight to the right leg for 3 second with their leg muscles as relaxed as possible and their knee joint in full extension.
- OTHER : measurement of midfoot pressure distrubition
- In standing, midfoot pressure distrubution was measured when participants shift all of their weight to the right leg
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 balerinas):
* receiving ballet training at least 10 h per week for at least 4 years
* receiving formal dancing training system
Inclusion Criteria (for non-dancer group)
* never receiving formal dancing training
* having sedentary lifestyle
Exclusion Criteria:
* Participants with a history of foot or ankle surgery,
* Participants with connective tissue disease,
* Participants with rigid pes planus-cavus,
* Participants with chronic venous insufficiency
* Participants with acute ankle injury in recent 3 months
Sex :
FEMALE
Ages :
- Minimum Age : 14 Years
- Maximum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 647 |
Target Study Title: Biologic Effects of DHEA in Humans
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to determine whether DHEA replacement therapy decreases abdominal fat and improves insulin sensitivity.
Detailed Description
Studies on rats and mice have shown that the adrenal hormone dehydroepiandrosterone (DHEA) reduces abdominal visceral fat and protects against insulin resistance. This study was done to learn if DHEA replacement therapy decreases abdominal obesity and improves insulin action in humans.
Participants were randomly assigned to receive 50 mg per day of DHEA or a placebo at bedtime for 6 months. Participants underwent magnetic resonance imaging (MRI) and oral glucose tolerance tests at the beginning and conclusion of the study. Other tests included measurements of hormones and lipids.
#Intervention
- DRUG : DHEA
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:
* 65 <= age <= 78 old
* Physically healthy
* Non-smoker
* On stable medications for at least 6 months
* Stable body weight for the past year
Exclusion Criteria:
* Serious active medical problems
* Hormone therapy
* Abnormal PSA (prostate specific antigen) in men
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Maximum Age : 78 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 648 |
Target Study Title: The Impact of COVID-19 Pandemic to Trauma Patients in Emergency Department: A Multicenter Experience of Istanbul
Target Study Description: #Study Description
Brief Summary
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. The aim of this multi-centered study is to guide for the approach, organization, diagnosis and treatment of the patients admitted due to trauma to emergency department during the pandemic period.
Detailed Description
COVID-19, which emerged in China in December 2019, has become a pandemic with its spread to many countries of the world. The investigators hypothesize that since the number of hospital applications expected to be decreased due to trauma during the COVID-19 period, the level of hospital trauma applications changed. Thus, the aim of this multi-centered study is to guide for the approach, organization, diagnosis and treatment of the patients admitted due to trauma to emergency department during the pandemic period.
#Intervention
- DIAGNOSTIC_TEST : COVID-19 PCR
- Nasopharyngeal samples were analyzed by PCR for the detection of Novel Coronavirus 2019 DNA
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:
* accepted to participate with an informed consent
* trauma patients who admitted to the study centers
Exclusion Criteria:
* lack of informed consent
* lack of data
Sex :
ALL
Ages :
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 649 |
Target Study Title: Cocaethylene Substitution Therapy and Tolerance Induction in Treating Cocaine Dependence
Target Study Description: #Study Description
Brief Summary
Cocaine has been cited as the primary drug threat in the United States. The purpose of this study is to determine if cocaethylene, used as a prototype drug, is a safe and effective treatment for cocaine dependence.
Detailed Description
Currently, there are no medications available to specifically treat cocaine addiction. Cocaethylene is an active metabolite of cocaine and has a similar chemical structure to cocaine. The purpose of this study is to determine whether substitution therapy with cocaethylene is a safe and effective treatment for cocaine dependence.
This double-blind, placebo-controlled trial will occur in 3 parts. In Part 1, the individual pharmacokinetics of an intravenous dose of cocaethylene will be determined in order to estimate individualized cocaethylene infusion rates and pharmacokinetic parameters. This will provide important information on how cocaethylene is processed by the body. In Part 2, an infusion of cocaethylene, producing a venous plasma concentration of 200 ng/ml, will be administered over an 8-hour period. Clinical monitoring and blood sampling will occur in order to determine the safety profile of cocaethylene. During Part 3, the ability of cocaethylene to modify the acute effects of intravenous cocaine will be determined. Cocaethylene will be administered in plasma concentrations of 0 ng/ml, 50 ng/ml, or 200 ng/ml over an 8-hour period. Participants will be randomly assigned to receive a challenge intravenous dose of cocaine (0.5 mg/kg or 1 mg/kg) or placebo at the 4-hour mark of cocaethylene infusion. Following the initial 8-hour period, cocaethylene infusion will be continued for an additional 5 hours. Behavioral and physiological measures will be collected throughout the study sessions at predetermined times to evaluate whether tolerance to cocaethylene develops. These measures will also help to determine whether cocaethylene modifies or produces tolerance to the effects of an acute dose of cocaine.
#Intervention
- DRUG : Cocaethylene
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:
* Meets DSM-IV criteria for cocaine dependence
* Cocaine use of at least 0.5 grams each week during the three months prior to enrollment, confirmed by a positive urine test for cocaine metabolite
* Females are eligible if currently using adequate contraception, not planning to become pregnant, or surgically sterilized
* Females of child-bearing potential must have a negative pregnancy test prior to study entry
* Currently not physiologically dependent on alcohol, but may meet DSM-IV criteria for alcohol abuse or dependence
Exclusion Criteria:
* Meets DSM-IV criteria for dependence on any drugs (other than nicotine or alcohol) within the year prior to enrollment
* Currently abuses other substances such as opiates, sedative-hypnotics, or amphetamines (excluding marijuana or nicotine) more than twice a week
* History of a serious medical illness or indication of a serious medical illness such as seizures, hypertension, heart disease, an abnormal ECG, anemia, diabetes, or abnormal blood flow sounds
* Meets DSM-IV criteria for a current major mental disorder, including major depression, bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, or organic mental syndrome
* Currently being treated with psychotropic medication
* At risk for suicide, as determined by a psychiatrist
* Greater than two times the normal level for liver or kidney function tests
* Currently seeking treatment for drug abuse
* Participants with liver function tests equal to or greater than three times the normal level will be discontinued from the study
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 650 |
Target Study Title: An Observational Chart Review Study to Describe the Real-world Outcomes and Use of Avelumab in Combination With Axitinib for Treatment of Patients With Advanced Renal Cell Carcinoma in the United Kingdom.
Target Study Description: #Study Description
Brief Summary
An observational chart review study to describe the real-world outcomes and use of avelumab in combination with axitinib for treatment of patients with advanced renal cell carcinoma in the United Kingdom.
#Intervention
- DRUG : avelumab
- as provided in real world setting
- DRUG : axitinib
- as provided in real world settings
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 meet all of the following inclusion criteria to be eligible for inclusion in the study:
* Patients with a documented diagnosis of aRCC.
* Patients aged >=18 years at the index event date.
* Patient initiated on treatment with avelumab in combination with axitinib ( >=1 dose) on or after 1st August 2019.
Exclusion criteria
* Patients meeting any of the following criteria will not be included in the study:
* Patients who received avelumab in combination with axitinib as part of a clinical trial
* Patients initiated on avelumab in combination with axitinib less than 12 months from the end of data collection.
* Patients who are known to have opted out of participation in any research
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>
| 651 |
Target Study Title: PHOspholamban RElated CArdiomyopathy STudy - Intervention (Efficacy Study of Eplerenone in Presymptomaticphospholamban R14del Carriers)
Target Study Description: #Study Description
Brief Summary
Phospholamban (PLN) R14del mutation carriers may develop dilated cardiomyopathy (DCM) and/or arrhythmmogenic cardiomyopathy (ACM). Analogous to other inherited cardiomyopathies, the natural course of the disease is age-related ('age-related penetrance'); after a presymptomatic phase of variable length many PLN R14del-carriers progress to overt disease, and are diagnosed with either DCM or ARVC. PLN is a regulator of the sarcoplasmic reticulum Ca2+-ATPase (SERCA2a) pump in cardiac muscle and thereby important for maintaining Ca2+ homeostasis. Cardiac fibrosis appears to be an early manifestation of disease. The investigators hypothesize that treatment of presymptomatic PLN R14del-carriers with eplerenone, which by virtue of its mineralocorticoid(aldosterone)-blocking properties is a strong antifibrotic agent, reduces disease progression and postpones onset of overt disease.
Detailed Description
In the Netherlands ≈15% of idiopathic dilated cardiomyopathy (DCM) and ≈10% arrhythmogenic right ventricular cardiomyopathy (ARVC) patients carry a single (founder) mutation in the gene encoding Phospholamban, PLN R14del. Analogous to other inherited cardiomyopathies, the natural course of the disease is age-related ('age-related penetrance'); after a presymptomatic phase of variable length many PLN R14del-carriers progress to overt disease, and are diagnosed with either DCM or ARVC. PLN is a regulator of the sarcoplasmic reticulum Ca2+-ATPase (SERCA2a) pump in cardiac muscle and thereby important for maintaining Ca2+ homeostasis. Cardiac fibrosis appears to be an early manifestation of disease. The investigators hypothesize that treatment of presymptomatic PLN R14del-carriers with eplerenone, which by virtue of its mineralocorticoid(aldosterone)-blocking properties is a strong antifibrotic agent, reduces disease progression and postpones onset of overt disease.
#Intervention
- DRUG : Eplerenone
- eplerenone (inspra; pfizer) one tablet (50mg standard dosis; 25mg reduced dosis) per day
- Other Names :
- Inspra
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:
* Phospholamban (PLN) R14del mutation carriers
* Age >=30 and <= 65 years
* New York Heart Association functional class <= 1
* LV ejection fraction >=.45 (measured with MRI)
Exclusion Criteria:
* Palpitations necessitating treatment (at the discretion of the attending physician)
* A diagnosis of DCM (see appendix 1). Note: regional LV wall motions abnormalities are acceptable.
* A diagnosis of ARVC (according to the task force criteria, see appendix 2)
* Global or regional RV dysfunction and/or structural alterations (according to task force criterion 1, see appendix 2).
* Ventricular premature complexes >1000 during 24hours Holter-monitoring
* Non-sustained ventricular tachycardia during Holter-monitoring or exercise-testing
* History of sustained ventricular tachycardia or ventricular fibrillation
* Hypertension requiring the use of antihypertensive drugs, or when this is anticipated within the coming 3 years
* Evidence of ischemic heart disease
* Treatment with cardioactive medication
* Hyperkaliemia (serum potassium >5.0 mmol/l)
* Severe renal dysfunction (eGFR <30 ml/min/1.73 m2)
* Severe hepatic impairment (Child-Pugh class C)
* Women who are currently pregnant or report a recent pregnancy (last 60 days) or plan on becoming pregnant.
* Concomitant use of CYP3A4-inhibitors (see appendix 5)
* Concomitant use of NSAIDs (see appendix 5)
* Concomitant use of potassium sparing-agents (see appendix 5)
* Known intolerance or contraindication to aldosterone antagonists
* Participation in another drug trial in which the last dose of drug was within the past 30 days.
* Contra-indications for MRI (claustrophobia, metal devices)
* Subjects unable or unwilling to provide written informed consent
Sex :
ALL
Ages :
- Minimum Age : 30 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>
| 652 |
Target Study Title: Obesity, Inflammation and Response to Therapy in Asthma - Ancillary to Asthma Clinical Research Network (ACRN) Trials
Target Study Description: #Study Description
Brief Summary
Asthma is a common, long-term disease that is caused by inflammation of the airways. Inflammation also plays a role in obesity and may affect the way a person responds to asthma medication. This study will examine the relationship between obesity and inflammation and the effect they have on response to corticosteroid asthma medications.
Detailed Description
Asthma affects 20 million people in the United States. It can be caused by many factors, including exposure to tobacco smoke, infections, and other allergens. Recent research suggests that there may be a relationship between obesity and asthma. It is not fully understood how these two conditions are linked, but inflammation may play a role. Obesity-related inflammation may increase the risk of airway inflammation, thereby elevating the risk of developing asthma. Increased inflammation related to obesity may also reduce the effectiveness of inhaled steroid asthma medications, including glucocorticoids. Compared with people of normal weight, people who are overweight or obese may have a higher risk of developing glucocorticoid insensitivity, resulting in intolerance to glucocorticoid medications. The purpose of this study is to examine the effect that obesity has on glucocorticoid insensitivity and inflammation. This study will also examine differences in the response to asthma steroid medications between people who are overweight or obese and those who are not.
This study will use previously collected data from participants in two clinical trials of the NHLBI-funded Asthma Clinical Research Network (ACRN): the Best Adjustment Strategy for Asthma in Long Term (BASALT) study (NCT00495157) and the Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC) study. There will be no additional study visits specifically for this study. Researchers will examine blood samples collected at participants' first BASALT or TALC study visit to analyze levels of inflammation biomarkers (including tumor necrosis factor-alpha \[TNF-α\], interleukin-6 \[IL-6\], and leptin) and proinflammatory cytokines levels, which influence glucocorticoid insensitivity. Additional BASALT and TALC study data, including lung function, asthma symptoms, and asthma exacerbations, will also be analyzed.
#Intervention
- DRUG : Beclomethasone dipropionate HFA
- Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
- Other Names :
- QVAR® 40 mcg or QVAR® 80 mcg
- DRUG : Tiotropium bromide
- Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
- Other Names :
- Spiriva®
- DRUG : Salmeterol xinafoate
- Participants will receive the BASALT and TALC study drugs as determined in those protocols NCT00495157, NCT00565266. This study is ancillary to those trials and observational only and does not have any control over study drug allocation
- Other Names :
- Serevent®
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:
Participation in either the BASALT or TALC studies of the Asthma Clinical Research Network. Inclusion and exclusion criteria are as determined by those studies, NCT00495157, NCT00565266.
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>
| 653 |
Target Study Title: Effects of Ranibizumab on Microvasculature, Oxidative Stress and Recurrence in Primary Pterygium Surgery
Target Study Description: #Study Description
Brief Summary
Pterygium is a common ocular surface disease in Malaysia. Without treatment, it can lead to severe visual impairment. Recurrence is the commonest complication and novel treatment approaches are crucial to prevent vision loss. The biological processes underlying the formation of pterygium are complex, but central to its pathogenesis is the angiogenic cytokine vascular endothelial growth factor (VEGF). VEGF is upregulated under conditions of increased oxidative stress, which plays an integral role in pterygium development (Cardenas-Cantu et al., 2016, Karaman, 2018, Norrby, 1998, Rossino et al., 2020, Shibunya, 2011).Various biomarkers on pterygium have been identified and are useful to determine the effectiveness of new modality treatment for pterygium. These markers can be identified via histopathological stain such as Masson Trichrome to observe changes of collagen fibres. Other identifiable markers include the use of special immunohistochemical stain such as anti CD34 antibody for microvascular density and anti-8-OHdG antibody for oxidative changes in the pterygium tissue. By analyzing the changes with or without Ranibizumab injection in addition to observation of clinical recurrence rate of pterygium, we are able to conclude the effectiveness of anti-VEGF on pterygium recurrence. The aim of the study was to evaluate the association between collagen fibres changes, microvascular density changes and inflammation resultant from oxidative stress with the clinical recurrence of pterygium following intralesional Ranibizumab injection in comparison to control group.
Detailed Description
This is a prospective interventional study conducted from May 2018 to April 2020. Patients with primary pterygium who attended eye clinic Hospital Universiti Sains Malaysia (HUSM) Kubang Kerian, Kelantan and fulfilled the inclusion and exclusion criteria were recruited as participants of this study. Convenient sampling method was applied for participants' recruitment where all patients will be given thorough explanation in regards to the study and subsequently divided into interventional and control group. Intervention group participants were given intralesional Ranibizumab (0.5mg/ 0.05mL) 2 weeks prior to pterygium excision surgery. Both groups of participants undergo pterygium excision with autologous conjunctival graft surgery thereafter. Excised pterygium tissues were sent to the laboratory for slide preparation and staining with specific reagents including Masson Trichrome for collagen fibers, anti CD34 antibody for microvascular density and anti-8 OHdG antibody for oxidative stress changes. Slides were then analysed by the pathologist and statistical analysis of the results were carried out with the Statistical Package for the Social Sciences (SPSS) Version 26.0. All participants had intralesional Ranibizumab injection and pterygium excision with autologous conjunctival graft surgery in May 2018. They were scheduled for follow-up visits for the next 24 months to observe for complications of intralesional Ranibizumab injection, pterygium excision and conjunctival autograft surgery and any signs of recurrence.
#Intervention
- BIOLOGICAL : intralesional ranibizumab
- Lucentis; Genentech, Inc, San Francisco, California, USA 0.5mg/ 0.05mL
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:
* primary nasal grade 2 to 3 pterygium based on the clinical stages outlined by Johnston et al (2004)
* who consented for pterygium excision and conjunctival autograft surgery
Exclusion Criteria:
* cornea pathology such as scarring, history of herpetic keratitis, eyelid abnormalities, previous ocular surgery, ocular trauma, and ocular or systemic inflammatory disease
* Pregnant women and lactating mothers
Sex :
ALL
Ages :
- Minimum Age : 40 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>
| 654 |
Target Study Title: The Effects of Wellbutrin (Bupropion) on Residual and Cognitive Symptoms in SSRI-treated Depression
Target Study Description: #Study Description
Brief Summary
Many people with depression are treated with a serotonin-specific reuptake inhibitor anti-depressant (SSRI) and feel 'better'. Although many people feel 'better', they do not feel completely 'well'. Often, individuals continue to complain of cognitive problems such as lack of attention, diminished motivation, and impaired problem-solving. This study looks at whether residual and cognitive symptoms of depression in individuals are affected by the addition of Wellbutrin (bupropion).
Detailed Description
As many as 65-75% of treated patients continue to experience residual symptoms of depression. Cognitive impairments feature frontal cognitive dysfunction. Many experts believe that executive functions are better predictors of functional level than psychiatric diagnoses.
Frontal cognitive impairment and changes in neuroimaging are seen in individuals depleted of tryptophan, a serotonin precursor. These cognitive changes do not improve following serotonin-specific reuptake inhibitor treatment and at least one study has found that executive dysfunction predicts non-response to fluoxetine. In many patients, remission of mood symptoms in depression requires medications to target non-serotonergic neurotransmitter systems. Brain areas mediating executive functions receive rich noradrenergic inputs, and norepinephrine is known to be intimately involved in many of the executive functions.
A better understanding of serotonergic and catecholaminergic interactions would enable evidence-based treatment of depression which maximizes executive cognitive functions. This study examines the hypothesis that individuals treated with Wellbutrin will have higher scores on tests of executive functions and lower scores on depression indices.
#Intervention
- DRUG : Wellbutrin
- Other Names :
- bupropion
- 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:
* Depression
* SSRI-treated
Exclusion Criteria:
* Bipolar disorder
* Serotonin-norepinephrine reuptake inhibitor (SNRI) or bupropion treatment
* Treatment-resistant depression
* Seizure disorder
* Bulimia or anorexia nervosa
* Pregnancy
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>
| 655 |
Target Study Title: The Effect of Specially Designed Eating Plates on Self-served Portions and Caloric Intake in Normal Weight and Overweight Children
Target Study Description: #Study Description
Brief Summary
Previous studies demonstrated that children served themselves more food when using larger plates and bowels. The purpose of this study is to evaluate if self-served portions and caloric intake in normal weight and overweight children will be influenced by a specially designed eating plates compared to similar size normal plates.
Detailed Description
40 normal weight and 40 overweight kindergarden and elementary school children will participate in this study.
Anthropometric measurements: weight, height, BMI and BMI percentiles will be measured and calculated for each participant.
The participants will take part in two non-exercise activities at the 'sport and health center for children and adolescence'. At the end of each activity, a lunch buffet that contains all food ingredients will be served. During one meeting the children will be handed a regular plate and at the second meeting they will be handed a specially designed plate (with marking of the recommended meal composition and portion).
The amount and composition of food on the plates will be assessed by weighing and photography before and after eating and analysed to report macronutrient consumption by a dietitian. The meetings for normal weight children will be separated from the overweight children.
#Intervention
- OTHER : Specially designed plates
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 weight / obese children
* Normal weight children
Exclusion Criteria:
* Organic disease that cause obesity
* Underweight children (BMI percentiles < 5)
Sex :
ALL
Ages :
- Minimum Age : 4 Years
- Maximum Age : 13 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 656 |
Target Study Title: Characteristics of Symptomatic Asthma Remissions
Target Study Description: #Study Description
Brief Summary
This study aims at determining the patterns of asthma remission, the prevalence of these different patterns, the various factors associated with such remissions and possible recurrences of asthma, in order to determine the mechanisms involved in these processes.
The investigators therefore want to document these specificities in subjects in complete remission of their asthma, and those in only symptomatic remission of their asthma, in comparison with mildly symptomatic asthmatic subjects and healthy controls.
Detailed Description
Primary Outcome Measures :
* Airway inflammation (% induced sputum eosinophils)
Secondary Outcome Measures:
* Perception of induced respiratory symptoms
* Airway response to methacholine and AMP, and perception scores
* Diurnal variation in Peak Expiratory Flows
* Profile of regulatory T cells in the peripheral blood
* Changes in these parameters over time (baseline, 6 months, 1 and 2 years)
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:
* In remission of their asthma: absence of respiratory symptoms, no rescue asthma medication need and (for complete remission) an optimal pulmonary function (FEV1 > 90%) and normal PC20 methacholine for more than two years (with no current treatment).
* With a proven past history of asthma from medical files (reversible airway obstruction (> 12% FEV1 after bronchodilator or 20% by other means) proven by spirometry, PEF measures or methacholine challenge according to current criteria + previous symptoms and asthma medication use), having no more asthma symptoms and not having used asthma medication for more than 2 years.
* Agree to sign the consent form.
* No other condition that could interfere with the study measurements.
Exclusion Criteria:
* Unable to adhere to the protocol requirements.
* Other current respiratory disease.
* Upper or lower respiratory tract infection or use of antibiotics < 1 month.
* Use of oral corticosteroids within the last 3 months.
* Signs or symptoms of progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
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>
| 657 |
Target Study Title: Single-port Thoracoscopic Sympathicotomy for Treatment of Raynaud's Phenomenon, a Feasibility Study
Target Study Description: #Study Description
Brief Summary
The goal is to investigate the effect of a single-port R3 sympathicotomy on microvascular circulation in the affected fingers. This effect is analysed by performing cooling plethysmography and nailfold capillary microscopy bilaterally, following a unilateral, single-port thoracoscopic sympathicotomy.
Detailed Description
Raynaud's phenomenon is discoloration, discomfort and numbness or pain in the fingers and toes as a result of excessively reduced blood flow due to sympathetic induced vasospasms, in response to a change in temperature or emotional stress. It usually affects multiple fingers of both hands and comes in frequent attacks, with little or no discomfort in between them. Current treatment consists of stepped-care, including preventive measures optimizing digital blood flow, oral and intravenous medical therapy aimed at improving microvascular circulation, surgical neuromodulation to achieve vasodilatation and neurostimulation.
While surgical sympathectomy is an established treatment of Raynaud's phenomenon, its more invasive nature has prevented widespread application as an initial therapy. After introduction of minimally invasive surgical techniques in recent years, the investigators have further optimized the endoscopic sympathicotomy procedure performed on hyperhidrosis patients, now needing only a single 1 cm port for a detailed, panoramic view of the sympathetic chain (1). This minimal invasive technique has proven to be a safe, efficient and reproducible treatment for several indications and seems also suitable for Raynaud's patients.
In this feasibility study, the researchers want to investigate the effect of a single-port R3 sympathicotomy on microvascular circulation in the affected fingers. This effect is analysed by performing cooling plethysmography and nailfold capillary microscopy bilaterally, following a unilateral, single-port thoracoscopic sympathicotomy.
#Intervention
- PROCEDURE : Sympathicotomy R3
- sympathicotomy R3 consists of transecting the sympathetic chain at the third costal level, cranial of the ganglia, leaving the ganglia themselves untouched
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:
* Severe form of SRP, defined as clinical need of prostacyclin analogue infusions and/or bosentan having been given in the preceding 2 years, without satisfying result.
* No concurrent neurological disease
Exclusion Criteria:
* Known Chronic Obstructive Pulmonary Disease > Gold class 1.
* History of smoking > 20 pack years, due to higher risk of complications following unilateral lung- deflation and re-insufflation.
* Documented substance addiction.
* Signs/symptoms of macrovascular disease, or abnormalities on Doppler/duplex studies
* Other signs/symptoms of systemic autoimmune disease
* Severe concomitant diseases of the liver (eg Liver Function tests > three times the upper limit of normal), kidneys (creatinine > 160 mol/l), heart (including history of myocardial infarction, heart failure or angina pectoris), lung, blood, endocrine system, gastrointestinal system, Central Nervous System.
* Previous intra-thoracic pleural drainage.
* Previous thoracic surgery (including sternotomy).
* Gross pulmonary or pleural abnormalities on chest X-ray.
* Pregnancy.
* Unsuitable anatomy (e.g. due to severe physical malformations).
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>
| 658 |
Target Study Title: A Multinational Randomised, Double-blind, Placebo Controlled Study to Evaluate the Antiviral Pharmacodynamic Effect, Safety, and Pharmacokinetics of Escalating Doses of BILB 1941 ZW Oral Solution Administered Q8H for Five Days to Patients With Chronic Hepatitis C Genotype 1 Virus Infection
Target Study Description: #Study Description
Brief Summary
To assess the antiviral effect, safety and pharmacokinetics of rising doses of 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, 150 mg, 200 mg, 300 mg, 450 mg, 650 mg, 900 mg oral BILB 1941 ZW administered Q8H in a polyethyleneglycol 400 (PEG 400): distilled water: Tromethamine (TRIS) drinking solution for five days to patients with chronic HCV genotype 1 infection
#Intervention
- DRUG : BILB 1941 ZW
- 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:
* Adult males from 18 - 65 years
* Written informed consent consistent with ICH (International Conference on Harmonisation)/GCP (Good Clinical Practice) and local legislation given prior to any study procedures
* Chronic HCV infection demonstrated by positive HCV IgG Antibody
* HCV genotype 1 which has to be confirmed by central laboratory test before Visit 2
* Liver biopsy consistent with active Hepatitis C virus (HCV) infection obtained within the last 24 months showing minimal to mild liver fibrosis and without cirrhosis (Ishak or Metavir grade <= 2)
* HCV ribonucleic acid (RNA) load greater than 100,000 IU RNA per ml serum at screening
* Willing to abstain from alcohol during the screening, treatment and until completion of the study (visit 11)
Exclusion Criteria:
* Males not using an adequate form of contraception (condom, sterilisation at least 6 months post operation) in case their partner is of childbearing potential and is not using an adequate form of contraception (hormonal contraceptives, oral or injectable/implantable, intra-uterine device (IUD).
* Any other or additional plausible cause for chronic liver disease, including the presence of other viruses known or suspected to cause hepatitis
* Evidence of decompensated liver disease: ascites, portal hypertension or hepatic encephalopathy
* Positive test for human immunodeficiency virus (HIV) or Hepatitis B surface (HBs) antigen at screening
* Current alcohol or drug abuse, or history of the same, within the past twelve (12) months. All patients must abstain from alcohol from enrolment until completion of the study (visit 11).
* Any concurrent medical illness or disease requiring treatment or concomitant medications
* History of malignancy (except for previously cured squamous cell or basal cell carcinoma)
* Usage of any investigational drug within thirty (30) days prior to enrolment or 5 halflives, whichever is longer; or the planned usage of an investigational drug during the course of the current study
* Patients treated with interferon and/or ribavirin within 6 months prior to screening
* Planned or concurrent usage of any other pharmacological therapy at screening, or during the trial period, including any antiviral therapy or vaccination
* Known hypersensitivity to drugs or excipients
* Patients with any one of the following laboratory values at screening:
* Alanine transaminase (ALT) or Aspartate transaminase (AST) > 2.5 x upper limit of normal (ULN) (at screening and during the last 3 months before screening demonstrated by at least 2 further determinations)
* Total bilirubin > 1x ULN
* Alkaline phosphatase > 1.5x ULN
* Prothrombin time (INR, prolonged) > 1.5
* Platelet count < 100,000 / mm3
* Hemoglobin < 10.5 g/dL
* White blood cell count < 2,000 / mm3
* Patients with any clinically significant laboratory abnormalities based on the investigator's medical assessment at screening
* Positive urine test for drug abuse at screening
* Patients with known Gilbert's disease
* Prior randomisation to active treatment with BILB 1941 ZW into dose groups 3 - 9 of this trial, or previous re-treatment based on amendment 2. To support selection, centers will receive lists of the placebo patients of the previous dose levels, however, only for each center separately
* Inability to comply with the protocol
Sex :
MALE
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>
| 659 |
Target Study Title: A Computer-Assisted Brief Motivational Intervention for Smoking During Pregnancy: The Healthy Pregnancy Project (HPP)
Target Study Description: #Study Description
Brief Summary
This study will develop:
1. Develop the computer-based brief intervention and Contingency Management (CM) components, with repeated feedback from experts, prenatal clinic staff, and participants.
2. Recruit 110 pregnant women who are actively smoking, and randomly assign recruited women to Brief Intervention, CM, combined, or control conditions.
3. Conduct follow-up evaluation at 12 weeks post-intervention to measure self-reported smoking, breath carbon monoxide (CO), and urinary cotinine levels.
4. Collect data regarding birth outcomes and evaluate the feasibility of various methods of post-partum follow-up.
Detailed Description
Participants \& Procedure
Women will be approached while in the waiting room of various clinics at the Detroit Medical Center. Clinic staff will inform patients of the study and its goals via a flyer that will be distributed at the reception window as women arrive for their appointments. If the women are interested, they will answer some questions and provide their contact information on the back of the flyer. Then they will place the flyer in a ballot box that is locked and only can be accessed by the Research Staff. Research staff may also be at the clinic to recruit women from the waiting room. When the research staff meets with potential participants. The study will be briefly described, and those indicating tentative interest will be screened for age and language ability (informally). Those indicating tentative interest, reporting age of at least 18 years, gestation 27 weeks or less, and demonstrating adequate ability to speak and understand spoken English will be brought to a nearby private room.
First, informed consent for screening will be obtained using an information sheet; this sheet will describe the purpose of the screening, and will emphasize that participation in the initial screening is anonymous. Those who agree will be given a very brief demonstration of the use of the computer, after which they will complete the brief (10-item) screener. All interactions with the computer will involve a touch-screen and headphones for private presentation of all information aurally as well as visually; in many previous studies, including pilot testing at this clinic, the software has been proven extremely easy to use, even for women lacking any prior computer experience. Those who endorse smoking cigarettes (even a puff) in the past week will be told of the full study in detail, and written informed consent will be sought (with a brief quiz to assure understanding). Those who provide consent will again interact directly with the computer.
Intervention
The computer itself will perform randomization and will gather all research data except for baseline breath CO (which is higher among persons who smoke), which will be obtained (via a Micro Smokerlyzer® from Bedfont Scientific Ltd.) and entered into the computer by the research staff. The entire process, including consent, will take approximately 40 minutes regardless of experimental condition (to which the research staff will be blind). Research staff will tell clinic staff of the patient's whereabouts so that the patient is not passed over when staff call her to an exam room; unfinished study procedures will be completed in the exam room prior to the physician's entrance, and/or after the appointment is completed.
Women (N = 110) who report smoking cigarettes (even a puff) during pregnancy will be randomly assigned to computer-based brief intervention alone, CM alone, brief intervention plus CM, or attention control conditions. Women randomly assigned to the computer-based intervention condition will receive an approximately 20-minute intervention modeled after motivational interviewing (MI).
Women randomly assigned to the CM condition will be told that, if they choose, they can ask to be tested (via provision of a urine sample) for smoking, up to five times, at a regularly scheduled prenatal visit. Research staff will conduct these tests.
8-Week Follow-Up
Women who enroll in the study will be contacted via mail and telephone, as necessary, to schedule a 8-week follow-up at the PI's lab or at the prenatal clinic, depending upon the participant's preference. Research staff completing follow-up testing will be kept blind to intervention condition. The primary outcome measure will be urinary cotinine-verified abstinence at follow-up; birth outcome data will also be gathered from hospital records. At follow-up, participants will (a) complete all measures on the computer again, (b) provide breath CO; (c) provide a final urine sample for testing of urinary cotinine (evidence of smoking).
#Intervention
- BEHAVIORAL : Computer-delivered brief intervention (5As)
- After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
- Other Names :
- Brief intervention, 5As, Brief motivational intervention
- BEHAVIORAL : Contingency Management
- Participants randomized by the computer into this condition will view a 20-minute music and tv videos after completing the brief assessment. The research assistant will then briefly describe the CM process, with a period for questions to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits. Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
- Other Names :
- Voucher-based reinforcement
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
* pregnant, gestation <= 27 weeks
* cigarette smoking in the past week (even if only one puff)
Exclusion Criteria:
* inability to speak or understand spoken English
* do not intend to carry pregnancy to full term
* frank psychosis
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>
| 660 |
Target Study Title: Assessment of the Predictors and Moderators of Health Behavior Change
Target Study Description: #Study Description
Brief Summary
This study will investigate three interventions-values clarification, planning, or combined (values clarification + planning)-for increasing goal-consistent health behavior (e.g., exercise or dieting). The investigators will also examine how intervention effects differ based on various psychological and neuropsychological factors, to better understand how interventions can be tailored to specific individuals.
The investigators hypothesize a) that the combined intervention will increase goal-consistent exercise behavior more than the other interventions; and b) that individuals scoring higher on self-concordance or goal-commitment will benefit more from planning, whereas those with more positive expectancies or scoring higher on neuropsychological measures (e.g., working memory) will benefit more from values clarification.
Detailed Description
The study will be a repeated measures design examining the between-subjects effect of intervention condition (values clarification, planning, and combined) on self-reported health goal progress and related outcomes at 1-week and 4-week follow-up, relative to baseline. Based on this design, participants will first be instructed to generate a health-related goal on which they want to make progress over the course of the next month (following procedures adapted from Little, 1993, and Sheldon \& Kasser, 1998; see details below). Participants will then be randomly assigned (using a random number table) to one of three intervention conditions: (1) values clarification, (2) planning, and (3) combined (values clarification + planning). All conditions are described in more detail below. Fifty-three participants will be randomized to each condition. Questionnaire measures assessing a variety of psychological variables as well as neuropsychological measures will be modeled as between-subject predictor and/or moderator variables of goal-consistent health behavior. Additionally, differences in self-concordance, goal commitment, and expectancies of success will be modeled as potential moderator and/or mediator variables.
#Intervention
- BEHAVIORAL : Values Clarification
- This intervention will incorporate elements from several widely established self-regulatory strategies aimed at enhancing the motivational aspects of goal pursuit, including mental contrasting (Oettingen, 2000), self-reflection (Koestner et al., 2002), self-affirmation (Schmeichel and Vohs, 2009), and the values clarification components of Acceptance and Commitment Therapy (ACT; Hayes, Strosahl, \& Wilson, 1999). Participants will be prompted to enter their selected health goal and will then be instructed to identify personal values that might be practiced in pursuit of this goal. Participants will write about these values for several minutes, after which they will be instructed to select a short phrase or image that conjures up for them the reasons they choose to engage in their goal. Participants will be asked to type the phrase into a textbox and will have the option of receiving a confidential print-out of their chosen phrase at the end of the study visit.
- BEHAVIORAL : Planning
- Participants in this condition will be guided to create detailed implementation intentions, or if-then planning statements (Gollwitzer \& Sheeran, 2006), specifying when, how, and where they will engage in their selected health goal. Participants will be provided with a detailed rationale adapted from earlier research on implementation intentions (e.g., Webb et al., 2010). Participants will be guided to generate a plan indicating when, where, and how they will enact their goal-based behavior over the next week. They will also be prompted to identify 3 obstacles they are likely to encounter during the pursuit of each goal, and to specify in an 'if-then' format what specific actions they will take to overcome each obstacle (following the procedures and sample 'if-then' responses of Koestner et al., 2002). They will be asked to rehearse each 'if-then' statement to themselves before the end of the visit.
- BEHAVIORAL : Combined
- Participants in this condition will complete abbreviated versions of both the 'values clarification' and 'planning' procedures, as detailed above. Participants will be prompted to identify 2 obstacles (as opposed to 3) they might encounter during the pursuit of each goal. For each of the obstacles they identify with respect to each of their target goals, they will be prompted to form an additional implementation intention in the form: 'When \[I encounter the specified obstacle\], I will do \[X\] and remember \[values-based statement or image identified during 'values clarification' exercise\]. They will be asked to rehearse these 'if-then' statements to themselves before the end of the 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:
* Boston University Psychology 101 students at least 18 years
* Able to provide informed consent for the study
* Sufficient command of the English language
* Have experience using a computer and mouse
Exclusion Criteria:
* None
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>
| 661 |
Target Study Title: Mebeverine For Daytime And Nocturnal Incontinence and After Orthotopic W-Ileal Neobladders - Assessment Of Efficacy And Quality Of Life Effect Within 1 Year Post-Surgery: A Randomized Controlled Study
Target Study Description: #Study Description
Brief Summary
A randomized controlled trial to assess clinically the efficacy of the selective ileum spasmolytic mebeverine on daytime incontinence and nocturnal enuresis of orthotopic w-ileal neobladders and quality of life effect within 1 year post-surgery.
Detailed Description
In appropriately selected patients an orthotopic neobladder (ONB) permits the elimination of an external stoma and preservation of body image without compromising cancer control after radical cystectomy. Voiding dysfunction (VD) following ONB can be divided into failure to empty bladder or failure to store urine. Failure to empty bladder by angulation of urethra is the most common cause. Failure to store urine can occur during daytime, night-time or both. VD that persists beyond 6 to 12 months warrants urodynamics evaluation to determine the cause and suggest plane of therapy. Voiding dysfunction has a detrimental impact on quality of life.
Among the various bowel segments studied, the ileum is ideal for ONB creation. A spherical reservoir, reconfigured from a de-tubularized ileal segment, offers the most desirable attributes like, adequate capacity, low intraluminal pressure, and good compliance. The patient of ONB reported 4-25% rate of clean intermittent self-catheterisation (CISC) for incomplete emptying. Daytime incontinence was present in 13% of patients. The rate of nocturnal incontinence is usually higher in the range of 15-40% in recent metanalysis. The success of ONB rely on detubularization of intestinal segment, sufficient capacity and proper configuration and position in the pelvis. Adequate capacity is achieved by using sufficient length, folding, and creation an ellipsoid or spherical configuration. The ONB should hold approximately 500 cc of urine at low pressure (at \< 15 cm H2O), empty completely (\< 100 cc urine), four to five times daily and allow the patient to sleep without awakening, while maintain normal body image
loss of the vesico-urethral reflex 'guarding reflex' in which increased urethral sphincter tone parallel to bladder distension, decreased patient vigilance during sleep resulting in reduced muscle tone and urethral closing pressure, decreased sensitivity of the membranous urethra after radical cystectomy, involuntary high-amplitude contractions of the reservoir secondary to bowel peristalsis and shifting of free water from the reservoir wall into the hyperosmolar urine are the main factor causing global and nocturnal polyuria in patient with ONB. Final, there is also evidence suggesting an increase in bowel activity during sleep. Maximum urethral closing pressure (MUCP) is the primary component responsible for daytime continence in patients with an ONB. However, Koraitim et al. suggest that nocturnal incontinence depends on three reservoir parameters: maximal contraction amplitude, baseline reservoir pressure at mid capacity, and MUCP.
Mebeverine is a derivative of reserpine, which has relatively specific effects on smooth muscle cells without atropine-like side effects in humans. It directly blocks voltage-operated sodium channels and inhibits intracellular calcium accumulation. It is three times more potent than papaverine in inhibiting the peristaltic reflex of the ileum.
#Intervention
- DRUG : Coloverin
- Mebeverine hydrochloride 135 mg
- Other Names :
- Mebeverine hydrochloride
- DRUG : Placebo
- 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:
* Men >= 18 years
* ONB within 1 year post-surgery.
Exclusion Criteria:
* Upper urinary tract deterioration
* Uncontrolled diabetes mellitus
* Evident local or pelvic recurrence
* Adjuvant chemotherapy
* Chronic retention
* Pouch stones
* Urethral stricture or urethro-ileal maldirection
* Sensitivity to Mebeverine
* Untreated chronic constipation
* Active symptomatic urinary infection
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>
| 662 |
Target Study Title: A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD5423 After Administration of Single and Multiple Ascending Doses in Healthy Male Japanese Subjects
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects (24-hours plasma cortisol area under curve, plasma cortisol pre and post ACTH stimulation, dehydroepiandrosterone sulphate (DHEAS), osteocalcin and 24 hours urine cortisol) of AZD5423 following administration of single and multiple ascending doses in healthy male Japanese subjects.
#Intervention
- DRUG : AZD5423
- Inhalation, suspension
- DRUG : Placebo
- Inhalation, solution
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Provision of signed and dated, written informed consent prior to any study specific procedures
* Healthy male Japanese subjects aged 20 <= age <= 45 with suitable veins for cannulation or repeated venepuncture
* Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after the last dose of investigational product
* Have a body mass index (BMI) between 18 and 27 kg/m2 and weight at least 50 kg and no more than 80 kg
* Be able to inhale from the I-nebⓇ according to given instruction
Exclusion Criteria:
* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational product
* Any clinically significant abnormalities in clinical chemistry, haematology, urinalysis or physical examination results as judged by the investigators
* Any positive results on screening for serum hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) and Syphilis
Sex :
MALE
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>
| 663 |
Target Study Title: The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers
Target Study Description: #Study Description
Brief Summary
To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.
Detailed Description
22 healthy participants will randomly be allocated to receive PACAP38 infusion followed by glibenclamide or placebo on two different days.
The aim of the study is to investigate the vascular effect of PACAP38 after glibenclamide administration.
Repeated measurements covering the arteria radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after PACAP38 infusion and glibenclamide/placebo administration
#Intervention
- DRUG : glibenclamide
- Oral administration of glibenclamide/placebo. To investigate the role of PACAP38 on cranial arteries in healthy volunteers after glibenclamide/placebo administration .
- DRUG : PACAP38
- PACAP38 infusion
- Other Names :
- Pituitary adenylate cyclase activating polypeptide-38
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 of both sexes.
* 18 <= age <= 60 years.
* 50 <= age <= 100 kg.
* Women of childbearing age must use adequate contraception
Exclusion Criteria:
* A history of serious somatic or psychiatric disease
* Migraine or any other type of headache (except episodic tension-type headache less than 5 days per month)
* Daily intake of any medication except contraceptives
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 60 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 664 |
Target Study Title: Effects of S-Adenosyl Methionine (SAMe) on Viral and Cell Signaling Response to Combination Therapy for Chronic Hepatitis C
Target Study Description: #Study Description
Brief Summary
This study will examine the effectiveness of S-adenosyl methionine (SAMe) in combination with peginterferon and ribavirin for treating hepatitis C virus. One out of three patients with hepatitis C develops cirrhosis of the liver, which can lead to liver failure or liver cancer. SAMe is a nutritional supplement that is made naturally in all cells of the body and acts to improve how the body handles stress. In laboratory experiments with liver cells, SAMe decreases the injury caused by liver toxins and improves the ability of interferon to block hepatitis C virus.
Patients 18 years of age and older with hepatitis C infection who did not respond successfully to prior treatment with interferon and ribavirin or peginterferon and ribavirin may be eligible for this study.
Participants receive the following treatment:
* Peginterferon (given by injection) and ribavirin (taken by mouth) for 2 weeks
* Washout period (no medications) for 4 weeks
* SAMe (taken by mouth) for 2 weeks
* Peginterferon, ribavirin and SAMe for 12-48 weeks, depending on patient response to treatment.
Participants have a thorough physical evaluation before beginning treatment and again at the study's end. After starting treatment, patients return for clinic visits and blood tests weekly for the first several weeks, then less frequently (at 2-week, then 4-week and 8-week intervals until up to 72 weeks) to monitor symptoms, drug side effects, hepatitis C virus levels, liver enzyme levels and immune responses to hepatitis C.
...
Detailed Description
S-adenosyl methionine (SAMe) is a nutritional supplement which is available as an over-the-counter formula. It is a naturally occurring, modified amino acid that is produced in virtually all cells and participates in many biochemical pathways as a major methyl donor and may play a role in intracellular interferon signaling.
This study will assess the effects of SAMe on antiviral responses to peginterferon and ribavirin in patients with chronic hepatitis C, genotype 1, who have failed to respond to a previous course of therapy. After screening evaluation, patients will receive a first course of 2 weeks of peginterferon alfa-2a (180 micrograms weekly) and ribavirin (1000-1200 mg daily) during which symptoms, routine laboratory tests, HCV RNA levels, natural killer (NK) cell activity, and lymphocyte interferon-signaling responses will be monitored. After a 4-week washout period, patients will start SAMe (800 mg twice daily) for 2 weeks and then begin a second course of peginterferon and ribavirin in the same doses with similar monitoring. Therapy will be continued for at least 12 weeks, and patients with an early viral response will continue for a full 48 weeks. The primary criterion for efficacy of SAMe will be improved HCV kinetic responses comparing the first and second courses of peginterferon and ribavirin. Secondary endpoints will be improvement in NK cell activity and intracellular interferon signaling.
This is a pilot study to determine whether SAMe improves responses to peginterferon therapy in terms of intracellular interferon signaling, innate immune responses, and decline in viral levels.
#Intervention
- DRUG : Peginterferon alfa-2a
- DRUG : Ribavirin
- DRUG : S-adenosyl methionine for Chronic Liver Disease
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria
* Age 18 years or above, male or female
* Serum alanine or aspartate aminotransferase (ALT & AST) activities that are above the upper limit of normal (ALT greater than 41 or AST greater than 31 IU/L).
* Presence of anti-HCV in serum.
* Presence of HCV RNA genotype 1 in serum at levels above 10,000 copies/ml.
* Previous adequate therapy with interferon and ribavirin or peginterferon and ribavirin without a sustained virological response. An adequate course of therapy is defined as at least 12 weeks of interferon in doses of 3 million units three times weekly or peginterferon in doses of 180 micrograms for peginterferon alfa-2a or 1.5 micrograms/kg for peginterferon alfa 2b once weekly and ribavirin in starting doses of at least 1000 mg daily. Patients who initiated therapy at these doses, but required dose modification due to side effects will also be eligible.
* Written informed consent: Patients will be informed of the risk/benefits and side-effects of the medications used in this protocol and will be advised of the research blood drawn at each clinic visit. They will be given ample time to read the consent form and to ask any protocol related questions. Once this is done, the patient's signature will be obtained on the consent form to enroll them into the protocol.
Exclusion Criteria
* Evidence of other forms of liver disease.
* Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg) in serum.
* Primary sclerosing cholangitis as defined by liver histology.
* Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease.
* Autoimmune hepatitis as defined by antinuclear antibody (ANA) of 3 EU or greater (ELISA) and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy for autoimmune hepatitis.
* Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency.
* Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D. Patients with iron saturation indices of greater than 45% and serum ferritin levels of greater than 300 ng/ml for men and greater than 250 ng/ml for women will undergo genetic testing for C282Y and H63D.
* Drug induced liver disease as defined on the basis of typical exposure and history.
* Bile duct obstruction as suggested by imaging studies done within the previous six months.
* Decompensated liver disease, as marked by bilirubin greater than 4 mg/dl, albumin less than 3.0 gm/l, prothrombin time greater than 2 sec prolonged, Child-Pugh score of 7 or greater or history of bleeding esophageal varices, ascites or hepatic encephalopathy. Patients with ALT levels greater than 1000 U/L (greater than 25 times the upper limit of the normal range) will not be enrolled but may be followed until three determinations are below this level.
* Significant systemic or major illnesses other than liver disease, including congestive heart failure, coronary artery disease, cerebrovascular disease, pulmonary disease with hypoxia, renal failure, organ transplantation, serious psychiatric disease including depression, malignancy and any other conditions that in the opinion of the investigator would preclude treatment.
* Pre existing, severe bone marrow compromise; anemia (hematocrit less than 34%), neutropenia (less than 1000 polymorphonuclear cells/mm(3)) or thrombocytopenia (less than 70,000 cells/mm(3)).
* Serious autoimmune disease that, in the opinion of the investigators, might be worsened by interferon therapy, such as lupus erythematous, rheumatoid arthritis or Crohn's disease
* Known HIV infection.
* Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year.
* Pregnancy, lactation or in women of child bearing potential or in spouses of such women, inability to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermicide, birth control pills/depot injection, or an intrauterine device.
* Evidence of hepatocellular carcinoma; either alpha-fetoprotein (AFP) levels greater than 50 ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.
* Immunosuppressive therapy with either corticosteroids (more than 5 mg of prednisone daily) or major immunosuppressive agents (such as azathioprine or 6-mercaptopurine).
* Clinical gout at presentation.
* History of hypersensitivity reactions to S-adenosyl methionine.
* Serum creatinine greater than 1.5mg/dl in men and greater than 1.4 mg/dl for women.
* Any other condition, which in the opinion of the investigators would impede the patient's participation or compliance in 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>
| 665 |
Target Study Title: The Effects of the Rivastigmine Patch on Attention and Behavior in Parkinson's Disease With Dementia (PDD)
Target Study Description: #Study Description
Brief Summary
This is an open-label study to investigate the effects of the rivastigmine patch on attention and behavior in Parkinson's disease when associated with memory and/or thinking problems. Rivastigmine (also sold under the name Exelon) is an FDA approved medication used for the treatment of mild to moderate Alzheimer's Disease (AD) and memory or thinking problems due to Parkinson's disease. Recently a rivastigmine patch was developed, which has shown similar effectiveness with fewer side effects and increased caregiver preference when compared to capsules. This is an open-label 12 week study where 15 subjects diagnosed with Parkinson's Disease who have mild to moderate memory and/or thinking complaints will be treated with the rivastigmine patch at UCSF. This study also analyzes the mechanism by which the rivastigmine patch works in people with Parkinson's disease and memory and/or thinking problems.
Detailed Description
Participation in this study requires four visits: a screening visit to ensure eligibility, an initial/baseline visit where the medication is distributed at a dosage lower than the optimal recommended dosage, a four week follow-up visit where the dosage of the medication is increased to the optimal amount, and a final twelve week follow up visit.
* In the screening visit the patient will undergo a neurological exam (including a review of their medical history and short physical exam), electrocardiogram ( a painless procedure that measures electrical activity of your heart), cognitive testing (such as memory and thinking tests), and a blood draw.
* At the Baseline/Initial visit the patient will receive a brief physical exam, additional cognitive testing, and an MRI scan. Afterwards, the study drug will be distributed.
* At the four week follow up visit the patient will be asked to do some abbreviated cognitive and neurological testing and the study drug will be re-distributed at the target dosage.
* At the final twelve week visit the patient will receive additional cognitive and neurological testing, and an MRI scan.
* Study compliance and adverse events will be reviewed every two weeks throughout the study, whether in person or over the phone.
#Intervention
- DRUG : Rivastigmine Patch 9.5 cm2
- Subjects will be started on a 5cm2/24hr rivastigmine patch. After 4 weeks, the dose will be increased to a recommended target dose of 9.5cm2/24hr patch for 8 additional weeks.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Must meet research criteria for Parkinson's Disease with Dementia (PDD)
* Males and females, ages between 55 and 100
* Able to undergo psychometric testing
* Mini-Mental State Examination >= 21 and Clinical Dementia Rating < 2
* Reliable informant with frequent contact with patient
Exclusion Criteria:
* Non-English speaking, as cognitive tests will be in English
* Evidence of other neurological or psychiatric disorders which preclude diagnosis of PDD (including, but not limited to, stroke, any psychotic disorder, severe bipolar or unipolar depression, seizure disorder, or head injury with loss of consciousness) within the past year
* Concurrent treatment with any acetylcholinesterase inhibitors (including rivastigmine in pill or patch form), antipsychotic agents (excluding quetiapine in dosages of 150 mg and lower, abilify and geodon as these medications are commonly used in treatment of Parkinson's Disease (PD) psychosis and should not affect results of study), mood stabilizers (valproate or lithium) or benzodiazepines (other than temazepam or zolpidem)
* Positive urine drug screen or suspected alcohol or substance abuse within last 1 year
* Current malignancy, or any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease. If the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included
* Systolic blood pressure over 180 or less than 90 mm Hg. Diastolic blood pressure not greater than 105 or less than 50 mm Hg
* ECG is abnormal and judged to be clinically significant by the investigator
* Use of investigational drugs or participation in investigational drug studies within 30 days of screening
* Geriatric Depression Score score > 15/30
* Hachinski score > 4
Sex :
ALL
Ages :
- Minimum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 666 |
Target Study Title: An Open-label, Fixed-sequence, 3-period Crossover Exploratory Study to Investigate the Effect of Urine Acid-base Disequilibrium on the Pharmacokinetics of Captopril in Healthy Male Volunteers
Target Study Description: #Study Description
Brief Summary
The aim of this study is to evaluate the effect of urine acid-base disequilibrium on the pharmacokinetics of captopril in healthy male volunteers.
Detailed Description
* Pharmacokinetic analysis of captopril before and after urine acid-base imbalance
* Safety analysis
#Intervention
- DRUG : Captopril 12.5 Mg
- 12.5 mg of captopril
- DRUG : Sodium bicarbonate 4 G
- 4 g of sodium bicarbonate
- DRUG : Torsemide 20 MG
- 20 mg of torsemide
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 volunteer aged 19 <= age <= 50 at screening
* Body weight between 50.0 kg and 90.0 kg and body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2 at screening
* Body Mass Index (kg/m2) = Weight (kg)/{Height (m)}2
* Participants who voluntarily decided to participate and agreed in writing to comply with study instructions after receiving sufficient explanation and complete understanding of the study
* Participants who are suitable as test subjects for this test as determined by the investigator through physical examination, clinical laboratory tests, and interviews, etc.
Exclusion Criteria:
* Participants who have or have a history of clinically significant hepatobiliary system (severe liver failure, viral hepatitis, etc.), kidney (severe renal impairment, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, blood/tumor, cardiovascular system (heart failure, Torsades de pointes, etc.), urinary system, mental system (mood disorder, obsessive-compulsive disorder, etc.), and sexual dysfunction, etc.
* Evidence or past history of gastrointestinal disease (Crohn's disease, gastrointestinal ulcer, gastritis, gastroesophageal reflux disease, etc.) or past history of gastrointestinal surgery (except for simple appendectomy and hernia repair) that might affect the safety and PK assessment of the investigational product.
* Hypersensitivity to drugs including captopril, sodium bicarbonate, and torsemide or other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity reactions
* Participants with genetic problems such as lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
* Positive serum test (HBs antigen, HCV antibody, HIV antigen-antibody, and RPR) at screening
* Past history of alcohol and drug abuse or a positive urine test for drugs with abuse potential at screening
* Any abnormalities in vital signs after 3 minutes rest at screening
* Systolic blood pressure < 90 mmHg or > 150 mmHg, Diastolic blood pressure < 60 mmHg or > 100 mHg
* QT/QTcF > 450 msec or any abnormalities on electrocardiogram (ECG) at screening
* Any abnormalities in blood tests at screening
* AST (SGOT), ALT (SGPT) > 60 IU/L, creatinine clearance (CKD-EPI equation) < 80 mL/min
* Past or planned treatment with any prescription drugs or herbal medicine within 2 weeks, or any over the counter drugs, health functional foods, or vitamin supplements within 1 week, prior to the first scheduled dose (individual who is eligible based on other criteria may participate in the study at the discretion of the investigator).
* Participants who have taken drugs that induce drug-metabolizing enzymes such as barbiturates or inhibit drug metabolism such as clarithromycin within 1 month prior to the first scheduled dose
* Treatment with any investigational product in another clinical trial within 6 months prior to the first scheduled dose
Sex :
MALE
Ages :
- Minimum Age : 19 Years
- Maximum Age : 50 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 667 |
Target Study Title: Cystic Fibrosis in Adults and Frailty
Target Study Description: #Study Description
Brief Summary
The goal of this observational study is to assess the main clinical and anamnestic characteristics, and frailty syndrome in an adult Cystic Fibrosis population. The main question it aims to answer is the possible association of the frailty status with the main clinical, therapeutical characteristics, including the genotyping classification of Cystic Fibrosis patients.
Detailed Description
Participants will be assessed for the pulmonary status by spirometry (for Forced Expiratory Volume in 1 second \[FEV1 - L\]; Forced Expiratory Volume in 1 second percent predicted \[ppFEV1%\]; Forced Vital Capacity \[FVC - L\]; Forced Vital Capacity percent predicted \[FVC %\]; Maximal Mid-Expiratory Flow \[MMEF\]); for the functional status by evaluating the activities of daily living \[ADLs\], and the instrumental ADLs \[IADLs\]; and for frailty by the Study of Osteoporotic Fractures \[SOF\] Index. The height and weight will be also recorded, and Body Mass Index \[BMI\] calculated as body weight divided by height squared \[Kg/m2\]. Body weight will be measured in a fasting state in the morning with a mechanical balance.
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:
* who met the diagnostic criteria for CF,
* > 18 years,
* pathological sweat chloride levels (chloride >60 mEq/L) and two CFTR mutations
Exclusion Criteria:
* who did not meet the diagnostic criteria for CF
* under 18 years
* > 18 years with normal sweat chloride levels (chloride >60 mEq/L)
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>
| 668 |
Target Study Title: The Effects of a Translational Health After School Program on Health-Related Knowledge/Behaviors and Exercise Perception in Minority Children
Target Study Description: #Study Description
Brief Summary
The aim of this study is to examine the effects of a translational health in nutrition and kinesiology (THINK) after school program on physical variables, nutrition and exercise knowledge base/behaviors, and exercise enjoyment and confidence.
Partnering with the YMCA investigators in the Kinesiology and Sport Sciences department at the University of Miami will set up the after-school THINK program offered three afternoons per week for nine months in two experimental and two control schools. The schools will consist of minority elementary school students (predominantly Hispanic and Black) in the South Florida area. The control schools will receive baseline, mid-year and follow-up testing nine months later, but will not go through the THINK program. They will instead go through their standard YMCA after school Sports, Play, and Active Recreation for Kids (SPARK) program.
Detailed Description
Two- thirds of American adults are overweight or obese, and that number continues to rise. Thus, it is not surprising that the prevalence of overweight/obesity has more than doubled in school children and tripled in adolescents. Concomitant with the rise in obesity has been a significant decrease in physical fitness levels (1,2). At least one study has shown the youth of today demonstrate lower aerobic fitness levels than their parents (3). Low aerobic fitness levels are most prevalent among Hispanic and Black (non-Hispanic) minority youth. No doubt the increases in TV viewing, computer time and technology have contributed to the increase in sedentary habits and decline in physical activity levels (4).
The THINK program translates fitness and health-related information into knowledge and skills that children can understand and incorporate into their own personal health and lifestyle behaviors. The program is unique in that it combines educational and hands-on clinical experiences with physical activity and exercise. The goal is to promote healthier, more active children of today who demonstrate improved levels of physical fitness, exercise knowledge, and enjoyment of tomorrow.
Each unit in the THINK program has three components: a seminar on the scientific aspects of a health-related theme, clinical experiences related to the theme, and related physical activities performed in the field. The THINK seminars engage students by getting them up and moving, while asking questions that prompt them to think creatively to come up with their own answers. Clinical experiences reinforce the educational themes allowing children to learn more about their bodies, how it functions, and how it adapts through various movement exercises. Finally, games and enjoyable physical activities round out the program contributing to enhanced motor skill development and improved physical fitness levels.
The THINK program will begin with a series of baseline physical assessments comprising both heath and performance-related physical fitness. Participants will also receive a quiz on nutrition and exercise-related information and two surveys regarding nutritional behaviors and physical activity levels. They will be asked to complete one survey on exercise enjoyment and self-confidence. Parents will also be asked to complete a survey each on their child's nutritional habits. This will be done in two experimental and two control YMCA after school programs comprising primarily minority (Hispanic and Black) participants. Testing will again take place midway through the program and at the conclusion of the program nine months later. The control group will not go through the THINK program but will instead go through the traditional SPARK curriculum.
The purpose of the study is to determine whether the THINK program results in improvements in physical fitness, nutrition and exercise knowledge/habits, and exercise enjoyment and self-confidence above that of the control group.
#Intervention
- BEHAVIORAL : THINK Program
- Lessons and laboratory sessions will be 60 minutes, followed by physical activity sessions lasting 60 minutes. Laboratory activities include assessing heart rate, making healthy meals, learning portion sizes, brain challenges, and more. To improve physical activity participation, a wide selection of developmentally appropriate and multiculturally sensitive activities will be offered, such as sports, games, obstacle courses, and dance.
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 in grades 3 <= age <= 5 (aged 8 <= age <= 12)
* enrolled in a YMCA after-school program
Exclusion Criteria:
* Inability to perform physical activity
* Any cardiovascular, metabolic, or neurological disorders that would affect the child's ability to participate in the program or in testing.
Sex :
ALL
Ages :
- Minimum Age : 8 Years
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 669 |
Target Study Title: Combinational Rehabilitative Therapy and Functional Brain Imaging for Patients Recovering From Motor Stroke
Target Study Description: #Study Description
Brief Summary
The present proposal aims to assess whether a combined rehabilitation approach using virtual reality based therapy with motivational feedback, levodopa for pharmacotherapy and standard rehabilitative occupational therapy and physiotherapy will lead to signifcantly better outcomes for stroke recovery.
It is a randomised controlled trial with blinding of the assessors only. It will be preceeded by a Phase 1 pilot trial of the VR physiotherapy and standard therapy only. Recruited in-patient rehabilitation ward patients who have recently suffered stroke will be randomized, through a computer-based random number generator, to either one of two treatment arms:
1. Control occupational therapy + pharmacotherapy for 2 weeks
2. Assisted Virtual-Reality physiotherapy + pharmacotherapy for 2 weeks
Detailed Description
The study is designed as a single-blinded randomized controlled trial, preceeded by a Phase 1 pilot trial of the VR physiotherapy and standard therapy only.
Phase 1 will comprise of recruitment of up to 5 patients who have recently suffered a stroke who will be informed that they will receive ten 15- 30 minutes of VR therapy in addition to their standard stroke therapy. They will not receive any pharmacotherapy during this period. At the start and end of the VR phase, clinical assessment (Fugl-Meyer scores, Action Research Arm Test) will be made of each patient by a blinded clinician investigator.
From this data, calibration to the VR program will be made to ensure reproducibility of effectiveness of movements assessed.
Subsequently, for the main phase of the trial, recruited in-patients who have recently suffered stroke will be randomized, through a computer-based random number generator, to either one of two treatment arms:
1. Control occupational therapy + pharmacotherapy
2. Assisted Virtual-Reality physiotherapy + pharmacotherapy
Each patient will receive an initial functional Magnetic Resonace Imaging (fMRI) scan prior to the start of the study. The initial pilot single-centre study will be run in the Singapore General Hospital Rehabilitation Ward across a 2-week period, where participants will undergo daily 15-30 minute VR based therapy in addition to the physiotherapy/occupational therapy session they receive daily.
The VR therapy session consists of the subject interacting with a computer-based program in which they guide an avatar to gather items by using flexion and extension gestures of the affected upper limb. VR therapy sessions will last for 15-30 minutes depending on the subject's tolerance and participation. For patients who are unable to overcome gravity fully, they can still participate in this therapy by resting their arm on a table.
Patients will receive a single dose of 100mg levodopa in combination with benserazide 2-3 hours before an additional half an hour of occupational therapy to the weaker arm or VR therapy session, depending on the assigned group.
At the start and end of the trial, clinical assessment (Fugl-Meyer scores, Action Research Arm Test and Functional Independence Measure) will be made of each patient by a blinded clinician investigator. At the final (10th) session, patients will undergo the final fMRI scan. MRI scans will be analysed by blinded assessors.
#Intervention
- DRUG : Levodopa
- Levodopa 100mg with benserazide 25mg will be administered 3 hours prior to the start of the daily PT/OT session to maximize its pharmacokinetic window ie. blood plasma levels in the narrow window during which functional rewiring of neural circuits is thought to occur.
Levodopa at the lowest available dose (100mg P.O qd) has been shown to improve motor function of stroke patients and their corresponding quality of life. The treatment proposed can be incorporated into their daily rehabilitation routine. Early intervention (within 7-21 days of the infarct) raises the chance for neuroplasticity and improved recovery of their motor function in the short and long run. Levodopa has been proven to be safe to be used in stroke patients (Lancet. 2001 Sep 8;358(9284):787-90., Arch Phys Med Rehabil. 2008 Sep;89(9):1633-41.), however, the side effects of this medication may include nausea, unusual tiredness, dizziness, excessive watering of mouth.
- Other Names :
- Madopar
- OTHER : Virtual Reality based therapy
- The VR therapy session consists of the subject interacting with a computer-based program in which they guide an avatar to gather items by using flexion and extension gestures of the affected upper limb. VR therapy sessions will last for 15-30 minutes depending on the subject's tolerance and participation. For patients who are unable to overcome gravity fully, they can still participate in this therapy by resting their arm on a table.
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: 25 <= age <= 99yrs
* Right-handed
* Cognitively coherent, able to provide informed consent (MMSE >25)
* Newly diagnosed, first episode ischemic stroke in the past 2 <= age <= 21 days
* Motor score: Strength of 2 <= age <= 3 out of 5 on affected side upper limb
Exclusion Criteria:
* Declined consent to participate in the study
* Cognitive impairment or significant aphasia with inability to understand study requirements and inability to participate in therapy
* Other neurological or physical ailments with pre-existing motor weakness
* Haemorrhagic stroke
* Patient due to undergo significant medical interventions such as carotid endarthrectomy
* Patients on neuroactive agents prior to the stroke such as antidepressants
* Hypersensitivity to benserazide, levodopa, sympathomimetics, or any component of the formulation
* Use of MAO inhibitors within the last 14 days
* Patients with clinical or laboratory evidence of uncompensated cardiovascular, endocrine, renal, hepatic, hematologic, or pulmonary disease
* Patients with decompensated endocrine, renal, hepatic, cardiac disorders, psychiatric disorders, narrow-angle glaucoma, or closed-angle glaucoma;
* Patients <25 years (due to possibility of skeletal abnormalities from benserazide)
* Pregnancy or use in women of childbearing potential without adequate contraception.
Sex :
ALL
Ages :
- Minimum Age : 25 Years
- Maximum Age : 99 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 670 |
Target Study Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Esophageal Squamous Cell Carcinoma(ALTER1102)
Target Study Description: #Study Description
Brief Summary
To compare the effects and safety of Anlotinib with placebo in patients with esophageal squamous cell carcinoma(ESCC).
#Intervention
- DRUG : Anlotinib
- Anlotinib p.o. qd
- DRUG : Placebo
- Placebo p.o. qd
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:
* Histological documentation of esophageal squamous cell carcinoma；
* Advanced esophageal squamous cell carcinoma with distant metastasis(Stage IV),at least one measurable lesion (by RECIST1.1)
* Patients who at least have failed to a platinum-based chemotherapy treatment or chemotherapy containing paclitaxel.
Note: (1) Each line treatment refers to treatment duration at least one cycle using monotherapy or drug combination; (2)Adjuvant chemotherapy or neoadjuvant chemoradiation is permitted before the study (if disease recurred during adjuvant chemotherapy/neoadjuvant chemoradiation or recurred within 6 months after stopping treatment, adjuvant chemotherapy/neoadjuvant chemoradiation can be considered as first line systemic chemotherapy;
* 18 <= age <= 75 years,ECOG PS:0 <= age <= 2,Life expectancy of more than 3 months
* 4 weeks or more from the last cytotoxic therapy, radiation therapy or surgery
* Main organs function is normal
* Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
* Patients should participate in the study voluntarily and sign informed consent
Exclusion Criteria:
* Patients whose primary lesion with active bleeding within 2 months
* Primary lesion not resected and has not shrinked after radiation therapy
* Patients who have been failure with anti-tumor angiogenesis drug treatment
* Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
* Brain metastases patients with symptoms or symptoms controlled < 3 months
* Patients with any severe and/or unable to control diseases，including：
1. Blood pressure unable to be controlled ideally(systolic pressure>=150 mmHg，diastolic pressure>=100 mmHg);
2. Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT>=480ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);
3. Patients with active or unable to control serious infections;
4. Patients with cirrhosis, decompensated liver disease, or active hepatitis;
5. Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)
6. Urine protein >= ++，and 24-hour urinary protein excretion>1.0 g confirmed
* Patients with non-healing wounds or fractures
* Patients with any CTC AE Grade 1 or higher bleeding events occurred in the lungs or any CTC AE Grade 2 or higher bleeding events occurred within 4 weeks prior to assignment;Patients with any physical signs of bleeding diathesis or receiving thrombolysis and anticoagulation
* Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism
* Patients with drug abuse history and unable to get rid of or Patients with mental disorders
* Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage
* Patients participated in other anticancer drug clinical trials within 4 weeks
* History of immunodeficiency
* Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
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>
| 671 |
Target Study Title: Efficacy of Manual Ankle Therapy on Fear of Falls, Range of Motion, and Functionality and Stability in Geriatric Patients. A Randomized, Double-blind Clinical Study
Target Study Description: #Study Description
Brief Summary
The range of movement of the ankle decreases with age and the plantar arch decreases, adopting a more pronated position of the foot.
The main objective is to analyze the effectiveness of manual therapy using ankle joint techniques in geriatric patients.
Randomized, double-blind clinical trial with follow-up period. Subjects will be assigned to control and experimental groups using a data analysis tool (Excel).
The dependent variable will be the fear of falls. The secondary variables will be the range of movement in dorsiflexion of the ankle, and the functionality and stability of the lower limbs.
Three evaluations will be carried out. A baseline measurement before the start of the study (T0), after the intervention (T1) and after a 3-week follow-up period (T2).
A manual therapy protocol will be carried out, lasting 3 weeks with 1 weekly session. Each session will last 10 minutes. The patients included in the experimental group will undergo the following manual therapy techniques: talus dorsal sliding technique and joint technique in '8' on the Lisfranc and Chopart joints. The patients included in the control group underwent the same techniques as those indicated for the experimental group, but without sliding or placing joint tension. The periodicity and times of administration will be the same
#Intervention
- OTHER : Experimental
- Manual therapy techniques:
* Talar dorsal sliding technique. Dorsal mobilization of the talus, with the patient in the supine position and ankle dorsiflexion, without pain or discomfort. The physiotherapist will exercise an anteroposterior mobilization of the talus, with a dorsal glide
* Mulligan movement mobilization technique: The patient will be in a standing position, with the ankle to be treated forward. You will be given an aid or support in the upper extremity to maintain stability.
- OTHER : Control
- The patients included in the control group underwent the same techniques as those indicated for the experimental group, but without sliding or placing joint tension. The periodicity and times of administration will be the same
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 older than 65 years
* Subjects of both sexes
* With impaired balance and gait
* With joint limitation of ankle dorsiflexion
* With established functionality or stability deficits (for example, who need third parties or technical aids to walk (crutches))
Exclusion Criteria:
* People with cognitive impairment that prevents their collaboration in the intervention and the different evaluations
* People with inability to stand
* People who have not given their written consent.
Sex :
ALL
Ages :
- Minimum Age : 65 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 672 |
Target Study Title: Real-World Betaseron® Outcomes Study (ROBUST): A Twelve-month, US Prospective, Observational, Open-label, Single-arm, Multi-center Outcomes Study of Interferon β-1b (Betaseron®) Given Every Other Day for Relapsing Forms of Multiple Sclerosis
Target Study Description: #Study Description
Brief Summary
A Web based real world observational study in Relapsing-Remitting Multiple Sclerosis (RRMS) population capturing outcomes reported by patients and by the physicians during 12 months after initiating or resuming Betaseron.
#Intervention
- DRUG : BAY86-5046_Interferon-beta-1b
- Electronic questionnaires
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:
* Provides written informed consent to participate in the study
* At least 18 but no more than 65 years
* Documented clinical diagnosis of a relapsing form of multiple sclerosis or confirmed clinically isolated syndrome (CIS)
* Initiating Betaseron therapy, or resuming Betaseron after not having used it for at least three months
* Willing and able to provide a valid e-mail address which will be in use for the duration of the study
* Willing and able to complete study questionnaires via the Internet
* Has reliable Internet access for the duration of the study
* Completes the baseline patient questionnaire
Exclusion Criteria:
* Kurtzke Expanded Disability Status Scale (EDSS) score greater than 6.0
* Cognitive dysfunction that, in the Investigator's judgment, raises doubts about the study participant's ability to provide informed consent or accurately complete the monthly patient questionnaire
* Any use of Betaseron within the three months prior to study entry
* Inability to read, write, or speak the English language
* Illness or disease other than multiple sclerosis that the Investigator believes is likely to cause the patient's death or incapacity within twelve months
* Any severe, uncontrolled illness or condition that the Investigator believes could dominate the patient's quality of life
* Coexistent autoimmune disease such as rheumatoid arthritis, lupus, or psoriasis that is likely to be exacerbated by treatment with Interferon
* Current use of any immunosuppressive medication
* Previous participation in a multiple sclerosis (MS) clinical trial within the three months prior to study entry
* Previous use of monoclonal antibodies treating MS within the three months prior to study entry
* Current use of any secondary treatment for multiple sclerosis other than the episodic use of steroids during relapses or exacerbations
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>
| 673 |
Target Study Title: A Follow-up Comparison of Sensory Discrimination in Patients With Low Back Pain: a Randomized Control Trial
Target Study Description: #Study Description
Brief Summary
To determine if there is any carry over difference with sensation training to the low back for patients with low back pain with the addition of a training at home. This will be looked at to see if there is a difference in pain or back / leg movement right after the training and in a few days after doing some exercises at home.
Detailed Description
In a previous case series patients with chronic Low Back Pain (LBP) who received tactile acuity training to their lower back in the absence of movement, experienced immediate positive changes in pain ratings and spinal movements. These changes, however, where only measured immediate post-intervention. This study aims to use a similar design of sensory discrimination for LBP, but will include a sensory discrimination home exercise program and compare groups at a follow-up visit for any difference between groups (48-96 hours) of the immediate changes. Changes will be assessed for pain and back and leg movement.
#Intervention
- OTHER : Home exercise program only
- After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program only
- OTHER : Home exercise program and home program of sensory discrimination
- After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program and two 5 minutes sessions of sensory training at home each day.
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 18
* patients presenting at PT with a primary complaint of LBP
* LBP being present for 3 months or more
* fluent in English
* willing to participate in the study
* They also will need someone who can assist with a sensory discrimination HEP.
Exclusion Criteria:
* under age 18
* not able to read/understand the English language
* prisoners
* no medical issues precluding physical therapy treatment (red flags)
* if they had undergone spinal surgery
* if they had any skin or medical condition preventing them from receiving tactile stimuli on the lower back or had specific movement-based precautions, i.e., no active spinal flexion. - Patients presenting with leg pain only
* Patients with neurological deficit only in the lower extremity
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>
| 674 |
Target Study Title: Writing About Experiences With Ovarian Cancer
Target Study Description: #Study Description
Brief Summary
This online study aims to understand whether writing about one's experiences with ovarian cancer may be beneficial for psychological and physical wellbeing in women with a history of ovarian cancer. Investigators are also interested in studying how certain individual characteristics may impact the effectiveness of writing. Participants will be asked to complete an initial survey (15 min), followed by writing about their experiences with ovarian cancer on four occasions (20 - 25 min each), over the course of two weeks. A final survey (10 min) will be completed one month afterwards.
Detailed Description
The purpose of this randomized controlled experiment is to examine the effects of writing about experiences with ovarian cancer on psychological and physical outcomes in English-speaking women with a history of ovarian cancer. It will also examine how certain individual characteristics may impact the effectiveness of the writing interventions for different women. After completing an initial survey, women will be asked to write about their experiences with ovarian cancer on 4 separate occasions of 20-25 min each in the course of 2 weeks. A final survey will be completed one month after the last writing session. The entire study will be conducted online.
#Intervention
- BEHAVIORAL : Expressive Writing
- Participants will be asked to write about their deepest thoughts and emotions about their experience with ovarian cancer
- BEHAVIORAL : Fact Writing (Control)
- Participants will be asked to write about the facts of their experience with ovarian cancer
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 with a history of ovarian cancer (any stage)
* At least 18 years
* English-speaking/Can comfortably read and write in English
* Able to provide informed consent
* Internet access
* Valid email address
* Any region/country
Exclusion Criteria:
* Minors (younger than 18)
* Lack of English proficiency
* Inability to provide informed consent
* Male
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>
| 675 |
Target Study Title: PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With [64]Cu-25%CANF-Comb
Target Study Description: #Study Description
Brief Summary
To demonstrate feasibility of imaging Cu\[64\]-25%-CANF-Comb uptake in the atherosclerosis of the carotid artery of patients for whom carotid artery endarterectomy surgery is planned in comparison to the carotid artery for which intervention is not planned.
Detailed Description
This study is a single center, open-label baseline controlled imaging study designed to demonstrate feasibility of PET imaging of radiopharmaceutical nanoparticle Cu\[64\]-25%CANF-Comb uptake by PET-MR. Patients will undergo Cu\[64\]-25%CANF-Comb PET-MR imaging of both carotid arteries. Both carotid arteries will be imaged at the same time. We hope to demonstrate differences in PET SUV (Standardized Uptake Value) in the significantly atherosclerotic artery in patients who will be going to carotid endarterectomy surgery in comparison to the PET SUV in the artery that is not significantly diseased (ie; the artery that will not undergo surgery) . We also will determine whether PET SUV of the Cu\[64\]-25%CANF-Comb by the plaque correlates to the American Heart Association classifications of atherosclerosis and tissue presence of NPR-C in the ex vivo carotid endarterectomy specimen post surgery as measured by RT-PCR.
#Intervention
- DEVICE : Cu[64]-25%-CANF-Comb PET-MR
- Single IV injection of a novel radiopharmaceutical for diagnostic imaging of atherosclerosis by PET-MR
- Other Names :
- Cu[64]-25%-CANF-Comb
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 carotid atherosclerosis
* Patients must be scheduled for carotid intervention (endarterectomy surgery)
* Signed informed consent.
Exclusion Criteria:
* Unstable clinical conditions
* Pregnancy and lactation
* Inability to lie still for up to 60 min with arms down at sides for PET-MR imaging
* Unwilling to comply with study procedures and unavailable for the duration of the study.
* Pacemakers, brain aneurysm clip, shrapnel and other typical contraindications for MRI imaging.
* Inability to provide written informed consent.
Sex :
ALL
Ages :
- Minimum Age : 21 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 676 |
Target Study Title: Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Patients With Colon Cancer at High Risk of Peritoneal Carcinomatosis
Target Study Description: #Study Description
Brief Summary
This study aims to determine the oncological effectiveness of adjuvant HIPEC, using intraperitoneal oxaliplatin with concomitant i.v. 5-FU/LV, following a curative resection of a T4 or intra-abdominally perforated Colon cancer in preventing the development of peritoneal carcinomatosis in addition to the standard adjuvant systemic treatment.
Hypothesis:
The hypothesis is that adjuvant HIPEC preceding routine adjuvant systemic therapy using i.p. oxaliplatin with concomitant i.v. 5-FU/LV following a curative resection of a T4 or intra-abdominally perforated colon cancer reduces the development of peritoneal carcinomatosis in comparison to standard adjuvant systemic treatment alone.
Detailed Description
Background:
The peritoneum is the second most common site of recurrence in patients with colon cancer. Early detection of peritoneal carcinomatosis (PC) by imaging is difficult and adjuvant systemic treatment does not seem to affect peritoneal dissemination in contrast to haematogenous dissemination in the liver or lungs. Of all patients eventually presenting with clinically apparent PC, only a quarter have potentially curable disease. The curative option is cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CR/HIPEC), but the effectiveness depends highly on the extent of disease and is associated with a considerable complication rate. These clinical problems underline the need for effective adjuvant intraperitoneal therapy in high risk colon cancer patients in order to prevent the development of PC with treatment at a subclinical stage.
Study design:
This will be a multicentre study in which 176 eligible patients will be randomized to adjuvant HIPEC followed by adjuvant systemic chemotherapy in the experimental arm, or the standard adjuvant systemic chemotherapy alone in the control arm. Adjuvant HIPEC will be performed preferably simultaneously or within 10 days after resection of the primary tumour, either by laparoscopy or open approach, similar to the technique used for resection of the primary tumour. If adjuvant HIPEC cannot be performed within 10 days (i.e. complicated postoperative course), the procedure will be delayed until 5 to 8 weeks postoperatively. Subsequently, patients will receive routine adjuvant chemotherapy (CAPOX) within 3 weeks from HIPEC. Diagnostic laparoscopy will be performed routinely after 18 months postoperatively in both arms of the study in patients without evidence of disease based on routine follow-up using CT imaging and CEA. If peritoneal carcinomatosis is found during staging laparoscopy, CR/ HIPEC will be performed in patients with a maximum of 5 involved regions and without evidence of systemic disease.
Study population:
Patients who underwent intentionally curative resection for a T4N0-2M0 or intra-abdominally perforated colon cancer.
Intervention:
Adjuvant HIPEC procedure: access to the abdominal cavity by laparoscopy or laparotomy under general anaesthesia, adhesiolysis if necessary, complete staging of the intra-abdominal cavity, positioning of in- and outflow catheters, perfusion with a minimum of 2l isotonic dialysis fluid at a flow rate of 1-2l/min and an inflow temperature of 42-43˚C. Before the beginning of HIPEC, 5-fluorouracil 400 mg/m2 and leucovorin 20 mg/m2 will be administered intravenously to potentiate oxaliplatin activity. Oxaliplatin (460 mg/m2) is added to the perfusate after attaining at least 42 degrees inflow temperature with a total of 30 minutes perfusion time.
Outcomes:
Primary endpoint is peritoneal recurrence-free survival at 18 months. Secondary endpoints are number of participants with adverse events as a measure of safety and tolerability, incidence of PC at end of follow-up with or without concomitant liver/lung metastases, percentage of false negative CT at 18 months (second look laparoscopy/laparotomy as gold standard), disease-free survival, overall survival, quality of life and costs.
#Intervention
- PROCEDURE : Adjuvant HIPEC (open/laparoscopic)
- Adjuvant HIPEC procedure: access to the abdominal cavity by laparoscopy or laparotomy under general anaesthesia, adhesiolysis if necessary, complete staging of the intra-abdominal cavity, positioning of in- and outflow catheters, perfusion with a minimum of 2l isotonic dialysis fluid at a flow rate of 1-2l/min and an inflow temperature of 42-43˚C. Before the beginning of HIPEC, 5-fluorouracil 400 mg/m2 and leucovorin 20 mg/m2 will be administered intravenously to potentiate oxaliplatin activity. Oxaliplatin (460 mg/m2) is added to the perfusate after attaining at least 42 degrees inflow temperature with a total of 30 minutes perfusion time.
- Other Names :
- I.V. leucovorin 20 mg/m2 (maximum 40 mg), I.V. 5-fluorouracil 400 mg/m2 (maximum 800 mg), Intraperitoneal oxaliplatin 460 mg/m2 (maximum 920 mg)
- DRUG : Standard adjuvant systemic chemotherapy
- Colon cancer patients with a high risk of developing PC, but do not have (yet) proven macroscopic peritoneal metastasis, are standardly treated with adjuvant systemic chemotherapy. Standard adjuvant systemic chemotherapy consists in the Netherlands of a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) for a total of 6 months.
- Other Names :
- adjuvant capecitabine and oxaliplatin (CAPOX), adjuvant 5-FU and oxaliplatin (FOLFOX)
- PROCEDURE : Diagnostic laparoscopy
- Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively in both study arms.
- Other Names :
- Diagnostic laparoscopic surgery
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* age between 18 and 75 years
* Intention to start routine adjuvant systemic therapy
* adequate clinical condition to undergo simultaneous HIPEC or re- laparoscopy or re-laparotomy with HIPEC within either 10 days or between week 5 <= age <= 8 from --primary resection
* written informed consent
* white blood cell count of at least 3000/mm3, platelet count of at least 100.000/mm3
* no bleeding diathesis or coagulopathy
* normal creatinine or creatinine clearance of at least 50 ml/min
Exclusion Criteria:
* postoperative complications that interfere with adjuvant HIPEC within 8 weeks (i.e. persisting intra-abdominal abscess, significant fascial dehiscence, enteric fistula)
* no intention to start routine adjuvant systemic therapy
* liver and/or lung metastases
* pregnant or lactating women
* unstable or uncompensated respiratory or cardiac disease
* serious active infections
* other concurrent chemotherapy
* hypersensitivity to fluorouracil, folinic acid or another substance of leucovorin or oxaliplatin
* stomatitis, ulceration in the mouth or gastrointestinal tract.
* severe diarrhea
* severe hepatic and / or renal dysfunction.
* plasma bilirubin concentrations greater than 85 μmol/l.
* pernicious anemia or other anaemias due to vitamin B12 deficiency.
* peripheral sensory neuropathy with functional impairment.
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>
| 677 |
Target Study Title: The Effect of Family-centered Care Educational Training on Nurses' Attitudes and Parental Satisfaction: A Semi-experimental Study
Target Study Description: #Study Description
Brief Summary
Family-Centered Care (FCC) is a care approach based on mutual respect, knowledge sharing, and collaboration among children, families, and healthcare professionals during the planning, implementation, and evaluation of healthcare. Nurses' supportive attitudes may positively influence their care practices and behaviors towards FCC. In this regard, educational training related to FCC may affect nurses' attitudes and behaviors. In the literature, it's evident that there is a need for studies examining how both the attitudes of nurses towards FCC a key determinant of their behavioral predispositions, and the parental satisfaction with healthcare services change in response to the provision of educational training. This study aims to determine the impact of the FCC educational training administered to nurses in pediatric clinics, primarily on nurses' attitudes towards FCC, and secondarily on parental satisfaction with healthcare. With this in mind, this study aims to determine the primary impact of the nurse centered FCC educational training, provided to nurses in pediatric clinics, on nurses' attitudes towards FCC, and its secondary impact on parental satisfaction with healthcare.
Detailed Description
Research Hypotheses H1: There is a difference between the mean scores of nurses' attitudes towards FCC before and after the educational training.
H2: There is a difference between the mean scores of parental satisfaction with healthcare before and after the educational training.
This study employs a non randomized experimental design with a pre test, post test format. It was conducted between February and June 2021 in the pediatric units of a university hospital in the Eastern Mediterranean region of Turkey. The target population comprised 134 nurses working across a variety of specializations including pediatric hematology, pediatric surgery, pediatric emergency care, pediatric intensive care (PICU), neonatal intensive care (NICU), pediatric infectious diseases, and general pediatrics. In this study, where specific sample selection was not applied, the aim was to reach at least 80% of the total population. The research was undertaken with the participation of 130 nurses, which accounted for 97% of the targeted population.
Data collection tools; Nurse Information Form: These questions pertain to the nurses' age, gender, education, length of professional experience, duration spent in pediatric clinics, and prior participation in FCC training.
Family Centered Care Attitude Scale (FCCAS): The measurement tool, developed by Kara and Güdücü Tüfekçi, is used to identify the attitudes of nurses providing care to children and their parents towards FCC. This self-report tool is composed of 58 Likert scale items distributed across two subscales. An increase in the scale score indicates an increase in positive attitudes of nurses towards FCC.
PedsQL Health Care Parents Satisfaction Scale (PedsQL HCPSS): The PedsQL Health Care Parents Satisfaction Scale, originally designed by Varni and later adapted for Turkish audiences by Ulus and Kublay, is a self-report instrument used for assessing the satisfaction levels of parents whose children are utilizing healthcare services. Comprising 25 items divided into six subscales. A higher score on this scale signifies increased satisfaction among parents with the provided healthcare services.
Interventions The planning of the educational intervention process, the development of e-learning modules, and the organization of nurse centered interactions benefited from expert opinions in three nursing education, ten pediatric nursing, and two educational sciences. A six week period February - April 2021 was planned for the educational training. One week before the educational training, the nurses were administered the Nurse Information Form and FCCAS pre tests, which were conducted using an online form. Immediately following the administration of the pre tests, the planning of the educational process, including the development of e-learning modules and video lectures, was shared with the nurses. Each week, the topics were delivered to the nurses through online interactive methods, with each session lasting approximately 45-60 minutes. Complementing these sessions, video lectures of around 30 minutes duration were prepared for each topic. The flexibility of the e-learning format allowed nurses to access these modules and video lectures from any location. From the second week of the educational training, nurse centered interactions and group discussions were initiated within the clinical setting, providing a platform for collaborative learning and engagement among the nurses. In this process, at the beginning of each shift, FCC practices for children and their parents were discussed. In intra team interactions, group discussions were to explore the content of each week's module. Six weeks after the completion of the six week educational training, the nurses were administered the FCCAS post test via an online form. The PedsQL HCPSS was utilized to assess the level of healthcare satisfaction among parents whose children received care in pediatric clinics.
Statistical Methods Data analysis was conducted using SPSS version 21 (Statistical Package for Social Sciences) software. The Kolmogorov-Smirnov test was utilized to assess the normal distribution of the scale scores. Descriptive statistics such as mean, standard deviation, confidence interval, frequency, percentage, and effect size (d) were used to present the data. Paired sample t tests were employed to compare the mean scores of the FCCAS before and after the training among the nurses. Furthermore, the mean scores of the PedsQL HCPSS in the post training period were compared to the pre training institutional data of the hospital using a one sample t test.
Ethical Considerations The study obtained approval from the clinical research ethics committee, written institutional permission from the hospital, and informed consent from both the participating nurses and parents.
#Intervention
- BEHAVIORAL : FCC educational training
- An educational training, grounded in six weeks of nurse-centered interactions, was implemented.
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 nurses:
* be working in the pediatric clinics between February and April 2021,
* be willing to participate in the research.
For parents:
* have a child receiving healthcare in the specified pediatric clinics during the period of May to June 2021 (post-training period),
* be willing to participate in the research.
Exclusion Criteria:
For nurses:
* don't be working in the pediatric clinics between February and April 2021,
* not willing to participate in the research.
For parents:
* haven't a child receiving healthcare in the specified pediatric clinics during the period of May to June 2021 (post-training period),
* not willing to participate in the research.
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>
| 678 |
Target Study Title: The Effect of Intravenous Lidocaine on Normal Sensation and Pain in Healthy Volunteers (Carl Koller Grant) (The Effect of Intravenous Lidocaine on Allodynia)
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to study if lidocaine, given intravenously, reduces pain.
Detailed Description
Clinicians use lidocaine intravenously in a fashion that suggests that it might have analgesic effects. Therefore, we test the hypothesis that lidocaine reduces pain intensity in response to experimental pain.
#Intervention
- DRUG : Lidocaine
- Lidocaine 2% (2mg/ml) was administered via a computer assisted infusion to achieve a target plasma concentration of 2 mcg/ml; infused within 20 minutes.
- Other Names :
- Local Anesthesia
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Healthy Adult Volunteers, age >19 years
Exclusion Criteria:
* History of Substance Abuse
* Coronary Artery Disease (CAD): unstable
* Congestive Heart Failure (CHF): unstable
* Heart Arrhythmia: symptomatic
* Chronic Obstructive Pulmonary Disease (COPD)
* Lidocaine Allergy
* Diagnostic and Statistical Manual of Mental Disorders (Rev IV): Axis I: Common Axis I disorders include depression, anxiety disorders,bipolar disorder, ADHD, and schizophrenia. Axis II: borderline personality disorder, schizotypal personality disorder, antisocial personality disorder, and mild mental retardation.
* Presence of Contraindications for MRI
* Presence of electronically, magnetically, and mechanically activated implants
* Electronically, magnetically, and mechanically activated implants
* Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators
* Cardiac pacemakers
* Metallic splinters in the eye
* Ferromagnetic haemostatic clips in the central nervous system (CNS)
* Claustrophobia
* Pregnancy
Sex :
ALL
Ages :
- Minimum Age : 19 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 679 |
Target Study Title: Acute Dose-response Effect of a Proprietary Botanical Blend Rich in Polyphenols on Flow-mediated Dilation in Healthy Subjects: Randomized, Cross-over, Double-blind Clinical Study
Target Study Description: #Study Description
Brief Summary
It is well established that endothelial dysfunction is an early predictor of cardiovascular events in at-risk patients. Finding safe and effective product able to improve endothelial function is of public health interest.
Many clinical studies have shown that monomer of flavanols from cocoa significantly improved endothelial function, in particular endothelium-dependent flow-mediated dilation (ED-FMD) after a single dose. Grape is also a main source of flavanol monomers, that's why many human studies have shown significant effects of grape-derived products on endothelial function within 2 hours following a single dose intake.
The objective of this study is to assess the effect of 2 doses of a proprietary and standardised botanical blend rich in polyphenols (SBRP), on ED-FMD in fasting conditions, in comparison to a placebo, in healthy adults. This blend is made of two botanical extracts: a grape extract and a blueberry extract. In order to provide supportive evidence on the mechanisms and biological plausibility to the clinical effects of the product, appropriate biological parameters and circulating metabolites will be assayed.
#Intervention
- DIETARY_SUPPLEMENT : Memophenol 300 mg
- 300 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.
- DIETARY_SUPPLEMENT : Memophenol 600 mg
- 600 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.
- DIETARY_SUPPLEMENT : Placebo
- Colored maltodextrin
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:
* Presenting at least two of the following risks of suboptimal endothelial function (but not under prescribed drug for this reason):
* Overweight, defined by: 25 <= BMI < 30 kg/m2;
* Central obesity defined according to IDE criteria (2009): for European subjects, waist circumference >= 94 cm (with a tolerance of -10%);
* High Normal Blood pressure defined according to ESC/ESH guidelines (2013): Systolic Blood Pressure >= 130 and <= 139 mmHg or Diastolic Blood Pressure >= 85 and <= 89 mmHg;
* Considered healthy based on their self-declaration and physical examination;
* Subjects capable of and willing to comply with the protocol and to give their written informed consent.
* Subjects affiliated with a social security scheme.
Non-inclusion Criteria:
* Metabolic abnormality or major cardiovascular risk factor, such as (but not limited to):
* clinically significant arrhythmia,
* diabetes mellitus (type I or II),
* chronic kidney disease.
* Consumption of food supplement(s) currently or within the past 4 weeks before entry into the study, such as but not limited to: botanicals, vitamins, minerals, amino acids;
* Smoking > 5 cigarettes/ day and > 5 pack-years for at least 2 years;
* Use of any type of medication currently or within 2 months before entry into the study (more especially antihypertensive drug);
* Use of any narcotic drug (including cannabis) within 2 months before entry into the study detected by the self-declaration of the participant and/ or by the urine THC test ;
* Endurance sport activities > 5 h/ week;
* Self-reported alcohol intake >10 units/ week (1 unit = 1 standard glass)
* Weight change > 5% of total body weight within the 3 months before V1;
* Currently under prescribed diet regimen, whatever the reason;
* Any intolerance or allergy documented or suspected to one of the components of the study products or to the Glyceryl trinitrate (GTN);
* Any contraindication to the GTN drug:
* severe hypotension,
* obstructive cardiomyopathy,
* myocardial infarction,
* intracranial hypertension,
* sildenafil intake (occasionally or regularly). .
* Subject presenting a psychological or linguistic inability to sign the informed consent;
* Subject under legal protection (guardianship, wardship) or deprived from his rights following administrative or judicial decision;
* Subject participating in another biomedical study or participation in another study within the 3 months before entry into this study;
* Any regulatory reason according to national applicable regulation.
Exclusion criteria :
Volunteers whose fasting blood sample at V0 will reveal a pathological level of glycaemia (> 1,26 g/L) and/ or a dyslipidemia (example : triacylglycerol > 1,75 g/L) will be excluded.
Sex :
MALE
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>
| 680 |
Target Study Title: Effect of Number of Pulses of Radial Extracorporeal Shock Wave Therapy on Hamstring Spasticity in Children With Cerebral Palsy
Target Study Description: #Study Description
Brief Summary
Cerebral palsy (CP) is a group of permanent disorders affecting movement and postural development that are caused by non-progressive disruptions of the brain, usually occurring during fetal period or infancy. It is commonly accompanied with sensory disorders and learning disability. In 2016, more than 17 million people are affected by CP with a prevalence of 1.5 to 2.5 per 1,000 live births. CP remains to be the most common cause of severe physical disability in children. The Centres for Disease Control and Prevention (CDC) estimated an economic cost of US$4.1 million per CP patient that comprises of medical services, special education and productivity loss.
Current management of spasticity involves physical manipulation such as passive stretching and splinting, sometimes combined with oral pharmacologic treatment, intrathecal baclofen therapy and botulinum toxin injection. At times, surgical procedures such as Surgical Dorsal Rhizotomy (SDR) can also be considered. Botulinum toxin injection has been shown to reduce spasticity for up to 6 months, however, the cost of the procedure remains to be an issue in developing countries like Indonesia. Therefore, other modality such as a non-invasive therapy should be considered as an alternative treatment for spasticity.
Radial Extracorporeal Shockwave Therapy (rESWT) is a non-invasive treatment that has been shown to effectively improve spasticity in patients with spastic motor type CP, despite unclear underlying mechanism. According to International Society for Medical Shockwave Treatment (ISMST), there has yet to be a recommended guideline for the treatment of spasticity in children using rESWT. One crucial physical parameter needed to be determined is the number of pulse required to efficiently reduce spasticity. The number of pulse directly affects the duration of ESWT per session (the higher the number of pulse given, the longer the therapy session). This may be a concern for spastic motor type CP due to accompanying sensory and learning disability. Therefore, the objective of this study was to understand whether the reduction in hamstring stiffness in children with spastic CP could be influenced by the number of pulse in a single ESWT session.
Detailed Description
This study was designed as a double-blinded and randomized controlled trial.
Children with spastic CP from the outpatient clinic of the Department of Physical Medicine and Rehabilitation at Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo (RSCM) participated in the study. The patients were randomly allocated to four groups: 500 pulses, 1,000 pulses, 1,500 pulses, and 2,000 pulses. All groups undergo routine rehabilitation, including physiotherapy. Ethical approval was obtained from the Ethical Committee of Faculty of Medicine, University of Indonesia - RSCM.
Spasticity of hamstring was evaluated as the degree of resistance to passive movement using ASAS (0: no spasticity to 4: severe spasticity). Evaluations were done at four time points: 1) pre-ESWT, 2) immediately post-ESWT, 3) 2 weeks post-ESWT, and 4) 4 weeks post-ESWT. All patients were examined by the same physiatrist with the patient lying on supine position on the stretcher.
BTL-6000 SWT Topline (BTL, Czech Republic) was used to apply rESWT on hamstring muscles, with the subject lying on prone position. The energy flux density was constant at 0.1 mJ/mm2 and the repetition frequency was at 4 Hz, with a pressure of 1.5 bars. For double-blinded treatment, spastic hamstring muscles from CP patients were allocated into four groups - each group receiving a varying total number of pulses (group I: 500 pulses, group II: 1,000 pulses, group III: 1.500 pulses, and group IV: 2,000 pulses). No anesthesia was given. Adverse events were closely monitored during and after therapy.
Intra-group changes in ASAS were evaluated with Friedman analysis of variance from baseline immediately post ESWT, 2 weeks post ESWT, and 4 weeks post ESWT; followed by post-hoc Wilcoxon signed-ranked test. Inter-group differences in ASAS reduction were analyzed using Kruskal Wallis test. Statistical analysis was conducted using SPSS ver. 23.0 (IBM Corporation, Armonk, NY, USA). The level of significance was set at \<0.05.
#Intervention
- DEVICE : radial Extracorporeal Shockwave Therapy
- rESWT was given on hamstring muscles, with the subject lying on prone position. No anesthesia was required.
- Other Names :
- rESWT
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 spastic CP aged 5 <= age <= 18 old
* at least one hamstring with an Australian Spasticity Assessment Scale (ASAS) of 2 or more
* ability of legal respondent to give written informed consent
Exclusion Criteria:
* 6 months or less since the last botulinum injection on hamstring
* surgical operation on lower limb within the last 12 months
* severe contracture on hamstring
Sex :
ALL
Ages :
- Minimum Age : 5 Years
- Maximum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 681 |
Target Study Title: A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of VRC-HIVMAB075-00-AB (VRC07-523LS) in the Sera and Mucosae of Healthy, HIV-1-Uninfected Adult Participants
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to evaluate the safety and pharmacokinetics of a human monoclonal antibody (VRC07-523LS) in the sera and mucosae of healthy, HIV-uninfected adults.
Detailed Description
This study will evaluate the safety and pharmacokinetics of a human monoclonal antibody (VRC07-523LS) in the sera and mucosae of healthy, HIV-uninfected adults.
Participants will be randomly assigned to one of two groups. Participants in Group 1 will receive 10 mg/kg of VRC07-523LS at Weeks 0, 16, and 32. Participants in Group 2 will receive 30 mg/kg of VRC07-523LS at Weeks 0, 16, and 32.
Study visits will occur at Weeks 0, 2, 16, 18, 32, 34, and 48. Visits may include physical examinations; blood and urine collection; rectal, cervicovaginal, and seminal secretion collection; cervical, rectal, and vaginal biopsy collection; HIV testing; risk reduction counseling; and questionnaires. Study staff will contact participants at Week 50 for follow-up safety monitoring.
#Intervention
- BIOLOGICAL : VRC07-523LS
- Administered by intravenous (IV) infusion
- Other Names :
- VRC-HIVMAB075-00-AB
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
General and Demographic Criteria
* Age of 18 <= age <= 50
* Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study
* Ability and willingness to provide informed consent
* Assessment of understanding: volunteer demonstrates understanding of this study and completes a questionnaire prior to first study product administration with verbal demonstration of understanding of all questionnaire items answered incorrectly
* Agrees not to enroll in another study of an investigational research agent until completion of the last required protocol clinic visit
* Good general health as shown by medical history, physical exam, and screening laboratory tests
HIV-Related Criteria:
* Willingness to receive HIV test results
* Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
* Assessed by the clinic staff as being at 'low risk' for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit. See the study protocol for US Low risk guidelines.
Laboratory Inclusion Values
Hemogram/Complete blood count (CBC)
* Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth, greater than or equal to 13.0 g/dL for volunteers who were assigned male sex at birth. For transgender participants who have been on hormone therapy for more than 6 consecutive months, determine hemoglobin eligibility based on the gender with which they identify (ie, a transgender female who has been on feminizing hormone therapy for more than 6 consecutive months should be assessed for eligibility using the hemoglobin parameters for persons assigned female sex at birth).
* White blood cell (WBC) count equal to 2,500 to 12,000 cells/mm^3
* WBC differential either within institutional normal range or with site physician approval
* Platelets equal to 125,000 to 550,000/mm^3
Chemistry
* Chemistry panel: Alanine aminotransferase (ALT) less than 1.25 times the institutional upper limit of normal and creatinine less than or equal to institutional upper limits of normal.
Virology
* Negative HIV-1 and -2 blood test: US volunteers must have a negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA).
* Negative Hepatitis B surface antigen (HBsAg)
* Negative anti-Hepatitis C virus (anti-HCV) antibodies, or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
Urine
* Normal urine:
* Negative or trace urine protein
Reproductive Status
* Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to biopsy collection and/or study product administration.
* Reproductive status: A volunteer who was assigned female sex at birth must:
* Agree to use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. Effective contraception is defined as using the following methods:
* Condoms (male or female) with or without a spermicide,
* Diaphragm or cervical cap with spermicide,
* Intrauterine device (IUD),
* Hormonal contraception, or
* Any other contraceptive method approved by the HVTN 128 Protocol Safety Review Team (PSRT)
* Successful vasectomy in any partner assigned male sex at birth (considered successful if a volunteer reports that a male partner has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy);
* Tubal ligation
* Or be sexually abstinent until at least 4 months following the last study product administration.
* Volunteers who were assigned female sex at birth must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit
Mucosal Specimen Collection
* Volunteers 21 years and older who were assigned female sex at birth: Pap smear (verified by medical records) is required within:
* the 3 years prior to enrollment with the latest result reported as normal or ASCUS (atypical squamous cells of undetermined significance), OR
* the 5 years prior to enrollment, with the latest result reported as normal, or ASCUS with no evidence of high risk HPV.
* If no Pap smear was done within the last 3 years (or within the last 5 years, if high risk HPV testing was performed), the volunteer must be willing to undergo a Pap smear with the result reported (verified by medical records) as normal or ASCUS prior to sample collection.
* Willing to have mucosal secretions and tissue biopsies collected at several timepoints
* Willing to abstain from sexual intercourse for the required period after each biopsy collection
Exclusion Criteria:
General
* Weight greater than 115 kg
* Blood products received within 120 days before first study product administration unless eligibility for earlier enrollment is determined by the HVTN 128 PSRT
* Investigational research agents received within 30 days before first study product administration
* Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the study
* Pregnant or breastfeeding
Vaccines and other Injections
* HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 128 PSRT will determine eligibility on a case-by-case basis.
* Previous receipt of humanized or human monoclonal antibodies (mAbs), whether licensed or investigational; the HVTN 128 PSRT will determine eligibility on a case-by-case basis.
* Previous receipt of monoclonal antibodies against HIV
Immune System
* Immunosuppressive medications received within 30 days before first infusion (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of oral/parenteral prednisone or equivalent at doses less than or equal to 20 mg/day and length of therapy less than 14 days)
* Serious adverse reactions to VRC07 <= age <= 523LS formulation components (sucrose, histidine, and sorbitol; see study protocol for more information), including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain.
* Immunoglobulin received within 90 days before first infusion unless eligibility for earlier enrollment is determined by the HVTN 128 PSRT
* Autoimmune disease (Not excluded from participation: Volunteer with mild, stable and uncomplicated autoimmune disease that does not require immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate Solicited and Unsolicited AE assessments)
* Immunodeficiency
Clinically significant medical conditions
* Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
* A process that would affect the immune response,
* A process that would require medication that affects the immune response,
* Any contraindication to repeated infusions or blood draws, including inability to establish venous access,
* A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period,
* A condition or process (eg, chronic urticaria or recent infusion with evidence of residual inflammation) for which signs or symptoms could be confused with reactions to the study product, or
* Any condition specifically listed among the exclusion criteria below.
* Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety, Solicited AEs, or a volunteer's ability to give informed consent
* Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
* Current anti-tuberculosis (TB) therapy
* Asthma other than mild, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report). Exclude a volunteer who:
* Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
* Uses moderate/high dose inhaled corticosteroids, or
* In the past year has either of the following:
* Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids;
* Needed emergency care, urgent care, hospitalization, or intubation for asthma.
* Diabetes mellitus type 1 or type 2. (Not excluded: type 2 cases controlled with diet alone or a history of isolated gestational diabetes.)
* Hypertension:
* If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined as consistently less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be less than or equal to 150 mm Hg systolic and less than or equal to 100 mm Hg diastolic. For these volunteers, blood pressure must be less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic at enrollment.
* If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure greater than or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or equal to 100 mm Hg at enrollment.
* Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
* Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study)
* Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years
* Asplenia: any condition resulting in the absence of a functional spleen
* History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
Mucosal Specimen Collection
* A rectal condition (for rectal biopsies), such as an active infection or inflammation of the colorectal area (eg, an HSV-2 outbreak or inflamed hemorrhoids or colitis/diarrhea), internal hemorrhoids, or any other condition noted during screening rectal exam via anoscope or in medical history that in the opinion of the clinician represents a contraindication to mucosal sampling.
* For those who were assigned female sex at birth (for vaginal and cervical biopsies), any condition noted during pelvic exam via speculum or in medical history that in the opinion of the clinician represents a contraindication to mucosal sampling (eg, bacterial vaginosis).
* An active genital tract condition, such as an active infection or inflammation of the genital tract (eg, genital sores or ulcers, penile or abnormal vaginal discharge, genital warts that are symptomatic or requiring treatment) or any other condition that in the opinion of the clinician represents a contraindication to mucosal sampling.
* Hysterectomy or bilateral oophorectomy
* Menopause
* Current use of anticoagulants
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>
| 682 |
Target Study Title: Caminamos: A Location-based Smartphone App for Latinas to Connect With Nearby Walking Partners Ph II
Target Study Description: #Study Description
Brief Summary
Despite numerous interventions designed to increase physical activity, few are specifically tailored to Latinas, a population where higher rates of obesity, diabetes, and other chronic diseases are present. This proposed smartphone app, ¡Caminemos Juntas!, will use location-based services to connect Latinas with one another in order to improve walking habits by increasing social support and decreasing perceived barriers, both of which are known to play a role in physical activity behaviors. Through a randomized comparative-effectiveness trial, this Phase II project will test the effectiveness of a smartphone application for improving physical activity among Latinas when providing them with real-time opportunities to connect socially with the goal of walking.
Detailed Description
Health disparities are high among Latinas. They are more likely to be overweight, diagnosed with diabetes, and physically inactive compared to their non-Hispanic White counterparts. Thus, interventions that target improving health access and ameliorating chronic diseases among Latinas are of high public health importance. Available data suggest that community-focused interventions produce improvements in physical activity (PA) and are well-received by Latinas especially when social and physical environments are considered (e.g., social support, safe walking areas, etc.). Research suggests that Latinos respond favorably to technological-based health interventions. Thus, health promotion interventions that can address Latinos' preferences regarding their physical and social environments while utilizing a preferred technology source (e.g., smartphone) could prove highly successful. In a Phase I SBIR, our team developed ¡Caminemos Juntas!, an innovative mobile phone app using Location-based Services (LBS) to connect women within geographically proximal neighborhoods as a way to provide social support for increased walking behaviors. Specifically, we (a) gathered feedback from an Expert Advisory Board (EAB) to help plan and assess the feasibility of creating the app; (b) built connections and gathered input from Latina community leaders to assist in the conceptual development of the app through a Community Advisory Board (CAB); (c) conducted an online survey of a national sample of Latinas on their smartphone usage for health promotion, and interest in social networking and LBS technology features; (d) conducted iterative focus groups with Latinas to guide development of app content, design, and aesthetics to fully develop a functioning prototype; (e) conducted field usability testing with Latinas to test the app's accuracy to establish users' location and connect users through the ¡Caminemos Juntas! system and users' use and satisfaction with the app; and (f) developed a specifications document to outline the Phase II development plan. The results of the Phase I activities provided strong support for this Phase II SBIR application. The proposed Phase II project will (1) develop a full-scale, fully programmed ¡Caminemos Juntas! app; (2) determine whether the ¡Caminemos Juntas! app can be translated and adapted to a new community environment; (3) test the performance, usage, and usability of the full-scale, fully-programmed app; and (4) evaluate whether ¡Caminemos Juntas! increases physical activity, social support for exercise, and quality of life (QOL) in Latinas. ¡Caminemos Juntas! will be evaluated in a randomized comparative-effectiveness trial (n=200) with Latinas age 18-55 in the Denver, CO and San Jose, CA areas. Overall, the proposed project has the potential to significantly impact Latinas' health by providing them with real-time opportunities to connect socially with the goal of walking. ¡Caminemos Juntas! will be the first app that use geo-location technology dedicated to walking with a social emphasis, for any population.
#Intervention
- OTHER : Caminemos Juntas App
- A tailored mobile app that encourages Latinas and Hispanic women to walk together using location-based services.
- OTHER : World Walking App
- A mobile app that encourages users to walk.
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 the ages of 18 and 69 years, identify as Hispanic or Latina, identify as a woman, able to read and speak either English or Spanish, own a smartphone, not pregnant, consent to participate
Exclusion Criteria:
* Not between the ages of 18 and 69 years, not identify as Hispanic or Latina, not identify as a woman, unable to read or speak Spanish or English, pregnant, not own a smartphone.
Sex :
FEMALE
Ages :
- Minimum Age : 18 Years
- Maximum Age : 69 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 683 |
Target Study Title: A Double Blind Study on the Efficacy of a Colostrum and Egg Yolk Supplement vs. Placebo to Reduce Frequency and Duration of Upper Respiratory Tract Infections in Healthy Adults
Target Study Description: #Study Description
Brief Summary
The goals of our study are to critically evaluate if a healthy population supplemented with Transfer factor experiences fewer incidences of colds and flu, or experience shorter duration of illness compared to an identical population taking placebo. In this study we will give either Transfer factor or a placebo to two groups of healthy adult men and women for a period of 7 weeks in a double-blind experimental design. The frequency and duration of colds and flu-like symptoms will be recorded during the course of the study. Saliva samples will be collected weekly and assessed for salivary IgA secretion rate. Data from this study will establish the efficacy of Transfer Factor to support a healthy immune system.
#Intervention
- DIETARY_SUPPLEMENT : transfer factor
- capsules, 2 per day by mouth for 7 weeks.
- DIETARY_SUPPLEMENT : Placebo
- cornstarch, 2 capsules per day by mouth.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Males and females (18 - 40) who are in good health
Exclusion Criteria:
* Subjects who are allergic to eggs (on which the supplement is based). If a volunteer is not sure if they are allergic to eggs or milk. Those who are currently smoking, have cardiovascular disease, cancer, diabetes, liver disease, renal insufficiency, any chronic disease that might interfere with study participation, BMI above 40 kg/m2, consumption of >12 alcoholic drinks weekly, or unwillingness to stop current supplement intake. Women who are pregnant or lactating will also be excluded from the study.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 684 |
Target Study Title: Registry for Eosinophilic Gastrointestinal Disorders (REGID)
Target Study Description: #Study Description
Brief Summary
Develop Registry tool
Detailed Description
The purpose of this research study is to develop a registry tool used for the management and care of patients with eosinophilic disorders, and create a research resource that will provide further insights into these disorders.
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:
* Eosinophilic Gastrointestinal Disorder diagnosis
Sex :
ALL
Ages :
- Minimum Age : 1 Year
- Maximum Age : 12 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 685 |
Target Study Title: A Multi-centre Proof-of-performance Clinical Study to Validate Blood-based Biomarker Candidates for the Diagnosis of Alzheimer's Disease
Target Study Description: #Study Description
Brief Summary
The objective of the ADDIA clinical Proof-of-Performance study is to validate the performance of ADDIA' blood biomarkers for diagnosis of Alzheimer's disease (AD).
ADDIA clinical study is a multi-centre, non-interventional, prospective, proof-of-performance study with only one visit.
About 800 well-characterized subjects will be recruited into 3 groups in 2:1:1 ratio, namely patients with Alzheimer's disease (AD), patients with non-AD neurodegenerative disease (NAD) and 200 control subjects (healthy as compared to their age).
* 400 patients with Alzheimer's disease (AD): 200 patients with mild AD, 200 patients with moderate-to-severe AD,
* 200 patients with non-Alzheimer's neurodegenerative diseases (NAD),
* 200 controls (healthy as compared to their age).
Detailed Description
ADDIA study is dedicated to the proof-of-performance (PoP) of blood biomarkers for diagnosis of Alzheimer's disease (AD) and will recruit approximately 800 subjects (400 AD and 400 non-AD).
CONTEXT OF USE:
To quantify the performance of ADDIA' blood biomarkers for AD diagnosis (yes/no).
Since the main objective of this study is to establish the performance of ADDIA' blood cell-based biomarkers β-amyloid (Aβ) and protein kinase C (PKC) and corresponding assays and to seek approval as In-Vitro Diagnosis (IVD) test(s) specific for diagnosis of AD, and to validate the newly identified metabolomics and RNA signatures and selected protein biomarker candidates, samples will be used from:
* the patients recruited in the AD group and patients recruited in the non-AD neurodegenerative disorders (NAD) group who are accurately diagnosed during the pre-screening period, including by using three types of diagnostic methods: clinical neuropsychological scores, neuroimaging (at least volumetric structural MRI) and retrospective cerebrospinal (CSF) data: Aβ, total-Tau and p-tau biomarkers. Alternatively to absence of retrospective CSF data, retrospective Aβ PET /Tau PET scans can be used if compatible to diagnosis of respective diseases.
* the subjects recruited in the control group have no objective memory loss, normal results on neuropsychology tests, and normal neuroimaging findings for their age, as well as normal Aβ PET scan Tau PET scan and normal CSF Aβ, total-Tau and p-Tau concentration if retrospectively available.
For further validation of ADDIA' biomarkers, an integrative tool combining ADDIA' blood biomarkers with cognitive scores and/or, neuroimaging (and/or retrospective CSF biomarker data) will be used. The impact of polymorphisms associated with AD, such as APOE e4 (known to be as risk factor of AD) on ADDIA' blood biomarkers will also be studied.
OBJECTIVES:
Objective 1: Validate the ADDIA biomarker candidates: two blood cell-based biomarkers measured by flow cytometry using Amoneta Diagnostics' proprietary probes specific to beta-Amyloid (Aβ) peptide and protein kinase C (PKC).
ADDIA' blood cell-based Aβ and/or PKC biomarkers will also be combined via an integrative tool with clinical neuropsychological scores (MMSE, MoCA, FCSRT) and/or neuroimaging (at least volumetric MRI) scores for diagnosis and/or differential diagnosis. The impact on these ADDIA biomarkers of genotyping in particular polymorphisms known to be associated with AD (e.g. APOE e4, e2 alleles) will also be tested. In addition, the levels of ADDIA' blood cell-based Aβ and/or PKC biomarkers will be correlated to the levels of CSF biomarkers Aβ and tau or phospho-tau (or Aβ PET and TAU PET levels).
Objective 2: ADDIA clinical PoP study will also validate additional new biomarker candidates (identified previously and/or under analytical validation in the ADKIT study and chronobiological studies) for AD diagnosis in peripheral body fluids; in particular, studies on a set of proteins (using immuno-detection methods), metabolomics/lipidomics signatures (using e.g. LC-HRMS method) and miRNA signature (using e.g. qPCR, HTG-NGS methods) are planned. These new biomarkers may be used if needed to further enhance the accuracy of ADDIA' blood-based Aβ and PKC biomarker test for diagnosis or differential diagnosis.
STUDY DESIGN
ADDIA clinical study is a multi-centre, non-interventional, prospective, proof-of-performance group study without a clinical follow-up. About 800 well characterized subjects will be enrolled into 3 groups in 2:1:1 ratio, namely Alzheimer's disease, non-AD neurodegenerative diseases and controls (healthy as compared to their age). The number of subjects is divided into 3 groups as following:
* 400 patients with Alzheimer's disease (AD),
* 200 patients with non-Alzheimer's neurodegenerative diseases (NAD),
* 200 controls (CC).
All groups will be age-matched and mean age similar in the three groups.
ADDIA clinical study needs to recruit well characterized subjects in each group, therefore a pre-screening or a diagnostic workup of the subjects needs to be performed by the clinical centres before the start of the clinical study (during Visit 0). In ADDIA clinical study, only one visit (Visit 1) is required for the subjects without any follow-up, in which the subjects will be recruited and sampling of blood and urine will be done in the same Visit 1. The following data sets will be collected:
1. Data set 1 and samples available from visit 0 collected in the e-CRF after informed consent signature:
• Data from all subjects of the three groups include neuropsychological scores (MMSE, MoCA, FCSRT scores), neuroimaging (at least structural MRI volumetric scores, and other neuroimaging as needed for diagnosis) and laboratory data (haematology, biochemistry) related to pre-screening and diagnosis. CSF samples obtained retrospectively by clinical centres are needed if available.
2. Data set 2 and samples from Visit 1 include in all three groups clinical MMSE, FCSRT, MoCA tests (MMSE and MoCA tests to be redone on Visit 1 if older than 3 months) and laboratory data (haematology, biochemistry), and blood and urine (and saliva and tear as optional) collected during Visit 1 (clinical centres). The clinical centres equipped with flow cytometry can perform experiments on ADDIA blood cell-based biomarkers utilizing Amoneta' proprietary Aβ and PKC probes.
Data set 3 will be obtained at the end of ADDIA clinical study (Amoneta Diagnostics/Firalis) and will comprise data on the performance of ADDIA biomarkers as described in details in objectives 1, 2.
SUBJECT RECRUITMENT AND SAMPLING
The subjects who meet the inclusion and exclusion criteria prior to the inclusion in the study (as checked by the clinical centres during Visit 0) will be enrolled in the ADDIA study after the informed consent signatures. Sampling will be performed for the following body fluids during Visit 1: blood (11 tubes, 2.5, 4 or 5 mL each) and urine (1 tube, 5 mL) from all subjects. Saliva (1 tube, 4 mL) and tear (2 tubes, 0.15 mL each) samples are optional.
Eleven tubes of blood and spot urine will be collected from each subject that has fasted for \> 12 hours. The samples will be used as follows:
* 2 (two) tubes will be used at the participating clinical centres for routine lab tests, haematology and biochemistry.
* 9 (nine) tubes will be sent to Amoneta facilities in the following format:
* 3 (three) fresh whole blood samples (3 Li-heparin tubes), 1 tube will be sent in the morning immediately after sampling to the flow cytometry laboratory (Amoneta laboratories or another laboratory chosen by Amoneta which can be a laboratory of the clinical centre if equipped with flow cytometry platform) to quantify the performance of ADDIA assays based on blood cell-based biomarkers Aβ and PKC for AD diagnosis and 2 tubes will be used to fix or prepare cells that will be later analysed by flow cytometry at Amoneta laboratories.
* 6 (six) fresh blood samples will be prepared on-site to obtain serum (dry tube), plasma (EDTA and Li-Heparin tubes), PAXgene and PAXRNA samples and PBMC (Li-Heparin tube) samples, which will be aliquoted and stored immediately at -80°C at the clinical centres before being shipped at -80°C later on Amoneta/Firalis central laboratory for testing: genotyping and gene, RNA expression (2 blood tubes), protein expression and metabolomics/lipidomics (1 Li-Heparin and 1 EDTA tubes of plasma, 1 dry tube of serum, and 1 Li-Heparin tube of PBMCs) during the ADDIA program and for validating the emerging biomarkers and for replication studies during or after the ADDIA program (as may be requested by regulatory authorities for IVD product approval).
* Urine samples (and saliva, tear samples as optional) will be aliquoted and frozen immediately at -80°C at the clinical centres and shipped at -80°C to Amoneta/Firalis central laboratory for testing in selected assays based on results that will be obtained on blood samples.
ENDPOINTS
* Performance evaluation of the ADDIA blood biomarkers Aβ and PKC (IVD) kit by AD diagnosis in the form of binary outcome (Yes/No) after quantification of sensitivity \& specificity of these biomarkers. This will be also achieved by using the integrative tool enabling comparison of ADDIA blood-based biomarkers Aβ and PKC to and combination with standard clinical diagnosis tests: cognitive scores, neuroimaging scores (and CSF Biomarkers if possible).
* Performance evaluation of the ADDIA' additional new biomarkers (RNA signature, metabolomics signature and/or other peripheral biomarkers) for AD diagnosis in the form of binary outcome (Yes/No) after quantification of sensitivity \& specificity of these biomarkers.
STATISTICAL CONSIDERATIONS
Primary consideration (for the evaluation of the diagnostic performance) will be the comparisons between the following groups:
* AD (Mild AD + Moderate-to-severe AD) versus healthy controls, and/or
* Mild AD versus healthy controls, and/or
* Moderate-to-severe AD versus healthy controls, and/or
* AD versus healthy controls+NAD groups.
Secondary considerations (for the evaluation of the differential diagnostic performance) will be the comparisons between the following groups:
* AD (Mild AD + Moderate-to-severe AD) versus NAD and/or
* Mild AD versus NAD and/or
* Moderate-to-severe AD versus NAD and/or
* Mild AD versus Moderate-to-severe AD Tertiary considerations will explore potential differences between NAD versus healthy controls and the subgroups of NAD (FTD, LBD, PDD, PSP, CBD) two by two as well as versus healthy controls and AD.
#Intervention
- OTHER : volumetric 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:
For all groups:
* Female and male subjects aged 40 <= age <= 85.
* Dated and signed informed consent by the subject (or its legal representative if applicable in accordance with the local regulations).
* AD, NAD patients and control subjects will be age-matched and mean age similar in the three groups.
* Able to comply with all study procedures.
For AD group:
* Diagnosis of AD: typical and atypical AD.
* MMSE score (measured in the last 3 months): < 21 for patients with moderate to severe AD. MMSE score > 21 in subjects with mild AD with sporadic or a familial form of AD due to mutation in APP or PSEN1 or PSEN2 genes.
* FCSRT, MoCA tests (MoCA measured in the last 3 months).
* Neuroimaging compatible with a diagnosis of AD:
* At least quantitative volumetric structural MRI: volumes of hippocampus and cortical areas.
* Visual semi-quantitative MRI if practiced shall show medial temporal lobe atrophy (MTA) and parietal atrophy with visual rating (semi-quantitative) on the MTA-score (e.g. Scheltens' scores 0 <= age <= 4). MTA score must be >= 2 in patients aged 40 <= age <= 75 years and >= 3 in patients aged above 75 years. For patients younger than 60 years, and with familial form of AD, who may have normal MTA-scores, Koedam score (0 <= age <= 3) for Parietal Atrophy showing atrophy of the precuneus characteristic of AD may be used with a Koedam score from 1 to 3.
Other neuroimaging data (retrospectively available) including PET Amyloid scan and FDG PET are desired if practiced by clinical centres and if available.
* Cerebrospinal fluid biomarker data (retrospectively available) showing positive levels of at least 2 out of 3 biomarkers: i.e. Aβ1 <= age <= 42 and tau (phosphorylated-Tau and/or total-Tau). Note: If retrospective CSF data are not available, retrospective Aβ PET and Tau PET data can be used.
For NAD group:
For all patients of the group NAD, except PSP subgroup (when PSP has a clear-cut typical phenotype, sometimes called Steele-Richardson phenotype), the CSF biomarker data must show levels for CSF biomarkers Aβ1 <= age <= 42, phosphorylated-Tau and total-Tau, compatible with the respective NAD subgroup. If retrospective CSF data are not available, retrospective Aβ PET and Tau PET data can be used.
Fronto-temporal dementia (FTD)
* Diagnosis of probable behavioural FTD (bvFTD) for all subjects of this FTD subgroup, whether with familial or non-familial forms. If with familial form, the subject must be a member of family with a known mutation in one of the FTD related genes: MAPT, PGRN. The predominant phenotype in the kindred must be cognitive/behavioural (i.e. kindred in whom Parkinsonism or Amyotrophic Lateral Sclerosis is the predominant clinical phenotype among affected relatives is excluded).
* Centrally rated frontal and/or anterior temporal atrophy score of 2 or greater on brain MRI.
* MMSE score compatible. If currently taking an acetylcholinesterase inhibitor and/or memantine, the subject must have been taking such medication(s) for >=3 months.
Dementia Lewy body (DLB)
* DLB should be diagnosed when dementia occurs before or concurrently with Parkinsonism.
* Patients diagnosed with probable DLB. Probable DLB can be made with the presence of two core features out of the following:
* Fluctuating cognition with pronounced variations in attention and alertness,
* Recurrent visual hallucinations that are typically well formed and detailed,
* Spontaneous features of Parkinsonism.
Probable DLB is diagnosed with the presence of one or more of the above core features and one or more of the following suggestive features. Probable DLB should not be diagnosed on the basis of suggestive features alone:
* REM sleep behaviour disorder,
* Severe neuroleptic sensitivity,
* Low dopamine transporter uptake in basal ganglia demonstrated by SPECT or PET imaging (if data retrospectively available).
Supportive diagnosis:
* Generalized low uptake on SPECT/PET perfusion scan with reduced occipital activity (if data retrospectively available),
* Abnormal (low uptake) MIBG myocardial scintigraphy,
* Prominent slow wave activity on EEG with temporal lobe transient sharp waves.
* MRI: Relative preservation of medial temporal lobe structures on CT/MRI scan.
* Clinical Dementia Rating (CDR) score is greater than or equal to 0.5.
* MMSE score compatible.
* Patients with familial forms caused by mutation in genes SNCA, SNCB.
Parkinson's disease dementia (PDD)
* Subjects with Parkinson's Disease Dementia (PDD) must have dementia after (not before) developing Parkinson's disease (PD).
* PD is diagnosed by the 3 typical PD symptomatic findings:
* tremor,
* rigidity, and
* slowed movement (bradykinesia).
* Subjects with dementia and with LRRK2 gene mutation (or with mutation in one of the following genes: PARK2 or SNCA, VPS35, PINK1, DJ1, ATP13A2, FBX07, SLC6A3, TAF1 are also included.
* L-DOPA responsive (a good response to levodopa as practiced by clinical investigator, retrospectively to the study).
* MMSE score < 21 for moderate to severe PDD and > 21 for mild PDD.
* MRI: evidence of relevant structural abnormality (i.e. basal ganglia for Parkinsonism and potentially medio-temporal or cortical findings that may be related to dementia). Functional imaging techniques such as fluoro-dopa PET, FDG PET or SPECT to document the presence of dopaminergic dysfunction if retrospectively available.
Progressive Supranuclear Palsy (PSP)
* Diagnosis of probable or possible PSP as defined by the National Institute of Neurological Disorders and Stroke and Society for Progressive Supranuclear Palsy (NINDS-SPSP) diagnostic criteria, and as summarized by Armstrong et al. (2013) for the conclusions on CBD criteria from an international consortium of behavioural neurology, neuropsychology, and movement disorders specialists):
* Gradually progressive disorder,
* Onset at age 40 or later,
* Vertical (upward or downward gaze) supranuclear palsy and prominent postural instability with tendency to fall in the first year of disease onset,
* No evidence of other diseases that could explain the foregoing features, as indicated by mandatory exclusion criteria.
* Brain MRI at Screening consistent with PSP: neuroradiologic evidence of relevant structural abnormality in the midbrain and frontal lobes (i.e. basal ganglia, lobar atrophy).
* MMSE score compatible.
* Be able to ambulate and stand unassisted for 5 minutes.
* Be able to cooperate with gait and balance testing.
Corticobasal degeneration (CBD)
* Diagnosis of possible CBD. Inclusion clinical criteria for possible CBD, with features of Cortico-Basal Syndrome (CBS); familial forms related to MAPT included, Progressive Supranuclear Palsy Syndrome (PSPS) phenotype included.
* Features of CBS: a) limb rigidity or akinesia, b) limb dystonia, c) limb myoclonus plus 1 of: d) orobuccal or limb apraxia, e) cortical sensory deficit, f) alien limb phenomena (more than simple levitation).
* Features of PSPS: Three of: a) axial or symmetric limb rigidity or akinesia, b) postural instability or falls, c) urinary incontinence, d) behavioural changes, e) supranuclear vertical gaze palsy or decreased velocity of vertical saccades.
Note: subjects with probable sporadic CBD (no familial form) are excluded.
* MRI findings: parietal cortical atrophy (asymmetric).
* MMSE score compatible.
Controls
* Normal cognitive performance with normal scores of neuropsychological tests for their age.
* MMSE >26 (performed in less than 3 months).
* At least volumetric structural MRI with normal findings. Normal retrospective finding in β-amyloid PET scan, FDG PET scan if practiced by clinical centres.
* If retrospectively available, normal CSF biomarkers concentrations: negative levels for all three CSF biomarkers Aβ1 <= age <= 42, phosphorylated-Tau and total-Tau.
* If retrospectively available, Aβ PET and/or Tau PET scan(s) shall be negative.
* Able to comply with the study procedures.
Exclusion Criteria for all subjects:
The following exclusion criteria apply to all subjects:
* Neutropenia (Neutrophils: < 1,500/mm3 according to ethnic group).
* Thrombocytopenia (platelets: < 100,000/mm3, rule out EDTA-induced pseudo-thrombocytopenia).
* Subjects with less than an elementary education are excluded.
* Subject with no medical insurance are excluded in the countries where medical insurance is mandatory such as in France. In the countries where medical insurance is not mandatory, subjects with no medical insurance may not be excluded.
* Psychiatric history: schizophrenia, psychosis.
* Vascular dementia.
* Infection diseases, chronic inflammatory diseases that affect blood cells, patients with an active infection/ immunosuppressive disorders/ treatment with immunosuppressive or immunomodulatory medication.
* Current malignancy or past diagnosis of malignancy affecting blood cells under treatment or with treatment stopped only during last 3 months.
* Medication interfering with cognitive functions and ADDIA biomarkers (i.e. kinase inhibitors and beta-amyloid and tau passive and active immunizations).
* Major sensory deficits that could interfere with cognitive assessment (visual and auditory).
* Epilepsy.
* Patients with known contraindication for MRI imaging such as MRI-incompatible stent or MRI-incompatible endoprosthesis.
Exclusion Criteria for AD group
* Mixed dementia.
* Vascular dementia.
* Other dementia type.
* Other neurodegenerative disease.
* Absence of CSF biomarker data and/or amyloid PET data is an exclusive criterion for all subjects with sporadic forms of AD, but it is not an exclusive criterion for subjects with a familial form of AD that is due to a mutation of a gene among APP, PSEN1, PSEN2.
Exclusion Criteria for NAD group
* AD diagnosis.
* Mixed dementia.
* Vascular dementia.
* Absence of either CSF biomarker data or amyloid PET data is an exclusive criterion for all subjects in sporadic DLB, PDD, FTD and CBD (but not for subjects with PSP when PSP has a clear-cut typical phenotype, sometimes called Steele-Richardson phenotype). However, absence of CSF biomarker and/or amyloid PET data is not an exclusive criterion for subjects with a familial form of NAD that is due to a mutation of a gene among MAPT, PGRN, SNCA, SNCB, PARK2 or SNCA, VPS35, PINK1, DJ1, ATP13A2, FBX07, SLC6A3 or TAF1, TREM2.
Exclusion Criteria for Control group
* AD patients.
* Dementia patients.
* Cognitive impairments.
Sex :
ALL
Ages :
- Minimum Age : 40 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 686 |
Target Study Title: A Pilot Study to Evaluate the Use of the MN4000 for Treatment of Cystic Fibrosis (CF) and Motor Neuron Disease (MND) Patients in the Home Setting
Target Study Description: #Study Description
Brief Summary
The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000.
This pilot study evaluated subject satisfaction with the therapy and adherence to the therapy during the 90-day treatment period, and also collected clinical outcome data. Outcomes were assessed before, during and after the MN4000 treatment period.
Detailed Description
The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000.
This pilot study evaluated subject satisfaction with the therapy and adherence to the therapy during the 90-day treatment period, and also collected clinical outcome data. Outcomes were assessed before, during and after the MN4000 treatment period. The study did not include a control group. This pilot study was designed to provide initial information that could inform decisions for future larger-scale studies.
Ten (10) patients total were enrolled from CF and NMD clinics. Eligible subjects were adult patients who were able to perform MN4000 therapy using a mouthpiece and who met all inclusion and none of the exclusion criteria.
All patients received therapy with the MN4000 following the labeled instructions for the device.
The MN4000 is an airway clearance and lung expansion therapy device that has been cleared to market by the FDA as The MetaNeb® System for Homecare environment, for clearance of pulmonary secretions and for treatment or prevention of pulmonary atelectasis. It is a Class II device, cleared to market on March 17, 2016 under premarket notification 510(k) K151689 as The MetaNeb® 4 System with application for homecare environment. It is commercially marketed as the MN4000. The device consists of a pneumatic compressor and an air pulse generator that delivers CHFO and CPEP to;
1. facilitate clearance of mucous from the lungs;
2. provide lung expansion therapy and;
3. enhance delivery of aerosol therapy.
This 'triple' mode device can provide aerosol therapy while alternating between CPEP for lung expansion and CHFO for airway clearance. Supplemental oxygen therapy may also be delivered when used with compressed oxygen.
The MN4000 has three therapy modes:
* CHFO (Continuous High Frequency Oscillation) - delivers aerosol therapy while providing oscillating pressure pulses to the airway
* CPEP (Continuous Positive Expiratory Pressure) - delivers aerosol therapy while providing continuous positive pressure to help hold open and expand the airways
* Aerosol - for delivery of aerosol only. In this mode, CHFO and CPEP are not available
After assessing baseline status, therapy with the MN4000 was introduced and incorporated into the daily home respiratory care treatment regimen for all patients.
Other airway clearance and/or lung expansion therapies were not to be performed during the three-month study period. The treatment regimen for other respiratory care modalities (e.g. aerosolized medications) was that which was prescribed by the patient's health care team in the routine standard care of each patient.
During the three-month follow-up period, adherence to the daily prescribed therapy regimen was assessed. Subjects/caregivers were asked to provide adherence information for each day during the 90-day study period.
Documentation of efficacy and safety Variables was completed by study staff at the time of occurrence, from review of the patient's medical records and from scores and rankings for questionnaires.
#Intervention
- DEVICE : MN 4000
- Patients who required regular home airway clearance therapy were enrolled in the study and were prescribed therapy with the MN4000. Adherence to the prescribed therapy regimen and patient/caregiver satisfaction with the therapy was assessed. Pulmonary function, was assessed for each subject at baseline, after 1 month and after 3 months of home therapy. Results from the therapy period was compared to the baseline period, during which the subject received their regular airway clearance regimen. Airway Clearance Satisfaction surveys were conducted at baseline, after 1 month, and after 3 months of therapy. Results from the MN4000 therapy period were compared to the baseline period, during which the subject received their regular regimen
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Documented diagnosis of CF or MND
* Age >= 18 years
* Signed informed consent
Exclusion Criteria:
* Requirement for continuous mechanical ventilation
* Anticipated requirement for hospitalization within the next three months
* History of pneumothorax within past 6 months
* History of hemoptysis requiring embolization within past 12 months
* Inability to perform MN4000 therapy using a mouthpiece (e.g. inability to create adequate mouth seal)
* Inability to perform MN4000 therapy as directed
* Inability or unwillingness to complete study visits or provide follow-up data as required by the study protocol
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>
| 687 |
Target Study Title: Randomized, Phase II Study Evaluating Concurrent or Sequential Fixed-Dose Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy in Intermediate or High Risk, Previously Untreated, Locally Advanced Head and Neck Cancer
Target Study Description: #Study Description
Brief Summary
The goal of this research study is to learn which therapy order (adding pembrolizumab during vs. after cisplatin and radiation) may be more effective in treating head and neck cancer, as well as learn the side effects of these combinations. Pembrolizumab is an immune therapy, a drug that stimulates the immune system to fight cancer, and is FDA approved in lung cancer and melanoma.
Detailed Description
The study regimen consists of cisplatin and radiation for all patients, the standard treatment for head and neck cancer. All patients will also receive pembrolizumab (the study drug), and will be randomized to two treatment schedules: either pembrolizumab with cisplatin-radiation, or pembrolizumab after completing cisplatin-radiation.
#Intervention
- DRUG : Pembrolizumab
- In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
- Other Names :
- Keytruda
- DRUG : Cisplatin
- Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
- Other Names :
- Platinol
- RADIATION : IMRT
- IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
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
* If a woman of childbearing potential, documentation of negative pregnancy
* Histologically-confirmed head and neck squamous cell carcinoma with no evidence of distant metastasis. The primary site may be the oral cavity, oropharynx, larynx, or hypopharynx. Patients with squamous cell carcinoma of unknown primary, metastatic to cervical lymph nodes, are permitted to enroll.
* High risk or intermediate risk disease, defined below. Staging evaluation should be determined by imaging studies and complete head and neck exam in accordance with the American Joint committee on Cancer Staging Manual, 7th edition.
o High risk patient must meet one of the following criteria:
* Surgically unresectable oral cavity. Patients who are technically resectable but refuse surgery due to morbidity (eg. total glossectomy) are also eligible. Medically inoperable patients are not eligible.
* Larynx: T4 any N; T2 <= age <= 3 and >= N2a
* Hypopharynx: T1 <= age <= 2N1 <= age <= 3 or T3 <= age <= 4N0 <= age <= 3
* Oropharynx: p16(-) AND T3 <= age <= 4 or >= N2a
* Unknown primary: p16(-) AND >= N2a
o Intermediate risk patients must meet one of the following criteria:
* Oropharynx: p16(+) AND one of the following
* T3 or >= N2a AND >= 10 pack-years tobacco exposure (see Tobacco Assessment Form, Appendix A)
* T4 or N3 disease irrespective of tobacco exposure
* Unknown primary: p16(+) AND one of the following
* >= N2a AND >= 10 pack-years tobacco exposure
* N3 disease irrespective of tobacco exposure
* Patients must be untreated with curative-intent surgery for current diagnosis of Stage III, IVa, or IVb disease. Diagnostic biopsy of primary tumor and/or nodal sites is permitted.
* Diagnostic simple tonsillectomy is permitted, provided patient has RECIST-measurable nodal disease.
* Patients with a second HNSCC primary tumor are eligible for this study, provided more than 2 years have elapsed since the first diagnosis of HNSCC, the original tumor was managed with surgery only (no adjuvant chemotherapy or radiotherapy), and has not recurred.
* Patients with simultaneous primaries or bilateral tumors are excluded, with the exception of patients with bilateral tonsil cancers or patients with T1 <= age <= 2, N0, M0 differentiated thyroid carcinoma (resected or management deferred), who are eligible.
* No prior systemic (chemotherapy or biologic/molecular targeted therapy) or radiation treatment for head and neck cancer.
* Patients may have received chemotherapy or radiation for a previous, curatively treated non-HNSCC malignancy, provided at least 2 years have elapsed.
* Patients must be untreated with radiation above the clavicles.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 <= age <= 1
* Age >= 18
* Patients must have measurable disease according to RECIST 1.1
* Patients must demonstrate adequate organ function as defined.
* Sexually active patients must agree to use adequate contraceptive measures, while on study and for 30 days after the last dose of study drug.
Exclusion Criteria:
* Nasopharyngeal primary site
* Current participation in or previous participation in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study treatment.
* History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent.
* Distant metastatic disease including CNS or leptomeningeal metastases is not allowed.
* History of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
* Received prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e. <= Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
* History of second malignancy within 2 years prior to Study Day 1 (except for excised and cured non-melanoma skin cancer, carcinoma in situ of breast or cervix, superficial bladder cancer, or T1a or T1b prostate cancer comprising < 5% of resected tissue with normal prostate specific antigen (PSA) since resection).
* Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents.
* Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
* Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
* Received a live vaccine within 30 days prior to the first dose of trial treatment.
* Received 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).
* Significant pulmonary disease, including pulmonary hypertension, interstitial lung disease, or active, non-infectious pneumonitis.
* History or current evidence of any other medical or psychiatric condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Peripheral neuropathy >= Grade 2
* Significant cardiovascular disease, including:
* Cardiac failure New York Heart Association (NYHA) class III or IV.
* Myocardial infarction, severe or unstable angina within 6 months prior to Study Day 1.
* History of serious arrhythmia (i.e., ventricular tachycardia, or ventricular fibrillation).
* Ventricular cardiac arrhythmias requiring anti-arrhythmic medications.
* Known left ventricular ejection fraction (LVEF) <= 50%.
* Significant thrombotic or embolic events within 3 months prior to Study Day 1.
* Major surgery within 6 weeks prior to Study Day 1 (subjects must have completely recovered from any previous surgery prior to Study Day 1). Biopsy, diagnostic tonsillectomy, airway tumor debulking or excisional lymph node biopsy do not constitute major surgery.
* Active infection requiring antibiotics or antifungals within 7 days prior to first dose of study drug.
* Significant electrolyte imbalance prior to enrollment (note that patients may be supplemented to achieve acceptable electrolyte values):
* Hypomagnesemia <1.2 mg/dL or 0.5 mmol/L.
* Hypokalemia < 3.0 mmol/L.
* Women must not be pregnant or breastfeeding.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 688 |
Target Study Title: Efficiency and Safety a Fixed Combination of Orphenadrine and Diclofenac for Postoperative Analgesia in Cardiac Surgery Patients
Target Study Description: #Study Description
Brief Summary
The study will include 60 patients after cardiac surgery. The first group will include 30 patients who will use the drug Neodolpasse manufactured by Fresenius Kabi, which is a fixed combination of 30 mg of orphenadrine and 75 mg of diclofenac; the second group will consist of 30 patients who will use patient-controlled morphine analgesia (РСА) in the form of monotherapy.
Detailed Description
The patient signs an informed consent to participate in the study after tracheal extubation.The application of one or another method of influence is carried out by the method of random sampling (the envelope method). The drug Neodolpasse is used according to the following plan: in the form of an intravenous infusion of 250 ml for 2 hours 1 or 2 times a day with intervals between infusions about 12 hours. The second injection will be prescribed at VAS \> 40 mm no earlier than 12 hours after the first. The first injection will begin immediately after tracheal extubation. Morphine analgesia controlled by the patient will begin 2 hours after tracheal extubation (the concentration of the drug will be 1 mg /ml; the initial or loading dose is 3 mg; the bolus dose was 1 mg; the lockout interval is 6 minutes; the 4-hour maximum dose is 10 mg; the rate of constant infusion is 0.1 mg / hour).
#Intervention
- DRUG : Analgesics Non Opioid (Neodolpasse manufactured by Fresenius Kabi)
- A decrease in the pain severity (VAS);opioid-sparing effect
- Other Names :
- Fixed combination of Orfenadrine and Diclofenac
- DRUG : Analgesics
- A decrease in the pain severity (VAS)
- Other Names :
- Patient-controlled analgesia (with Morphine)
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 from 18 years to 80 years inclusive
* surgical access - median sternotomy
* the first 2 hours after tracheal extubation
* clear consciousness and productive contact with the patient
* absence of erosive or ulcerative lesions of the mucous membrane of the esophagus, stomach and duodenum during preoperative esophago-gastro-duodenoscopy and clinical manifestations of gastrointestinal bleeding
* no signs of renal dysfunction (KDIGO 0)
* stable state of hemodynamics
Exclusion Criteria:
* a history of mental illness
* the presence of contraindications to the appointment of diclofenac and orphenadrine or individual intolerance to drugs of these groups
* renal and hepatic insufficiency
* perioperative brain lesions
* postoperative bleeding>1.4 ml/kg/hour
* severe cardiovascular (inotropic index>10) and/or respiratory (RaO2 /FiO2<200 mmHg) insufficiency
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 80 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 689 |
Target Study Title: Impact of Protecting TPN Solution From Light on the Oxidant-antioxidant State of Preterm Infant
Target Study Description: #Study Description
Brief Summary
Urinary peroxides and plasma glutathione/glutathione disulfide (GSH/GSSG) ratio will be measured in preterm infants less than 32 weeks gestation before and 7 days after receiving either Light-protected (Group 1) or Light-exposed (Group 2) Total Parenteral Nutrition (TPN) solutions.
Detailed Description
This study will be a prospective single blinded randomized control trial.
Inborn preterm infant less than 32 wks gestational age, receiving TPN in neonatal intensive care unit (NICU) of Mansoura University Children's Hospital as a part of their care will be included.
Preterm infant will be randomly divided into 2group:- Group 1 includes preterm infant who will receive their TPN through bags and tubing system that are protected from light by aluminum foil.
Group 2 includes preterm infant who will receive their TPN through bags and tubing system that are exposed to light.
Randomization will be done using random table technique with opaque sealed envelopes containing the serial number and the group to which the subject will be enrolled.
These envelopes will be kept in the unit ready for use at any time; each one has a number which is the serial number of the baby and group of TPN to which the baby will be enrolled.
The urine sample will be sent to the laboratory with this serial number with no information about the group of study to which this sample follows for peroxide level as well as blood sample for GSH\\GSSG.
Two blood samples and two urine samples will be collected. The first one will be at 0 hour before starting TPN regimen as a base line and the second will be at 7 days of starting TPN regimen. Blood sample will be at least 1cc of blood for GSH/GSSG assay. Urine collection bag will be placed on the infant to obtain minimum of 1cc of urine for urinary peroxide level assay.
Other secondary outcomes will be assessed with duration of NICU admission including death and /or bronchopulmonary dysplasia in preterm infant at time of hospital discharge, necrotizing enterocolitis (NEC), sepsis with positive blood cultures, length of hospital stay, retinopathy of prematurity (ROP), time to full enteral feeding, duration of respiratory support, liver function, cholestasis defined as an elevated serum conjugated bilirubin \>2 mg/dL, and metabolic response.
#Intervention
- OTHER : Light-protection of TPN solutions
- TPN bags and infusion sets in the Light-protected group will be covered by aluminum foils to protect the inside TPN solution from exposure to ambient or photo-therapy lights in the NICU. Protection will be made throughout the study period until the infant reaches full feeding and TPN is discontinued.
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 infant less than 32 weeks gestational age
Exclusion Criteria:
* Infant with major congenital anomalies
* Infant of diabetic or hypertensive mother
Sex :
ALL
Ages :
- Minimum Age : 24 Hours
- Maximum Age : 7 Days
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 690 |
Target Study Title: Optimizing Function Outcomes After Bariatric Surgery With Core Stabilization Training: A Randomized Controlled Study
Target Study Description: #Study Description
Brief Summary
Bariatric surgery has been reported to be the most effective treatment option for losing and maintaining body weight and improving comorbidities and mortality associated with morbid obesity. Nevertheless, even though physical activity is recommended to optimize bariatric surgery results. Very little is known, about whether engaging in an exercise program after surgery can provide additional improvement in health outcomes. While to date there are relatively few researches studied the effect of exercise in patients who have undergone bariatric surgery.
Detailed Description
This study will investigate the effect of core stabilization exercise on patients who underwent bariatric suergery.
#Intervention
- OTHER : Core stabilization training
- Exercise training will be given to the participants in the study group in the form of core training exercises for 8 weeks.
- Other Names :
- Exercises
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 male and female
* age ranged from 18 <= age <= 25 years,
* at least 6 months after BS
Exclusion Criteria:
* Patients with nerve root compression
* spine disorders
* spinal fracture
* previous spinal surgery
* pregnancy
* lower limb injury
* Any contraindication to the exercise therapy
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 40 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 691 |
Target Study Title: Assessment of Mandibular Bone Invasion With Magnetic Resonance Imaging (MRI) Using Sweep Imaging Fourier Transformation (SWIFT)
Target Study Description: #Study Description
Brief Summary
The primary objective of this study is to improve the diagnostic accuracy and specificity of MRI in detecting the degree of bone involvement and invasion in oral cancer. The presence and degree of bone invasion determines the extent of surgery and has great effect on the morbidity of patients with oral cancer and bone/soft tissue tumors.
MRI scanning in 3 Tesla (3T) and 4Tesla (4T) MR magnet will be performed on up to 10 patients with possible maxillofacial and/or mandibular bone invasion. We will then compare the conventional imaging results of the patients with 3T and 4T MRI results and post operative pathology results.
Detailed Description
Unfortunately, detecting bone invasion and extension of bone involvement prior to surgery is often difficult with the currently available imaging techniques. MRI with high contrast resolution and the ability to perform multiplanar imaging plays an integral role in the delineation of tumoral involvement of the bone. Although MRI is an excellent tool in the assessment of bone invasion in carcinoma, its overestimation of cortical invasion and tumor extent to the bone marrow have been a diagnostic challenge, leading to false positive results. Like many of the musculoskeletal system tissues, cortical bone produces no signal with conventional MRI techniques, limiting the characterization of image contrast and differentiation of adjacent soft tissues. A novel MRI technique called Sweep Imaging with Fourier Transformation (SWIFT) appears to be a suitable tool to overcome this challenge. The main advantage of SWIFT is to obtain signal from the cortical bone. We believe that the SWIFT technique will overcome the false positive results.
Patients enrolled in this study will be asked to come to the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota, Minneapolis, Minnesota for a scheduled MRI. Brief scans will be obtained (less than 1 minute) to localize the area of interest. Longer MRI scans (around 5-15 minutes each) will then be obtained. The total time required for scanning will be about 1 hour.
To determine how well our MR images will predict the presence of mandibular invasion, we will compare our results with clinical, operative, radiological and pathological findings. Thus, patients will be asked to give permission to the investigators to access the relevant medical records.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Patients with a diagnosis of oral cancer with clinical or imaging findings suggestive of maxillofacial or mandibular bone invasion.
* Patients who will be undergoing surgery as treatment for their oral cancer.
Exclusion Criteria:
* Pregnancy
* Ferromagnetic implant
* History of shotgun wounds and shrapnel
* Obesity (>250 pounds)
* Cardiac pacemaker
* MR incompatible medical device
* Severe claustrophobia
* Surgeries with potential ferromagnetic implants
* Metallic ink tattoo in close proximity to area of interest.
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>
| 692 |
Target Study Title: A Prospective Open Label, Pharmacokinetic Study of an Oral Hydroxyurea Solution in Children With Sickle Cell Anemia.
Target Study Description: #Study Description
Brief Summary
An open label, safety and pharmacokinetic study of oral hydroxyurea solution administered to children from 6 months to 17.99 years (i.e. to the day before 18th birthday), with a 12 to 15 month treatment period for each participant. The study treatment duration will be for 6 months at the maximum tolerated dose \[MTD\], which is usually reached by 6 months after initiation of treatment. For patients in whom time to MTD is longer than 6 months or not achieved at all, the maximum duration of study treatment will be 15 months.
#Intervention
- DRUG : Oral Hydroxyurea (100 mg/mL) Solution
- Participants received Oral Hydroxyurea 15 mg/kg once daily. Escalated by 5 mg/kg/day every 8-12 weeks until maximum tolerated dose achieved, up to a maximum 35 mg/kg/day.
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 from 6 months to 17.99 years (i.e. to the day before 18th birthday).
* Diagnosis of sickle cell anemia (HbSS and HbSβº).
* Parent(s)/legal guardian able and willing to provide written informed consent for the child to take part in the study.
* Where applicable, the child should assent to undergo blood sampling for pharmacokinetic and biochemistry purposes and to allow physiological measurements to be made.
Exclusion Criteria:
* Any clinically significant medical condition or abnormality, which, in the opinion of the Investigator, might have compromised the safety of the patient or which might have interfered with the study.
* Hydroxyurea use within 6 months before enrolment.
* Renal insufficiency (known creatinine more than twice the upper limit of normal (ULN) for age and >1.0 mg/dL [88.4 μmol/L]).
* Clinical evidence of hepatic compromise with alanine aminotransferase (ALT) >3 times the ULN (a temporary swing in ALT did not result in exclusion).
* Other significant organ system dysfunction based on the site Investigators discretion.
* Severe active infections: fungal, viral or bacterial (as confirmed by culture), examples included tuberculosis, malaria, active hepatitis, osteomyelitis or any other illness that would have precluded the use of HU in normal clinical practice.
* Active chronic leg ulcers.
* Known allergy to oral HU solution or any of the excipients.
* Positive pregnancy test for females of child-bearing potential (in post-menarcheal females) before initiation of treatment, unless participant was sexually abstinent. Note: True abstinence was considered as being in line with the preferred and usual lifestyle of the participant. Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
* Inadequate contraception measures in sexually active females (post-menarcheal females) and males of child-bearing age (see Section 9.5.1.10.4).
* Breastfeeding at study initiation.
* Participation in another clinical trial of an IMP.
* Known infection with HIV.
Sex :
ALL
Ages :
- Minimum Age : 6 Months
- Maximum Age : 17 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 693 |
Target Study Title: An Epidemiological Study of Acute Coronary Syndromes in The Greek Population
Target Study Description: #Study Description
Brief Summary
This is a multicenter, 2-phase observational study of acute coronary syndromes (ACS) in Greece, designed to provide real world data on the risk factors of patients presenting to a hospital emergency department with an index event, as well as to depict the current management practices and outcomes of these clinical conditions in Greece.
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 an ACS (STEMI, NSTEMI, UA).
* Informed Consent
Exclusion Criteria:
* Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at the study sites).
* Participation in other clinical study in period between the index event and 6- month follow-up assessment with the exception of registering in registries or surveys not influencing the management of the ACS.
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>
| 694 |
Target Study Title: Evaluation of the Bioavailability of Methylprednisolone Succinate Administered Intranasally
Target Study Description: #Study Description
Brief Summary
This study is aimed to evaluate the bioavailability of methylprednisolone in healthy subjects of both genders, with administration intranasally versus intravenous
Detailed Description
The most important property of a drug dosage is its ability to deliver the active ingredient to the site of action in a quantity sufficient to exert the expected pharmacological effect. This ability is known as bioavailability. Methylprednisolone is a drug with wide clinical use in patients with inflammatory pathologies (infectious or non-infectious). The main routes of administration are oral and intravenous. The intranasal route could be one more effective, less invasive that would allow to obtain a faster therapeutic concentration and in greater concentration in the lungs and in the central nervous system than the intravenous route, maintaining very similar systemic concentrations to those achieved intravenously. For these reasons, it is important to know the bioavailability of methylprednisolone administered by this route in order to establish the best dosing regimen. The pilot study is of an exploratory nature (descriptive, comparative or informative), whose objective is to know the pharmacokinetic characteristics of a new route of administration of a drug in the study population to establish the pharmacokinetic parameters, and the comparison between the intranasal bioavailability against the intravenous administration by determining confidence intervals and calculating one-sided double t of Scuirmann.
Objetive: To evaluate the bioavailability of methylprednisolone in healthy subjects of both genders, with administration intranasally versus intravenous dose of 1 ml of methylprednisolone sodium succinate equivalent to 62.5 mg of methylprednisolone.
#Intervention
- DRUG : Evaluation of bioavailability of methylprednisolone succinate administered intravenously
- Bioavailability of methylprednisolone in healthy subjects of both genders, when administered intravenously. The nominal doses were similar, volunteers were randomly assigned to receive a single dose of MEP by IV bolus of 1.5 mL. Venous blood samples were obtained via an indwelling catheter before administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 and 24 h for DXM. Plasma was separated and frozen at -70 °C for further analysis.
- DRUG : Evaluation of bioavailability of methylprednisolone succinate administered intranasally
- Bioavailability of methylprednisolone in healthy subjects of both genders, when administered intranasally. Volunteers were randomly assigned to receive a single dose of MEP intranasally by using a Mucosal Atomization Device (MAD Nasal). allowing direct pharmacokinetic comparison without dose normalization. Venous blood samples were obtained via an indwelling catheter before administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 and 24 h for DXM. Plasma was separated and frozen at -70 °C for further analysis.
Task Instruction:
1. Please provide the Eligibility Criteria in the following format (the item within the square brackets [] are the options that you can choose from):
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria 1
* Inclusion Criteria 2
* Inclusion Criteria 3
* ...
Exclusion Criteria:
* Exclusion Criteria 1
* Exclusion Criteria 2
* Exclusion Criteria 3
* ...
##Sex :
[MALE|FEMALE|ALL]
##Ages :
- Minimum Age : ... Years
- Maximum Age : ... Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : [ADULT|CHILD|OLDER ADULT] comma separated
##Accepts Healthy Volunteers:
[YES|NO]
</FORMATTED_CRITERIA>
|
<FORMATTED_CRITERIA>
#Eligibility Criteria:
Inclusion Criteria:
Age between 18 and 55 years. Clinically healthy. Body mass index between 18.0 and 27.0 Kg/m2. Negative results to detect the presence of human immunodeficiency virus [HIV], Hepatitis B [HBV], Hepatitis C [HCV) and test for detection of Syphilis (VDRL).
Subjects with negative results in tests for the detection of drugs of abuse such as: amphetamines, benzodiazepines, cocaine, methamphetamines, morphine and tetrahydro-cannabinoids.
Negative (qualitative) pregnancy test.
Exclusion Criteria:
Subjects with any condition or alteration of the nose or nasal mucosa. Subjects with a history of hypersensitivity to the study drug. Subjects with a history of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurological, endocrine, hematopoietic disorders (any type of anemia), mental illness or other organic abnormalities that could affect the pharmacokinetic study of the product under study.
Subjects who require any medication during the course of the study. Principal Investigator will not include the subject in the study. Subjects who have been hospitalized for any reason within the sixty days prior to the start of the study or who have been seriously ill within the thirty days prior to the start of the study.
Subjects who have received an investigational drug within ninety days prior to the start of the study.
Subjects who have donated or lost 450 ml or more of blood within the ninety days prior to the start of the study.
Subjects who have smoked tobacco, ingested alcohol, consumed beverages or foods containing xanthines.
Positive (qualitative) pregnancy test.
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 55 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 695 |
Target Study Title: Effectiveness of a Needs-tailored Nurse-led Recovery Program for Community-dwelling People With Schizophrenia: A Cluster-randomized Controlled Trial
Target Study Description: #Study Description
Brief Summary
Meeting people's needs is positively correlated with their recovery. However, recovery services rarely include nurse-led programs tailored to the needs of these people. This study aimed to evaluate the effectiveness of a new needs-tailored recovery program by using a cluster-randomized controlled trial design.
Detailed Description
First year, investigators used the pilot study to test the needs tailored recovery program feasibility, acceptability and preliminary usefulness of the needs-tailored nurse-led recovery program. In the second year, based on the findings of the pilot study, a cluster randomized controlled trial was conducted to assess the effectiveness of the needs-tailored nurse-led recovery program in two psychiatric centers in northern Taiwan. The treatment group receive the needs-tailored nurse-led recovery program by their home-care nurses over 6 months. The control group receive the usual community psychiatric care only. Data were collected before the intervention, after the intervention, and at a follow-up session three months after the end of the intervention period. The outcomes were recovery, needs, hope, empowerment, psychotic symptoms, and medication adherence. The investigators used repeated measures ANOVA tests to examine the effect of the group × time interaction.
#Intervention
- BEHAVIORAL : needs-tailored nurse-led recovery program
- The needs-tailored nurse-led recovery program were divided into five major stages of care, which were build partnership, conduct integrated needs assessment, set needs-based recovery goals and provide empowerment-oriented care, conduct continuous monitoring of goals, and conduct effectiveness evaluations.
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:
* were living in the community and had a diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* were aged 20 <= age <= 64 years
* were able to communicate in Mandarin or Taiwanese.
Exclusion Criteria:
* were living in a community institution such as a recovery home, community rehabilitation center, nursing home, or day hospital
* had a neurocognitive disorder, substance abuse disorder, or comorbidity.
Sex :
ALL
Ages :
- Minimum Age : 20 Years
- Maximum Age : 64 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT
Accepts Healthy Volunteers:
No
</FORMATTED_CRITERIA>
| 696 |
Target Study Title: Use of Valproic Acid to Purge HIV From Resting CD4+ Memory Cells/ A Proof-of-concept Study
Target Study Description: #Study Description
Brief Summary
The purpose of this study is to examine whether the co-administration of valproic acid (Epival®), with highly active antiretroviral therapy (HAART) can reduce the size of HIV latent reservoirs in infected CD4 cells.
Detailed Description
Participants must be on HAART with a suppressed viral load (\< 50 copies/ml) for at least the previous 12 months. They will be randomly assigned to one of two groups, one group will start the valproic acid right away at week 1 for 16 weeks, and the other group will wait until week 17 to add valproic acid to their treatment for 32 weeks. Subjects will be followed every four weeks for one year and evaluated by a variety of assays, all carried out using well-established methods, to assess the main outcome defined by changes in HIV reservoir size measured by the mean frequency of resting CD4 memory cells carrying HIV proviral DNA.
#Intervention
- DRUG : Valproic Acid
- Oral valproic acid twice daily for 16 or 32 weeks. Dosage varies based on plasma levels.
- DRUG : HAART
- As per 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:
Documented HIV seropositive infection by Western Blot, EIA assays or viral load.
* Aged 18 years or older.
* Viral load <50 copies/ml for at least the previous 12 months.
* Circulating CD4+ cell count ³ 200 cells/ml.
* Taking HAART.
* Vital signs, physical examination and laboratory results do not exhibit evidence of diseases such as advanced cirrhosis and advanced liver disease (ALT or AST > 5 x upper limit of normal value).
* Karnofsky performance status 80%.
* Subject does not require and agrees not to take, for the duration of the study, any medication that is contraindicated with VPA.
* Willing and able to give informed consent.
* All participants will agree to abstinence or to used effective methods of contraception while on the study.
Exclusion Criteria:
* Pregnant or breast-feeding women.
* Psychiatric or cognitive disturbance or illness that could preclude compliance with the study.
* Current use or use within four weeks prior to the baseline visit, of cytotoxic agents, systemic corticosteroids or any immunomodulatory agents such as intravenous immunoglobulin, or hydroxyurea.
* HIV vaccine within six months of screening visit
* Allergic reaction to VPA.
* Active intravenous drug users.
* History of bleeding disorders.
* Unstable or treated hypertension.
* Past-history of pancreatitis or chronic liver disease (ALT or AST > 5 x upper limit of normal value). However subject co-infected with hepatitis B or C can participate if ALT or AST is < 5 x upper limit of normal value.
* Renal failure (creatinine > 2 x upper limit of normal value).
* Ammonemia (> 2x upper limit of normal value).
* Taking Zidovudine (AZT), or combination of drugs containing AZT like Combivir or Trizivir. However this subject will be asked to switch to another NRTI,at least two weeks prior to Valproic Acid initiation, to become eligible.
* Taking on daily basis: phenytoin, carbamazepine, phenobarbital, warfarin or aspirin.
* Subject has any of the following abnormal laboratory results Hemoglobin < 100 g/L. Absolute neutrophil count < 0.75 x 10 9 cells/L. Platelet count < 50 x 10 9 cells/L.
* Subject suffering from urea cycle disorders.
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>
| 697 |
Target Study Title: Comparison of the Efficacy of Antiseptics With Povidone Iodine and Hypochlorous Acid Active Substance in Catheter Dressings in Preventing Central Catheter-Related Bloodstream Infection in Intensive Care Units
Target Study Description: #Study Description
Brief Summary
Intensive care units (ICUs) are care centers where many different technological tools and equipment are used to support the highest level of life functions for patients with severe physical condition. With the developing treatment and care methods, the use of more tools and equipment for invasive or non-invasive procedures has increased, however, complications related to the use of devices and the complications caused by them have also increased. Intensive care centers are centers where invasive procedures are frequently applied and instruments are used frequently, and central venous catheters (CVCs) are widely used, especially for patient-related reasons. CVCs have become one of the most important tools of intensive care units due to the different areas in which they are used and the benefits they provide.
Detailed Description
1.625 / 5.000 Çeviri sonuçları star_border A CVC is a cannula placed in a venous vein that goes directly to the heart. 4 CVCs are used for frequent blood sampling, continuous Total Parenteral Nutrition (TPN) administration, blood and blood product transfusions, hemodialysis, long-term fluid replacements, drug treatments in cases where vascular access cannot be used due to long-term and intensive treatments. It is used for a variety of purposes, such as the delivery of inotropes.
In addition to the benefits they provide, CVCs also have many negative side effects. The most common complications are infection, thrombosis and bleeding. central venous catheter-associated bloodstream infections (LVMI-CDE); It is seen as an important problem related to the use of central venous catheters in health services in ICUs.
The day the CVC is placed is recorded as day 1. Laboratory-confirmed BSI can be placed on the 3rd day of the catheter at the earliest, and the day after the catheter removal at the latest.9 The most important step in the management of LVMI-BSI is the prevention of infection. In order to prevent these unavoidable infections, precautions should be taken and antiseptic rules should be followed during the placement, use and maintenance of CVCs. Nurses are responsible for catheter care, monitoring and reporting in case of complications. Therefore, the specific care given by nurses has an effect on other catheter-related complications and increased infection. Catheter dressings can be considered as risk factors for bloodstream infection. For this reason, the antiseptics used during the dressing are also important.
Hypochlorous acid (HOCl), another antiseptic, is a highly effective product that is frequently used in dressings and wound care in recent years. Hypochlorous acid is also a physiological molecule synthesized by neutrophil cells during phagocytosis and plays an active role in the destruction of all microorganisms.
It has been shown in studies that HOCl inactivates various viruses, including coronaviruses, in less than 1 minute. 26 It has been stated that the use of HOCl in eyelid inflammation reduces the rate of bacteria on the skin surface. Twenty minutes after application of a saline hygiene solution containing HOCl at 100 ppm, more than 99% reduction in staphylococcal load was reported.27 In a clinical study of intraperitoneal wound care, in a randomized controlled study with forty-four patients aged 3-14 years, 20 patients were lavaged with 100 ml/kg isotonic into the peritoneal cavity and the wound was washed with 200 ml of isotonic, and 26 patients were poured 100 ml/kg into the peritoneal cavity. Lavage was done with HOCl and the wound was washed with 200 ml of HOCl. It was stated that no side effects were observed. HOCl is extremely ecological because its breakdown produces only brine and traces of chloride gas. It is economical as its source is only unsterilized tap water and salt.28 In a study examining the effect of stabilized hypochlorous acid solution (HOCl) on the killing rate, biofilm formation, antimicrobial activity in the biofilm on frequently isolated microorganisms and the migration rate of injured fibroblasts and keratinocytes, all microorganisms were killed within 0 minutes and the exact killing time was stated to be 12 seconds. The stabilized HOCl solution had dose-dependent positive effects on fibroblast and keratinocyte migration compared to povidone-iodine and medium alone. It was stated that it can be used as an ideal wound care agent.
In a study on diabetic foot wound, povidone iodine was compared with HOCl. The duration of antibiotic use decreased in cases where HOCl acid was used compared to povidone iodine. In the studies, in soft tissue and bone tissue; It has been shown to reduce inflammation and accelerate wound healing. Topically stabilized HOCl provides an optimal wound healing environment and when combined with silicone can be ideal for reducing scarring. Used as an antiseptic skin preparation, HOCl poses no concerns of ocular or ototoxicity. The fact that it is cheaper than other antiseptic solutions for dressings and is effective in many bacterial infections without damaging the tissue may cause more frequent use of hypochlorous acid. This study is extremely important in terms of providing evidence to the literature. Studies have shown that as a result of the correct nursing care and dressings made with the correct products, the rate of bloodstream infections, mortality and morbidity, as well as hospital costs due to the catheter, are greatly reduced. In this study, it was aimed to compare the effectiveness of antiseptics containing chlorhexidine, povidone iodine and hypochlorous acid active ingredient in catheter dressings in preventing central catheter-related bloodstream infection in intensive care units.
#Intervention
- OTHER : hypochlorous active substance
- Poviodin iyot
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:
1- >= 18 years 2- Opening the central venous catheter in the intensive care unit 3- Verbal consent from the relatives of the patients to participate in the study is accepted to participate in the study.
*
Exclusion Criteria:
* Being under the age of 18
* Exitus before the expected follow-up period of the patient
* Being pregnant
* Transferring from another unit or center to the Intensive Care Unit by CVC
* Patients with a previous diagnosis of LVMI-CDE
* Patients whose CVC was opened and CVC dressing was changed outside the control of the researcher -
Sex :
ALL
Ages :
- Minimum Age : 18 Years
- Maximum Age : 85 Years
- Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : OLDER_ADULT, ADULT
Accepts Healthy Volunteers:
Yes
</FORMATTED_CRITERIA>
| 698 |
Target Study Title: A Multi-Center, Open-Label, Single-Arm, Phase IV Study to Evaluate the Safety and Clinical Efficacy of Oral Administration With Nemonoxacin in Treating Elderly Patients With Community-Acquired Pneumonia
Target Study Description: #Study Description
Brief Summary
This study was to evaluate the safety and efficacy of oral nemonoxacin in treating elderly patients (aged ≥ 65 years) with community-acquired pneumonia (CAP).
#Intervention
- DRUG : Nemonoxacin
- 500 mg, oral administration, once daily for 7-10 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:
* Age >=65 years
* Clinical diagnosis of CAP
* Evidence of inflammatory exudates or infiltrates on chest X-ray
Exclusion Criteria:
* Suspect viral pneumonia, aspiration pneumonia, ventilator-associated pneumonia or hospital-acquired pneumonia
* History of hypersensitivity to quinolone or fluoroquinolone
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>
| 699 |
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