linjc16/ctgov huggingface dataset:
Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program

Study Overview
=================
Brief Summary
-----------------
Knowledge Translation Program for the guidelines and evidence-based management of PAH patients

Detailed Description
-----------------
To improve the management of PAH patients through an evidence-based approach aimed at achieving optimal WHO functional class (defined as: 1) improvement of FC III or IV to FC II; 2) improvement of FC II to FC I; or 3) maintaining FC II or I)

Official Title
-----------------
Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female adults (≥ 18 years of age) Documented diagnosis of PAH (all of the following): i. RHC demonstrating mPAP > 25 mm Hg and PCWP ≤ 15 and PVR > 3 ii. FEV 1 > 50% predicted normal iii. V/Q and/or CT scan excluding the thromboembolic etiology Diagnosis of PAH < 3 years Need for PAH specific treatment Desire to participate and signs an informed consent Exclusion Criteria: Any of the criteria below: Poor mental function, drug or substance (e.g.,alcohol) abuse, or unstable psychiatric illness, which, in the opinion of the investigator, may interfere with optimal participation in the study Prior participation in this program Patients with pulmonary hypertension classified as group 2 - 5 Updated Clinical Classification of Pulmonary Hypertension (5th World Symposium on PH Modified Classification of PH)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of care<br>Observational study to improve the management of PAH patients through an evidence-based approach aimed at achieving optimal WHO functional class (FC) treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi. | Drug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi<br>* observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients achieving guideline-recommended treatment | Proportion of patients achieving guideline-recommended treatment | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients achieving optimal functional class | Proportion of patients achieving optimal functional class using an evidence-based treatment algorithm | 3 years |
The Hope Soap Study: a Hand-washing Intervention Among Children in South Africa

Study Overview
=================
Brief Summary
-----------------
The Hope Soap Study is a randomised-control pilot study of a hand-washing intervention in which children in treatment households received a bi-monthly delivery of HOPE SOAP©, a colourful, translucent bar of soap with a toy embedded in its centre.

Official Title
-----------------
The Hope Soap Study: a Randomized Controlled Trial of a Hand-washing Intervention Among Children in South Africa

Conditions
-----------------
Hand-washing Behavior, Diarrhea

Intervention / Treatment
-----------------
* Combination Product: Hope Soap
* Combination Product: Control group soap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in the Family-in-Focus program Caregiver provided informed consent the age-eligible children were not involved in any other sort of ECD program (e.g. crèche or other day-care) Exclusion Criteria: Enrollment in an ECD program

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 9 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hope Soap group<br>Children in treatment households received a bi-monthly delivery of HOPE SOAP©, a colourful, translucent bar of soap with a toy embedded in its centre | Combination Product: Hope Soap<br>* HOPE SOAP© is a colourful, translucent bar of soap with a toy embedded in its centre.<br>|
| Active Comparator: Control group<br>Children in control households received a colourful, translucent bar or soap with the toy alongside it. | Combination Product: Control group soap<br>* A colourful, translucent bar or soap with the toy alongside it<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Direct observation of hand washing prior to eating a snack | Hands washed unprompted prior to eating a snack | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire data on hand washing after using the toilet (scale of 1-10) | A score of 1-10 of hand washing after using the toilet | 8 weeks | 
| Questionnaire data on hand washing prior to meals (scale of 1-10) | A score of 1-10 of hand washing prior to eating meals | 8 weeks | 
| Questionnaire data on general soap usage when washing hands (scale of 1-10) | A score of 1-10 of soap usage when hands are washed | 8 weeks | 
| Questionnaire data on experience of illness (13 items) | A score of 1-13 based on self-reported symptoms of illness | 2 weeks |
BAP1 Testing in Instance Choroidal Nevi or Uveal Melanoma

Study Overview
=================
Brief Summary
-----------------
The BAP1 trial will examine the blood of patients diagnosed with choroidal nevi or uveal melanoma for a germline BAP1 mutation and other genetic markers associated with developing malignancy as well as additional sequencing of the uveal melanoma genome.

Detailed Description
-----------------
A germline BAP1 mutation predisposes a person to developing uveal melanoma and other cancers. If a mutation is discovered, it changes the potential approach to managing the nevus. In the presence of a known genomic change associated with aggressive disease, closer follow up and more aggressive treatment could preserve the patient's vision and prevent micrometastatic spread. This new screening technique will be able to extend the length and quality of life of patients with more frequent targeted cancer screens.

Official Title
-----------------
Identification of Germline BAP1 Mutation In Subjects With Choroidal Nevi or Uveal Melanoma

Conditions
-----------------
Choroidal Nevi, Uveal Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any person with choroidal nevi Willingness to provide signed informed consent Age > 18 years Diagnosis of choroidal nevi or uveal melanoma Threre are no exclusionary criteria for this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine the rate of germline BAP1 mutations in young patients, diagnosed with choroidal nevi |  | 1 Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nevus, Choroidal Melanoma, BAP1 mutation
Transversus Abdominis Plane Block During Kidney Transplant Surgery

Study Overview
=================
Brief Summary
-----------------
The surgeon places the catheter in the thickness of the oblique internal and transverse muscles at the moment the wall is closed, under visual control. A multiperforated catheter whose length corresponds to that of the incision is chosed. The catheter will deliver one of two products chosen at random: either ropivacaine or placebo. This study will evaluate postoperative pain during the first 24 hours thanks to a recognized indicator the VAS (Visual Analogue pain Scale). The total consumption of analgesics will also be recorded, starting with the titration of morphine in the post-op room, and then the consumption of classical analgesics in the nephrology department. These will only be given if the VAS score is equal to 4 or above. This is a prospective, single-centre, controlled, double blind study of ropivacaïne 0.2% versus placebo in continuous TAP block during the first 24 hours after the operation in patients undergoing kidney transplant surgery.

Official Title
-----------------
Transversus Abdominis Plane Block During Kidney Transplant Surgery: Prospective Controlled Randomized Double-blind Trial Comparing Ropivacaine 0.2% With Placebo.

Conditions
-----------------
Kidney Transplant

Intervention / Treatment
-----------------
* Drug: Ropivacaine 500mg/100ml Naropeine
* Drug: 0.9% sodium chloride BAXTER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient opéré for kidney transplant Patients who have provided written informed consent Patients with national health insurance cover Patients aged 18 years and above Exclusion Criteria: Pregnant or breast-feeding women allergies/hypersensitivity to paracetamol (or propacetamol chlorhydrate (paracetamol pro-drug) or one of its excipients), to local anesthetics, morphines (or other constituents) patients under guardianship or ward of court

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP-Bloc<br> | Drug: Ropivacaine 500mg/100ml Naropeine<br> <br> |
| Placebo Comparator: Control<br> | Drug: 0.9% sodium chloride BAXTER<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mesurement of VAS (Visual analogue scale) scores for pain |  | During the first 24 hours post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of analgesic consomption |  | During the first 24 hours post-op |
Central Landmark vs USG for IJV Catheterization

Study Overview
=================
Brief Summary
-----------------
This study is planned to compare right internal jugular vein catheterization entry points determined by ultrasound and the central landmark guided method, and the relationship of each with sternocleidomastoid muscle length and body mass index.

Official Title
-----------------
Comparison of Internal Jugular Vein Catheterization Entry Points Determined by Ultrasonography Versus the Central Landmark Guided Method

Conditions
-----------------
Value of Central Landmark Method for Juguler Vein Catheterization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -patients undergoing cardiovascular surgery who needed to have internal jugular vein catheterization aged 18y or older- Exclusion Criteria: -previous neck surgery, burns, limited neck movement, diffuse goiter or bleeding problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IJVC intervention<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate with the Central Landmark Method |  | 1 mounth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vein catheterization; Ultrasound; Landmark; Complication
Diagnosis of Coronary Artery Disease in High Risk Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine in high risk diabetics if the positive predictive value of stress echocardiography is superior to the positive predictive value of stress scintigraphy in the diagnosis of coronary stenosis > 50%.

Detailed Description
-----------------
Comparison Between Stress Echocardiography and Stress Scintigraphy in the Detection of Silent Myocardial Ischemia

Official Title
-----------------
Diagnosis of Coronary Artery Disease in High Risk Diabetic Patients :Comparison Between Stress Echocardiography and Stress Scintigraphy in the Detection of Silent Myocardial Ischemia

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetic patients in women> 60 yo or men > 55 yo, with high risk of coronary artery disease (EF < 40%, ECG abnormalities, renal failure , 2 others risk factors of atherosclerosis) Exclusion Criteria: previous documented CAD acute coronary syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>SPECT | |
| 2<br>dobutamine echocardiography | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery disease, stress myocardial scintigraphy, stress echocardiography
Use of Nutraceuticals in Clinical Practice

Study Overview
=================
Brief Summary
-----------------
The aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended in the clinic. In particular the study will analyze how much the nutraceutical is prescribed and what are the purposes for which it is used and at what dosages.

Detailed Description
-----------------
The aim of this study will be to evaluate the use of the nutraceutical with cardio-metabolic actions in clinical practice in addition to a Mediterranean diet scheme, normally recommended in the clinic. In particular the study will analyze how much the nutraceutical is prescribed and what are the purposes for which it is used and at what dosages. In particular, attention will be focused on the following substances: berberine (500-1000 mg/day), monacolin (5-10 mg/day), phytosterols (0.9-1.8 g/day), resveratrol (100-500 mg/day), omega-3 (1-3 g/day), alpha lipoic acid (400-800 mg/day), curcumin (400 mg/day), psyllum (3.5 g/day), coenzyme Q10 (100-200 mg/day), inositol (250-600 mg/day), glucomannan (1-4 g/day), chitosan (800-1200 mg/day), guar fiber (10-20 g/day), L-arginine (250 mg/day).

Official Title
-----------------
Observational Study on the Use of the Nutraceutical With Cardio-metabolic Actions in the Patient in Primary and Secondary Prevention

Conditions
-----------------
Dyslipidemias, Diabetes Mellitus, Type 2, Hypertension

Intervention / Treatment
-----------------
* Dietary Supplement: Nutraceutical


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetic patients in primary and secondary prevention or Hypertensive patients in primary and secondary prevention or Dyslipidemic patients in primary and secondary prevention Exclusion Criteria: Patients with hystory of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Nutraceutical|Nutraceutical with action on glycemia, dsylipidemia or hypertension will be considered.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of the use of nutraceutical in clinical practice | Prevalence | From 2010 to 2015 |
Testosterone Regulation of the Natriuretic Peptide System

Study Overview
=================
Brief Summary
-----------------
The proposed study is a physiologic investigation of the effects of testosterone on the natriuretic peptide system. The hypotheses of the study are that testosterone administration will decrease natriuretic peptide levels and salt excretion. The entire protocol is 8 weeks in duration.

Official Title
-----------------
Testosterone Regulation of the Natriuretic Peptide System

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Testosterone
* Drug: Nesiritide
* Drug: Leuprolide
* Drug: Anastrozole
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men: aged 18 to 40 years, normal testosterone and free testosterone levels, no history of hypertension, and BMI between 18.5 and 25. Women: aged 18 to 40 years old, regular menstrual periods, negative pregnancy test, no oral contraceptives for ≥ 3 mos, no history of hypertension, BMI between 18.5 and 25. Exclusion Criteria: Antihypertensives, diuretics or insulin, diabetes mellitus, prior cardiovascular, abnormal liver or renal disease, history of cancer, atrial fibrillation, or abnormal sodium or potassium level.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Testosterone<br>Testosterone cream applied daily | Drug: Testosterone<br>* Testosterone cream applied daily for two weeks<br>Drug: Nesiritide<br>* Administered IV once during the study<br>Drug: Leuprolide<br>* Administered twice during the study by injection<br>Drug: Anastrozole<br>* Daily pill for 8 weeks<br>|
| Placebo Comparator: Placebo<br>Identical placebo cream applied daily | Drug: Nesiritide<br>* Administered IV once during the study<br>Drug: Leuprolide<br>* Administered twice during the study by injection<br>Drug: Anastrozole<br>* Daily pill for 8 weeks<br>Drug: Placebo<br>* Inert cream otherwise identical to testosterone cream applied daily for two weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial natriuretic peptide levels |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary salt excretion |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Natriuretic Peptide
A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to give one of three different triple-drug combinations to HIV-infected patients who have never been treated with anti-HIV drugs.

Detailed Description
-----------------
In this open-label, strategic study patients are evaluated at Weeks 0, 1, 2, 4, 8, 12 to Week 48 after being treated on one of the following regimens: Stavudine (d4T) + Didanosine (ddI) + Lamivudine (3TC) or d4T + ddI + Indinavir or d4T + ddI + Nevirapine.

Official Title
-----------------
A Randomized Open-Label Strategic Study to Evaluate the Safety and Efficacy of 3 Different Convergent and Divergent Drug Combination Therapies in Anti-Retroviral Naive HIV-1 Infected Patients With CD4+ Counts Above 200/mm3

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Indinavir sulfate
* Drug: Nevirapine
* Drug: Lamivudine
* Drug: Stavudine
* Drug: Didanosine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Diagnosed asymptomatic HIV infection. HIV-1 RNA greater than 500 copies/ml. CD4+ T-cell count greater than 200/mm3. Never received antiretroviral therapy. Exclusion Criteria Co-existing Condition: Excluded: Severe non-HIV-related disease. Patients with the following prior conditions are excluded: History of neuropathy. Prior Medication: Excluded: Investigational drug within 1 month prior to study. Immunomodulatory drug within 1 month prior to study. Prior Treatment: Excluded: Radiation therapy within past month. Chemotherapy within past month.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Nevirapine|nan|
|Drug: Lamivudine|nan|
|Drug: Stavudine|nan|
|Drug: Didanosine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |