linjc16/ctgov huggingface dataset:
Rapamycin Therapy for Patients With Tuberous Sclerosis Complex and Sporadic LAM

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine if rapamycin reduced angiomyolipomata volume in patients with tuberous sclerosis complex or lam.

Detailed Description
-----------------
The study design was an open label, phase I/II trial of sirolimus for one year followed by one year off therapy.Patients were seen at baseline,at two weeks to four weeks, and at 2,4,6,9,12,18 and 24 months. Angiomyolipomata imaging was performed at all but the two to four week visit. Complete pulmonary function tests and six-minute walk were obtained at baseline,6 or 9 month, 12 and 24 month visits, while simple spirometry only was performed at all other visits.

Official Title
-----------------
Rapamycin Therapy of Angiomyolipomas in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis

Conditions
-----------------
Tuberous Sclerosis, Lymphangioleiomyomatosis

Intervention / Treatment
-----------------
* Drug: Rapamycin, sirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with angiomyolipomas and have either Tuberous Sclerosis complex or Lymphangioleiomyomatosis Between the gaes of 18 and 65 years Competency to voluntarily consent Clinically definite diagnosis of tuberous sclerosis or S-LAM Adequate contraception At least one angiomyolipoma of 1 cm or greater in largest diameter Exclusion Criteria: Use of continuous supplemental oxygen Concurrent infection Recent surgery Ongoing or planned pregnancy Lactation Use of an investigational drug within the last 30 days of study entrance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rapamycin, sirolimus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of Angiomyolipomata |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TSC and LAM, Tuberous Sclerosis Complex and sporadic LAM
Short Term and Day to Day Reproducibility of Reflectometric Measurement of Retinal Oxygen Saturation in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Adequate perfusion and oxygenation is essential for the function of the inner retina. Although this is a well known fact, measurement of oxygen saturation in the eye is still a delicate and not fully explored task. However, recently a new instrument for the non-invasive measurement of retinal vessel oxygen saturation has been introduced. Unfortunately, no data about reproducibility in humans is yet available for this instrument. Consequently, the current study seeks to evaluate the short term and day to day reproducibility of retinal vessel oxygenation in healthy volunteers. 20 healthy volunteers will be included and oxygen saturation of retinal vessels will be determined. The reproducibility of the results will be tested by repeated measurements and the collected data will be independently analyzed by two observers.

Official Title
-----------------
Short Term and Day to Day Reproducibility of Reflectometric Measurement of Retinal Oxygen Saturation in Healthy Subjects

Conditions
-----------------
Ocular Physiology

Intervention / Treatment
-----------------
* Device: Measurement of oxygen saturation of retinal vessels with optical reflectometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and Women aged between 18 and 35 years, Nonsmokers Body mass index between 15th and 85th percentile Normal ophthalmic findings, ametropia < 3 Dpt. Exclusion Criteria: Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study Treatment in the previous 3 weeks with any drug except oral contraceptives Symptoms of a clinically relevant illness in the 3 weeks before the study day Blood donation during the previous 3 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| Healthy subjects<br> | Device: Measurement of oxygen saturation of retinal vessels with optical reflectometer<br>* 5 repeated measurements on both study days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coefficients of variation of oxygen measurement |  | 5 measurements on both study days |
Temperature Control During Dialysis Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose is to measure the effect of glucose in the dialysis water on blood pressure, pulse rate, and plasma glucose with and without body temperature control

Detailed Description
-----------------
To clarify the influence of temperature in dialysis water on blood pressure and vasoactive hormones

Official Title
-----------------
Effect of Temperature Control During Dialysis Treatment With Glucose in Dialysis Water in Patients With Chronic Renal Failure

Conditions
-----------------
Renal Failure, Chronic

Intervention / Treatment
-----------------
* Procedure: temperature control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years, both men and women, chronic renal failure and dialysis treatment for at least three months Exclusion Criteria: Heart failure, Lung insufficiency, Chronic liver disease, Diabetes mellitus, Malignant disease, Nephrotic syndrome, Lack of compliance, Unwillingness til participate

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: temperature control|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of temperature control on blood pressure, pulse rate and blod glucose during dialysis treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glucose in dialysis water, dialysis treatment, temperature
To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fasted Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride capsules under fasted conditions.

Official Title
-----------------
Comparative, Randomized, 2-way Crossover Bioavailability Study of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules In Health Adult Males Under Fasted Conditions

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)
* Drug: Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals) | Drug: Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)<br> <br> |
| Active Comparator: 2<br>Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel) | Drug: Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 34 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antidepressant
A Sustainable Diet for Hadassah Employees Workers

Study Overview
=================
Brief Summary
-----------------
The aim of this protocol is to use a multidisciplinary approach to convey nutrition and activity messages to randomly selected Hadassah Medical Center employees. The intervention will be for one academic year and include frontal talks, email and internet focus group interactions, public demonstrations and a focused intervention within the hospital kitchen. The outcomes are specific parameters of dietary modifications, degree of physical activity and health related perspectives. Outcomes will be recorded at baseline and by the end of the intervention ( one year).

Detailed Description
-----------------
The participants will be selected randomly from the campus employees. They will be exposed to multiple levels of health promotion at the work place as well as via multiple media tools. Analysis will be performed at baseline by using multiple nutrition and health perception questionnaires. A second group from the employees will be selected for assessment of the same outcomes at the end of the year.

Official Title
-----------------
A Sustainable Diet for Hadassah Employees

Conditions
-----------------
Obesity, Physical Activity

Intervention / Treatment
-----------------
* Behavioral: Nutritional and Activity Promotion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hadassah medical center employees Age 21-67 - Exclusion Criteria: - Refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 67 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The study has a single arm<br>The study has one arm The whole population of the campus will be exposed to the intervention. the effectiveness will be assessed using a random selection twice - before and after the intervention | Behavioral: Nutritional and Activity Promotion<br>* Multi disciplinary nutritional and behavioral messages to improve diet and activity levels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in amount of fruit/vegetable consumption per day | Amount of fruit/vegetable consumption will be evaluated via questionnaires | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of physical activity per week | Amount of physical activity will be assessed via questionnaires | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sustainable diet, Health promotion, Obesity
Impact of Fibroblast Growth Factor 23 (FGF-23) and Serum Phosphate on Allograft Function and Mortality in Kidney Allograft Recipients

Study Overview
=================
Brief Summary
-----------------
The present study will examine whether serum FGF-23 and serum phosphate at baseline of kidney transplant recipients can predict progression of allograft dysfunction at 3 years and all-cause mortality at 5 years.

Official Title
-----------------
Impact of FGF-23 and Serum Phosphate on Allograft Function and Mortality in Kidney Allograft Recipients

Conditions
-----------------
Kidney Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least one year post-transplantation no more than 10% increase in serum creatinine for the past 3 months Exclusion Criteria: refuse to participate in the study any acute illnesses

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 |
| --- | --- |
| Kidney transplant recipients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of allograft dysfunction and all-cause Mortality |  | 3 and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of FGF-23 and 25-OH-D, 1-25-OH-D, PTH, calcium, phosphate, urine phosphate and eGFR |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FGF-23, vitamin D, phosphate, allograft dysfunction, mortality
The Innate Immune System and Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
The study includes individuals with ulcerative colitis, Crohn's disease and healthy controls. The purpose of this study is to examine the innate immune system (IIS) by exposing peripheral blood monocytes to various ligands relevant for stimulation of the IIS and study the immune response. Colonic mucosal samples are examined to find gene expression patterns which may distinguish the two forms of disease from each other and from healthy controls. The hypothesis is that the innate immune system has responses unique for the disease states, and that the diseases may be differentiated by examination of gene expression patterns in mucosal biopsies.

Official Title
-----------------
The Innate Immune System and Inflammatory Bowel Disease

Conditions
-----------------
Ulcerative Colitis, Crohn's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of ulcerative colitis Presence of Crohn's disease Healthy (no sign of inflammatory bowel disease) Exclusion Criteria: Anticoagulation Cardiac valvular disease Intravascular prosthesis Coagulation disorders Gastrointestinal malignancy

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene expression patterns in mucosal biopsies |  | 2 years |
Home Usage of Conception Kit Instructions

Study Overview
=================
Brief Summary
-----------------
Patients will use the Conception Kit in their home and fill out a 22 question questionnaire in order to demonstrate their knowledge of the method of usage as described in the instructions and on the website: www.conceptionkit.com.

Detailed Description
-----------------
Patients will be given a Conception Kit and take the Kit home and read the instructions and if needed consult the website. The patient will then complete a 22 question questionnaire in order to demonstrate their knowledge of the method of use. All Components have 510K clearance. This study is a validation of the instructions for use (IFU) only. OPK Class I Device 21CFR 862.1485, Conception Cap K993953, Pregnancy Test Kit K974059, Semen Collection Device K902936 (21CFR 884.5300), Conception Kit has CE Marked by GMED. (Certificate 2037) Conceivex is an ISO 13485: 2003 company

Official Title
-----------------
Home Usage of Conception Kit Instructions

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who are actively trying to become pregnant Exclusion Criteria: Women who are contraindicated for a pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
infertility, pregnancy, conception, conceive, conceiving, trying to conceive, get pregnant, conception kit, conception cap, fertility, Women who are actively trying to become pregnant
Exploring the Effects of Strength Training on Depressive Symptoms and Cardiovascular Risk in Black Men

Study Overview
=================
Brief Summary
-----------------
This study will address a gap in the literature and advance the field of minority men's health. Specifically, it will be the first randomized controlled trial of resistance exercise as a dual intervention for depression symptoms and CVD risk reduction with depressed Black men.

Official Title
-----------------
Exploring the Effects of Strength Training on Depressive Symptoms and Cardiovascular Risk in Black Men

Conditions
-----------------
Depressive Symptoms

Intervention / Treatment
-----------------
* Behavioral: Exercise
* Behavioral: Health Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Experiencing depression symptoms and generally healthy. Exclusion Criteria: Anyone assessed to be unsafe to be enrolled.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 2 group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>This arm will use a resistance exercise curriculum. | Behavioral: Exercise<br>* A 12 week resistance exercise curriculum<br>|
| Active Comparator: Health Education<br>This arm will use health education curriculum. | Behavioral: Health Education<br>* A 12 week health education curriculum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression symptoms | The Quick Inventory of Depression Symptomatology will be used to assess depression. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lipids | Total cholesterol, HDL, LDL, and triglycerides will be assessed from a blood sample. | 6 months |
The Influence of Antenatal Classes on Pregnancy, Birth and Parenthood

Study Overview
=================
Brief Summary
-----------------
To study the influence of antenatal classes for first time parents and their effect ob pregnancy, birth and parenthood. Randomized into two groups (a. 3 courses in midpregnancy and b. no courses) Data on pregnancy, birth and parenthood are collected from register and questionaire

Detailed Description
-----------------
Data collected contain register data and data from questionnaire, which also contains psychometric tests

Official Title
-----------------
The Influence of Antenatal Classes on Pregnancy, Birth and Parenthood

Conditions
-----------------
Pregnancy, Parturition

Intervention / Treatment
-----------------
* Other: Antenatal classes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant Over 18 years of age Singleton Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 52 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventon<br>Antenatal classes for the parents | Other: Antenatal classes<br>* 3 sessions of 3 hours each<br>* Other names: 3. The parental role and the relationship;|
| No Intervention: Control<br>No programme are offered | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrival for birth |  | prospective | 
| Birth experience |  | prospective | 
| Medical interventions during delivery |  | prospective | 
| Use of birth analgesia |  | prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Birth |  | prospective | 
| Post partum depression |  | prospective | 
| Breastfeeding duration and experience |  | prospective | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Parturition, Depression, Randomized, Antenatal classes