linjc16/ctgov huggingface dataset:
Vitamin D Levels in Women With Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
Polycystic ovary syndrome is the commonest endocrinopathy among women of reproductive age. Its worldwide prevalence has been estimated between5-10%. Vitamin D, a fat-soluble vitamin, can be produced in two ways: by intestinal absorption and endogenous synthesis from a precursor of 17-hydroxyl cholesterol on the skin with sufficient exposure to ultraviolet sunlight.

Detailed Description
-----------------
The aim of this work is assessment of the level of vitamin D in female have polycystic ovary syndrome & healthy female.and also make diagnostic criteria for patient who is in need for supplementations with vitamin D.

Official Title
-----------------
Assessment of Serum Vitamin D Levels in Women With Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Vitamin D Levels measurement using chemiluminescent assay
* Device: Vitamin D level assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Hyperandrogenism Polycystic ovary syndrome Exclusion Criteria: Thyroid disease Parathyroid disease Diabetes Mellitus Cushing syndrome Congenital adrenal hyperplasia Hyperprolactinemia Renal, liver or chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control women without polycystic ovary syndrome<br>Normal fertile women without polycystic ovary syndrome | Drug: Vitamin D Levels measurement using chemiluminescent assay<br>* Measurement of serum vitamin D levels<br>Device: Vitamin D level assessment<br>* Using lIAISON DEVICE<br>|
| Experimental: Case women with polycystic ovary syndrome<br>Women with polycystic ovary syndrome | Drug: Vitamin D Levels measurement using chemiluminescent assay<br>* Measurement of serum vitamin D levels<br>Device: Vitamin D level assessment<br>* Using lIAISON DEVICE<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of vitamin D in Polycystic ovary syndrome | vitamin D levels is assumed to be significantly decreased | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of vitamin D in fertile women | vitamin D level is expected to be normal | 1 year |
Physical Activity and Symptom Disturbance Regarding Cross-Trimester

Study Overview
=================
Brief Summary
-----------------
This study will explore pregnant women's regular exercise intentions and behavior across trimesters (from first trimester, second trimester to third trimester).

Detailed Description
-----------------
Based on the TPB, this study will explore pregnant women's regular exercise intentions and behavior across trimesters (from first trimester, second trimester to third trimester). Moreover, the study will explore the effect factors, predictors and transition factors regarding pregnant women's regular exercise intention and behavior across trimesters.

Official Title
-----------------
Pregnant Women's Intention and Behavioral Regarding Cross-Trimester Regular Exercise-Based on the Theory of Planned Behavior

Conditions
-----------------
Pregnancy Related

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria were women in 8-16 weeks of gestation with a singleton pregnancy who had no obstetric or medical complications Exclusion Criteria: Excluded were those who had American college of Obstetrics and Gynecology (ACOG) absolutely contraindication exercise, such as insulin-dependent diabetes, gestational diabetes, hypertension, and multiple-gestation pregnancies

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|standard prenatal care|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of physical activity across different trimesters of pregnancy | The pregnancy physical activity questionnaire (PPAQ) was used to measure women's physical activity during pregnancy | The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-28 weeks), third trimester (>36 weeks) | 
| Change of symptom distress across different trimesters of pregnancy | The pregnancy-related symptom Disturbance was used to measure women's symptom disturbance. The highest total score was severe levels of pregnancy-related distress. | The data were collected before the intervention to childbirth: <16 week gestation, second trimester (24-28 weeks), third trimester (>36 weeks) |
Safety and Efficacy of Ramipril in the Treatment of Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess which drug is more effective of Ramiprin®(ramipril) and Tritace®(ramipril) in the Treatment of Essential Hypertension

Official Title
-----------------
Phase 4 Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Ramiprin Tab. in Essential Hypertension

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: Ramipril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild and moderate essential hypertension (90mmHg≤DBP≤110mmHg) Exclusion Criteria: 180mmHg≤SBP If differences greater than 20mmHg for SBP and 10mmHg for DBP between both arms are present on 3 consecutive readings If differences greater than 20mmHg for SBP and 10mmHg for DBP are present on 3 consecutive readings impaired hepatic function imapaired renal function angioedema aortic valvular stenosis or obstrcutive ejection disorder primary hyperaldosteronism renal transplantation, bilateral renal artery stenosis or unilateral stenosis in a single kidney, hemodialysis severe respiratory disease congestive heart failure( New York Association functional class Ⅲ or Ⅳ) malignant hypertension labile angina pectoris or myocardial infarction in the last 3 months before study entry

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ramipril|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of DBP(diastolic blood pressure) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of SBP(systolic blood pressure) |  |  | 
| Percentage of patients with Dcrease of BP(blood pressure) |  |  | 
| Percentage of patients with a Normalization of BP(blood pressure) |  |  | 
| Artery stiffness(chang of pulse wave velocity) |  |  | 
| Left ventricular diastolic function |  |  | 
| Change of BNP |  |  | 
| Change of CRP |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ramipril, hypertension, blood pressure, artery stiffness, BNP, CRP
Effect of High-calcium Intake on Substrate Metabolism During Exercise

Study Overview
=================
Brief Summary
-----------------
A high-calcium intake can accelerate fat loss under energy-restricted diets. Part of this may be due to a shift in substrate metabolism where there is an increase in the rate of fat oxidation. However, whether high-calcium intake can influence substrate metabolism during exercise is not known. Accordingly, we aim to investigate the effect of 2 weeks of high-calcium intake on substrate metabolism during exercise.

Official Title
-----------------
The Impact of a Calcium Supplementation on Lipid Metabolism During Exercise.

Conditions
-----------------
Lipid Metabolism

Intervention / Treatment
-----------------
* Dietary Supplement: Calcium
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physically active (moderate-vigorous exercise >3 time per week) Male 18-40 yrs of age Exclusion Criteria: Smoker Known Food Allergies Metabolic disorders

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>A chocolate milkshake with a normal calcium content will be consumed daily (235 kcal; 13 g protein; 42 g carbohydrate; 1 g fat, 400 mg calcium per serving). | Dietary Supplement: Placebo<br> <br> |
| Experimental: High-Calcium<br>A chocolate milkshake with a high calcium content will be consumed daily (235 kcal; 13 g protein; 42 g carbohydrate; 1 g fat, 1400 mg calcium per serving). | Dietary Supplement: Calcium<br>* Milk-extracted calcium supplement will be used to modulate the calcium content of the milkshakes used.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substrate metabolism | Substrate metabolism will be assessed by the respiratory exchange ratio (rate of carbon dioxide production/rate of oxygen consumption) from samples of expired gas collected during the first 15 minutes of an incremental cycling test. | 60 s samples every 3 min for 15 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma non-esterified fatty acid concentrations | Non-esterified fatty acid concentrations will be determined from plasma samples collected during the first 15 minutes of an incremental cycling test to indicate fatty acid availability. | Every 3 min for 15 min | 
| Plasma glycerol concentrations | Glycerol concentrations will be determined from plasma samples collected during the first 15 minutes of an incremental cycling test as a marker of lipolysis. | Every 3 min for 15 min |
Major Depressive Disorder Study In Adults

Study Overview
=================
Brief Summary
-----------------
A study to obtain safety and tolerability data

Official Title
-----------------
An Open Label Study Assessing Paxil CR (Paroxetine CR) in Patients With Major Depressive Disorder Who Discontinued Treatment With Selective Serotonin Reuptake Inhibitors or a Selective Serotonin/Norepinephrine Reuptake Inhibitor Due to Intolerability

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: paroxetine CR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must have primary diagnosis of Major Depressive Disorder (MDD). Discontinued a selective serotonin reuptake inhibitor (SSRI)or serotonin-norepinephrine reuptake inhibitor (SNRI) regimen due to intolerability. Minimum time frame between last dose of previous antidepressant and initiation of study drug is one week. Maximum time frame between last dose of prior antidepressant and initiation of study drug is 2 months. Exclusion Criteria: Patient has previously been treated with the study drug. Is experiencing an adverse event attributed to previous SSRI/SNRI use that has not been resolved at least one week prior to Baseline Visit. Has a history of seizure disorder. Has met criteria for substance abuse or dependence within 6 months prior to Baseline Visit. Currently using an antidepressant. Currently pregnant.

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: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paroxetine CR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rates of adverse events causing intolerability of previous SSRI/SNRI, Adverse event incidence rates, Mean change from baseline in the Beck Depression Inventory-II total score, Proportion of responsers based on teh CGI Global Improvement Item |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major Depressive Disorder Open-label discontinued
Automatic Adaptive System Dialysis (AASD)

Study Overview
=================
Brief Summary
-----------------
AASD is a new dialysis technique based on the use of a mathematical model of intradialytic solutes and fluid kinetic, for the automatic elaboration of dialysate sodium and ultrafiltration rate profile. The aim of dialysate sodium and ultrafiltration rate profile is to obtain the higher stabilization of intradialytic extra cellular compartment, in consideration of end session targets: body weight and final patient's natremia. In this multicenter prospective controlled randomized trial the primary end-point is the clinical efficiency validation of AASD on intradialytic hypotension but also on thirst, cramps, headache, nausea, vomiting, hypotensive events observed in basal treatment (HD or HDF).

Official Title
-----------------
Automatic Adaptive System Dialysis (AASD) for Dialysis Related Hypotension and Intolerance: a Prospective Long-term Multicenter Study

Conditions
-----------------
Dialysis Intolerance

Intervention / Treatment
-----------------
* Other: AASD dialysis technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients in HD/HDF (bicarbonate dialysis/hemodiafiltration) for at least 6 months aged more than 18 years on chronic thrice-weekly HD symptomatic hypotension during at least 30% of dialysis sessions on basal treatment in the last month before admission or/and 1 hypotension /week disequilibrium symptoms (cramps, headache, nausea, vomiting, hypotensive events) in at least 30% of dialysis sessions on basal treatment dialysis session time: 4 hours (as much as possible) Signed inform consent form Patients having no vascular access related problems (bi-ponction, blood flow rate 300ml/min) Exclusion Criteria: Patients in a pregnant state Patients whose life expectancy is less than study period Patients with progressive acute pathology (neoplasia…) Patients included in an other protocol Psychiatric patients or patients unable to consent or unable to follow the study

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: basal hemodialysis<br> | |
| Active Comparator: AASD<br> | Other: AASD dialysis technique<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of intradialytic hypotensive events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of dysequilibrium symptoms |  |  |
Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

Study Overview
=================
Brief Summary
-----------------
The investigators will compare doxycycline and ceftriaxone in treatment of patients with suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that the efficacy and adverse effects of both antibiotics are comparable.

Official Title
-----------------
Doxycycline and Ceftriaxone in Patients With Suspected Early Lyme Neuroborreliosis and Normal CSF Cell Count.

Conditions
-----------------
Suspected Early Lyme Neuroborreliosis

Intervention / Treatment
-----------------
* Drug: doxycycline
* Drug: ceftriaxone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >15 years erythema migrans in 4 months period before neurologic symptoms normal CSF cell count absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy). Exclusion Criteria: pregnancy lactation allergy on doxycycline and ceftriaxone immune deficiency.

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LNB-doxycycline<br> | Drug: doxycycline<br>* 100 mg bid, 14 days<br>|
| Active Comparator: LNB-ceftriaxone<br> | Drug: ceftriaxone<br>* 2g x 1 iv, 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective sequelae and post-treatment subjective symptoms in patients treated for suspected early Lyme neuroborreliosis with normal CSF cell count with doxycycline or ceftriaxone for 14 days. |  | 1 year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lyme neuroborreliosis, Lyme borreliosis, erythema migrans, doxycycline treatment, ceftriaxone treatment, outcome, subjective symptoms
Prediction of Drug Interactions With CYP2C9 Substrates

Study Overview
=================
Brief Summary
-----------------
CYP2C9, is one of the major drug metabolism enzymes accounting for about 20% of the hepatic cytochrome P450 content and being second only to CYP3A4. The proposed study will explore different possible drug interactions with CYP2C9 substrates by evaluating the effect of prototype inducers and inhibitors on the phenotypic trait measurement. It is expected that the identification of drugs that might interact with CYP2C9 substrates will be used to rationalize future drug interaction studies designed to evaluate the actual magnitude of effect and its clinical implications. This approach should be particularly useful when applied to those CYP2C9 drugs characterized by a narrow therapeutic index (i.e. warfarin). This study will consist of three study periods separated from each other by a two weeks washout period. In the course of the study the subjects will receive in a double blind, crossover fashion, rifampin 300 mg. twice daily, diclofenac 50 mg twice daily. and fluconazole 200 mg. twice daily, each for one week. All drugs will be administered as identical looking tablets that will be prepared at the pharmacy of the Hadassah University Hospital and their order of administration will be randomized.On the day prior to, on day 6 of and 7 days following each drug period, the activity of CYP2C9 will be evaluated by the administration of a single phenytoin 300 mg. dose. The subjects will be requested to collect their urine for 24 hours and a single blood sample will be obtained 12 hours post phenytoin intake.

Official Title
-----------------
Prediction of Potential Drug Interaction With CYP2C9 Substrate by Using Phenytoin Metabolic Ratio as a Marker of Its Activity in-Vivo.

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Phenytoin
* Drug: Rifampicin
* Drug: Diclophenac
* Drug: Fluconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range 20-50 Absence of significant disease states Exclusion Criteria: Known hypersensitivity to one of the drugs used in the study Significant disease states Regular use of drugs (including birth control pills)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Phenytoin|nan|
|Drug: Rifampicin|nan|
|Drug: Diclophenac|nan|
|Drug: Fluconazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenytoin metabolic ratio prior to and following exposure to fluconazole, diclophenac and rifampicin. |  |  |