linjc16/ctgov huggingface dataset:
The Effects of Mirtazapine Versus Placebo on Alcohol Consumption in Male Alcohol High Consumers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effects of 8 weeks of treatment with mirtazapine on alcohol consumption in alcohol high consuming men. This study is a randomized, double-blind placebo controlled clinical trial with parallel group design(N=59).

Official Title
-----------------
The Effects of Mirtazapine vs Placebo on Alcohol Consumption in Male Alcohol High Consumers; a Randomized Controlled Trial

Conditions
-----------------
Alcohol Dependence

Intervention / Treatment
-----------------
* Drug: mirtazapine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years of age male sex alcohol high consumption signed informed consent Exclusion Criteria: psychiatric disorders (except nicotine and alcohol dependence) severe somatic disorders inadequate knowledge of the Swedish language

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mirtazapine, tablet, 30 mg<br>n=29 | Drug: mirtazapine<br>* oral tablet, 30 mg daily<br>|
| Placebo Comparator: sugar pill<br>n=30 | Drug: placebo<br>* oral tablet, 1 daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol consumption measured by alcohol diary (units/week). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
5-HT, alcohol dependence, anti-depressant, NE
Assessment of Serum Asprosin Level in Male Patients With Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
Subject of interest is to evaluate serum level of asprosin in male patients with acne vulgaris, demonstrate the relation between acne vulgaris severity and level of asprosin in these patients & the relation between metabolic syndrome in acne vulgaris and level of asprosin.

Official Title
-----------------
Assessment of Serum Asprosin Level in Male Patients With Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Diagnostic Test: serum asprosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acne vulgaris male patients (>18 years) will be included. Exclusion Criteria: Age <18 years. Females. Patients with other inflammatory skin disorders. Patients with associated systemic diseases. Current or previous treatment with isotretinoin in the last 3 month ,anti-inflammatory drugs, systemic antibiotics, androgen or anti androgen therapy, and steroid therapy). Patients known on treatment of diabetes, hypertension and dyslipidemia. Athletes. Patient refusal.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: case<br> | Diagnostic Test: serum asprosin<br>* assessment of serum asprosin by a commercially available double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) kit.<br>|
| Active Comparator: control<br> | Diagnostic Test: serum asprosin<br>* assessment of serum asprosin by a commercially available double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) kit.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess serum asprosin level in male patients with acne vulgaris. | Assess serum asprosin level in male patients with acne vulgaris. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asprosin
Prevention of Type 2 Diabetes Mellitus in Children

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to examine the short-term effects of supervised exercise on metabolic risk factors for type 2 diabetes mellitus in children from a population that is at high risk for this disease. We hypothesize that exercise will significantly improve insulin sensitivity in all children, especially in children who are already insulin resistant, thereby lowering the risk that they will go on to develop type 2 diabetes mellitus. The specific hypotheses being tested are: Insulin resistance will be most evident in overweight children while an impaired ability of the pancreas to release insulin will be most evident in children with a family history of type 2 diabetes mellitus. Exercise will significantly improve insulin resistance (as measured by the fasting glucose/insulin ratio) with little or no effect on insulin secretory capacity (as measured by circulating insulin concentration at 1, 3, and 5 minutes following an intravenous glucose load) in children. Participation in a school-based health, nutrition, and exercise education program will have long-term beneficial effects on health-related behaviors and on insulin resistance.

Official Title
-----------------
Prevention of Type 2 Diabetes Mellitus in Children

Conditions
-----------------
Diabetes Mellitus, Type 2

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Early adolescent

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Exercise|nan|

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
-----------------
diabetes, adolescent
CPAP Versus Bilevel Pressure Support Ventilation in Cardiogenic Pulmonary Edema

Study Overview
=================
Brief Summary
-----------------
To evaluate whether bilevel positive airway pressure more rapidly improves ventilation than continuous positive airway pressure (CPAP) in patients with acute pulmonary edema. CPAP is delivered via a simple device connected to oxygen.

Official Title
-----------------
CPAP Boussignac Versus Bilevel Pressure Support Ventilation in Severe Acute Cardiogenic Pulmonary Edema

Conditions
-----------------
Severe Acute Cardiogenic Pulmonary Edema

Intervention / Treatment
-----------------
* Device: Boussignac CPAP - bilevel ventilation support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 16 yrs, acute onset of severe respiratory distress, bilateral rales and typical findings of congestion on chest radiograph breathing frequency of > 30/min, SpO2 >90%, use of accessory respiratory muscles
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 |
| --- |
|Device: Boussignac CPAP - bilevel ventilation support|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in PaCO2 at the end of ventilation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotracheal intubation, myocardial infarction and mortality during the first 24 hours |  |  | 
| Duration of the ventilation |  |  | 
| Blood gases, vital signs |  |  | 
| Time to transfer to medical ward |  |  | 
| Time to hospital discharge |  |  | 
| Easiness to use was evaluated by nurses |  |  | 
| Patients operational tolerance |  |  | 
| Complications of each ventilation mode |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary edema, respiratory failure, pressure support ventilation, continuous positive pressure
Coronary Artery Stent Evaluation With 320-slice Computed Tomography - The CArS 320 Study

Study Overview
=================
Brief Summary
-----------------
The investigators aim at analyzing the diagnostic accuracy of 320-row CT for coronary stents.

Official Title
-----------------
Coronary Artery Stent Evaluation With 320-slice Computed Tomography - The CArS 320 Study

Conditions
-----------------
Coronary Artery Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected coronary artery in-stent restenoses based on clinical findings or findings on other noninvasive imaging tests and planned coronary angiography within the next 14 days. Able to understand and willing to sign the Informed CF. Exclusion Criteria: Creatinine of above 2.0 mg/dl Age below 40 years Women of child bearing potential (no hysterectomy, no menopause, or menopause since less than 12 months) must demonstrate a negative pregnancy test performed within 24 hours before CT. Resting heart rate above 70 beats per minute and contraindications to beta blockers (e.g. moderate to severe bronchospastic disease, asthma) Atrial fibrillation, uncontrolled tachycardia, A-V block II or III degree or other non-sinus rhythms Inability to hold the breath for 10 seconds Hypotension < 80 mmHg systolic Unstable angina pectoris, acute myocardial infarction < 48h Continuous therapy with Dipyridamol Severe aortic stenosis

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Men or women of any ethnic group scheduled to undergo conventional coronary angiography for suspected coronary artery stent stenosis
Cath Lab Performance Improvement

Study Overview
=================
Brief Summary
-----------------
In 2004, the Cardiac Cath Lab at Children's Healthcare of Atlanta was asked to conduct a Quality Improvement Review examining radiation exposure.

Detailed Description
-----------------
In 2004, the Cardiac Cath Lab at Children's Healthcare of Atlanta was asked to conduct a Quality Improvement Review examining radiation exposure. To perform radiological procedures with minimal radiation exposure and to ensure safe care during catheterization procedures, we conducted a chart review of all patients requiring fluoroscopy in the lab during the period of January - June, 2004. • Based on our Retrospective Review, we were able to present Our New Standards to the Cardiac Cath Lab Committee at the end of June, 2004 with the following: Diagnostic procedure time decreased from 45 minutes standard to 30 minutes standard. Intervention and Electrophysiology procedure time reduced from 90 minutes to 45 minutes.

Official Title
-----------------
Cardiac Catheterization Laboratory Radiology Performance Improvement

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical charts of all patients requiring fluoroscopy in the cardiac catheterization lab at Children's Healthcare of Atlanta, Egleston,during January - June, 2004. Exclusion Criteria: Those who did not meet inclusion criteria.

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric, Cardiac Catheterization, Fluoroscopy time
Evaluation of a Novel Human Milk Fortifier in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.

Official Title
-----------------
Evaluation of a Novel Human Milk Fortifier in Preterm Infants

Conditions
-----------------
Preterm Infants

Intervention / Treatment
-----------------
* Other: Experimental human milk fortifier
* Other: Control human milk fortifier


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 700-1500g birth weight 33 weeks or less gestational age Appropriate for gestational age Initiate enteral feeds of human milk by 21 days of life Mother provided exclusive human milk feeds Parents allow both human milk and study human milk fortifier Singleton or twin birth Exclusion Criteria: Feeding preterm infant formula or non-study human milk fortifier Expected at facility less than 15 days Congenital anomalies/disease affecting growth and development 5 minute APGAR of 4 or less Steroid use ECMO Grade III or IV PVH/IVH Mechanical ventilator dependency Maternal incapacity History of major surgery Asphyxia Confirmed NEC or sepsis Use of probiotics

Ages Eligible for Study
-----------------
Maximum Age: 21 Days

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 |
| --- | --- |
| Experimental: Experimental Human Milk Fortifier<br>Experimental human milk fortifier to be added to human milk | Other: Experimental human milk fortifier<br>* Human milk fortifier to be added to human milk feedings<br>|
| Active Comparator: Control Human Milk Fortifier<br>Control human milk fortifier to be added to human milk | Other: Control human milk fortifier<br>* Control human milk fortifier to be added to human milk<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric variables | Length and head circumference | 29 days | 
| GI tolerance | stool characteristics, periods of nil per os (NPO), and withheld feedings due to abdominal distention, gastric residuals, vomiting, etc. | 29 days |
Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be randomized to either continue this regimen or CNI therapy will be discontinued and replaced by sirolimus therapy (in combination with MMF and corticosteroids). The effect of these 2 regimens on efficacy, safety and renal function will be evaluated.The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

Official Title
-----------------
A Randomized, Open-label Study of the Effect of Replacing CNI With Sirolimus in a Standard Care Regimen of CNI, CellCept, and Steroids on Renal Function in Heart Transplant Patients

Conditions
-----------------
Heart Transplantation

Intervention / Treatment
-----------------
* Drug: mycophenolate mofetil [CellCept]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult (>=18 years of age) heart transplant patients (4-6 weeks post-transplant); receipt of first heart (single-organ) transplant; standard care regimen of CNI, MMF, and corticosteroids since transplantation. Exclusion Criteria: positive donor-specific cross-match at time of transplantation; history of malignancies, other than non-melanoma skin cancer that has been totally excised with no recurrence for 2 years; patients participating in another interventional clinical trial or requiring treatment with unmarketed investigational drugs.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1 | Drug: mycophenolate mofetil [CellCept]<br>* 1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function assessed by calculated GFR at 24 months post-transplant, and incidence of biopsy-proven acute rejection (BPAR) or HDC, graft loss or lost to follow-up\n |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of BPAR, number of episodes of BPAR per patient, time to first BPAR, incidence of re-transplant, death, rejection including antibody treated rejection, time to graft loss or death, rejection associated with HDC\n |  |  |
Translation and Validation of MPCOSQ in Urdu Language

Study Overview
=================
Brief Summary
-----------------
To translate and validate modifies polycystic ovary syndrome quality of life (MPCOQ) questionnaire into Urdu. To evaluate the reliability, validity and of Urdu version of modified polycystic ovary syndrome quality of life questionnaire (MPCOQ).

Detailed Description
-----------------
All statistical analyses will be conducted using the Statistical Product and Service Solution version 21 software. Continuous variables will be shown by mean and standard deviation and the categories will be demonstrated in frequency and percentage. In this study, factor structure of the (MPCOQ) will be analyzed using the principal component factor analysis with varimax rotation. Intraclass Correlation Coefficient (ICC) (95% confidence interval) will be used for test-retest value and Cronbach's Alpha will be used for internal consistency analysis. Measurement error will be determined by calculating the standard error of measurement (SEM) and the Smallest Detectable Change (SDC). Independent t-test will be used to determine the differences between groups

Official Title
-----------------
Translation and Validation of Modified Polycystic Ovary Syndrome Questionnaire in Urdu Language

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Age 18 - 30 Married Female patients diagnosed with PCOS, having 2 of the following Rotterdam diagnostic criteria: I. Polycystic ovaries visualized on ultrasound scan (presence of 12 follicles or more in one or both ovaries and/or increased ovarian volume >10ml II. Clinical signs of hyperandrogenism (the hirsutism score based on the Ferriman-Gallwey score >7 or obvious acne) III. Having an interval between menstrual periods >35 days and/or amenorrhea as the absence of vaginal bleeding for at least 6 months, i.e. 199 days Patients who are willing to participate Exclusion Criteria: • Non-adrenal hyperplasia, thyroid dysfunction, and hyperprolactinemia Female undergoing Hormone Replacement Therapy Female with malignancies Any recent fractures, surgeries Patient with nephrological and neurological conditions Dementia or cognitive impairments

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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 |
| --- | --- | --- |
| Modified polycystic ovary syndrome quality of life questionnaire | The tool is to measure health related quality of life of females suffering from PCOS. it contains 30 items with 6 main areas related to hirsutism , acne, weight, infertility, emotional disturbance, menstrual difficulties to define different symptoms of PCOS. then quality of life will be measured of respective patients. The total is 210 with higher score indicating a better quality of life. | 6 months |