linjc16/ctgov huggingface dataset:
Sex Steroids, Obesity and Lipids in Adolescent Females

Study Overview
=================
Brief Summary
-----------------
To prospectively explore the relationships of endogenous sex steroid hormones and obesity and their interactions with lipoprotein cholesterol and apolipoprotein levels in nine and ten year old Black and white adolescent girls for five years during puberty.

Detailed Description
-----------------
BACKGROUND: In 1987, there was growing evidence that androgens, particularly when elevated, had an unfavorable effect on lipo/apo levels, tending to lower HDL cholesterol (HDLC) and raise LDL cholesterol (LDLC). Previous studies confirmed that although pre-pubertal boys and girls had similar lipo/apo levels, post-pubertal boys had a higher ratio of LDLC/HDLC than girls, in part because of their androgen levels. Such lipo/apo levels had been associated with an increased risk of coronary heart disease. There was also evidence that obese girls tended to be hyperandrogenic and thus had unfavorable lipo/apo levels and a higher risk of coronary heart disease. This study sought to elucidate whether high androgen levels preceded or were a consequence of obesity. DESIGN NARRATIVE: The longitudinal study was ancillary to the National Growth and Health Study (NGHS), a multicenter study which investigated the occurrence of obesity in Black and white adolescent girls, predictors of the transition to the obese state, the correlates of the transition, and the relationship of the transition to other coronary heart disease risk factors. As part of the NGHS, participants from the Cincinnati, Ohio and Washington, D.C. public and parochial schools received physical examinations with attention to pubertal staging and anthropometric measurements including weight, height, and skinfold thickness. Along with NGHS blood samples, additional blood was obtained in years 1, 3, and 5 for measurements of lipids, lipoprotein cholesterols, apolipoproteins A1, A2, and B, and sex steroid hormones including plasma total and free testosterone, dehydroepiandrosterone sulfate, estradiol, and testosterone estrogen binding globulin. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Obesity, Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Bioequivalence of Two Tablet Forms of MK0974 (0974-045)

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the bioequivalence of two solid dose formulations of MK0974.

Official Title
-----------------
An Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Bioequivalence of a Single Dose of a Tablet Form of MK0974 Ethanolate vs. a Single Dose of a Tablet Form of MK0974 Hydrate in Healthy Subjects

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: MK0974 Ethanolate formulation
* Drug: Comparator: MK0974 Hydrate formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is in good health Subject is a non-smoker Subject is willing to comply with the study restrictions Exclusion Criteria: Subject has a history of stroke, chronic seizures, or major neurological disorder Subject has a history of cancer Subject is a nursing mother Subject has or has a history of any disease or condition that might make participation in the study unsafe or that might confound the results of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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 |
| --- | --- |
| Active Comparator: 1<br>MK0974 Ethanolate | Drug: MK0974 Ethanolate formulation<br>* Single dose MK0974 280 mg tablet in one of two treatment periods<br>|
| Active Comparator: 2<br>MK0974 Hydrate | Drug: Comparator: MK0974 Hydrate formulation<br>* Single dose MK0974 280 mg tablet in one of two treatment periods<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC(0 to infinity) following single dose administration of MK0974 ethanolate or hydrate formulations |  | Through 48 hours postdose | 
| Peak plasma concentration (Cmax) following single dose administration of MK0974 ethanolate or hydrate formulations |  | Through 48 Hours Post Dose |
Water Bolus Volumes During Continuous Exercise in Heat

Study Overview
=================
Brief Summary
-----------------
Hydration is important to all individuals including occupational workers who complete physical activity in the heat. Current best practice guidelines suggest drinking a cup of water every 15-20 minutes during activity in a hot environment, but research shows this may not be ideal for best maintaining hydration. The goal of this study is to determine if larger, more frequent water boluses better maintain hydration than smaller, less frequent water boluses during moderate intensity physical activity in the heat.

Official Title
-----------------
Water Bolus Volumes During Continuous Exercise in Heat

Conditions
-----------------
Dehydration (Physiology), Hyperthermia

Intervention / Treatment
-----------------
* Other: Hydration protocol - 237 mL water bolus
* Other: Hydration protocol - 500 mL water bolus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 18-39 y old Self-reported to be healthy Exclusion Criteria: Female Not within defined age range History of any cardiovascular, neurologic, or metabolic disease Current tobacco use or regular use within the last 2 years. Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.) Inability to follow the rules of the protocols or understand the consent form

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, counterbalanced, crossover study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Current Best Practice - 237 mL water bolus<br> | Other: Hydration protocol - 237 mL water bolus<br>* Subjects consume 237 mL of water every 20 minutes during 2 hours of high intensity work in the heat.<br>|
| Experimental: New Intervention - 500 mL water bolus<br> | Other: Hydration protocol - 500 mL water bolus<br>* Subjects consume 500 mL of water every 40 minutes during 2 hours of high intensity work in the heat.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent body mass loss | Percent body mass loss after water intake | 2 hours | 
| Core temperature | Core temperature after water intake | 2 hours |
Social Anxiety Disorder in Medical Students in Sohag University

Study Overview
=================
Brief Summary
-----------------
The study will be done in Sohag University to assess the prevalence and associated factors of Social Anxiety Disorder among undergraduate medical students .

Detailed Description
-----------------
Social anxiety disorder (SAD) is highly prevalent and it's the most common anxiety disorder among all types of anxiety disorders and the third most common psychiatric condition after major depression and alcohol dependence. Social anxiety disorder (SAD) is characterized by persistent fear/anxiety about one or more social or performance situations in social settings. SAD had a negative impact on learning ability, educational achievement, professional achievement, quality of life and social relationship & may lead to substance abuse and depressive disorders.

Official Title
-----------------
Social Anxiety Disorder in Medical Students in Sohag University

Conditions
-----------------
Social Anxiety Disorder

Intervention / Treatment
-----------------
* Other: Validated questionnaire : Social Phobia Inventory ( SPIN ) questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical undergraduate students who are still studying for Bachelor of Medicine and Bachelor of Surgery ( M.B.B.Ch ) . Exclusion Criteria: students who will refuse to participate in this study .

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Validated questionnaire : Social Phobia Inventory ( SPIN ) questionnaire|Social Phobia Inventory ( SPIN ) questionnaire which is consisted of 17 items. . The answers of each item ranged from 0 ( Not at all ) to 4 ( Extremely ). The total score will be calculated to determine the severity of the problem .|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Phobia Inventory ( SPIN ) questionnaire | Social Phobia Inventory ( SPIN ) questionnaire which is consisted of 17 items. The answers of each item ranged from 0 ( Not at all ) to 4 ( Extremely ). The total score will be calculated to determine the severity of the problem as the following: - less than or equal 20 points means no disease, 21-30 means mild, 31-40 means moderate, 41-50 means severe , 51 or more means very severe. | It will be measured after completion of the study , approximately in May 2023. |
A Single-center, Prospective, Clinical Study of VersaWrap Utilization in the Hand

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy on the use of VersaWrap® in surgery of the hand/fingers, including tendon repair, fracture repair, or tenolysis of the hand/fingers. VersaWrap is designed to allow tendon gliding and to protect tendon gliding postoperatively

Detailed Description
-----------------
This is a prospective, post-market, observational, single center study evaluating the use of VersaWrap. Patients identified by the Investigator in his practice as needing surgery of the hand/fingers and meeting all the inclusion and none of the exclusion. Patients will consent to participating in the study, prior to any study procedures.

Official Title
-----------------
A Single-center, Prospective, Clinical Study of VersaWrap Utilization in the Hand

Conditions
-----------------
Tendon Repair, Fracture Repair, Tenolysis

Intervention / Treatment
-----------------
* Device: VersaWrap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18-70 at the time of surgery Patients undergoing hand/finger surgery, including tendon repair, fracture repair or tenolysis Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule, study requirements with a signed informed consent with a study collaborator present at the time of signing to ensure compliance. Exclusion Criteria: Non-English speaking Known allergy or sensitivity to citrate, alginate or hyaluronate Pregnant or breastfeeding Currently a prisoner Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| VersaWrap<br>All enrolled patients will received VersaWrap applied prior to surgical closure on the affected tendon. | Device: VersaWrap<br>* VersaWrap is applied to the affected tendon to allow post-operative gliding.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants diagnosed with post-operative tenolysis |  | 6 months |
EPIdemiological Approaches to the Cardiovascular Consequences of COVID-19

Study Overview
=================
Brief Summary
-----------------
The COVID-19 pandemic highlights the importance of the prognosis of co-morbidities, such as coronary artery disease, which significantly increase the risk of mortality in patients infected with SARS-CoV2. Investigators have recently studied the complex links between respiratory infections, particularly pneumonia, and type 2 myocardial infarction (MI) in many respects. The etiology of type 2 MI is based on an imbalance of myocardial oxygen supply/need in the absence of rupture/erosion of atheromatous plaques. Based on the RICO survey data, the investigators investigated whether COVID-19-related sepsis and/or respiratory failure could be an underlying mechanism of MI2.

Official Title
-----------------
EPIdemiological Approaches to the Cardiovascular Consequences of COVID-19

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Biological: Biological data
* Other: Clinical data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients hospitalized for a type 2 MI in CCU from CHU Dijon Bourgogne With or without pneumonia patients hospitalized for a type 2 MI in CCU from CHU Dijon Bourgogne With or without COVID 19 Exclusion Criteria: None

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 |
| --- | --- |
| A<br>Type 2 MI with COVID-19 | Biological: Biological data<br>* Biological data<br>Other: Clinical data<br>* Clinical data<br>|
| B<br>Type 2 without COVID-19 | Biological: Biological data<br>* Biological data<br>Other: Clinical data<br>* Clinical data<br>|
| C<br>Type 2 MI with pneumonia without COVID-19 | Biological: Biological data<br>* Biological data<br>Other: Clinical data<br>* Clinical data<br>|
| D<br>Type 2 MI without pneumonia and without COVID-19 | Biological: Biological data<br>* Biological data<br>Other: Clinical data<br>* Clinical data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterizing type 2 myocardial infarction associated with CoV-2 SARS infection |  | Through study completion, an average of 1 year |
Efficacy of the Additional Mechanical Pleurodesis for Surgical Management of Primary Spontaneous Pneumothorax

Study Overview
=================
Brief Summary
-----------------
For the definite treatment of primary spontaneous pneumothorax(PSP), thoracoscopic bleb obliteration with pleural adhesive procedure is generally accepted as a standard. But additional pleurodesis is potentially useless procedure on the parietal pleura for treating visceral pleural disese. Furthermore, pleural symphysis could deteriorates normal pleural physiology and cause chronic pain. According to our previous study, stapling resection of the bulla without pleurodesis gave comparable result in recurrence comparing with articles with additional pleurodesis. The purpose of this study is to evaluate surgical outcome of thoracoscopic surgery with or without pleural abrasion and to know whether adhesive procedure is essential in the management of PSP.

Official Title
-----------------
Phase III Study of Evaluation of the Efficacy of Additional Mechanical Pleurodesis After Thoracoscopic Wedge Resection for the Management of Primary Spontaneous Pneumothorax

Conditions
-----------------
Primary Spontaneous Pneumothorax

Intervention / Treatment
-----------------
* Procedure: thoracoscopic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: recurrent pneumothorax bilateral pneumothorax total collapse/tension pneumothorax previous history of contralateral pneumothorax visible bulla on simple X-ray special occupation/situation air leakage more than 2 days with drainage catheter for 1st attack patients Exclusion Criteria: patient refusal and reoperation case

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 35 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: thoracoscopic surgery|stapled wedge resection of the lung mechanical pleural abrasion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence |  | follow up more than 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications |  | follow up more than 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pneumothorax, thoracoscopy, pleurodesis
Systematic Pelvic Lymphadenectomy Versus no Lymphadenectomy in Clinical Stage I-II Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine whether the addition of systematic pelvic lymphadenectomy to hysterectomy with bilateral adnexectomy improves disease-free survival (DFS) and overall survival (OS) in patients with preoperatively supposed Stage I-II endometrial cancer

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Procedure: Systematic pelvic lymphadenectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven endometrioid or adenosquamous endometrial carcinoma. Patients having myometrial invasion Age =/< 75 years Informed consent. Exclusion Criteria: Serous papillary and clear cell tumors. Karnofsky index < 80 or severe diseases contraindicating surgery Concomitant neoplasia (basalioma cutis excluded) Distant metastasis or abdominal metastasis detected intraoperatively. Absence of myometrial invasion at frozen section.

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

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

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 |
| --- |
|Procedure: Systematic pelvic lymphadenectomy|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
-----------------
Histologically proved endometrial carcinoma preoperatively supposed stage I-II
Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to measure the influence of both short term water restriction and high water intake on total kidney volume, measured by Magnetic Resonance Imaging (MRI) scan in Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients.

Detailed Description
-----------------
Patients will be randomized to either water restriction for 3 hours or high water intake (20 ml/kg) for 1 hour. Before intervention and after intervention patients will have an MRI scan of the kidneys to measure the total kidney volume (TKV) (differentiated in cortex, medulla and cyst volume). The objective is to identify whether water restriction or high water load will change the TKV. Secondly investigators will analyze different biomarkers (aldosterone, renin, vasopressin/copeptin, urine- and blood-osmolarity) before and after the intervention.

Official Title
-----------------
Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney: The HYDRA Study

Conditions
-----------------
ADPKD

Intervention / Treatment
-----------------
* Other: water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ADPKD CKD stage 1-3 Exclusion Criteria: Patients treated with diuretics Pregnancy Change in antihypertensive treatment < 1 month Any condition contraindicating MR scan

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: water restriction<br>20 patients will be subjected to 3 hours of water restriction following MR scan of the kidneys. | |
| Active Comparator: high water intake<br>20 patients will be subjected to 1 hour of high water intake (20 ml/kg) following MR scan of the kidneys. | Other: water<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total kidney volume |  | Baseline and 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total cyst volume |  | Baseline and 3 hours | 
| Change in plasma renin |  | Baseline and 3 hours | 
| Change in plasma aldosterone |  | Baseline and 3 hours | 
| Change in plasma copeptin |  | Baseline and 3 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADPKD, total kidney volume, kidney disease