linjc16/ctgov huggingface dataset:
Lifestyle and Obesity

Study Overview
=================
Brief Summary
-----------------
The objective of this trial is to determine the effect of different lifestyle interventions such as aerobic exercise and alternative resistance training methods, combined with a hypocaloric diet, on weight, body composition and metabolic risk factors in overweight and obese adults.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Whole body vibration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index > 24.9 kg/m² age > 18 y pre-menopauzal Exclusion Criteria: Body mass index > 40 kg/m² Pregnancy Diabetes Joint replacement surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Whole body vibration|Frequence: 35 Hz Amplitude: 'high' (approx. 4 mm)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Growth Hormone and Heart Failure

Study Overview
=================
Brief Summary
-----------------
Heart failure induces modification in several neurohormonal systems. The aim of this study is to determine if the growth hormone/IGF1 axis is modified in heart failure patients compared to healthy volunteers.

Detailed Description
-----------------
One hundred and sixty three heart failure patients were evaluated by clinical examination, echocardiography, exercise test and measurement of blood BNP. Growth hormone and IGF-1 plasma levels were determined in each patient. The same biological measurements were performed in a group of 148 healthy controls. Comparisons were performed between groups for Growth hormone plasma level, IGF-1 plasma level and Growth hormone/IGF-1 index. A correlation between the severity of heart failure and the different biological parameters was searched.

Official Title
-----------------
Modifications of the Growth Hormone/IGF1 Axis in Heart Failure Patients

Conditions
-----------------
Heart Failure, Congestive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart failure patients in stable condition Exclusion Criteria: cancer pituitary disease

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart failure, hormones, growth substances
Coronary Atherosclerosis Evaluation by Arterial Wall Magnetic Resonance Imaging (MRI)

Study Overview
=================
Brief Summary
-----------------
The overall goal of this study is to use MRI to: Examine the relationship between known risk factors for cardiovascular disease and coronary artery wall thickness; Examine the relationship between coronary artery wall thickness and other markers of subclinical coronary atherosclerosis, such as carotid wall thickness and coronary calcium scores; and, Examine the feasibility of measuring the progression of coronary artery wall thickness over time in a subset of participants.

Detailed Description
-----------------
Each enrolled participant will undergo MR Imaging of the coronary arteries in conjunction with their routine MESA follow-up visit. The MRI will last approximately 45-60 minutes

Official Title
-----------------
Coronary Atherosclerosis Evaluation by Arterial Wall MRI

Conditions
-----------------
Coronary Arteriosclerosis, Arteriosclerosis, Coronary, Atherosclerosis, Coronary, Coronary Artery Disease, Coronary Atherosclerosis

Intervention / Treatment
-----------------
* Procedure: MR Imaging of the Coronary Arteries


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior enrollment in the MESA Study at the Hopkins MESA Field Center or the Northwestern University MESA Field Center Male or Female adult equal to or older than 45 years of age Willing/able to provide informed consent Exclusion Criteria: Any known contraindications to MRI (i.e. severe claustrophobia, pacemaker, etc.) Metal in the eyes

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: MR Imaging of the Coronary Arteries|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Coronary Wall Thickness | Average thickness of the wall of the left anterior descending, right and left main coronary artery measured by magnetic resonance imaging (MRI). | n/a (cross sectional analysis) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, MESA, Cardiovascular, Cardiac, Coronary, Atherosclerosis
Efficacy and Safety Study of Norethindrone Acetate Transdermal Delivery System in Contraception

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether NEA TDS is effective in the prevention of pregnancy. The safety of this product will also be evaluated.

Detailed Description
-----------------
An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System.

Official Title
-----------------
An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System

Conditions
-----------------
Contraceptive Usage

Intervention / Treatment
-----------------
* Drug: Norethindrone Acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy females 18-45 years Regular, consistent menstrual cycles between 25 and 35 days Sexually active and at risk of becoming pregnant Exclusion Criteria: History of infertility Known contraindications to progestogen administration Pap smear suggestive of a high-grade precancerous lesion(s) Clinically significant deviation from normal in any of the screening tests or exams

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

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

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

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: Active treatment<br>Norethindrone Acetate Transdermal Delivery System | Drug: Norethindrone Acetate<br>* Norethindrone Acetate Transdermal Delivery System<br>* Other names: NEA TDS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate | The pregnancy rate will be calculated using the Pearl Index that defined as 1300*Number of pregnancies/Number of cycles of treatment. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contraception, pregnancy
A Multi-center Post-Market Surveillance Registry

Study Overview
=================
Brief Summary
-----------------
This multicenter, prospective, observational registry will evaluate the safety and performance of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent, and of all future generation of commercially approved Cordis Sirolimus-eluting Stents (SES), in routine clinical practice. Its objective is to measure the incidence and identify the predictors of acute, sub-acute and late stent thrombosis and Major Adverse Cardiac Events (MACE). Additional analyses will be performed in patient sub-populations, such as diabetes, in-stent restenosis (ISR), acute myocardial infarction (AMI) and multivessel coronary disease.

Detailed Description
-----------------
The data will be collected in consecutive subjects treated with commercially available product and following standard clinical practice. This registry will be limited to subjects who have received only the CYPHER SELECT™ Sirolimus-eluting Coronary Stent during the index procedure. While no inclusion or exclusion criteria have been specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up. All subjects should be treated according to the Instruction For Use (IFU) including conduct of the stenting procedure, application of antiplatelet medication and any other medical therapy should be provided according to local usual practice. Data collection (Electronic Data Capture), data management, statistical analyses, monitoring and core laboratory evaluations will be assigned to independent organizations.

Official Title
-----------------
The e-SELECT Registry a MULTICENTER POST-MARKET SURVEILLANCE

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: drug-eluting stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This registry will be limited to subjects who have received only the CYPHER SELECT™ Sirolimus-eluting Coronary Stent during the index procedure; Males and females; Exclusion Criteria: None.
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CYPHER SELECT™ Sirolimus-eluting Coronary Stent | Device: drug-eluting stent<br>* CYPHER SELECT™ Sirolimus-eluting Coronary Stent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute, sub-acute and late stent thrombosis; Major Adverse Cardiac Events (MACE) |  | 1, 6, 12, 24 and 36 months |
Effects of Passive Smoking on Children During Gastrointestinal Endoscopy

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of passive smoking in children during Gastrointestinal Endoscopy.

Detailed Description
-----------------
When the patients and their parents are arrived in the endoscopy unıt about 1 h before the procedure, the anesthetist is obtained a medical history and carried out a physical examination and clinical assesment. Then the parents smoking habits are documented about to detect the magnitude of passive smoking. Endoscopist and anesthesiologist are blinded to the patients passive smoking history. Then the sedation is applied and esophagogastroduodenoscopy procedures performed. Side effects (e.g laryngospasm, coughing) during the study are recorded.

Official Title
-----------------
Effects of Passive Smoking on Children During Gastrointestinal Endoscopy

Conditions
-----------------
Gastro-Intestinal Disorders

Intervention / Treatment
-----------------
* Behavioral: Control Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA ( American Society of Anesthesiologists) I- ASA II patients Aged 1- 18 Year old patients Exclusion Criteria: Smoker patients

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Effects of passive smoking on children<br>The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents smoking. | Behavioral: Control Group<br>* The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents no smoking.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| laryngospasm ratio | The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents smoking. | an average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypoxia ratio (oxygen saturation < % 90) | The prevalence of hypoxia (oxygen saturation < % 90) in sedation applied to endoscopic intervention whose parents smoking. | an average of 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
esophagogastroduodenoscopy, laryngospasm, passive smoking, sedation
Therapeutic and Prognostic Impact of Circulating Tumor Cells in Peripheral Blood in Patients With Non Small-cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the association between the number of circulating tumor cells and response to treatment in non small-cell lung cancer patients

Detailed Description
-----------------
In spite of technological advantages in diagnosis and treatment, lung cancer remains one of the most deadly malignant neoplasias. Moreover, there are no markers for monitoring response to treatment. The objective of the study is to associate the number of circulating tumor cells (CTC) before and after treatment and correlate it with tumor response rate, progression-free survival and overall survival.

Conditions
-----------------
Circulating Tumor Cells

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histopathologic diagnosis of non small-cell lung cancer Clinical stage IV ECOG functional status 0 or 1 No renal function alteration (GFR >50%) No hepatic function alteration (ALT and AST less than 2 times its normal value) Leucocytes more than 2,000/mcl Hemoglobin more than 10mg/dL Platelets more than 100,000/mcl Exclusion Criteria: Non-advanced disease

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 |
| --- | --- |
| Stage IV NSCLC<br>Stage IV non small-cell lung cancer patients will be recruited for this protocol | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate, progression-free survival and over-all survival |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of CTCs |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non small-cell lung cancer, Circulating tumor cells, Carcinoembryonic antigen, Cytokeratin
Modulation of Visually Evoked Potentials by an Antidepressant

Study Overview
=================
Brief Summary
-----------------
12 normal healthy controls will be treated with 50 mg sertraline once daily for three weeks. Early amplitudes of visually evoked potentials will be examined at day 0, 10 and 21 and statistically compared. This study aims to examine a putative modulation of synaptic transmission and plasticity by an antidepressant and is part of a series of studies in healthy individuals and depressed patients.

Official Title
-----------------
Modulation of Visually Evoked Potentials by an Antidepressant

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

Intervention / Treatment
-----------------
* Drug: Sertraline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy individuals 18-65 years Exclusion Criteria: history of affective oder other psyhiatric disorder severe medical condition pregnancy or ineffective contraception active illicit drug use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitudes and latencies of early visually evoked potentials. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, SSRI, Sertraline, synaptic plasticity, visually evoked potentials
Detection of Minor Changes in Fluid Volume or Tonicity in Healthy Volunteers.

Study Overview
=================
Brief Summary
-----------------
This study is aimed at detecting minor changes in hydration volume and tonicity. We will use healthy students of both sexes who will ingest fluids and nutrition that should lead to specific changes in both intracellular and extracellular volumes. The protocol is based on laboratory exercises previously carried out at The Arctic University of Norway (UiT).

Official Title
-----------------
Detection of Minor Changes in Fluid Volume or Tonicity in Healthy Volunteers.

Conditions
-----------------
Healthy Nutrition

Intervention / Treatment
-----------------
* Device: New medical device (ReBalans)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Healthy volunteer Exclusion Criteria: Kidney disease, neurological, heart or endocrine disease, hypertension. Eating disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 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 volunteers<br>Adult healthy volunteers (students). Intervention 1: Intake of water (2% of body weight) Intervention 2: Intake of sports drink (2% of body weight) Intervention 3: Intake of soya saus (salt): 10 ml (equal to 8 g salt) Intervention 4: Intake of 90 g sugar (jelly figures) | Device: New medical device (ReBalans)<br>* Body worn, battery powered bioimpedance measuring patch device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to detect tonicity or volume change | Accurately depict each of the four interventions with a sensitivity better than 0.9. | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dehyration
Cardiac Monitor Employee Study

Study Overview
=================
Brief Summary
-----------------
This purpose of this study is to collect ECG data from a wearable cardiac monitor in order to evaluate end-to-end performance of a cardiac monitor system and associated data management accessories.

Detailed Description
-----------------
The objective of this study is to evaluate the usability of the Wearable Cardiac Monitor (WCM) system including the WCM, Mobile Monitors (patient and clinician), Magnet and LATITUDE Clarity(TM) Server. The study will exercise the end-to-end system utilizing human ECG data generated by the wearable cardiac monitor.

Official Title
-----------------
Cardiac Monitor Employee Study

Conditions
-----------------
Arrhythmias, Cardiac

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and capable to provide informed consent Age 18 or above Employee of the study sponsor Willing and able to follow protocol requirements Exclusion Criteria: Currently enrolled in another clinical study that interferes with data collection Currently implanted with an active medical electronic device Known allergies to the materials that may come in contact with the skin Any active skin condition on the chest reported by the subject

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Cohort<br>All participants are considered to be in the study cohort and will have the study device placed externally on their skin in order to collect human ECG data. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate WCM System End-To-End Performance | Characterize rate of success of wireless data transmissions from wearable cardiac monitor to LATITUDE Clarity(TM) server | 3 months |
Chinese Network of Pediatric Antiretroviral Therapy

Study Overview
=================
Brief Summary
-----------------
This is an observational cohort in pediatric HIV patients in China. Children who receive antiretroviral drugs will be recruited in this study. The main objectives are as follows: 1. To establish simpler and smarter pediatric antiretroviral therapy in China including both first-line and second-line regimens. 2. To study the nature, characteristics and mechanisms of immunoreconstitution in HIV-infected children using the data and samples from the pediatric antiretroviral therapy cohort. 3. To establish a basic science and clinical research network based on the pediatric antiretroviral cohort.

Official Title
-----------------
Chinese Study of Pediatric Antiretroviral Therapy

Conditions
-----------------
Acquired Immunodeficiency Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of HIV infection receiving triple antiretroviral drugs Exclusion Criteria: clinical status not stable

Ages Eligible for Study
-----------------
Maximum Age: 15 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 |
| --- | --- |
| Pediatric ART patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The immunology and virologic outcomes |  | 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children, Acquired Immunodeficiency Syndrome, antiretroviral therapy, China, Mortality