linjc16/ctgov huggingface dataset:
Odiparcil QT Definitive Study

Study Overview
=================
Brief Summary
-----------------
This study is being completed to demonstrate the lack of effect of repeat dosing with Odiparcil on the QTc interval.

Official Title
-----------------
A Study to Evaluate the Effect of Repeat Oral Doses of Odiparcil on Cardiac Conduction as Assessed by 12-lead Electrocardiogram Compared to Placebo and a Single Oral Dose of Moxifloxacin.

Conditions
-----------------
Fibrillation, Atrial, Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Odiparcil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Healthy volunteers Exclusion: Cardiac abnormalities Hepatic or renal insufficiency Anti-coagulant medications Bleeding history

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| demonstrate lack of effect of repeat dose on QT interval with ECG measured on Days -1, 5 and 6 at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics, CMAX, AUC, TMAX, PK samples taken at 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 16, 18, 20 and 24 hours on days 5 and 6 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
QT,, interval,, atrial fibrillation, odiparcil,
Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity

Study Overview
=================
Brief Summary
-----------------
This study is being done to better understand the relationship between inflammation in adipose tissue (AT), abnormal deposition of fat around the liver and how this affects its appearance and function and ultimately insulin resistance.

Official Title
-----------------
Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity- AIM 1

Conditions
-----------------
Obesity, Morbid, NASH - Nonalcoholic Steatohepatitis, Chronic Inflammation

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing gastric bypass surgery Confirmed AUROC F=0 or F>2 liver fibrosis Age 30-70 years BMI greater than 40 kg/m2 Negative pregnancy test (female only) Lab Values: Normal TSH Exclusion Criteria: Autoimmune diseases Hepatitis B or C positive Heavy alcohol use Active smoking history Active cancer history History of asthma History of COPD Taking Plavix or Coumadin Blood donation within past 2 months Glucocorticoid Therapy Taking antihistamine on regular basis

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| Weight loss surgery<br>Gastric bypass surgery will be followed by weight loss as standard of care. Liver fibrosis by elastography will be determined before surgery. | Procedure: Bariatric surgery<br>* Evaluate liver fibrosis by elastography before gastric bypass surgery.<br>* Other names: Roux en Y gastric bypass, sleeve gastrectomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver fibrosis | evaluate the liver fibrosis by elastography before surgical intervention | Baseline | 
| Adipose tissue inflammation | Evaluate markers of adipose tissue inflammation by mRNA levels | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, nash, adipose tissue inflammation, insulin resistance
Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The long-term objective of this research is to develop a non-invasive approach for early assessment of which patients are at high risk for future development of skeletal muscle atrophy. The investigators hypothesize that the rate constant for the terminal portion of the isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine (D-3MH) provides an accurate measure of this increased risk and that this rate constant can be measured non-invasively from timed spot urine samples.

Official Title
-----------------
Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients

Conditions
-----------------
Cachexia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 30-75 years old Body Mass Index (BMI) <27 kg/m2 Exclusion Criteria: Uncontrolled hypertension Glomerular filtration rate less than 60 mL/min/1.73 m2 History of recurrent gastrointestinal bleeding Unable or unwilling to provide informed consent Ongoing anti-coagulant therapy

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy control male<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Seroprevalence of COVID-19

Study Overview
=================
Brief Summary
-----------------
Coronavirus disease pandemic has been started in late 2019. Since this date, the number of cases has been increased reaching 32.7 million cases worldwide in 27 September, 2020. . Herd immunity is achieved when enough people become immune to a virus to stop its spread. Around 70% to 90% of a population needs to be immune to protect the uninfected. In A Spanish study of more than 30,000 people estimates that around just 5% of the Spanish population has developed antibodies

Detailed Description
-----------------
Aims of work: A cross-sectional study to detect the seroprevalence to COVID 19 in chronic hemodialysis patients and compare it with the COVID 19 seroprevalence in healthy control in Sohag governorate Egypt Methods: After taken informed consent according to Sohag University Ethical Committee A questionnaire on coronavirus symptoms will be asked including epidemiological characters and history of previous COVID 19 infection and infection control measures to prevent it 5 ml of the blood sample will be taken for IgG antibodies testing with a chemiluminescent microparticle immunoassay.

Official Title
-----------------
Seroprevalence of COVID19 in Sohag Governorate Egypt

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: laboratory test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient accept to participate Exclusion Criteria: vaccinated people
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 |
| --- | --- |
| group 1 chronic haemodialysis patients<br>seroprevalnce of COVID 19 | Diagnostic Test: laboratory test<br>* seroprevalnce<br>|
| healthy control<br>seroprevalnce of COVID 19 | Diagnostic Test: laboratory test<br>* seroprevalnce<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seroprevalnce | antibody measurement | 3-6-2021 to 30-8-2021 |
The Effect of Fish Oil in Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The whole study was divided into two major parts: (A) the 12-week, double-blind, randomized controlled, parallel omega-3 fatty acid monotherapy study in 60 patients with mild to moderate major depressive disorder. (B) The double-blind, randomized controlled, parallel omega-3 fatty acid add-on prevention study in 60 patients with major depressive disorder in recovery status. The goals of this study were to examine the therapeutic and recurrence prevention effects of omega-3 fatty acids on major depressive disorder.

Official Title
-----------------
The Effect of Fish Oil in Major Depressive Disorder: a Double-blind Placebo-controlled Monotherapy Trail and a RCT for Recurrence Prevention

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

Intervention / Treatment
-----------------
* Dietary Supplement: Omega-3 fatty acids
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV criteria for major depressive disorder. Age being age 18-65. Capacity and willingness to give written informed consent. Exclusion Criteria: Any major medical illnesses. A recent or past history of any Axis-I diagnoses besides major depressive disorder, including psychotic disorders; cognitively impaired mental disorders; impulse control disorders; substance use disorder or substance abuse (last 6 months prior to the studies); primary anxiety disorders, including post-traumatic stress disorder and panic disorder; and bipolar disorders; or Axis-II diagnoses, i.e. borderline and antisocial personality disorder.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: omega-3 fatty acids<br>EPA 2.1 g/d+DHA 1.1 g/d | Dietary Supplement: Omega-3 fatty acids<br>* EPA 2.1 g/d+DHA 1.1 g/d<br>|
| Placebo Comparator: Placebo<br>high oleic oil | Dietary Supplement: Placebo<br>* high oleic oil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAMD |  | W0 W2 W4 W8 W12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDI |  | W0 W2 W4 W8 W12 | 
| Adverse effects |  | W0 W2 W4 W8 W12 | 
| Recurrence rate |  | M0 M1 M2 M3 M4 M6 |
Counseling of Pregnant Women During Corona

Study Overview
=================
Brief Summary
-----------------
Corona virus is known as covid 19 And is transmitted through droplet infection

Detailed Description
-----------------
Symptoms of Corona include cough Fever and dyspnea

Official Title
-----------------
Effect of Counseling Between Pregnant Women During Corona Infection

Conditions
-----------------
Respiratory Tract Infections

Intervention / Treatment
-----------------
* Other: Women receiving extra remembering by healthcare


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women Exclusion Criteria: non pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 43 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: patients receiving remembering<br> | Other: Women receiving extra remembering by healthcare<br>* Women receiving extra remembering by healthcare in covid infection<br>|
| No Intervention: patients not receiving extra remembering<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of pregnant women who know the exact symptoms of the disease | The number of pregnant women who have awareness about the disease | Within one month |
Physiological Brain Atlas Development

Study Overview
=================
Brief Summary
-----------------
Enrollment of candidates undergoing a deep brain stimulator (DBS) implant.

Detailed Description
-----------------
The study proposes the enrollment of candidates undergoing a deep brain stimulator (DBS) implant. Data will be collected before, during and after surgery and will be electronically entered into the Atlas database where it will be stored indefinitely. The purpose of the study is to create an Atlas to store physiological information utilizing non-rigid MRI normalization algorithms. In addition to collating and analyzing the physiological atlas in a statistical manner that allows the surgeon to predict optimal targeting locations for DBS implants based on multiple physiological variables, including pre-operative severity of disease, intraoperative neurophysiological observations, and post-operative response to DBS stimulation therapy.

Official Title
-----------------
Physiological Brain Atlas Development

Conditions
-----------------
Parkinson Disease, Dystonia, Tremors, Obsessive Compulsive Disorder, Depression

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient between the age of 7-90 Patients who have undergone deep brain stimulation (DBS) surgery as standard of care at The Ohio State University Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| optimal DBS target location | To create an atlas that will allow physiological information to be assigned to anatomical locations in MRI space, utilizing non-rigid MRI normalization algorithms. | intra-operative identification |
Multi-marker Approach for Risk Assessment in PAH

Study Overview
=================
Brief Summary
-----------------
Prospective registry including incident patients and prevalent patients which pretends to identify clinical characteristics, treatment trends in-hospital and ten years follow-up outcome through major adverse cardiovascular events (MACE) in a China population with well characterized PAH.

Detailed Description
-----------------
baseline include: An echocardiogram to assess the size, shape, pumping action and the extent of any damage to the heart. Lung function tests which include blowing measurements to assess gas volumes within the lungs as well as assessment of how the lungs exchange gases. Right heart catheterisation (RHC) to diagnose PAH Optional Cardiac Magnetic Resonance tests. 6 minute walk distance (6MWD). To measure exercise capacity Electrocardiogram (ECG), a test that measures the electrical activity of the heart Blood tests MACE include: death heart/lung transplantation atrial septostomy hospitalization due to worsening of PAH start of new specific PAH treatment persistent decrease of >15% from baseline in 6MWD (or >30% compared with last study-related measurement) persistent worsening of World Health Organization (WHO) Functional Class (FC）

Official Title
-----------------
Multi-marker Approach for Risk Assessment in Pulmonary Arterial Hypertension (PAH)

Conditions
-----------------
Pulmonary Arterial Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of PAH (by RHC) Exclusion Criteria: Refusal to participate.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 85 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 |
| --- | --- | --- |
| survival | To recruit a cohort of group 1 PAH cases. define the death as the primary outcome | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical worsening | one of the following: death, heart/lung transplantation, atrial septostomy, hospitalization due to worsening of PAH, start of new specific PAH treatment, persistent decrease of >15% from baseline in 6MWD (or >30% compared with last study-related measurement), persistent worsening of WHO FC | 5 years |
A Study of V110 a Pneumococcal Vaccine in Healthy Adults (V110-013)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adults.

Official Title
-----------------
A Comparative Study in Healthy Adults of the Safety, Tolerability, and Immunogenicity of V110 Formulated With Either All New Process Polysaccharides or All Current Process Polysaccharides

Conditions
-----------------
Healthy, Pneumococcal Infections

Intervention / Treatment
-----------------
* Biological: V110, pneumococcal vaccine polyvalent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females in good health, ages 20-40, with no history of pneumococcal vaccination Exclusion Criteria: Subjects with a recent febrile illness Known or suspected immune dysfunction, conditions associated with immunosuppression, and receipt of immunosuppressive chemotherapy, including long-term corticosteroid therapy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: V110, pneumococcal vaccine polyvalent|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  |
Studies of Patients With Skin Disease, Patients With Neurological Degenerations, and Normal Volunteers

Study Overview
=================
Brief Summary
-----------------
It is proposed that patients with skin disease due to presumed immunologic, genetic or viral-induced abnormalities, patients with neurological degenerations, and normal controls be evaluated with various in vitro studies of immunologic, genetic, and virologic function. This is to include studies of peripheral blood (cells and serum) as well as studies of skin obtained with a biopsy instrument. In addition, studies of gastrointestinal function will be performed where appropriate.

Detailed Description
-----------------
It is proposed that patients with skin disease due to presumed immunologic, genetic or viral-induced abnormalities, patients with neurological degenerations, and normal controls be evaluated with various in vitro studies of immunologic, genetic, and virologic function. This is to include studies of peripheral blood (cells and serum) as well as studies of skin obtained with a biopsy instrument. In addition, studies of gastrointestinal function will be performed where appropriate.

Official Title
-----------------
Studies of Patients With Skin Disease, Patients With Neurological Degenerations, and Normal Volunteers

Conditions
-----------------
Healthy, Muscular Dystrophy, Retinal Degeneration, Skin Diseases, Virus Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with skin diseases of presumed genetic, immunologic, or virologic origin are eligible. Patients with neurological degenerations are eligible, including patients with inflammatory, neoplastic and viral skin diseases and also heterozygous carriers of such inherited diseases. Volunteers without skin diseases are eligible, except children.
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genetic Evaluation, Immunologic Evaluations, Inflammatory Skin Disease, Muscular Dystrophies, Neoplastic Skin Diseases, Neuronal Degenerations, Retinal Degenerations, Viral Diseases