linjc16/ctgov huggingface dataset:
Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases

Study Overview
=================
Brief Summary
-----------------
An observational study aiming to assess the serological profile of SARS-Cov2 patients with systemic diseases such as systemic lupus erythematosus, Sjogren syndrome, sarcoidosis, inflammatory myopathies, Behçet's disease, Rheumatoid arthritis and Spondyloarthritis

Detailed Description
-----------------
The study is a prospective, observational, multicenter clinical trial to be conducted in the internal medicine, rheumatology and virology departments of Military Hospital of Tunis. After obtaining informed consent from the patient, the investigator will perform an inclusion visit made of a patient interview and performing blood sample to search for IgG and anti-SARS IgM CoV2. Patients with IgM-like antibodies will have an RT-PCR test for active infection. If the study participants will be diagnosed with COVID-19 positive during the study period, the attending physician is entitled to decide on their management based on the severity of the clinical status.

Official Title
-----------------
Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases

Conditions
-----------------
SARS-CoV Infection, Systemic Disease, Systemic Lupus Erythematosus, Sjogren's Syndrome, Sarcoidosis, Inflammatory Myopathy, Behçet Disease, Rheumatoid Arthritis, Spondyloarthritis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years old One of the following conditions: systemic lupus, Sjögren's syndrome, rheumatoid arthritis, inflammatory myopathies, spondyloarthritis, sarcoidosis and Behçet's disease. Informed consent obtained and signed Exclusion Criteria: Refusal to repeat blood sampling if the first one was badly performed Informed consent not obained

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Serological test|Positive serological test of SARS Cov2|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serological Profile | Number of patients with positive serological test of SARS Cov2 | Inclusion |
Response to SLT vs. ALT in Patients Under 60 Years of Age

Study Overview
=================
Brief Summary
-----------------
Laser trabeculoplasty is a routine treatment for glaucoma and can be performed with either argon (ALT) or selective Yag (SLT) lasers. The effectiveness of each has not been studied in patients under 60 years, which is younger than average for the procedure. The study hypothesis is that there will be no difference between the two laser types.

Detailed Description
-----------------
Forty-two young patients (age 29 to 60) had one eye randomized to ALT (n = 22) or SLT (n = 20). Intraocular pressure was measured prior to laser and 1 hour, 1 day, 6 weeks, 3 months, every 3 months until 2 years, and then yearly post-laser. χ2 analysis and student's t-test were used to determine statistical significance.

Official Title
-----------------
A Prospective, Randomized, Clinically Based Study on the Response to Selective Laser Trabeculoplasty Versus Argon Laser Trabeculoplasty in Patients Who Are Under 60 Years of Age

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Procedure: Argon laser trabeculoplasty
* Procedure: Selective laser trabeculoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age < 60 years Intraocular pressure not adequately controlled Exclusion Criteria: Prior laser treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Argon laser trabeculoplasty<br>Patients received standard argon laser treatment | Procedure: Argon laser trabeculoplasty<br>* Argon laser 600-800 mW, 0.1seconds, 50 micron spot size, 45 - 55 burns over 180 degrees of trabecular meshwork<br>* Other names: ALT;|
| Active Comparator: Selective laser trabeculoplasty<br>Patients received a standard selective laser treatment | Procedure: Selective laser trabeculoplasty<br>* Selective laser trabeculoplasty 0.7 - 0.8 mJ, 400 micron spot size, 3 nanosecond, 45 - 55 burns over 180 degrees of trabecular meshwork.<br>* Other names: SLT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure | The intraocular pressure was measured at 6 weeks, 4.5 months, 9, 12, 18 and 24 months following the laser treatment. | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, laser trabeculoplasty, intraocular pressure
Mechanism of Action and Efficacy of Muraglitazar in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn more about how muraglitazar lowers blood sugar in people with type 2 diabetes. The safety of this treatment will also be studied.

Official Title
-----------------
Mechanism of Action and Efficacy of Muraglitazar (BMS298585) in the Treatment of Type 2 Diabetic Patients

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

Intervention / Treatment
-----------------
* Drug: Muraglitazar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes; Serum triglyceride concentration < or = 600 mg/dL; Body mass index < or = 37 kg/m2 Exclusion Criteria: Type 1 diabetes; History of myocardial infarction (MI), coronary angioplasty, bypass graft(s), valvular disease, unstable angina pectoris, transient ischemic attack (TIA), or cerebrovascular accident (CVA) within 6 months; Congestive heart failure (NYHA Class III and IV); Uncontrolled hypertension; Women of Child Bearing Potential History of renal disease, peripheral vascular disease (PVD), pulmonary disease, gastrointestinal disease, active liver disease, or endocrine disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in insulin medicated glucose disposal after 16 weeks of treatment with Muraglitazar |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes
A Study Using Botulinum Toxin Type A in Patients With Axillary Hyperhidrosis

Study Overview
=================
Brief Summary
-----------------
This is a three-year study in subjects with axillary hyperhidrosis involving injection of Botulinum Toxin Type A into the axilla to reduce sweating.

Conditions
-----------------
Hyperhidrosis

Intervention / Treatment
-----------------
* Drug: Botulinum Toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Marked axillary hyperhidrosis Exclusion Criteria: Previous use of botulinum toxin for hyperhidrosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Botulinum Toxin Type A|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's assessment of the severity of hyperhidrosis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of axillary sweat production |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Axillary Hyperhidrosis
A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.

Official Title
-----------------
A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Drug: 120 mg orlistat
* Drug: 60 mg orlistat
* Drug: orlistat experimental dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 18-60 years Body Mass Index: 25-33 Exclusion Criteria: gastrointestinal disease organ transplant HIV, hepatitis B or C food allergies alcohol or other substance abuse smoking

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>60 mg orlistat | Drug: 60 mg orlistat<br>* 60 mg orlistat<br>|
| Active Comparator: Arm 2<br>120 mg orlistat (2 X 60 mg capsules) | Drug: 120 mg orlistat<br>* 2 X60 mg capsule<br>|
| Experimental: Arm 3<br>orlistat experimental formulation | Drug: orlistat experimental dose<br>* experimental<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal fat excretion |  | 9 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orlistat, overweight, bioequivalence
A Pharamcogenomic Study for Isoniazid According to NAT2 Polymorphism Status

Study Overview
=================
Brief Summary
-----------------
A clinical trial to investigate the appropriate dose of isoniazid according to NAT2 polymorphism status in Korean subjects

Official Title
-----------------
Clinical Trial to Investigate the Appropriate Dose of Isoniazid According to NAT2 Polymorphism Status in Korean Subjects

Conditions
-----------------
Tuberculosis, Drug-Induced Liver Injury, Adverse Drug Event

Intervention / Treatment
-----------------
* Drug: Isoniazid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Agreement with written informed consent Adult healthy male or female subject age 20 to 45 Exclusion Criteria: Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy Medication with any drug which may affect the pharmacokinetics of isoniazid within 14 days Previously donate whole blood within 30 days or Previously participated in other trial within 60 days Subject with known for hypersensitivity reactions to isoniazid Subject who can not perform contraception during study periods Female woman who are pregnant or are breast feeding An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rapid metabolizer (Standard treatment)<br>Standard isoniazid dose regimen (300 mg qd) | Drug: Isoniazid<br>* One of the first line anti-tubercolosis drug<br>|
| Active Comparator: Slow metabolizer (Standard treatment)<br>Standard isoniazid dose regimen (300 mg qd) | Drug: Isoniazid<br>* One of the first line anti-tubercolosis drug<br>|
| Experimental: Slow metabolizer (PGx treatment)<br>Decreased isoniazid dose regimen (200 mg qd) | Drug: Isoniazid<br>* One of the first line anti-tubercolosis drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver toxicity | Number of participants with drug-induced liver injury as assessed by below criteria. AST or ALT > 5 ULN AST or ALT > 3 ULN and total bilirubin > 2 ULN (Hy's law case) ALT ratio/ALP ratio > 5 | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug exposure | Plasma isoniazid concentration | Day 1 and day 29 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 post-dose |
A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior to placebo when added to current therapy in reducing HbA1c in patients with type 2 diabetes.

Official Title
-----------------
Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: ITCA 650
* Other: ITCA placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HbA1c between 7.5% - 10% On diet & exercise, metformin (MET), sulfonylurea (SU) or thiazolidinedione (TZD) alone or in combination or combined (SU + TZD) or in combination with Met + SU, Met + TZD, Met + TZD + SU BMI between 25 & 45 kg/m2 Exclusion Criteria: taking DPP-4 inhibitors, exenatide, liraglutide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months history of pancreatitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITCA 650 40 mcg/day<br> | Drug: ITCA 650<br>* ITCA 650 is exenatide in DUROS<br>|
| Experimental: ITCA 650 60 mcg/day<br> | Drug: ITCA 650<br>* ITCA 650 is exenatide in DUROS<br>|
| Placebo Comparator: ITCA placebo<br> | Other: ITCA placebo<br>* Formulation in DUROS (no exenatide)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | 39-week Treatment Period | 39 weeks |
Prokinetic Drugs and Enteral Nutrition

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of two drugs that can help in the prevention of regurgitation during the administration of enteral nutrition and define which one is the most effective.

Detailed Description
-----------------
Two prokinetic drugs (metoclopramide and erythromycin) will be compared during the administration of enteral nutrition in critically ill patients. We would like to know which one is the most effective in preventing regurgitation and risk of aspiration, which is a common complication of enteral nutritional support. This will be evaluated by measuring gastric residue every six hours.

Official Title
-----------------
Effect of Prokinetic Drugs During the Administration of Enteral Nutrition

Conditions
-----------------
Critically Ill, Enteral Nutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: critically ill patients intubated mechanically ventilated 18 or older age enterally fed Exclusion Criteria: prokinetic drugs before start study allergy to study medication interactions odf study medication with other drugs recent gastro-intestinal surgery history of esophagectomy or gastrectomy suspicion of gastrointestinal perforation myasthenia gravis liver dysfunction less than 7 days in study gastro- or jejunostomy

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
-----------------
gastroesophageal reflux, respiratory aspiration
Post-resuscitation Care Registry for Survival From Out-of-hospital Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to construct multi-center post-cardiac arrest care registry that can be used for data warehousing and clinical research.

Detailed Description
-----------------
This registry prospectively enrolls adults patients survived out-of-hospital cardiac arrest in 3 academic hospital emergency departments. Registered data can be used for quality control and clinical research to reduce post-cardiac arrest syndrome-related mortality.

Official Title
-----------------
Post-resuscitation Care Registry for Survival From Out-of-hospital Cardiac Arrest

Conditions
-----------------
Out-Of-Hospital Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 20 years old or older who presents to the ED of the participating hospitals with any of the following criteria: Sustained ROSC from OHCA at pre-hospital level Sustained ROSC from OHCA at the ED of the participating hospitals after ACLS Patients sustained ROSC from OHCA and transferred from other hospital to the ED of the participating hospitals for post-cardiac arrest care Exclusion Criteria: Age less than 20 years old Patients with advanced directives not to deliver aggressive organ supportive management

Ages Eligible for Study
-----------------
Minimum Age: 20 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 | One year survival | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | Mortality on the 28th day | 28-day | 
| 28-day CPC | Brain function at 28th day | 28-day | 
| 6-month CPC | Brain function at 6-month | 6-month | 
| 1-year CPC | Brain function at 1-year | 1-year | 
| Organ support treatment (mechanical ventilation) | Mechanical ventilation | Hospital discharge (non-survivors) or 1-year (survivors) | 
| Organ support treatment (renal replacement therapy) | Renal replacement therapy | Hospital discharge (non-survivors) or 1-year (survivors) | 
| ICU length of stay | ICU length of stay | Hospital discharge (non-survivors) or 1-year (survivors) | 
| Hospital length of stay | Hospital length of stay | Hospital discharge (non-survivors) or 1-year (survivors) |
Study of Olmesartan Medoxomil (CS-866) in Patients With Chronic Glomerulonephritis or Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
The treatment period was 16 weeks, the initial dose, 5 mg, was unforcedly titrated to 10 mg, 20 mg and 40 mg after confirming tolerance at weeks 4, 8 and 12. The primary endpoint for efficacy was the change in the urinary protein/creatinine ratio from baseline to the end of treatment. The secondary endpoint was creatinine clearance (Ccr).

Official Title
-----------------
An Open-label Study of Olmesartan Medoxomil (CS-866) in Normotensive Patients With Chronic Glomerulonephritis or Diabetic Nephropathy

Conditions
-----------------
Chronic Glomerulonephritis, Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: olmesartan medoxomil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: urinary protein/creatinine ratio in the 0.50 g/g to 3.50 g/g creatinine range normal sitting blood pressure values: systolic blood pressure of 100 mmHg or above but below 140 mmHg; diastolic blood pressure of 50 mmHg or above but less than 90 mmHg Exclusion Criteria: treatment with corticosteroids or immunosuppressants treatment with antihypertensives (other than ARBs and ACE inhibitors) serum potassium level of 5.5 mEq/l or above serum creatinine level of 2.0 mg/dl or above

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>16 weeks of treatment starting with 5 mg of olmesartan medoxomil. If tolerated, the dose was increased to the next higher dose at weeks 4, 8, and 12. | Drug: olmesartan medoxomil<br>* olmesartan medoxomil tablets, once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the urinary protein/creatinine ratio from baseline to the end of treatment. |  | baseline to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of creatinine clearance |  | baseline to 16 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Glomerulonephritis, Diabetic Nephropathy, Angiotensin II Receptor Blocker, Urinary Protein