linjc16/ctgov huggingface dataset:
Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis

Study Overview
=================
Brief Summary
-----------------
There was no sensitive and specific biomarker for tuberculosis infection, disease progression and predicting the prognosis of treatment. Therefore, the investigators aimed to investigate and evaluate the newer biomarker for the diagnosis of TB infection. To investigate the new biomarker for TB infection, the investigators will recruit the participants including active TB patients, healthy household contacts, healthy community control.

Official Title
-----------------
Characterization and Evaluation of Diagnostic Biomarkers for Tuberculosis

Conditions
-----------------
Active Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: active TB patients : diagnosed with active TB through the microbiologic examination, imaging findings healthy control : no history of TB treatment, no respiratory symptoms, no evidence of active infectious disease including TB on chest X-ray, no history of close contacts of active pulmonary TB patients Exclusion Criteria: pregnant woman positive result of human immunodeficiency virus examination

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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 |
| --- | --- |
| active tuberculosis<br>active TB patients : diagnosed with TB through microbiologic examination | |
| healthy control<br>healthy control : no evidence of respiratory disease, no respiratory symptoms, and no history of close contact of active pulmonary TB patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of antigens of Mycobacterium tuberculosis K strain for serodiagnosis of tuberculosis |  | 6months |
Cocaine-Metyrapone Interaction Study - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the safety of two consecutive days of metyrapone (MRP) in subjects who may use cocaine concurrently.

Detailed Description
-----------------
To evaluate the safety of metyrapone (MRP) for using in an outpatient study in which participants would be given 2 750 mg doses of MRP per week. Secondary study goals are to evaluate the possible efficacy of MRP as a treatment for cocaine dependence and to compare 3 factors hypothesized to induce cocaine craving: cocaine cues, stress, and cocaine itself. This study will utilize a Double Blind, placebo-controlled crossover design with 3 factors: 1) medication 2) relapse trigger and 3) infusion for an 11 day in-patient treatment.

Official Title
-----------------
Cocaine-Metyrapone Interaction Study

Conditions
-----------------
Cocaine-Related Disorders, Infusions, Intravenous

Intervention / Treatment
-----------------
* Drug: Metyrapone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Females between 18 and 45 yrs of age; cocaine dependence according to DSM-4; females of child-bearing potential must test non-pregnant and use adequate birth control; be able to provide consent, comply with protocol requirements and try to complete all study treatments. Exclusion Criteria: Additional criteria available during screening at the site.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine craving |  |  |
Hypernet- Hypertension Screening

Study Overview
=================
Brief Summary
-----------------
Identify untreated, asymptomatic hypertension in ER patients

Detailed Description
-----------------
this was a prospective study done with no intervention- the study has since been completed

Official Title
-----------------
Hypernet- Hypertension ED Surveillance

Conditions
-----------------
Asymptomatic Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: asymptomatic hypertension Exclusion Criteria: cardiac symptoms

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 |
| --- | --- |
| adult ED patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Falling in Patients With COPD Referred to Pulmonary Rehabilitation: Incidence, Risk Factors and Prediction Tools

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to investigate the incidence of falling in a cohort of patients with chronic obstructive pulmonary disease (COPD) referred to a pulmonary rehabilitation program and to verify the risk factors. The secondary aim is to verify whether available balance assessment tools are feasible in clinical practice and which tools and values can best predict falls in people with COPD.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a primary diagnosis of COPD according to internationally accepted guidelines All patients referred to the outpatient PR program of Gasthuisberg University Hospital (Leuven, Belgium). Exclusion Criteria: None
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 |
| --- | --- | --- |
| incidence of falling |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| association between falling status and the score in balance tests |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary rehabilitation, balance assessment, Chronic Obstructive Pulmonary Disease
Swiss Childhood Health and Nutrition Survey

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to assess the prevalence of overweight and obesity in 6 to 12 year old children in Switzerland. This data will be used to investigate trends in the development of overweight and obesity in Switzerland. In addition, a questionnaire will be used to assess data on physical activity, nutrition, health and socioeconomic background and waist circumference as well as skin fold thicknesses will be measured.

Official Title
-----------------
National Studie Gesundheit Und Ernährung Von Primarschülern

Conditions
-----------------
Overweight and Obesity in Schoolchildren

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 6 and 12 years Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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 |
| --- | --- | --- |
| Prevalence of overweight and obesity | Based on weight and height measurements BMI z-scores will be calculated for the classification in the different weight status groups (underweight, normal weight, overweight, obese) | 1 day of first visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference |  | 1 day of first visit | 
| body fat % | Based on the measurement of skinfold thicknesses at 4 sites body fat % will be calculated | 1 day of first visit | 
| Physical activity | Assessed using a questionnaire | 1 day of first visit | 
| Nutrition | Assessed using a questionnaire | 1 day of first visit | 
| General health | Assessed using a questionnaire | 1 day of first visit | 
| Socioeconomic background | Assessed using a questionnaire | 1 day of first visit |
Sedation for Endoscopic Procedures

Study Overview
=================
Brief Summary
-----------------
Endoscopic procedures for biliary strictures, stenting or drainage (ERCP) and ultrasonic imaging or biopsies (EUS) are performed under sedation or anesthesia. The main purpose of the study is to evaluate aspects of procedure treatability and patients´ quality of recovery.

Detailed Description
-----------------
The main aim of this study is to evaluate the effects on treatability and procedure failur; also aspects of post-procedure quality of recovery from patients cognitive function and from the choice of sedation/anesthesia for ERCP and EUS-procedures. Before endoscopic procedures, patients do not always read the written information sent to them. That´s a problem since patients tend to be insufficient prepared for the procedures. Therefore, evaluation of patients' health literacy was performed. Patients are sedated (patient-controlled sedation or by nurse anesthetists) or in general anesthesia. No randomisation.

Official Title
-----------------
Sedation for Endoscopic Procedures - a Follow-up Study of Efficiency and Safety

Conditions
-----------------
Endoscopic Surgical Procedure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (≥18 years) Patients cheduled for ERCP or/and EUS Patients who have given their informed and written concent to participate Exclusion Criteria: Patients with confusion dementia communication problems.

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 |
| --- | --- | --- |
| Dimensions of recovery recorded by Quality of Recovery 15 swedish version | Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better | Baseline (Day 0) | 
| Dimensions of recovery recorded by Quality of Recovery 15 swedish version | Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better | Day 1 | 
| Dimensions of recovery recorded by Quality of Recovery 15 swedish version | Quality of recovery (QoR15 swedish version) Max 150 points Min 0, higher scores are better | Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health literacy measured by the use of FHL (swedish version) | Health literacy (FHL swedish version), Max 0 Min 5, 0 is good, 5 is bad | Before procedure (Day 0) | 
| Aborted or increased difficulty to performed the planned procedure | Procedure failure, numbers of aborted procedures and numbers of difficult performance | From start of procedure to the end of it (Day 0) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of recovery, Health Literacy, Moderate sedation, Deep sedation, Anesthesia
The Pharmacokinetics of Sirolimus When Combined With Cyclosporine or Tacrolimus in Renal Transplant Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the pharmacokinetic of sirolimus in different regimens, as well as the dose-level relationship of cyclosporine and tacrolimus, and design the most appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose regimen for Taiwanese.

Detailed Description
-----------------
The dose and pharmacokinetic of an immunosuppressant may differ in different ethnics, and different combinations. The purpose of this study is to determine the dose-level relationship of sirolimus through pharmacokinetic study. The dose-level relationship of cyclosporine and tacrolimus was also assessed. From clinical outcome and blood level of sirolimus and cyclosporine or tacrolimus, we can design the most appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose regimen for Taiwanese.

Official Title
-----------------
The Pharmacokinetics and Dosage Regimen of Sirolimus in a Cyclosporine or Tacrolimus-Based Immunosuppression in Renal Transplant Patients

Conditions
-----------------
Transplantation, Kidney Transplantation, Immunosuppression

Intervention / Treatment
-----------------
* Drug: sirolimus, cyclosporine, tacrolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: De novo kidney transplantation patients, aged 13-65 years,have aminotransferase concentrations within 2 times the upper limit of normal. Exclusion Criteria: pregnancy, tuberculosis, hepatitis B or C carrier status, human immunodeficiency virus-positive status, retransplantation or multiorgan transplantation, or history of rheumatoid arthritis.

Ages Eligible for Study
-----------------
Minimum Age: 13 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: sirolimus, cyclosporine, tacrolimus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of sirolimus in different regimens |  |  | 
| Dose-concentration relationship of sirolimus |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of rejection prevention |  |  | 
| Dosage regimen of sirolimus + cyclosporine or tacrolimus |  |  | 
| Dose-concentration relationship of cyclosporine/tacrolimus |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sirolimus, Tacrolimus, Cyclosporine, Pharmacokinetics, Immunosuppressive Agents, Immunosuppression, Kidney Transplantation, Transplantation
Infant Diet Effects on Brain Function and Language Processing (fMRI)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify neurocognitive functions and language processing of 8-year-old children who were fed either breast milk, milk-based formula or soy-based formula during the first year of life.

Official Title
-----------------
Effects of Neonatal Diet on Language, Neurocognitive Functions at Eight Years Old: fMRI, ERP and Standardized Behavioral Measures

Conditions
-----------------
Healthy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy 8-year-old children Full term Birth weight between the 5th - 95th weight-for-age Use of Breast milk, milk-based formula or soy-based formula throughout first year of life English as primary language Right handed first visit BMI between 5th - 95th percentile-for-age Exclusion Criteria: Children with sleep disorders Children who use certain medications that may interfere with study assessments Illnesses or diseases or conditions that may interfere with study assessments

Ages Eligible for Study
-----------------
Minimum Age: 90 Months
Maximum Age: 101 Months

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 |
| --- | --- |
| No groups<br>IDE used for outcome measurement not intervention | Device: No intervention<br>* IDE used for outcome measurement not intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain function test |  | 8 year old | 
| Language processing tests |  | 8 year old | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERP, Healthy children, Brain Function, Diet, Nutrition, Language, fMRI, Behavior
Triple Combination Therapy of Choroidal Neovascularization in AMD, a Cost Effect and Efficient Therapeutic Treatment

Study Overview
=================
Brief Summary
-----------------
We propose to undertake a retrospective review of approximately 200 patients with a diagnosis of exudative macular degeneration treated with triple combination therapy (Bevacizumab, Dexamethasone and Photo-dynamic therapy) during the years of 2006 to 2010 at The Retina Center and compare those results with an additional group of approximately 200 patients also treated with triple combination therapy and 20 mg of daily oral zeaxanthin.

Detailed Description
-----------------
Study parameters will include best corrected visual acuity, number of combination treatments, reduction of central foveal thickness by OCT measurement and development of exudative macular degeneration in the fellow eye. Follow up will include all patients with a minimum of two years. Retrospective review of patient charts in the office of The Retina Center.

Official Title
-----------------
Triple Combination Therapy of Choroidal Neovascularization in Exudative Age-related Macular Degeneration - a Cost Effect and Efficient Therapeutic Treatment

Conditions
-----------------
Exudative Macular Degeneration

Intervention / Treatment
-----------------
* Procedure: TRIPLE COMBINATION THERAPY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - MUST HAVE AGE RELATED MACULAR DEGENERATION Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| 2006 TO 2010 PATIENTS<br>PATIENTS TREATED WITH TRIPLE COMBINATION THERAPY | Procedure: TRIPLE COMBINATION THERAPY<br>* TREATMENT WITH BEVACIZUMAB, DEXAMETHASONE AND PHOTODYNAMIC THERAPY<br>|
| CURRENT PATIENTS<br>PATIENTS TREATED WITH TRIPLE COMBINATION THERAPY AND ADDITION OF 20 MG OF ORAL ZEAXANTHIN | Procedure: TRIPLE COMBINATION THERAPY<br>* TREATMENT WITH BEVACIZUMAB, DEXAMETHASONE AND PHOTODYNAMIC THERAPY<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BEST CORRECTED VISUAL ACUITY |  | REVIEW OF EXAMINATION SHEETS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NUMBER OF COMBINATION TREATMENTS |  | REVIEW OF CHART | 
| REDUCTION OF CENTRAL FOVEAL THICKNESS BY OCT MEASUREMENT |  | REVIEW OF CHART | 
| DEVELOPMENT OF EXUDATIVE MACULAR DEGENERATION IN THE FELLOW EYE |  | REVIEW OF CHART |
Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate the safety and effectiveness of Interferon gamma-1b (IFN-g 1b) on lung function when given to patients with cystic fibrosis by inhalation (breathed into the lungs) three times a week for 12 weeks. The FDA has not approved Interferon gamma-1b for use with cystic fibrosis patients, which is the condition being examined in this study.

Official Title
-----------------
A Phase I/II Study of Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: interferon gamma-1b


Participation Criteria
=================
Eligibility Criteria
-----------------
Key inclusion criteria: At least 12 years of age Diagnosis of cystic fibrosis with mild to moderate pulmonary impairment Must be receiving ongoing chronic treatment with TOBI (inhaled tobramycin) OR not receiving ongoing chronic treatment with TOBI and no use of TOBI or other inhaled antibiotic within 4 weeks prior to study drug administration· Other specific diagnostic indicators of CF and other factors must meet minimum requirements.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: interferon gamma-1b|500 or 1000 mcg, inhalation, 3x per week|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in FEV1, sputum bacterial density |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cystic fibrosis, pulmonary impairment