linjc16/ctgov huggingface dataset:
Drug Use-Results Survey in Participants Infected With Hepatitis C Virus Genotype 2

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir with ribavirin used for participants infected with chronic hepatitis C virus (HCV) genotype 2 in daily practice in Japan.

Official Title
-----------------
Drug Use-Results Survey in Patients Infected With Hepatitis C Virus Genotype 2

Conditions
-----------------
Chronic Hepatitis C Virus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCV genotype 2 participants treated with paritaprevir/ritonavir/ombitasvir plus ribavirin in daily practice. Exclusion Criteria: Participants who have been previously treated with paritaprevir/ritonavir/ombitasvir and ribavirin.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Chronic infection of hepatitis C virus (HCV) genotype 2<br>Participants with confirmed chronic HCV genotype 2, receiving paritaprevir/ritonavir/ombitasvir and ribavirin according to standard of care and in line with the current local label | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Sustained Virologic Response (SVR12) | Hepatitis C virus (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last dose of study drug. | 12 weeks after last dose of study drug. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Virologic Failure During Treatment (breakthrough) | HCV RNA levels reach less than the LLOQ, then increase to greater than or equal to the LLOQ at any point during treatment. | Up to 12 Weeks | 
| Percentage of Participants with Virologic Failure After Treatment (relapse) | Undetectable viremia (HCV RNA less than LLOQ) at the end of the 16 weeks treatment but subsequent viremia (HCV RNA greater than or equal to LLOQ) during the follow-up period of 24 weeks after treatment. | Post-treatment 24 weeks | 
| Percentage of Participants with Sustained Virologic Response (SVR24) | HCV RNA less than the LLOQ 24 weeks after the last dose of study drug. | 24 weeks after the last dose of study drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genotype 2, Paritaprevir, Hepatitis C Virus (HCV), Ritonavir, Ombitasvir
Acute Effect of Topical Menthol on Carpal Tunnel Syndrome

Study Overview
=================
Brief Summary
-----------------
Topical menthol gels are classified 'topical analgesics' and are used to relieve pain of the musculoskeletal system. However, double-blind randomized controlled trials are lacking. Here the investigators examine - in a double-blind randomized controlled cross-over trial - the acute effect of topical menthol (Biofreeze) and placebo (gel with a menthol scent) on pain symptoms in slaughterhouse workers with symptoms of Carpal Tunnel Syndrome.

Official Title
-----------------
Acute Effect of Topical Menthol on Pain Symptoms in Slaughterhouse Workers With Symptoms of Carpal Tunnel Syndrome: Randomized Controlled Trial

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Other: Menthol
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: positive Phalen test positive Tinel test nocturnal hand/wrist pain pain intensity of at least 4 in the hand/wrist the pain should have lasted at least 3 months Exclusion Criteria: pregnancy life-threatening disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 67 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menthol<br>Biofreeze topical gel containing 3.5% menthol | Other: Menthol<br>* The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm<br>* Other names: Topical analgesic;|
| Placebo Comparator: Placebo<br>Topical gel containing a menthol scent, but no active menthol | Other: Placebo<br>* The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in arm/hand pain intensity (scale 0-10) during work | the participant rates pain intensity during the last hour on a scale from 0-10 immediately before, and 1,2,3 hours after application of the gel. The primary outcome is the change from before to after (average of 1,2 and 3 hours after) application of the gel | change from before to after (average of 1,2 and 3 hours after) application of the gel | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GROC | Global Rating of Change (GROC) on a scale from - 5(much worsening of pain) to 5(much improvement of pain) | 3 hours after application of the gel | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carpal tunnel syndrome, hand pain, wrist pain, arm pain, topical menthol
Dose Ranging Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the dose of recombinant human insulin-like growth factor I that minimizes or decreases the need for exogenous glucose support without causing hypoglycemia.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a dose escalation study. Patients receive an escalating dose of recombinant human insulin-like growth factor I (IGF-I). IGF-I is given subcutaneously twice a day. The dose of IGF-I is increased each day for 4 days. Glucose is administered intravenously, when necessary, to prevent hypoglycemia. Following the study treatment patients resume prior medication and may undergo surgery. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Hyperinsulinism

Intervention / Treatment
-----------------
* Drug: insulin-like growth factor I


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of hyperinsulinism (i.e., evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action) Intractable hypoglycemia (i.e., persistent IV glucose requirement for maintaining glucose levels greater than 60 mg/dL) Failed standard treatment regimen of diazoxide, octreotide, and frequent feedings to control hypoglycemia No other major medical problems

Ages Eligible for Study
-----------------
Minimum Age: 3 Weeks
Maximum Age: 3 Months

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin-like growth factor I|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endocrine disorders, hyperinsulinism, rare disease
Randomized Study on Salt Intake and Energy Metabolism

Study Overview
=================
Brief Summary
-----------------
To perform a randomized, double-blind clinical study on the effects of an increased salt intake on metabolic, cardiovascular and immunological parameters and the gut microbiota

Official Title
-----------------
Effects of Increased Salt Intake on Energy Metabolism in Healthy Volunteers - a Randomized Clinical Study

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

Intervention / Treatment
-----------------
* Dietary Supplement: Salt
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women 18 - 50 years Body mass index 18.5 - 29.9 kg/m2 Exclusion Criteria: Clinically relevant heart, lung, liver, and kidney diseases Current or chronic infection Habitual use of probiotics or dietary supplements Pregnancy, lactation

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Salt<br>6 grams sodium chloride per day for 14 days | Dietary Supplement: Salt<br>* 10 capsules daily for 14 days<br>|
| Placebo Comparator: Placebo<br>6 grams gelatine per day for 14 days | Dietary Supplement: Placebo<br>* 10 capsules daily for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary induced thermogenis (%) | Decrease of dietary induced thermogenis after salt vs. placebo | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure (mmHg) | Increase of systolic blood pressure after salt vs. placebo | 14 days | 
| Lymphocytic pro-inflammatory mediators | Increase of lymphocytic pro-inflammatory mediators after salt vs. placebo | 14 days | 
| Gut microbiome | Change of gut microbiome composition after salt vs. placebo | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Calorimetry, Blood pressure, Immunophenotyping, Gut microbial composition
Collagenase in the Treatment of Cellulite

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if collagenase injection will reduce or eliminate the appearance of cellulite of the thigh.

Detailed Description
-----------------
This is an open label study of collagenase injection therapy for reduction and/or elimination of cellulite of the posterolateral thighs.

Official Title
-----------------
Collagenase in the Treatment of Cellulite

Conditions
-----------------
Cellulite

Intervention / Treatment
-----------------
* Drug: Collagenase
* Biological: Biological


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 10 x 10 cm area of cellulite of the posterolateral thigh(s) Exclusion Criteria: any chronic, serious or uncontrolled medical condition inability to conform to study visits (12-15 per year)

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Collagenase|One 0.58mg injection every two weeks for six weeks (total three 0.58mg injections)|
|Biological: Biological|Collagenase injection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction and/or elimination of cellulite in the posterolateral thigh |  | 6 months |
Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test

Study Overview
=================
Brief Summary
-----------------
Low vitamin D levels were found to be associated with cardiovascular morbidity and mortality. Low zinc levels are associated with an increased atherosclerotic burden. Therefore we hypothesized that patients with pathological stress test would have low levels of Vitamin D and zinc compared to patients with a normal stress test.

Detailed Description
-----------------
Hypovitaminosis D is generally defined as 25(OH)D levels of < 20ng/ml, while levels of 21-29ng/ml indicate insufficiency and those above 30ng/ml are regarded as sufficient. The rational behind the observations associating vitamin D deficiency with CVD is that on the one hand, hypovitaminosis D was found to be associated with traditional risk factors such as hypertension (HTN),diabetes mellitus (dm),obesity, dyslipidemia and metabolic syndrome , on the other hand, experimental data demonstrated that vitamin D could affect cardiac muscle cells directly, control parathyroid (PTH) hormone secretion, regulate the rennin- angiotensin- aldosterone system and the immune system, all of which could influence cardiovascular risk. Epidemiological studies further support this association, demonstrating high prevalence of hypovitaminosis D among U.S. adults with cardiovascular disease (74%). An association between low vitamin D levels and increased myocardial infarction risk as well as total mortality has been also observed. Low 25hydroxyvitamin D[ 25(OH)D] levels were also independently associated with all cause and CVD mortality among patients scheduled for coronary catheterization.

Official Title
-----------------
Vitamin D and Zinc Levels in Patients Undergoing Ergometry Test

Conditions
-----------------
Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years old CCT > 60 ml/min No IHD No hyper/hypoparathyroidism No active malignancy Not taking calcium, phosphate Exclusion Criteria: Under 18 years of age Not fulfilling inclusion criteria

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 |
| --- | --- |
| positive ergometry<br>positive ergometry as specified by a cardiologist on site. | |
| negative ergometry.<br>negative ergometry as specified by cardiologist on site. | |
| patients with positive stress test<br>100 patients with positive ergometry test as specified by the cardiologist in charge. All patients are ambulatory patients referred for routine check up. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positive stress test |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ergometry, vitamin d, zinc
HuMax-CD20 in Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine the safety and efficacy of HuMax-CD20 as a treatment for Chronic Lymphocytic Leukemia.

Official Title
-----------------
An Open-labeled, International, Multicenter, Dose Escalating, Phase I/II Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Conditions
-----------------
Chronic Lymphocytic Leukemia

Intervention / Treatment
-----------------
* Drug: HuMax-CD20


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Lymphocytic Leukemia Circulating lymphocytes above a specific level Circulating lymphocytes showing certain markers Exclusion Criteria: Previous treatment with rituximab or alemtuzumab within 6 months prior to enrollment in study. Previous stem cell transplantation. Received any of the following treatments within 4 weeks prior to entering this trial: A) Anti-cancer therapy, B) Glucocorticoids unless less than 10 mg per day, C) Radiotherapy. HIV positivity. Hepatitis B or hepatitis C. Other cancerous diseases, except certain skin cancers and cervix cancer. Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, heart, hormonal, nerve or blood diseases. Participation in another trial with a different new drug 4 weeks prior to enrollment in study. Current participation in any other clinical study. Pregnant or breast-feeding women. Women of childbearing age who are unable or unwilling to use adequate contraception.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: HuMax-CD20|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Lymphocytic Leukemia, B-cell Lymphoma
Biomarker in Lung Diseases

Study Overview
=================
Brief Summary
-----------------
Disease related biomarkers have been established decades ago, e.g. blood glucose for diabetes diagnosis and management. Their discovery has grown dramatically during the past decade and they have the potential to lead the physician in diagnosis -especially differential diagnosis - and therapy. However, a specific serum-biomarker in lung diseases has not been established. Aim of the current study is to to measure lung specific proteins in the serum in patients with various lung diseases and to correlate those with disease severity, lung function and other laboratory results

Official Title
-----------------
Feasibility Study on Establishing Biomarkers in Lung Diseases

Conditions
-----------------
Lung Diseases

Intervention / Treatment
-----------------
* Other: biomarker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >= 18 acute or chronic lung disease Exclusion Criteria: HIV lactation or gestation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| lung disease<br>patients with various chronic or acute lung diseases | Other: biomarker<br>* measuring serum-biomarkers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum biomarker expression |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarker, lung disease
A Comparison of Survey Methodologies to Elicit Sensitive Information From Adolescents in Urban India

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to use three different survey methodologies to evaluate whether adolescents report on their knowledge, attitudes and behaviors on sexual and reproductive health issues differently based on the manner in which questions are asked.

Detailed Description
-----------------
Specific Aims and Research Questions Aim 1: To compare adolescents' levels of reporting of their own reproductive health knowledge, attitudes and behaviors using three survey methodologies: (1) Face-to-face interview (2) Audio-CASI (Computer Assisted Self Interview) and (3) a culturally appropriate interactive methodology. The following hypothesis will be tested: • Overall, adolescents will be more likely to divulge their own reproductive knowledge, attitudes and behaviors with Audio-CASI and the interactive method as compared to face-to-face interviews. Levels of knowledge, attitudes and behaviors will vary by education, age and gender. Aim 2: To compare respondents' levels of comfort, accuracy and honesty with the survey methodologies (i.e. face to face, audio-CASI and interactive methodology) to their reporting of knowledge, attitudes and behaviors related to sexual and reproductive health.

Official Title
-----------------
A Comparison of Survey Methodologies to Elicit Information on Sexual and Reproductive Health From Adolescents in Urban India

Conditions
-----------------
Unmarried Male and Female Adolescents in the Age Group 15-19 Years in Pre-Identified Slums in Delhi, India

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unmarried male and female adolescents in the age group 15-19 in pre-identified slums in Delhi, India Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 19 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 |
| --- | --- | --- |