linjc16/ctgov huggingface dataset:
Role of FXR in Hepatitis C Virus Replication

Study Overview
=================
Brief Summary
-----------------
In vitro in the hepatitis C virus (HCV) replicon system, modulation of the biliary salts nuclear receptor FXR by either agonists or antagonists respectively increases or decreases the replication of HCV (J Hepatol, 2008, 48: 192-9). One antagonist of FXR is a vegetal sterol, guggulsterone, that is extracted from the Commiphora mukul tree and that has already been given safely to hyper cholesterolemic patients in a clinical trial (JAMA 2003, 290: 765-72). The aim of this trial is to test the effect of the FXR antagonist guggulsterone given orally, three times a day, on the viral load in 15 HCV genotype 1 chronically infected patients.

Official Title
-----------------
Study of the Role of the Biliary Salts Nuclear Receptor FXR in Hepatitis C Virus Replication

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

Intervention / Treatment
-----------------
* Other: guggulsterone, a natural FXR antagonist.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients infected by HCV genotype 1, with anti-HCV antibodies, non responders to at least one first line of therapy Viral load > 1 x 105 UI/mL for more than 6 months and not treated for at least the last two months. METAVIR score < F4 Exclusion Criteria: Alcohol intake > 20 g/day Immuno - suppressive therapy Obesity BMI > 30, diabetes Dyslipidemia requiring specific therapy Liver cirrhosis or carcinoma HIV or HBV co-infections Other liver diseases Major organ failures Therapy with cytochrome P450 metabolized drugs

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

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

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: Guggulsterone<br>One arm of 15 chronically HCV genotype one infected patients | Other: guggulsterone, a natural FXR antagonist.<br>* Gugulipid®, natural extract from Commiphora mukul tree, containing 2.5% guggulsterone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone. |  | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modification of the fraction of the circulating viral forms associated with apolipoprotein B |  | One week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C virus, Biliary salts, Farnesoid X receptor, Guggulsterone
PORTAS 2, Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to investigate if the success rate of punction the vena subclavia (99% in retrospective studies) will be 15% higher than the success rate of venae sectio (80% in retro and prospective studies) for implantation of a totally implantable access ports.

Official Title
-----------------
Randomized Controlled Trial Comparing Venae Sectio Versus Punction of Vena Subclavia for Insertion of a Totally Implantable Access Port

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Procedure: Venae sectio
* Procedure: Punction of V. subclavia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age equal or greater than 18 years Patients scheduled for primary elective implantation of TIAP Exclusion Criteria: Participation in another clinical trial which could interfere with the primary endpoint of this study Lack of compliance Impaired mental state or language problem Patients with known allergy to contrast agent
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Venae Sectio technique will be used to insert totally implantable access port (TIAP) by a surgeon | Procedure: Venae sectio<br>* surgical preparation of the cephalic vene to insert a totally implantable access port.<br>|
| Experimental: B<br>Punction of Vena Subclavia will be used to insert totally implantable access port (TIAP) by a radiologist. | Procedure: Punction of V. subclavia<br>* radiological punction of the v. subclavia with Seldinger technique to implant a totally implantable access port<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary success rate of the randomized intervention |  | Assessed on the day of surgery (day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-/postoperative complication rate for the randomized intervention |  | Assessed after 90 day post operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
permanent venous access, chemotherapy, parenteral nutrition, Patients with a benign and/or malignant diseases which demand a safe and permanent venous access, e.g. for chemotherapy and/or parenteral nutrition, benign diseases, malignant diseases
Association Between Renal Reserve Function and Progression of Renal Function to Predict CKD Risk in Thai Elderly

Study Overview
=================
Brief Summary
-----------------
This study investigates renal functional reserve in elderly.

Detailed Description
-----------------
The prevalence of CKD in elder is high as age has been a variable in eGFR equation. eGFR by calculation always declines in parallel with age. The assumption that a persistent over 3 months of eGFR less than 60 mL/min/1.73m2 define CKD with risk of progression and need refer to nephrologist may not necessary true in aging population. We study renal functional reserve in elderly population who risk of CKD progression and ESRD is the highest prevalence in human life cycle and explore whether renal functional reserve can be used as ad additional marker of CKD progression in elderly.

Official Title
-----------------
Study of the Association Between Renal Reserve Function and Progression of Renal Function to Predict Chronic Kidney Disease Risk in Thai Elderly

Conditions
-----------------
Elder, Renal Function Abnormal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age > 60 years at screening Patient willing to participate in the study and can provide inform consent Patient have residual kidney function ≤ 90 ml/min/1.73m2 by CKD-EPI equation Exclusion Criteria: Patient active smoking Patient have Charlson comorbidity index > ..... Patient active cancer Patient contraindications for blood collection Patients with a history of hypersensitivity to cimetidine or amino acid IV solution

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| Change of renal functional reserve per 12 months (mL/min) | Renal functional reserve defined as the difference between baseline creatinine clearance and creatinine clearance achieved under stimulation with amino acid infusion. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal functional reserve, CKD progression, Elderly
A Two-week Study Assessing the Onset of Effect Questionnaire (OEQ) Administered Daily Versus Weekly in Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) using a 1 week recall period versus a 1 day recall period.

Official Title
-----------------
A Two-week, Randomised, Double-blind Study Assessing the Onset of Effect Questionnaire Administered Daily Versus Weekly in Adult Subjects (≥ 18 Years) With Mild to Moderate Asthma, Receiving SYMBICORT® pMDI 80/4.5 μg x 2 Actuations Twice Daily or Budesonide HFA pMDI 80 μg x 2 Actuations Twice Daily

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Budesonide/formoterol pMDI
* Drug: Budesonide HFA pMDI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female, > 18 years of age Mild to moderate asthma requiring treatment with an inhaled corticosteroid Diagnosis of asthma for at least 6 months Exclusion Criteria: Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular) Subjects with severe asthma, as judged by investigator Any significant disease or disorder that may jeopardize a subject's safety

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: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Budesonide/formoterol pMDI|nan|
|Drug: Budesonide HFA pMDI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) items 2 and 5 using a 1 week recall period versus a 1 day recall period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the value to subjects of feeling an asthma maintenance medication begins to work right away; to assess the correlation between subject's responses to weekly/daily Onset of Effect Questionnaires with lung function and with diary variables. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mild asthma, Moderate asthma
PAF-HEFT (Permanent Atrial Fibrillation in Heart Failure Trial)

Study Overview
=================
Brief Summary
-----------------
Examination of CRT efficacy in patients with progressive heart failure and atrial fibrillation at the same time

Official Title
-----------------
Permanent Atrial Fibrillation in Heart Failure Trial

Conditions
-----------------
Atrial Fibrillation, Heart Failure

Intervention / Treatment
-----------------
* Procedure: Ablation
* Other: Rate Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LVEF <35% QRS time ≥150ms LBB NYHA classification ≥ NYHA III permanent (> 6 months) Atrial Fibrillation sinus rhythm (control group) Condition after Implantation of a Medtronic CRT device written informed consent Exclusion Criteria: exchange of the current CRT device mitral incompetence (2. degree) no compliance participation in another study pregnancy patients with AV node patients after heart transplant or those who are on the transplant list

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AV ablation<br> | Procedure: Ablation<br>* AV-node ablation<br>|
| Active Comparator: Rate control<br>Rate control by drugs | Other: Rate Control<br>* Rate control by drug<br>|
| No Intervention: Sinus rhythm<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End systolic left ventricular diameter |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NYHA-Class, Echo-parameters, ECG-parameters, VO2 max,6 minutes hallwalk-test |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, Heart Failure
Predictive Factors and Outcome in Medical Thoracoscopy

Study Overview
=================
Brief Summary
-----------------
Retrospective survey for factors predicting the outcome of medical thoracoscopy

Detailed Description
-----------------
Retrospective survey for factors predicting the outcome of medical thoracoscopy in patients with malignant pleuritis

Official Title
-----------------
Predictive Factors and Outcome in Medical Thoracoscopy

Conditions
-----------------
Pleuritis

Intervention / Treatment
-----------------
* Drug: sterile talc pleurodesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: progressive malignancy pleuritis Exclusion Criteria: respiratory failure unable to consent

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 |
| --- | --- |
| responders<br>amelioration of dyspnea radiological amelioration after sterile talc pleurodesis | Drug: sterile talc pleurodesis<br>* medical thoracoscopy and talc pleurodesis. No specific device is studied.<br>* Other names: medical thoracoscopy;|
| failed intervention<br>unchanged symptoms and radiology after sterile talc pleurodesis | Drug: sterile talc pleurodesis<br>* medical thoracoscopy and talc pleurodesis. No specific device is studied.<br>* Other names: medical thoracoscopy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest X-ray | radiological resolution of pleuritis; 3 level severity grading (A, B, C, with C as worst grade) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time interval | survival in months | 12 months |
Dose-escalation Study of IMC-001 in Subject With Metastatic or Locally-advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This is a phase 1, Open-label, Multiple-ascending Dose Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of IMC-001 in Subjects with Metastatic or Locally-advanced Solid Tumors

Detailed Description
-----------------
IMC-001 is a PD-L1 targeting, fully human monoclonal antibody. The purpose of this study is to determine safety and evaluate PK, PD and clinical activity of IMC-001. Multiple dose levels of IMC-001 will be tested in subjects with metastatic or locally-advanced solid tumors. Data from this study will also help determine the recommended phase 2 dose of IMC-001.

Official Title
-----------------
A Phase 1, Open-label, Multiple-ascending Dose Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of IMC-001 in Subjects With Metastatic or Locally-advanced Solid Tumors

Conditions
-----------------
Solid Tumor, Metastasis, Locally Advanced

Intervention / Treatment
-----------------
* Drug: IMC-001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Form (ICF). Adult (19 years or older). Histologically or cytologically proven metastatic or locally-advanced solid tumors Exclusion Criteria: Treatment with non-permitted drugs (within the past 28 days of Screening), including but not limited to systemic immunosuppressive agents, any other investigational medicinal product (IMP), anti-coagulant, or live vaccines. Any prior cancer immunotherapy Concurrent anticancer treatments

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMC-001<br>Multiple Dose Level (IMC-001 2 mg/kg etc. every 2 weeks) | Drug: IMC-001<br>* Different IMC-001 dose level for each cohort group (IMC-001 2 mg/kg etc. every 2 weeks)<br>* Other names: Not confirm yet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of DLTs | To investigate the occurrence of DLTs of IMC-001 treatment. | During the first 21 days of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IMC-001
Long-Term Specified Drug Use-results Survey of Betanis Tablets

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the safety and efficacy of long-term use of Betanis (generic name: mirabegron), and to determine the adherence to treatment with mirabegron.

Official Title
-----------------
Long-Term Specified Drug Use-results Survey of Betanis Tablets

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: Betanis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who administer mirabegron for treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder and also who have no treatment history of mirabegron.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Betanis<br>the usual adult dosage of mirabegron once daily after a meal | Drug: Betanis<br>* oral<br>* Other names: mirabegron;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events |  | Up to 36 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overactive Bladder Symptom Score (OABSS) |  | At the start of treatment and 3, 6, 12, 18, 24, 30, and 36 months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Betanis®, mirabegron, Overactive Bladder
Effects of Early Nutrition on Growth

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to compare the growth of infants fed standard infant formula with infants fed a reduced calorie and protein formula.

Official Title
-----------------
Effects of Early Nutrient Intake on Growth and Body Composition

Conditions
-----------------
Infant Newborn

Intervention / Treatment
-----------------
* Other: Human Milk
* Other: Investigational infant formula
* Other: Milk based standard infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: good health singleton birth with gestational age 37-42 weeks infant's birth weight >or = to 2500 grams exclusive breastfeeding or exclusively formula feeding within a defined geographical boundary mother has no problems communicating in English Exclusion Criteria: adverse maternal, fetal or infant medical history congenital disease or malformation affecting growth or development illness or social problems in mother or infant temporary residents

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 24 Hours

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Human Milk<br>ad lib | Other: Human Milk<br>* ad lib<br>|
| Active Comparator: Milk based standard infant formula<br>ad lib | Other: Milk based standard infant formula<br>* ad lib<br>|
| Experimental: Milk based investigational infant formula<br>ad lib | Other: Investigational infant formula<br>* ad lib<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain |  | 1- 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal tolerance |  | 1-365 days | 
| Infant Anthropometrics |  | 1 - 365 days; 24 months |