linjc16/ctgov huggingface dataset:
Evaluation of the Performance and Use of Non-Invasive Glucose Monitoring Device

Study Overview
=================
Brief Summary
-----------------
Diabetes is a leading cause of death in the Western World with medical costs increasing annually. There is no cure for diabetes, and blood glucose monitoring is a key component in diabetes treatment and management. Self-monitoring of blood glucose levels is essential to the self-management of diabetes and has become widespread over the past decade. Blood glucose determinations are currently done by invasive methods (finger tip pricking), followed by measuring the blood drop characteristics. The purpose of this trail is to demonstrate the performance and use of GlucoTrack device in measuring blood glucose levels. The rationale for development of the device is to improve the patient's quality of life by providing a device that is easily used and provides a painless measurement method, thereby leading to higher compliance, and to better managed diabetes

Detailed Description
-----------------
See Brief summary

Official Title
-----------------
Evaluation of the Performance and Use of GlucoTrack Model DF-F Non-Invasive Glucose Monitoring Device.

Conditions
-----------------
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: GlucoTrack


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1or 2 Diabetes Anatomically suitable earlobe Exclusion Criteria: Subjects requiring dialysis Any conditions that may hamper good contact between the PEC and the earlobe Pregnancy Nursing mothers

Ages Eligible for Study
-----------------
Minimum Age: 10 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>subjects with a diagnosis of type 1 or 2 diabetes; GlucoTrack results will be compared with the readings from approved invasive glucose meter device. | Device: GlucoTrack<br>* comparison of different glucose monitoring devices<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clarke Error Grid |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Satisfaction | Based on user questionnaire, user satisfection will be analyzed | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glucose monitoring, GlucoTrack, Self glucose monitoring
Evaluation of Varenicline Safety, Tolerability, Pharmacokinetics and Pro-Cognitive Effects in Healthy Elderly Non-Smoking Subjects

Study Overview
=================
Brief Summary
-----------------
Characterize the tolerability and safety of repeated doses of varenicline in healthy non-smoking elderly subjects. Describe the steady state pharmacokinetics of varenicline in healthy non-smoking elderly subjects. Evaluate the potential effects of repeat doses of varenicline on cognition in healtly non-smoking elderly subjects.

Official Title
-----------------
A Randomized, Investigator and Subject Blind, Sponsor Open Parallel Group Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pro-Cognitive Effects of Varenicline, Under Various Titration Schemes, in Healthy Elderly Non-Smoking Subjects

Conditions
-----------------
Healthy, Non-Smoking

Intervention / Treatment
-----------------
* Drug: varenicline
* Drug: varenicline
* Drug: varenicline
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, Elderly (65-85 years inclusive), Non-smoker Exclusion Criteria: Creatinine Clearnace < 30 ml/min, Evidence or history of clinically significant, unstable diseases

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Weekly titration<br> | Drug: varenicline<br>* 0.5 mg once daily for 7days followed by 0.5 mg twice daily for 7days followed by 1mg twice daily for 7 days<br>* Other names: Champix, Chantix;|
| Active Comparator: Two Week QD<br> | Drug: varenicline<br>* 0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days<br>* Other names: Champix, Chantix;|
| Active Comparator: Two Week BID<br> | Drug: varenicline<br>* 0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days<br>* Other names: Champix, Chantix;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo for 21 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability and safety (adverse events, electrocardiogram, vital signs, clinical safety labs, self reported nausea visual analogue scales) |  | 21 days | 
| Steady state pharmacokinetics |  | 21 days | 
| Effects on cognition (computerized battery of cognitive tests) |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No secondary outcomes. |  | Time frame n/a | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Tolerability, Pharmacokinetics, Cognition
Camostat Mesylate for Protein-losing Enteropathy After Fontan Operation

Study Overview
=================
Brief Summary
-----------------
This study is phase 2 open-label, single-arm, multi-center clinical trial to evaluate the efficacy and safety of Camostat mesylate in patients with Protein-losing enteropathy after Fontan operation.

Official Title
-----------------
Phase 2 Open-label, Single-arm, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Camostat Mesylate in Patients With Protein-losing Enteropathy After Fontan Operation

Conditions
-----------------
Fontan Operation, Protein-Losing Enteropathy, Camostat Mesylate

Intervention / Treatment
-----------------
* Drug: Camostat mesylate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of protein-losing enteropathy after Fontan operation more than 6 months after Fontan operation more than 3 months of protein-losing enteropathy history (ascites, edema, diarrhea, etc) and less than 3.0 mg/dL of serum albumin without evidence of renal or liver disease Exclusion Criteria: inability to take oral camostate mesylate hypersensitivity to camostate mesylate patients with taking similar medication or prohibited combination drug patients participating in other clinical trials patients with diet limitation patients with genetic disease such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

Ages Eligible for Study
-----------------
Minimum Age: 4 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: protein-losing enteropathy after Fontan operation<br>single-arm with protein-losing enteropathy after Fontan operation | Drug: Camostat mesylate<br>* 4 12 years old: Camostate mesylate 100 mg, 2 times a day greater than 13 years old: Camostate mesylate 100 mg, 3 times a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum albumin | change compared with baseline | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum albumin | change ratio compared with baseline | 6 months | 
| Stool alpha-1 antitrypsin | change compared with baseline | 6 months | 
| Stool alpha-1 antitrypsin | change ratio compared with baseline | 6 months | 
| diarrhea | change of presence and number | 6 months | 
| ascites | ascites amount change by abdominal ultrasound | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fontan operation, Protein-Losing Enteropathy, Camostat mesylate
Prevention of Missed Opportunities for HIV Diagnosis by Promoting HIV Testing of Patients With Pneumococcal Pneumonia at Nice University Hospital (PneumoVIH)

Study Overview
=================
Brief Summary
-----------------
According to usual practices, HIV testing should be performed for each patient diagnosed for pneumococcal pneumonia. Unfortunately, in 2018, only 27% of patients were tested for HIV following pneumococcal pneumonia in Nice University Hospital. The aim of PneumoVIH protocol is to promote HIV testing by reminding good practices to physicians. To achieve this, the team of the bacteriology laboratory will contact physicians for each patient positive for pneumococcal antigenuria to suggest HIV testing. This prospective public health action will aim to integrate this HIV test into routine care and to evaluate benefits through the number of HIV positive patients that will be diagnosed.

Official Title
-----------------
PneumoVIH : Prevention of Missed Opportunities for HIV Diagnosis by Promoting HIV Testing of Patients With Pneumococcal Pneumonia at Nice University Hospital

Conditions
-----------------
Hiv, Pneumonia, Pneumococcal

Intervention / Treatment
-----------------
* Diagnostic Test: HIV testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 18 years or older with validated diagnosis of bacterial pneumococcal pneumonia. Exclusion Criteria: documented history of HIV infection.

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 |
| --- | --- |
| Patients with positive pneumococcal antigenuria<br> | Diagnostic Test: HIV testing<br>* serology for HIV testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testing rate | To evaluate the implementation of the recommendations, HIV testing rate in this population during the study period will be compared with the previous year. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of HIV-positive status discovery | TEvaluating the HIV positivity in patients with bacterial pneumonia or discharged after a visit at the emergency department at the university hospital | 1 year |
A Phase I Study of Pazopanib in Adult Patients With Liver Cancer

Study Overview
=================
Brief Summary
-----------------
Liver cancer is a good target for anti-angiogenic treatments such as pazopanib. The effect of pazopanib in patients with liver cancer are unknown. This study is designed to evaluate the safety, tolerability and best dose of pazopanib to be given to patient with liver cancer.

Official Title
-----------------
A Phase I, Open-Label, Dose-Escalation, Multi-Center Study or Pazopanib (GW786034) in Adult Patients With Hepatocellular Cancer

Conditions
-----------------
Carcinoma, Hepatocellular

Intervention / Treatment
-----------------
* Drug: pazopanib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of advanced liver cancer adequate bone marrow, liver and kidney function Any local therapy for tumor must have been completed at least 4 weeks prior to enrolling in study Exclusion criteria: Pregnant or breastfeeding Any serious or unstable medical or psychiatric conditions History of metastases to central nervous system History of ulcer, inflammatory bowel disease or disease of the gut History of HIV, or uncontrolled infection Have had a cardiac condition or stoke during the past 6 months High blood pressure Have had a blood clot during the past 6 months History of bleeding blood vessels

Ages Eligible for Study
-----------------
Minimum Age: 21 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pazopanib Arm<br>Different doses of oral pazopanib once daily for the duration of the study starting on Day 1 of Treatment Period 1. Treatment continues until disease progression or withdrawl from study. | Drug: pazopanib<br>* Pazopanib is a potent, multi-target receptor tyrosine kinase inhibitor of VEGFR.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AEs) and changes in vital signs and laboratory values. A dose regimen where no more than 1 out of 6 subjects experience a dose-limiting toxicity (DLT) will define the maximum tolerated dose (MTD). |  | throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Various pharmacokinetic parametersAlpha-fetoprotein (AFP) measurements and scans |  | throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pazopanib, liver cancer, hepatocellular cancer
Peritoneal Dialysis Versus Haemodialysis

Study Overview
=================
Brief Summary
-----------------
Study in order to quantify toxin removal during dialysis

Official Title
-----------------
Clinical Study in Order to Quantify Solute Removal in Peritoneal Dialysis Versus Haemodialysis

Conditions
-----------------
Hemodialysis

Intervention / Treatment
-----------------
* Procedure: Peritoneal dialysis
* Procedure: Haemodialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Substudy 1: includes new starting dialysis patients on peritoneal dialysis PD or haemodialysis HD Substudy 2: stabile haemodialysis patients and peritoneal dialysis patients. Patients will be matched for gender, time on dialysis, diabetes, renal function at the start of dialysis. Substudy 3: patients on CAPD (continuous ambulant PD) or CCPD (continuous cyclic PD).

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Peritoneal dialysis | Procedure: Peritoneal dialysis<br>* Blood, urine and dialysate sampling<br>|
| Active Comparator: 2<br>Haemodialysis | Procedure: Haemodialysis<br>* Blood, urine and dialysate sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Registration of toxin removal efficiency |  | After 1 week and after 1, 3, 6, 9, 12, 18 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic renal insufficiency (patients under dialysis)
Safety and Pharmacokinetics of ELB353 in Healthy Men

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study the safety and tolerability of repeated oral doses of ELB353, to evaluate the plasma levels of ELB353 and to study their effect on substances mediating inflammation.

Official Title
-----------------
A Multiple Ascending Dose Study to Assess the Safety and Pharmacokinetics of Oral ELB353 in Healthy Male Volunteers - A Double-Blind, Randomized, Placebo-controlled, Sequential Group Study

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: ELB353


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Exclusion Criteria: Concomitant medication Concomitant disease

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

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral, 10 days<br>|
| Experimental: ELB353<br> | Drug: ELB353<br>* Oral, 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event frequency and intensity |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of ELB353 |  | 1 month | 
| Inflammatory transmitter response ex vivo |  | 2 weeks |
Effect of Hypnotherapy in Irritable Bowel Syndrome (IBS)

Study Overview
=================
Brief Summary
-----------------
In this trial, the effects of two psychological interventions - i.e. hypnotherapy and relaxation training - are compared with care as usual in IBS treatment. The investigators hypothesized that hypnotherapy is most effective in reducing complaints in IBS.

Official Title
-----------------
Effectiviteit Van Hypnotherapie Bij Prikkelbare Darmsyndroom (Effectiveness of Hypnotherapy in Irritable Bowel Syndrome)

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Behavioral: Hypnotherapy (HYP)
* Behavioral: Relaxation training (RT)
* Other: Care as usual (CON)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Irritable bowel syndrome (Rome II) Presence of complaints < 12 months Exclusion Criteria: Gastrointestinal disorders, other than IBS Previous psychotherapeutic treatment for IBS Severe psychological comorbidity

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 |
| --- | --- |
| Other: Care as usual (CON)<br>CON was given to a subgroup of patients as control treatment in IBS treatment | Other: Care as usual (CON)<br>* CON was given to a subgroup of patients as control intervention in IBS treatment<br>|
| Other: Hypnotherapy (HYP)<br>HYP was given to a subgroup of patients as intervention in IBS treatment | Behavioral: Hypnotherapy (HYP)<br>* Hypnotherapy was given to a subgroup of patients as intervention in IBS treatment<br>|
| Other: Relaxation training (RT)<br>RT was given to a subgroup of patients as intervention in IBS treatment | Behavioral: Relaxation training (RT)<br>* RT was given to a subgroup of patients as intervention in IBS treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean symptom score (MSS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological measures, i.e. anxiety and depression (HADS) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Symptoms, Psychological status, Hypnotherapy, Relaxation training
High Doses of Candesartan Cilexetil on the Reduction of Proteinuria

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of high doses of candesartan cilexetil and also to assess which dose (16mg, 64mg, 128mg) is the most optimal for the maximum reduction of proteinuria.

Official Title
-----------------
A Double-Blind, Randomised, Dose Ranging, Multi-Centre, Phase IIIb Study to Evaluate the Efficacy and Safety of High Doses of Candesartan Cilexetil (Atacand®) on the Reduction of Proteinuria in the Treatment of Subjects With Hypertension and Moderate to Severe Proteinuria

Conditions
-----------------
Proteinuria

Intervention / Treatment
-----------------
* Drug: candesartan cilexetil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Stable hypertension defined as no new antihypertensive medication started within 6 weeks of Visit 1 Minimum 6-month history of hypertension and primary glomerular disease Hypertensive nephrosclerosis Diabetic nephropathy with stable proteinuria as defined by ≥ 1g/24 hours on more than one occasion within 6 months prior to Visit 1 Exclusion Criteria: Persistent hypertension New anti-hypertensive medications started within 6 weeks of Visit 1 Significant cardiac disease or Liver disease Females of childbearing potential without reliable contraception Pregnant women and women who are breast-feeding

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: candesartan cilexetil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effects of high dose candesartan cilexetil on the overall reduction in proteinuria from baseline as evidenced by the 24-hour urine collection |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effects of high dose candesartan cilexetil on renal function as measured by serum creatinine and 24-hour creatinine clearance |  |  | 
| To determine the effects of high dose candesartan cilexetil on blood pressure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension