linjc16/ctgov huggingface dataset:
Phase I Hepatitis C Vaccine Trial of Virosome-formulated Peptides

Study Overview
=================
Brief Summary
-----------------
Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic hepatitis C virus infection. The vaccine is based on a combination of the PeviPRO and PeviTER platforms using synthetic peptide antigens from the hepatitis C virus. Generally, a cellular immune response by cytotoxic T-lymphocytes (CTL) seems to be crucial in overcoming a hepatitis C virus infection. In-depth research in recent years has shown that the cellular immune response is even more effective when supported by helper T-cells. Pevion Biotech's HCV vaccine candidate utilizes this effect inducing specific CTL responses (PeviTER) together with a supportive helper T cell response (PeviPRO). This virosome-based technological combination in a single product represents a new generation of modular therapeutic vaccines.

Official Title
-----------------
A Phase I Single-blind Randomised Placebo Controlled Dose Escalating Study of One Virosome Formulated CD4 and Two Virosomes Formulated CD8 Hepatitis C Virus (HCV) Vaccine Components (PEV2A and PEV2B) Administered to Healthy Adult Volunteers

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

Intervention / Treatment
-----------------
* Biological: PEV2A PEV2B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers of both sexes Aged between 18 and 45 years Free of obvious health problems With a BMI between 18.5 and 29.9 are included if they give written informed consent Exclusion Criteria: Chronic or acute illness Immunosuppression HCV and/or HBV infection history of allergic disease Pre-existing immune response against peptide of the vaccines

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: PEV2A PEV2B|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  |  | 
| Specific cellular immune response by Elispot and FACS |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific proliferative response |  |  | 
| Humoral immunity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, Liver disease, Viral infection, Virosome, Vaccine, therapeutic vaccine, Chronic hepatitis C virus infection
An Exploratory Study To Look At The Effect Of Two Investigational Drugs On Body Fat And Inflammation

Study Overview
=================
Brief Summary
-----------------
The investigational drugs administered in this study activate proteins called PPARs. Data in the scientific literature on PPARs, as well as animal data and early clinical data generated by GSK with these drugs, suggest that activation of PPARs may cause the body to increase its use of fatty acids for energy, and lead to a reduction in body fat. There are also data to suggest a role for PPARs in regulating lipid (e.g., cholesterol) levels and inflammation. These and other activities of PPARs are being further explored in this clinical study.

Official Title
-----------------
A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect of 12-week Treatment With GW590735X (20ug) or GW501516X (10mg) Relative to Placebo on Measures of Adiposity and Inflammation in Overweight and Obese Subjects

Conditions
-----------------
Hypercholesterolemia, Dyslipidaemias, Obesity

Intervention / Treatment
-----------------
* Drug: GW501516
* Drug: GW590735


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Body Mass Index in the range of 27 - 43 kg/m2 Waist circumference > 95cm Exclusion criteria: Clinically relevant abnormalities on screening ECG/holter, labs or medical examination Use of tobacco within 6 months of the study Regular strenuous exercise Use of prescription or non-prescription medications, including vitamins and herbal/dietary supplements LDL < 80mg/dL; TG <100mg/dL or >400mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW501516|nan|
|Drug: GW590735|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat levels |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of multiple proteins/biomarkers in blood and fat tissue, as well as specific lipid in muscle and liver (via imaging). Gene expression in blood and fat tissue. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholesterol, inflammation, fat
Effect of Oxygen During Percutaneous Coronary Intervention for Pain Relief

Study Overview
=================
Brief Summary
-----------------
Nasal oxygen is widely used as pain relief against ischemic pain during Percutaneous Coronary Intervention (PCI). However, to our knowledge no randomised clinical trials have tested this. In contrast, oxygen causes coronary artery vasoconstriction in man. Furthermore, a recent Cochrane meta-analysis has shown no evidence of beneficial effect of oxygen for patients with acute myocardial infarction (with normal blood saturation. The investigators therefore wanted to examine if oxygen reduces ischemic pain during PCI for stable angina or NSTEMI.

Official Title
-----------------
Phase II Randomised Study of Nasal Oxygen Treatment for Pain Relief During Percutaneous Coronary Interventions

Conditions
-----------------
Angina

Intervention / Treatment
-----------------
* Drug: Nasal oxygen
* Drug: Regular nasal air


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable angina or NST-ACS undergoing PCI Exclusion Criteria: Blood oxygen <95% Cognitive dysfunction STEMI Intubation
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nasal oxygen<br>3 liter per minute | Drug: Nasal oxygen<br>* 3 l oxygen<br>|
| Placebo Comparator: Nasal Air<br>3 l regular nasal air | Drug: Regular nasal air<br>* 3 l nasal air<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest pain measured with VAS | After PCI patient is asked in a double blinded about maximum chest during PCI. | 1 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Troponin-levels after PCI | Peak troponin the first days after PCI | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCI, oxygen
Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
This clinical trial is to determine an effective dosage and to study the safety of an investigational drug -lidorestat (IDD-676)- which is intended to stop or slow the progression of diabetic peripheral neuropathy.

Detailed Description
-----------------
Diabetic peripheral neuropathy is one of the most important and serious complications of diabetes. It can cause pain and loss of sensation, loss of mobility and lead to chronic wounds and amputations. Studies indicate 50% or more of people who have diabetes now have or will have significant neuropathy. Several currently marketed or investigational drugs are available to treat the painful symptoms of diabetic peripheral neuropathy, but there are no approved drugs that have been shown to prevent or slow the progression of the neuropathy itself. The current clinical trial is an early phase II study designed to investigate the safety of the investigational drug lidorestat (IDD-676) and to determine the effect of various dose levels on important biochemical processes in the pathology of diabetic neuropathy. Participants who enter and complete this study will, if the agent is successful, help in a very important way to bring an effective treatment from research laboratories to widespread availability for treatment. On the basis of the results of this study, large scale studies will be undertaken to support application for product registration and distribution in the U.S. and other countries throughout the world.

Conditions
-----------------
Diabetic Polyneuropathy

Intervention / Treatment
-----------------
* Drug: Lidorestat (IDD 676)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Clinical diagnosis of Type 1 or Type II diabetes with mild to moderate diabetic peripheral neuropathy. Healthy status except for diabetes Ability to make frequent clinic visits over a 7-month period. Willingness and ability to understand and sign consent form. Exclusion: Pregnancy or breast feeding Presence of uncontrolled hypertension History or presence of significant kidney or liver 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: Lidorestat (IDD 676)|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
-----------------
ARI, Diabetic polyneuropathy, Diabetic complications
The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to investigate the efficacy and mechanism in fecal microbiota transplantation in the treatment of ulcerative colitis. About 20 Ulcerative Colitis (UC) patients will be recruited into our trial for Fecal Microbiota Transplantation (FMT) treatment,the safety and efficacy of FMT will be observed.

Conditions
-----------------
Ulcerative Colitis, Fecal Microbiota Transplantation

Intervention / Treatment
-----------------
* Biological: Fecal Microbiota Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to moderate UC patients male volunteered to our FMT trial Exclusion Criteria: severe UC Hb < 6g/dL

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Ulcerative Colitis<br> | Biological: Fecal Microbiota Transplantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of mayo criteria in UC patients after FMT. |  | one year | 
| Number of patients with adverse events after FMT. |  | one year |
A Retrospective Study of the Effects of Molecular Diagnostics on Wound Care Outcomes

Study Overview
=================
Brief Summary
-----------------
A retrospective molecular diagnostic review on wound care outcomes between two time periods. The time periods include June, July, August of 2008 and June, July, August of 2009. The retrospective review would analyze the days of healing during those two timeframes, upon the introduction of molecular diagnostic testing.

Official Title
-----------------
A Retrospective Study of the Effects of Molecular Diagnostics on Wound Care Outcomes

Conditions
-----------------
Wounds

Intervention / Treatment
-----------------
* Other: data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A patient record captured during June, July, August 2008 and June, July, or August of 2009. Exclusion Criteria: A patient record captured outside the time frame of June, July August 2008 or June, July, August of 2009.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no treatment<br>retrospective data analysis | Other: data collection<br>* retrospective data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A retrospective molecular diagnostic review on wound care outcomes between two time periods. | The retrospective review would analyze the days of healing during those two timeframes, upon the introduction of molecular diagnostic testing. | The time periods include June, July, August of 2008 and June, July, August of 2009. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retrospective data collection
Effects of Whole Egg Consumption on Inflammation, Mood, and Recovery in Collegiate Female Gymnasts

Study Overview
=================
Brief Summary
-----------------
The objectives were to investigate the effects of whole egg consumption by collegiate female gymnasts on inflammatory markers, mood, and recovery.

Official Title
-----------------
Effects of Whole Egg Consumption on Inflammation, Mood, and Recovery in Collegiate Female Gymnasts

Conditions
-----------------
Inflammation

Intervention / Treatment
-----------------
* Other: Whole egg consumption


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Membership on the university gymnastics team Exclusion Criteria: egg allergies, asthma, coronary artery disease, depression, diabetes, hypertension, migraines, cancer or cancer-related complications, or auto-immune disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 22 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole egg consumption<br> | Other: Whole egg consumption<br>* The participants in the whole egg group consumed two whole eggs immediately after exercise.<br>|
| No Intervention: No egg control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum C-reactive protein (CRP) |  | 8 months | 
| Serum interleukin-6 (IL-6) |  | 8 months | 
| Serum soluble interleukin-6 receptor (sIL-6R) |  | 8 months |
UNCOVER - a Non-interventional Study to Investigate Undiagnosed Severe Asthma

Study Overview
=================
Brief Summary
-----------------
UNCOVER is a non-interventional study to investigate the prevalence of difficult-to-treat and severe Asthma eligible for treatment with biologics in a cohort of patients with suspected, so far undiagnosed severe Asthma which were previously treated by General practitioners and Office-based pulmonologists.

Official Title
-----------------
UNCOVER - a Non-interventional Study to Investigate Undiagnosed Severe Asthma

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older at inclusion written informed consent currently diagnosed with Asthma fulfilling at least one of the criteria of potential severe Asthma willing and able to complete the study questionnaire miniAQLQ Exclusion Criteria: biological Treatment for Asthma during the past 12 months participation in a clinical Trial within the last 3 months patients who are not able to read or write, who do not understand the nature of the study or the ICF or who are dependent from the investigator

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 |
| --- | --- | --- |
| The Primary objective is the Investigation of the prevalence of difficult-to-treat and severe Asthma eligible for Treatment with biologics. | Number of patients with diagnosis of severe Asthma according to the ATS/ERS Definition of severe Asthma and number of severe Asthma patients eligible for one or more biologic Treatments for Asthma. | 18 months |
LATAM Bif Registry

Study Overview
=================
Brief Summary
-----------------
The LATAM Bif Registy is an international and prospective registry of percutaneous coronary interventions (PCI) in coronary bifurcation lesions. The main goal of the study is to investigate the current state and long-term outcomes of PCI in this complex subset of coronary lesions in Latin America.

Official Title
-----------------
Latin American Registry of Percutaneous Interventions in Coronary Bifurcations

Conditions
-----------------
Coronary Bifurcation Lesion

Intervention / Treatment
-----------------
* Procedure: Percutaneous coronary interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years Any type of bifurcation lesion Side-branch reference diameter >= 2 mm Exclusion Criteria: Protected left main disease in patients with previous CABG Patients who refuse to be included in the registry

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Percutaneous coronary interventions|Percutaneous coronary interventions in coronary bifurcation lesions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Death |  | 5 years | 
| Myocardial Infarction |  | 5 years | 
| Target Lesion Revascularization |  | 5 years | 
| Stent thrombosis |  | 5 years | 
| Major bleeding |  | 5 years |
Neurological Outcome of VLBW Infants With Early Hypotension

Study Overview
=================
Brief Summary
-----------------
Comparison of short and long term neurological outcome of VLBW infants with and without early onset hypotension required intervention. The cohort includes all VLBW infants born in our institution between January 1997 and December 2000.

Conditions
-----------------
1. VLBW Infants, 2. Hypotension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -VLBW infants born at the Sheba Medical Center between January 1997 and December 2000 Exclusion Criteria: - none

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 12 Months

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 |
| --- | --- | --- |
The RATIO: Registry of Infections and Lymphoma in Patients Treated With TNF-a Antagonists

Study Overview
=================
Brief Summary
-----------------
The RATIO registry is a French registry designed by a multidisciplinary group to collect data on opportunistic and severe bacterial infections and lymphoma in patients treated with TNF-a antagonists ( infliximab, etanercept and adalimumab). A total of 486 medical units in metropolitan France participate in the RATIO registry. All diagnosis are retained after validation by 2 qualified infectious disease or haematologist physicians (on the basis of the standardized case report form, the hospitalisation summary, and the microbiological and radiological results). Risk factors for developing these conditions when treated by TNF-a antagonists will be identified in a case control study. Incidence of these diseases will be calculated.

Official Title
-----------------
The RATIO Registry: French Registry on Opportunistic and Severe Bacterial Infections and Lymphoma in Patients Treated With TNF-a Antagonists

Conditions
-----------------
Rheumatoid Arthritis, Crohn's Disease, Ankylosing Spondylitis, Psoriasis

Intervention / Treatment
-----------------
* Drug: TNF-alpha antagonists


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for cases: past or current treatement with TNF-a antagonists either lymphoma severe bacterial infection opportunistic infection Inclusion Criteria for controls: matched with cases by gender, age (+/- 5 years), underlying disease (rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, or psoriasis) past or current treatement with TNF-a antagonists no lymphoma, severe bacterial infection, opportunistic infection (same as case) Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: TNF-alpha antagonists|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
-----------------
TNF alpha antagonists, infections, lymphoma, safety