linjc16/ctgov huggingface dataset:
Safety Study of Elvucitabine in HIV-1 Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this 28 day study is to assess the viral kinetics and safety of elvucitabine.

Detailed Description
-----------------
This is a 14 day on treat/14 day off treatment randomized, double blind viral kinetic study of elvucitabine versus lamivudine administered once daily to HIV infected subjects with a documented M184V variant.

Official Title
-----------------
14-Day Randomized Double-Blind Comparative Viral Kinetic Study of Elvucitabine Versus Lamivudine Once Daily to HIv-1 Subjects With M184V

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: elvucitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected, clinically stable, adults HIVRNA 5000 -150,000, CD4 100 Genotypically documented M184V variant Receiving stable ART. Exclusion Criteria: Hep B HIV-1 genotype for 4 protease inhibitors HIV-1 genotype positive for 2 NNRTI mutations Previous therapy with system myelosuppressive potential within 3 months of study start Use of Epogen or Neupogen History of cirrhosis Alcohol or drug dependence Inability to tolerate oral medication Women who are pregnant or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: elvucitabine|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
-----------------
HIV-1, Treatment Experienced
Clinical Relevance of Anti-Neutrophil Cytoplasm Antibody (ANCA)in Hospitalized Patients

Study Overview
=================
Brief Summary
-----------------
Laboratory testing of Anti-Neutrophil Cytoplasm Antibody (ANCA) is used to confirm diagnosis of patients who have a high level of suspicion for ANCA-related vasculitis. In these patients the specificity and sensitivity to the ANCA test is very high. This study hopes to prove that when this lab test is performed on blood of patients who do not have a high level of suspicion for ANCA-related vasculitis, the sensitivity and specificity is reduced and there are many false positive results. Because of this, it should not be used as a screening test for a more general patient population.

Conditions
-----------------
ANCA-related Vasculitis

Intervention / Treatment
-----------------
* Other: Interpretation of blood test results


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Blood samples sent for ANCA lab test Exclusion Criteria: Patients with ANCA vasculitis Patients with known malignancy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospitalized patients<br> | Other: Interpretation of blood test results<br>* Interpretation of blood test results<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mostly negative lab results |  | One year |
Effect of Antioxidant on Endurance Performance in Healthy Men

Study Overview
=================
Brief Summary
-----------------
oligomerized litchi fruit extract may enhance the submaximal endurance exercise performance

Detailed Description
-----------------
Regular physical exercise has many beneficial effects, but it has been reported that strenuous exercise could elevate the production of free radical and other reactive oxygen species (ROS) which eventually injure the tissues and decrease the muscle function.So many kinds of antioxidant supplementations have been tried to decrease the muscle fatigue and enhance the exercise performance. polyphenolic flavonoids abundant in fruits and leafy vegetables have strong antioxidant effect. oligomerized litchi fruit extract has strong antioxidant capacity and higher bioavailability compared to that of grape seed polyphenol. The aim of this study was to determine whether oligomerized litchi fruit extract could induce endurance exercise performance more than Vit C + Vit E mixture or placebo could do. Therefore, we designed double blind randomized controlled trial, setting the change of running time to exhaustion under submaximal treadmill test as the primary endpoint.

Official Title
-----------------
Effect of Antioxidant on Endurance Performance in Healthy Men -Double Blind Randomized Placebo and Active Controlled Trial-

Conditions
-----------------
Exercise Tolerance

Intervention / Treatment
-----------------
* Dietary Supplement: Oligomerized litchi fruit extract
* Dietary Supplement: VItamin C + Vitamin E mixture
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men over 20 years old non-smoker Exclusion Criteria: BMI>25 or body fat>25% he who intakes the antioxidant supplement in recent 2 weeks

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Dietary Supplement: Oligomerized litchi fruit extract<br>* 100mg at once twice a day for 1 month<br>* Other names: oligonol; brand name of oligomerized litchi fruit extract;|
| Active Comparator: 2<br> | Dietary Supplement: VItamin C + Vitamin E mixture<br>* Vitamin C 400mg + Vitamin E 160IU at once twice a day for 1 month<br>|
| Placebo Comparator: 3<br> | Other: placebo<br>* twice a day for 1 month<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of running time to exhaustion under 80% of maximal heart rate |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2max, anaerobic threshold |  | 1 month |
Pharmacokinetic Study Investigating the Extent of Paracetamol Absorption From a New Formulation of Paracetamol Compared With Panadol®

Study Overview
=================
Brief Summary
-----------------
A single dose pharmacokinetic study investigating two paracetamol formulations

Official Title
-----------------
A Single Dose PK Study Investigating the Extent of Paracetamol Absorption From Two Sustained Release Paracetamol Formulations

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Marketed paracetamol
* Drug: Experimental paracetamol formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good general heatlh with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination Exclusion Criteria: Subject does not agree to refrain from alcohol consumption for the 10-day period prior to visit 2 and throughout the remainder of the study. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. Current (within 14 days of screening) or regular use of any prescription, over the counter drugs including paracetamol/acetaminophen, herbal medicine or drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to dosing.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Marketed paracetamol<br>marketed formulation | Drug: Marketed paracetamol<br>* Marketed formulation<br>|
| Experimental: Experimental paracetamol formulation<br>Experimental formulation | Drug: Experimental paracetamol formulation<br>* Experimental formulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare bioavailability as measured by Area under the Curve in both fed and fasted states |  | Visit 1 through Visit 3 (Day 13) | 
| To assess the effect of food on extent and rate of paracetamol absorption as measured by Area Under the Curve and Cmax |  | Visit 1 through Visit 3 (Day 13) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess descriptive pharmacokinetic characteristics (Tmax, T1/2, AUC, Cmax) |  | Visit 1 through Visit 3 (Day 13) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
paracetamol, pharmacokinetic
Prostaglandin F2-alpha (PGF2α) in Vitiligo

Study Overview
=================
Brief Summary
-----------------
study the cutaneous expression of PGF2α in vitiligo patients and compare it with normal control subjects.

Detailed Description
-----------------
Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy controls.

Official Title
-----------------
Study of the Cutaneous Expression of Prostaglandin F2-alpha (PGF2α) in Vitiligo Patients: a Case-control Study.

Conditions
-----------------
Vitiligo

Intervention / Treatment
-----------------
* Other: Skin biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with non-segmental vitiligo. Both sexes. Age < 18 years old. New cases or cases not receiving any medications for at least 3 months ago. Exclusion Criteria: Age: Patients < 18 years. Segmental or universal vitiligo. Pregnant and lactating females.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vitiligo patients<br>Two skin biopsies (lesional and non-lesional) will be taken from every patient. | Other: Skin biopsy<br>* Two skin biopsies (lesional and non-lesional) will be taken from every patient. Also a skin biopsy will be taken from each control subject.<br>|
| Experimental: healthy controls<br>A skin biopsy will be taken from each control subject. | Other: Skin biopsy<br>* Two skin biopsies (lesional and non-lesional) will be taken from every patient. Also a skin biopsy will be taken from each control subject.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy controls. | Measurement of tissue levels of PGF2α in vitiligo patients and compare them with healthy controls to study and verify the hypothesis of involvement of PGF2α in the pathogenesis of vitiligo.• Skin biopsy for assessment of tissue levels of the PGF2α will be taken from both lesional and non lesional skin of patients of vitiligo and from normal skin of healthy controls. All skin biopsies are from non-sun exposed sites. | 6 months |
Compressive Device to Prevent Keloïd Scars Recurrence [SCARWARS]

Study Overview
=================
Brief Summary
-----------------
SCARWARS study deals with the first on-human evaluation of a compressive device dedicated to the prevention of keloïd scars recurrence after surgery. The tested device is made with clinical grade silicon. SCARWARS is a monocentric study. 27 patients will be include and follow during one year. The primary outcome of this study is the number of keloid recurrence after treatment.

Official Title
-----------------
First Study Evaluating Efficiency and Safety of a Compressive Device to Prevent Keloid Scars Recurrence After Surgery

Conditions
-----------------
Keloid

Intervention / Treatment
-----------------
* Device: Compression device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 yo; Patient with aer lobe keloid; Patient with an indication of reconstructive surgery; Signature of informed consent from the patient; Indication that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study; Patient with French social insurance. Exclusion Criteria: Patient with cutaneous dermatosis or other skin pathology able to interfere with evaluated parameter (recurrence and healing quality); Patient with know nickel allergy; Patient with know silicon allergy; Pregnant women; Legal incapacity or limited legal capacity; Patient unlikely to cooperate in the study and / or low cooperation anticipated by the investigator; Patient without health insurance; The patient is in the period of exclusion of another study.

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compression device<br> | Device: Compression device<br>* interventions on patient are : surgical excision of ear lobe keloid application of compression device on sutured skin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of keloid scar | Recurrence will be assessed during each visit by surgeon | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ear lobe, compression, medical device, recurrence
Coronary Calcification Progression Study

Study Overview
=================
Brief Summary
-----------------
To investigate use of Fast Gated Helical Computed Tomography (FGHCT) measures of coronary artery calcium (CAC), FGHCT-CAC, for discrimination of coronary artery disease (CAD) and to quantify progression of coronary artery calcium over time.

Detailed Description
-----------------
BACKGROUND: While advances have been made in control of some coronary heart disease (CHD) risk factors, especially smoking and high dietary fat intake, much of the decline in age-adjusted CHD mortality rates has been due to medical treatment and procedural interventions for overt CHD as well as hypertension and hypercholesterolemia. In this context, the availability of an inexpensive, sensitive and specific method for noninvasive detection of both early coronary atherosclerosis and asymptomatic but advanced CHD could allow beneficial treatments to be targeted at many high-risk individuals. The study was designed to determine whether fast-gated helical computed tomography (FGHCT), a more advanced and readily-available variant of a technique (EBCT) that has not achieved its full promise, could play such a role. DESIGN NARRATIVE: Dr. Crouse and his colleagues augmented ongoing case-control studies, HL35333, Carotid Atherosclerosis Progression Study and HL59503, Vascular Disease, Structure and Function. HL35333 comprises 280 symptomatic individuals > 45 years equally divided between men and women, half with and half without angiographically defined coronary artery disease evaluated for risk factors and extracranial carotid intimal-medial thickness (ECIMT, with B-mode ultrasound) at baseline and yearly for three years. The grant has quantified the associations of coronary artery disease and coronary artery disease risk factors for ECIMT and its progression. HL59503 quantifies flow-mediated brachial artery reactivity (FM-BAR) in this cohort. Literature review suggests that while ECIMT predicts coronary artery disease status in clinical samples it does less well in asymptomatic samples; longitudinal data (CLAS study) suggest that progression of ECIMT best predicted incident coronary artery disease, and Electron Beam Computed Tomography (EBCT) quantification of Coronary Artery Calcium (CAC) likely has even greater discriminatory power for coronary artery disease than ECIMT. However, EBCT has limited accessibility. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Evaluation of the Safety and Tolerability of a Higher Potency Dose of an Investigational Vaccine Among Adults 50 Years of Age and Older (V211-009)

Study Overview
=================
Brief Summary
-----------------
This study compared the safety and tolerability profile of a higher potency investigational vaccine to that of the investigational vaccine at a lower potency dose.

Official Title
-----------------
Evaluation of the Safety and Tolerability of a Higher Potency Dose of Varicella Zoster Virus Vaccine Live (Oka/Merck)Among Adults 50 Years of Age or Older

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

Intervention / Treatment
-----------------
* Biological: Comparator: Varicella Zoster Virus Vaccine
* Biological: Comparator: Varicella Zoster Virus Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals 50 years of age or older with a history of chickenpox who have not had herpes zoster Exclusion Criteria : Preexisting conditions that might affect vaccine safety such as conditions that inhibit an immune response

Ages Eligible for Study
-----------------
Minimum 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Higher Potency Dose | Biological: Comparator: Varicella Zoster Virus Vaccine<br>* Single 0.65 mL subcutaneous injection of higher potency zoster vaccine ( 207,000 plaque-forming units [PFU]/0.65-mL dose)<br>|
| Experimental: 2<br>Lower Potency Dose | Biological: Comparator: Varicella Zoster Virus Vaccine<br>* Single 0.65 mL subcutaneous injection of lower potency zoster vaccine ( 58,000 plaque-forming units [PFU]/0.65-mL dose)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs) | The incidence of vaccine-related SAEs occurring Day 1 through Day 42 postvaccination. Whether a serious clinical adverse experience occurring Day 1 through Day 42 postvaccination was vaccine-related was determined by the investigator who was a qualified physician . The difference in the risk of developing a vaccine-related SAE between the two groups was compared at the 2-sided 0.05 level. | Day 1-42 post vaccination | 
| Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter) |  | Day 1-5 postvaccination |
Glycocalyx Damage and Beta-lactam Antibiotics in Surgical Critically Ill

Study Overview
=================
Brief Summary
-----------------
GCX damage and its relationship to pharmacodynamics and pharmacokinetics of beta lactam antibiotics in critically ill Hypothesis to be tested: GCX damage impairs pharmacodynamics and pharmacokinetics of beta-lactam antibiotics in critically ill patients. There is correlation between GCX damage and insufficient beta lactam levels in patients with commonly used dosing. The aim of the study: Evaluation of relationship between GCX damage and pharmacodynamics and pharmacokinetics of beta-lactam antibiotics in critically ill. Type of the study: Observational. Subjects: Adult patients admitted to ICU with beta-lactam antibiotic therapy (meropenem or piperacillin/tazobactam empirically or based on culture results). Sample size calculation: 20 patients (expected correlation coefficient 0,6, alpha error = 0,05) will lead to power study = 0,89. Intervention: none. Data to be recorded and analyzed: Demographics, type of patients (trauma, post surgical, medical, after cardiac arrest), severity score - Apache II, SOFA, fluid balance, a presence of delirium, clinical outcome, sublingual microcirculation by SDF imaging will be recorded three times during antibiotic treatment at the time points for blood samples required for pharmacodynamics and pharmacokinetic analysis, microcirculatory data and Perfused Boundary Region.

Official Title
-----------------
Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Drug: Meropenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients admitted to ICU with beta-lactam antibiotic therapy (meropenem or piperacillin/tazobactam empirically or based on culture results). Exclusion Criteria: None.

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 |
| --- |
|Drug: Meropenem|Patients will receive intravenous antibiotics eighter empirically or based on a culture.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasmatic concentrations of antibiotics | Concentration of antibiotics will be assessed in plasma after their administration in mmol/l to calculate their pharmacokinetic and pharmacodynamic profile. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perfused Boundary Region | PBR is a parameter obtained automatically by specialized software after examination of the sublingual microcirculation by handheld microscope that describes the amount of glycocalyx destruction. | 6 months |