linjc16/ctgov huggingface dataset:
Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
Working hypothesis and aims: 1) To explore the pathophysiology of postoperative troponin elevations and 2) whether ranolazine, a new anti-ischemic drug that has no effect on blood pressure or heart rate, prevents postoperative myocardial injury.

Detailed Description
-----------------
High-risk patients undergoing non cardiac surgery will be randomized to receive either Ranolazine or placebo perioperatively and troponin will be measured on the first 3 days after surgery.

Official Title
-----------------
Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial

Conditions
-----------------
Coronary Artery Disease,

Intervention / Treatment
-----------------
* Drug: Ranolazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All patients age 18 and above, undergoing major surgery that require at least 24 hours (overnight) stay in the post anesthesia care unit (PACU) or intensive care unit (ICU), and who either have known history of CAD or at least 3 of the following Revised Cardiac Risk Index (RCRI) criteria29F17: 1) high-risk type of surgery, 2) history of ischemic heart disease, 3) history of congestive heart failure, 4) history of cerebrovascular disease, 5) diabetes mellitus, 6) renal failure (creatinine > 2mg/ml). Exclusion Criteria: Pregnancy, LV ejection fraction ≤35%, patients with severe valvular disease, patients with poor echocardiographic images, patients who cannot swallow the pill after surgery, refusal to participate

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranolazine treatment<br>Ranolazine 500-1000mg bid | Drug: Ranolazine<br>* Ranolazine versus placebo<br>* Other names: Ranexa;|
| Placebo Comparator: Placebo<br>Placebo | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative troponin |  | 3 days |
Study Evaluating Levonorgestrel and Ethinyl Estradiol for Oral Contraception

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and contraceptive efficacy of an oral contraceptive containing a combination of LNG 90 mg/EE 20 mg in a continuous-use regimen.

Official Title
-----------------
A Phase 3, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Levonorgestrel 90 mg and Ethinyl Estradiol 20 mg in a Continuous Daily Regimen for Oral Contraception

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Drug: Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women aged 18 to 49 years Regular (21- to 35- day) menstrual cycles for the 3-month period preceding visit 1 Must be sexually active and at risk for becoming pregnant. Exclusion Criteria: Planned use of any other form of birth control other than the test article. Depression requiring hospitalization or associated with suicidal ideation within the last 3 years. High blood pressure (defined as elevated sitting blood pressure: > 140/90 mm Hg).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levonorgestrel 90 mg/Ethinyl Estradiol 20 mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety and contraceptive efficacy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effects of this LNG/EE combination on bleeding profile, endometrial histology, hemostasis measures, hemoglobin levels, discontinuation rates, subject satisfaction, and cycle-related symptoms and work productivity at baseline. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contraception
Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of IMM0306-02 in patients with refractory or relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL).

Official Title
-----------------
Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)

Conditions
-----------------
B-cell Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: IMM0306


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-75 years old Diagnosed with B-NHL Relapsed after or be refractory to at least 2 line of standard therapy Exclusion Criteria: Active central nervous system (CNS) metastases Positive Direct Antiglobulin Test (DAT) Active autoimmune disorder Skin disorders that do not requires hormone replacement therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: IMM0306<br>IMM0306 Dose escalation: 0.1mg/kg, 0.2mg/kg, 0.4mg/kg, 0.8mg/kg,1.2mg/kg and 1.6mg/kg through intravenous administration weekly up to 52 weeks. | Drug: IMM0306<br>* IMM0306 is an bi-specific antibody<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose (MTD) of IMM0306 as measured by incidence of DLTs (Dose Limiting Toxicity) | DLT is defined as one of the following toxicities occurring during the DLT assessment for Cycle 1. | End of Study (52 Weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IMM0306
Diffusion Tensor and Functional Connectivity Imaging in Pediatric Epilepsy: Imaging/Histology Correlation

Study Overview
=================
Brief Summary
-----------------
To determine the utility of diffusion tensor magnetic resonance imaging in the preoperative workup of children with intractable epilepsy referred for surgery.

Detailed Description
-----------------
To determine if diffusion tensor and functional connectivity magnetic resonance imaging helpful to better understand and diagnose intractable epilepsy in children. All enrolled children will undergo standard preoperative and postoperative MRI imaging, plus a 15 minute set of functional connectivity and diffusion tensor sequence with no additional sedation. This imaging data will be stripped of identifiers and be processed to provide both quantitative analysis, resting state functional connectivity changes and three dimensional modeling of white matter tracts adjacent to epileptogenic foci. This study is being done to determine if diffusion tensor and functional connectivity magnetic resonance imaging are helpful to better understand and diagnose intractable epilepsy in children.

Official Title
-----------------
Diffusion Tensor and Functional Connectivity Imaging in Pediatric Epilepsy: Imaging/Histology Correlation

Conditions
-----------------
Intractable Epilepsy

Intervention / Treatment
-----------------
* Procedure: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children diagnosis with Intractable Epilepsy Exclusion Criteria: No Intractable Epilepsy

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Observational cohort<br>Observing MRI changes in subjects. | Procedure: Observation<br>* Observation of MRI changes in subjects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with seizure outcome as determined by Engel |  | 5 years |
Ethnic Variations in Antidepressant Response

Study Overview
=================
Brief Summary
-----------------
This 11-week study aims to determine how genetic factors affect the way African Americans and Caucasians with major depression respond to antidepressant medication [citalopram (Celexa®)].

Detailed Description
-----------------
Depressed patients vary substantially in their responses to antidepressants. Genetic factors may account for a large part of these differences in response. This study will include both African Americans and Caucasians to examine the role of genetic factors in treatment response. Participants receive citalopram (Celexa) for 8 weeks and a placebo for 1 week. Visits occur once a week for 11 weeks. A variety of interviews, scales, tests, and questionnaires are used to assess participants.

Official Title
-----------------
Ethnic Variations in Antidepressant Response

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Drug: Citalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV criteria for Major Depression African-American or Caucasian ethnic background (both parents and 3 out of 4 grandparents) Exclusion Criteria: Schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression, or bipolar disorder Current drug abuse or history of drug abuse within the past 6 months Unstable medical or neurological conditions that interfere with the treatment of depression Allergy to citalopram Failure to respond to adequate citalopram drug trial (40 mg for at least 6 weeks) Seizure disorder Pregnancy Psychotropic medications, including antidepressants and neuroleptics Suicidal ideation or other safety issues Fluoxetine (Prozac) or MAOIs (Nardil, Parnate) in the last 2 months Ongoing cognitive behavioral therapy or intensive psychotherapy. General talk therapy is acceptable

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Citalopram<br>All subjects receive an FDA approved dose of Citalopram | Drug: Citalopram<br>* PDA Approved antidepressant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression |  | Measured weekly for 11 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depressive Disorder
Effect of Energy Density Over 5 Days in Preschool Children

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators will vary the energy density of foods served during three 5-day periods. There will be a baseline condition, and then a condition where the energy density of food is lower and a condition where the energy density of food is higher. The primary aim is to determine the effect of varying the energy density of foods served over 5 days on energy intake in preschool children. It is hypothesized that mean daily energy intake will be greater when children are served higher energy dense foods over 5 days than when served lower energy dense foods over the same period. Additionally, it is hypothesized that daily energy intake in the conditions with higher and lower energy densities will begin to converge across the 5-day period.

Conditions
-----------------
Feeding Behavior

Intervention / Treatment
-----------------
* Other: Food Energy Density


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Attending one of the designated daycare centers Exclusion Criteria: Food Allergies Food restrictions Health Issues that Preclude Participation Not available for duration of the study

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100% Food Energy Density<br>Baseline Food Energy Density | Other: Food Energy Density<br>* Food Energy density manipulated<br>|
| Experimental: 80% Food Energy Density<br>Lower Food Energy Density | Other: Food Energy Density<br>* Food Energy density manipulated<br>|
| Experimental: 120% Food Energy Density<br>Higher Food Energy Density | Other: Food Energy Density<br>* Food Energy density manipulated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Food and Beverage Intake by Energy | Differences in daily intake of food and beverages by energy, in kcal | Days 1-5 in Weeks 1, 2, and 3 | 
| Differences in Food and Beverage Intake by Weight | Differences in daily intake of food and beverages by weight, in grams | Days 1-5 in weeks 1, 2, and 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Food and Beverage Intake by Energy Density | Differences in daily intake of food and beverages by energy density, in kcal/g | Days 1-5 in weeks 1, 2, and 3 |
Study of High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of treatment with rosuvastatin on the capacity of plasma to promote cholesterol efflux, which is the first and likely rate limiting step in reverse cholesterol transport.

Official Title
-----------------
A Randomised, Double-blind, Placebo-controlled, Crossover Pilot Study to Define the High Density Lipoprotein Cholesterol (HDL-C)-Raising Mechanism of Rosuvastatin (CRESTOR™) by Quantifying the Key Steps of Reverse Cholesterol Transport (RCT)

Conditions
-----------------
Metabolic Syndrome, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent males aged 45-65 insulin resistance central obesity LDL-C <6 mmol/L plasma triglycerides >=1.7 and ≤5.5 mmol/L HDL-C ≤1.2 mmol/L. Exclusion Criteria: total cholesterol >7mmol/L pre-existing cardiovascular disease, diabetes, proteinuria or renal failure

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosuvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the effect of treatment with rosuvastatin on the capacity of plasma to promote cholesterol efflux, which is the first and likely rate limiting step in reverse cholesterol transport. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the effect of treatment with rosuvastatin on: |  |  | 
| - cholesterol esterification by measuring plasma lecithin:cholesterol acyl transferase concentration and capacity to esterify cholesterol, one of the stops in RCT. |  |  | 
| - plasma concentration of cholesterol ester transfer protein and capacity to transfer cholesterol from HDL-C to apoB-containing lipoproteins, one of the steps in RCT. |  |  | 
| - plasma concentration of preβ1-HDL. |  |  | 
| - plasma concentration of LDL cholesterol, HDL-C and apoA-1. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic Syndrome, Dyslipaemia
Topical Application of Latanoprost in Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
Randomized double-blinded two-year intervention study with topical application of latanoprost or placebo eye drops in patients with diabetic retinopathy.

Detailed Description
-----------------
The primary objective is to study if a sustained contraction of pathologically dilated retinal arterioles can be obtained. Retinal arteriolar diameter and the diameter response to increased blood pressure is studied using the Dynamic Vessel Analyzer (Imedos, Germany. The secondary objective is to study whether the intervention can halt the development of diabetic retinopathy, which is assessed by optical coherence tomography (OCT) scanning and fundus photography.

Official Title
-----------------
Topical Application of Latanoprost in Diabetic Retinopathy

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Drug: Latanoprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20-36 years old Diabetes mellitus with retinopathy Exclusion Criteria: Pregnancy Previous ocular disease other than diabetic retinopathy General disease with possible influence on the eye

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 36 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Latanoprost<br>Topical treatment with latanoprost | Drug: Latanoprost<br>* Topical application<br>* Other names: No other names;|
| Placebo Comparator: Placebo<br>Placebo arm | Drug: Latanoprost<br>* Topical application<br>* Other names: No other names;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diameter of retinal arterioles | The diameter of retinal arterioles will be assessed using the Dynamic Vessel Analyzer | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity of diabetic retinopathy | Severity of diabetic retinopathy will be measured by optical coherence tomography (OCT) scanning and fundus photography | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Latanoprost, vasodilation, diabetic retinopathy
Optimizing Prograf® Therapy in Renal Transplant Patients

Study Overview
=================
Brief Summary
-----------------
A study to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients.

Detailed Description
-----------------
A 3 arm study (2 Active, 1 Active Control) to determine the optimal dose and blood level of Prograf® in long-term maintenance of kidney transplant patients

Official Title
-----------------
OPTIMA (Optimizing Prograf® Therapy in Renal Transplant Patients)

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: Tacrolimus, Prograf®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient was 18 years of age at the time of transplant. Patient is at least 6 months post-transplant. Exclusion Criteria: Patient is the recipient of a solid organ transplant other than the kidney. Patient is a known carrier of any of the HIV viruses.

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

| Intervention/Treatment |
| --- |
|Drug: Tacrolimus, Prograf®|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of conversion from cyclosporine to Prograf-based therapy on renal function |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of renal function, Cystatin C, TGF-beta, biopsy proven rejection, and patient and graft survival |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal Transplantation, Therapeutics, Treatment Outcome, Safety