linjc16/ctgov huggingface dataset:
Assessment of New Biomarkers in the Management and Triage of Patients With Chest Pain and Suspicion of Non ST Elevation Acute Coronary Syndrome.

Study Overview
=================
Brief Summary
-----------------
To assess diagnostic and prognostic value of new biomarkers in patients admitted for suspicion of non ST elevation acute coronary syndrome (NSTE ACS).

Official Title
-----------------
Assessment of New Biomarkers in the Management and Triage of Patients With Chest Pain and Suspicion of Non ST Elevation Acute Coronary Syndrome.

Conditions
-----------------
Coronary Syndrome

Intervention / Treatment
-----------------
* Other: Biological analysis of biomarkers
* Other: Biological analysis of biomarkers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects over 18 years, subject about having a chest pain of coronary syndrome, subject about not having received heparin or LMWH Exclusion Criteria: subject minor subject without informed consent, subject after receiving an anticoagulant treatment, transplanted heart, kidney or liver

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients with coronary syndrome | Other: Biological analysis of biomarkers<br>* Biological analysis of biomarkers<br>|
| Other: 2<br>Subjects without coronary syndrome | Other: Biological analysis of biomarkers<br>* Biological analysis of biomarkers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess diagnostic and prognostic value of new biomarkers in patients admitted for suspicion of non ST elevation acute coronary syndrome (NSTE ACS). |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the characteristics of biological markers to those of usual or innovative markers |  | 24 months |
Neuroinflammatory Response in Patients With ICH and IVH Treated With rtPA

Study Overview
=================
Brief Summary
-----------------
This study compares the neuroinflammatory response in patients with hypertensive ICH associated with IVH treated with intraventriculary applied rtPA, and the control group. The inflammatory mediator concentration is analyzed in local cerebrospinal liquor.

Official Title
-----------------
Neuroinflammatory Response in Patients With ICH and IVH Treated With rtPA

Conditions
-----------------
Hypertensive Intracerebral Hemorrhage, Intraventricular Hemorrhage, Brain Injuries

Intervention / Treatment
-----------------
* Drug: intraventricual recombinant tissue plasminogen activator application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with primary ICH with IVH ICH score 2-4, , with origin of the hematoma in the basal ganglia and blood in the third and/or ventricle Patient is not considered a surgical candidate by neurosurgery service Exclusion Criteria: No history of diseases or drugs that affect the immunological system. ICH score 1 and 5 Current participation in another research drug treatment protocol Previously known intracranial arteriovenous malformation or aneurysms Intracerebral hematoma considered to be related to trauma ICH is located in the pons Blood in the subarachnoid space visualized on CT scan

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Applied rtPA | Drug: intraventricual recombinant tissue plasminogen activator application<br> <br> |
| Control study<br>rtPA not applied | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine concentration difference between two groups | Cytokine concentration measured from CSL | Samples taken on day 0, day 1, day 3 and day 7. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
secondary brain injury, neuroinflammation
Study of Olanzapine vs. Aripiprazole in the Treatment of Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of the protocol is to evaluate the efficacy of olanzapine compared with Aripiprazole in patients with schizophrenia.

Official Title
-----------------
A Randomized Double-Blind Study of Olanzapine Versus Aripiprazole in the Treatment of Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Olanzapine
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female inpatient or outpatients, ages 18-65 Exclusion Criteria: Participation in a clinical trial of another drug including olanzapine or aripiprazole within 30 days prior to study entry (visit 1). Treatment with clozapine within the past 12 months. Have known uncorrected narrow-angle glaucoma. Have a diagnosis of Parkinson's disease, dementia or related disorder

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Olanzapine|nan|
|Drug: Aripiprazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the long-term effectiveness and tolerability as measured by time to all-cause treatment discontinuation of olanzapine and aripiprazole relative to each other in patients with schizophrenia during 28 weeks of double-blind therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess olanzapine versus aripiprazole in the following: |  |  | 
| improvement in psychopathology of schizophrenia as measured by PANSS change |  |  | 
| change in CGI-S and PGI-I scores |  |  | 
| level of activation as measured by PANSS change |  |  | 
| depressive symptoms as measured by MADRS score |  |  | 
| response rates |  |  | 
| time to failure to maintain response |  |  | 
| quality of life as measured by the SWN-S and SF-36 |  |  | 
| cognitive functioning as measured by the MOS |  |  | 
| sexual functioning as measured by the GISF |  |  | 
| health resource utilization and resource utilization costs |  |  | 
| hospitalization time |  |  | 
| treatment emergent adverse events |  |  | 
| EPS as measured by the Simpson-Angus, Barnes, and AIMS |  |  | 
| laboratory values |  |  | 
| vital signs |  |  |
Predictive Value of 18F-FAZA in Rectum Cancer

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to investigate 18F-FAZA-PETs role as predictor of response to neoadjuvant chemoradiation of locally advanced rectum cancer.

Official Title
-----------------
The Predictive Value of 18F-FAZA-PET/CT in Neoadjuvant Radiation for Patients With Locally Advanced Rectum Cancer

Conditions
-----------------
Locally Advanced Rectum Cancer

Intervention / Treatment
-----------------
* Other: 18F-FAZA-PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histopatologically verified adenocarcinoma in the rectum T4 tumor eller T3 tumor < 10 cm from the anus and < 5 mm from the mesorectal fascie measured by MR scan. At the distal part of the rectum the distance to the mesorectal fascie is < 5 mm and therefore all T3 tumors are included in this area Suitable for preoperative radiation and chemotherapy No distant metastases Age >18 years Hematology ANC ≥1.5x10^9/l. Thrombocytes ≥ 100x10^9/l. Biochemistry Bilirubin ≤ 3 x UNL. ALAT ≤ 5 x UNL Creatinine ≤ UNL Contraception for fertile women Written and orally informed consent Exclusion Criteria: Other malignant disease within 5 years, excl. non-melanotic skin cancer Previous radiation treatment of the pelvis Pregnant or breastfeeding women Surgery within 6 weeks prior to enrollment Serious concurrent medical disease Enrollment in study A prospective observational study of patients with rectum cancer after concomitant radiation and chemotherapy, where the patients are potientially not operated.

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 |
| --- | --- |
| 18F-FAZA-PET/CT<br> | Other: 18F-FAZA-PET/CT<br>* Contrast fluid injected prior to scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to chemoradiotherapy measured by TRG |  | 8 weeks after chemoradiation treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival |  | From date of inclusion till date of verified recurrence | 
| Survival |  | From date of inclusion till date of death by any cause | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rectum cancer, FAZA, 18F-FAZA-PET/CT, Radiotherapy, Chemoradiotherapy
Pilot Placebo Controlled Study With Lovaza in Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
Several studies have shown that there is an increased risk of heart disease in people with HIV. In this study the investigators are looking at the effect of Lovaza (Omega-3 fatty acid) on improving endothelial function and decreasing inflammation which may contribute to this increased risk. The investigators will also be doing studies to analyze coagulation and inflammation markers.

Official Title
-----------------
Prospective Randomized Placebo Controlled Trial of Omega-3 Fatty Acids in HIV Infected Subjects to Modulate Cardiovascular Risk

Conditions
-----------------
HIV Infections, Heart Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV+ Ages 18-70 HIV-1 RNA <400 copies/ml. On stable ART (antiretroviral therapy) regimen for 12 weeks with no intent of modifying regimen, and cumulative ART before study entry of 12 mos. Exclusion Criteria: Active infection Inflammation or malignancy Uncontrolled diabetes or hypothyroidism LDL (low density lipoprotein) cholesterol >160 and triglyceride levels >750 Framingham risk score <6.

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lovaza<br>Lovaza 1 gram by mouth twice a day for 24 weeks. | Drug: Lovaza<br>* Lovaza one gram twice a day for 24 weeks<br>* Other names: Omega-3 fatty acid;|
| Placebo Comparator: Placebo<br>Placebo capsule by mouth twice a day x 24 weeks. | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Flow Mediated Dilation (FMD) of the Brachial Artery | Flow mediated dilation (FMD) of the brachial artery measured by ultrasound is a measure of endothelium dependent endothelial cell function. FMD is expressed as a percent change from baseline brachial artery diameter to brachial artery diameter after reactive hyperemia. | baseline and week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Omega-3 Fatty Acids, HIV, Heart Disease, Treatment experienced
Bioequivalence Study Of Pediatric Appropriate Formulation

Study Overview
=================
Brief Summary
-----------------
To determine bioequivalence of pediatric appropriate 80 mg atorvastatin formulation comparing to the 80 mg commercial atorvastatin calcium tablet formulation.

Detailed Description
-----------------
Determination of Bioequivalence

Official Title
-----------------
An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A New 80 Mg (2x40 mg) Pediatric Appropriate Formulation To A 80 Mg Commercial Atorvastatin Calcium Tablet Formulation In Healthy Subjects

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Atorvastatin
* Drug: Atorvastatin pediatric appropriate formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female volunteers Mass Index (BMI) of approximately 18 to 30 kg/m2 Exclusion Criteria: Any condition possibly affecting drug absorption A positive urine drug screening

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Reference<br>Commercial 80 mg atorvastatin tablet | Drug: Atorvastatin<br>* A single dose of 80 mg atrovastatin tablet<br>|
| Other: Test<br>Pediatric appropriate atorvastatin 40mg formulation | Drug: Atorvastatin pediatric appropriate formulation<br>* A single dose of pediatric appropriate atorvastatin 80 mg formulation<br>* Other names: Atorvastatin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary study endpoints will be AUClast, AUCinf (if data permit) and Cmax from plasma atorvastatin concentration data. |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoints will include Tmax and t1/2 (if data permit) of atorvastatin ; AUClast, AUCinf, Cmax, Tmax, and t1/2 (if data permit) of o-hydroxyatorvastatin and p-hydroxyatorvastatin. |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular Diseases
Evaluation of an Opt-Out Inpatient Smoking Cessation Service on Smoking Behavior Study #1

Study Overview
=================
Brief Summary
-----------------
The modest goal of this study is to replicate the behavioral outcomes of the opt out MUSC-Tobacco Treatment Program in the following three patient groups: 1) psychiatric inpatients housed in the Institute of Psychiatry (IOP) in Charleston; 2) non-IOP patients seen in Charleston; and 3) patients seen in the other four MUSC affiliated hospitals combined (i.e., Chester, Florence, Lancaster, and Marion). The aims and the design/methods utilized for evaluation will be the same for each of the three patient groups.

Official Title
-----------------
Dissemination of an Inpatient Smoking Cessation Program to South Carolina Hospitals Study #1

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: Enhanced Care
* Behavioral: Basic Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18+ years and older hospitalized cigarette smokers eligible for either enhanced or basic care discharged from the hospital back to their home Exclusion Criteria: patients without a phone number those unable to communicate in the English language

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Care Condition<br> | Behavioral: Enhanced Care<br>* Smokers in the enhanced care group will receive live counseling (either in person or telehealth consult) while hospitalized combined with post-hospital discharge automated calls using interactive voice recognition (IVR) technology.<br>|
| Active Comparator: Basic Care Condition<br> | Behavioral: Basic Care<br>* Smokers assigned to the basic care group will only receive the post-discharge IVR phone calls.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported smoking prevalence 6-weeks after hospitalization. | Hypothesize that patients exposed to the enhanced care intervention compared to basic care will report a 2-fold higher 7-day non-smoker prevalence rate after hospitalization (i.e., 20% vs 10%) | Assessed 6-weeks post-discharge | 
| Self-reported use of FDA Approved Smoking Cessation Medication | Hypothesize that patients exposed to the enhanced care intervention compared to basic care will report a 2.5-fold greater use of an FDA approved stop smoking medication after hospitalization (i.e., 20% vs 8%) | Assessed 6-weeks post-discharge |
Prediction of Medication Compliance Following Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to quantitate pre-transplant medication compliance, dialysis compliance, and related psychological variables, and then examine their validity as predictors of post-transplant noncompliant behaviors and clinically relevant outcomes (acute rejection, graft loss, or death). Hypothesis: Noncompliance with pre-transplant medication or with the dialysis prescription, and specific psychological variables predict similarly noncompliant behaviors after transplantation.

Detailed Description
-----------------
This pilot study is intended to provide preliminary data about the feasibility of recruiting a cohort of subjects on hemodialysis and following them prospectively through the transplant procedure. The study will document patient adherence to medications and treatment, both before and after surgery. These preliminary data will permit appropriate design and power calculations for a future study assessing our ability to predict post-transplant compliance, based on pre-transplant behaviors.

Official Title
-----------------
Prediction of Medication Compliance Following Renal Transplantation

Conditions
-----------------
Kidney Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult hemodialysis patients in renal transplant evaluation Able to read test forms Responsible for their own medications Exclusion Criteria: Patients with a major risk of recurrent primary renal disease, e.g. hemolytic uremic syndrome, oxalosis, membranoproliferative glomerulonephritis type II, focal segmental glomerulosclerosis with nephrotic syndrome. Patients with active psychosis Patients who do not speak English. Patients who live and will be followed outside the United States, except Canada. Patients who are physically unable to open the Medication Event Monitoring System (MEMS) cap. Patients who are not responsible for taking their own medications, e.g. living in a medical care facility. Patients who are younger than 14 years old Patients who will receive an extra renal organ (except pancreas), either simultaneously or previously.

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- | --- |
| Prediction of early medication adherence | Prediction of declining medication adherence during first three months post kidney transplantation. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medication adherence, Patient compliance, Kidney transplant, Organ rejection, Allograft loss, Drug monitoring