linjc16/ctgov huggingface dataset:
Fluvastatin, Rosuvastatin Added to Pegylated Interferon and Ribavirin

Study Overview
=================
Brief Summary
-----------------
Hypothesis: addition of fluvastatin will increase the cure rate of standard anti-HCV therapy. Summary: This trial is limited to veterans in Oklahoma who qualify for care with the Veterans Administration. It is a randomized control format including genotypes 1 and 3. There will also be pilot arms for HCV carriers who present for screening already on a statin, who will be allowed to stay on their current statin or switched to another statin. In all ways, standard therapy as noted on pegylated interferon and ribavirin will be given per FDA package insert.

Official Title
-----------------
A Randomized Controlled Trial of Adding Fluvastatin to Standard Medical Treatment (SMT) and a Pilot Trial of Rosuvastatin and Other Statins With SMT, for Patients Infected With Chronic Hepatitis C Who Are Naive to Therapy.

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

Intervention / Treatment
-----------------
* Drug: standard of care
* Drug: fluvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not previously treated. Off alcohol and marijuana for 6 months HCV RNA positive Exclusion Criteria: HIV positive Advanced liver disease Advanced cardiopulmonary disease Chronic renal failure

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 Plus statin<br>The addition of fluvastatin or rosuvastatin or other statins to the standard of care of peginterferon and ribavirin. | Drug: fluvastatin<br>* Add fluvastatin at 20-40 mg/day to standard of care<br>* Other names: Lescol;|
| Active Comparator: 2<br>Administration of the standard of care for hepatitis C of peginterferon and ribavirin. | Drug: standard of care<br>* peginterferon/RBV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Viral response |  | 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load at 4, 12 and 24 weeks |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fluvastatin, hepatitis C, chronic hepatitis C, not previously treated with pegylated interferon and ribavirin
Blood Pressure Assessment in Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
This is a cross-sectional study including patients with permanent atrial fibrillation. Assessment will include: clinic blood pressure measurements (mercury sphygmomanometer and automated oscillometric device) 24-hour ambulatory blood pressure monitoring determination of various serum markers and cardiac ultrasound. evaluation of a 24h ambulatory blood pressure monitoring device (Microlife WatchBPO3) in terms of its diagnostic value for the detection of atrial fibrillation compared with the reference 24h Holter ECG

Official Title
-----------------
Evaluation of the Oscillometric Blood Pressure Measurement in Atrial Fibrillation and Relation of Blood Pressure With Serum Biomarkers and Echocardiographic Indexes

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertensives adults in atrial fibrillation Exclusion Criteria: Renal disease (Cr > 2 mg/l). Patients with pacemaker rhythm during the study. Each patient with acute disease (inflammation, surgery), malignancy, collagen diseases, pulmonary fibrosis, renal failure, liver failure, chronic inflammatory diseases.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 85 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 |
| --- | --- |
| AF<br>Hypertensive patients in AF | |
| Non-AF<br>Hypertensive Patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Measurement in Atrial Fibrillation,Serum Markers and echocardiographic indexes in atrial fibrillation (AF) | Evaluation of the oscillometric technique of an electronic device in blood pressure measurement. Evaluation of the relationship of blood pressure levels with serum markers and ultrasonographic cardiac indexes. Evaluation of a 24h ambulatory blood pressure monitoring device (Microlife WatchBPO3) in terms of its diagnostic value for the detection of atrial fibrillation compared with the reference 24h Holter ECG | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood Pressure Measurement, Atrial Fibrillation, Blood pressure measurement in atrial fibrillation, Atrial Fibrillation diagnosis
A Study to Evaluate the Efficacy and Safety of AD-221 and AD-221A

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of AD-221 and AD-221A

Detailed Description
-----------------
The purpose of this study is to evaluate the efficacy and safety of AD-221 and AD-221A in patients with primary hypercholesterolemia

Official Title
-----------------
A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy and Safety of Administrated AD-221 and AD-221A in Patients With Primary Hypercholesterolemia

Conditions
-----------------
Primary Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: AD-221
* Drug: AD-221A
* Drug: AD-221B
* Drug: AD-221C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Subjects with primary hypercholesterolemia Exclusion Criteria: Patient with secondary dyslipidemia Other exclusions applied

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AD-221<br>AD-221, Placebo of AD-221A, AD-221B and AD-221C | Drug: AD-221<br>* PO, Once daily(QD), 8 weeks<br>|
| Experimental: AD-221A<br>AD-221A, Placebo of AD-221, AD-221B and AD-221C | Drug: AD-221A<br>* PO, Once daily(QD), 8 weeks<br>|
| Active Comparator: AD-221B<br>AD-221B, Placebo of AD-221, AD-221A and AD-221C | Drug: AD-221B<br>* PO, Once daily(QD), 8 weeks<br>* Other names: Ezetimibe;|
| Active Comparator: AD-221C<br>AD-221C, Placebo of AD-221, AD-221A and AD-221B | Drug: AD-221C<br>* PO, Once daily(QD), 8 weeks<br>* Other names: Atorvastatin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low density lipoprotein cholesterol (LDL-C) | LDL-C change at Week 8 | Baseline, Week 8 |
A Study to Estimate the Time Course of PF-00241939 Concentration in the Blood Following Dosing by Oral Inhalation From Dry Powder Inhalers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the time course of PF-00241939 concentrations in the blood following dosing by oral inhalation using dry powder inhalers.

Official Title
-----------------
An Open Study To Estimate The Plasma Pharmacokinetics Of PF-00241939 Administered Via Oral Inhalation Using Dry Powder Inhalers.

Conditions
-----------------
Pharmacokinetics

Intervention / Treatment
-----------------
* Drug: Treatment A
* Drug: Treatment B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the ages of 21 and 55 years. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Pregnant or nursing females. A positive urine drug screen.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br> | Drug: Treatment A<br>* PF-00241939 750ug using inhaler A<br>|
| Active Comparator: Treatment B<br> | Drug: Treatment B<br>* PF-00241939 750ug using inhaler B<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetic parameters: AUClast & Cmax. |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma pharmacokinetic parameters: AUC0-12, AUC0-24, AUCinf, Tmax and t½. |  | 48 hours |
The Impact of the Opiate Antagonist Naltrexone on the Emotional Valence of Dreams

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators pose the question which influence the opioid circuit has on positive valent situations in dreams.

Official Title
-----------------
The Impact of the Opiate Antagonist Naltrexone on the Emotional Valence of Dreams

Conditions
-----------------
Neuroscience of Dreaming, Healthy

Intervention / Treatment
-----------------
* Drug: Naltrexone
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Healthiness Good capacity of remembering dreams No opiate consumption Exclusion Criteria: Simultaneous participation in other studies Addictive disorder Abnormal liver function Abnormal kidney function Hypersensitivity to active ingredient or pharmaceutical additives Hereditary galactose intolerance Lactase deficiency Glucose-galactose malabsorption Intake of opioid medication

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Baseline<br>reporting of dreams | |
| Experimental: Naltrexone<br>daily administration of 50mg Naltrexone, reporting of dreams | Drug: Naltrexone<br>* one week<br>* Other names: Naltrexin;|
| Placebo Comparator: Placebo<br>daily administration of Placebo, reporting of dreams | Other: Placebo<br>* one week<br>* Other names: Placebo Pills;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS-difference concerning the emotional valence of dreams | Difference between the mean values of emotional valence of dreams reported in the conditions (Naltrexone, Placebo), as captured in VAS [visual analog scales] for every dream | 7 days per condition (Naltrexone, Placebo), intermitted by 14 days of washout | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semiquantitative score of emotional valence of dreams | Based on computational linguistic analysis of the dreams | 7 days per condition (Baseline, Naltrexone, Placebo), intermitted by 14 days of washout | 
| Qualitative score of emotional valence of dreams | Based on lexical coding of the dreams | 7 days per condition (Baseline, Naltrexone, Placebo), intermitted by 14 days of washout | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychology, Dreams
VA Genetic Tissue Banking

Study Overview
=================
Brief Summary
-----------------
This project is a program-wide genetic tissue databank for the Department of Veterans Affairs Cooperative Studies Program (CSP). The genetic tissue bank has four components: a central repository for DNA and other genetic tissue specimens; a Scientific Advisory Committee of individuals with expertise in the genetics and epidemiology of diseases with special importance to the VA (including cardiovascular, neurologic, respiratory, psychological and other disorders); an Ethics Oversight Committee of individuals with expertise in bioethics and the law, as they apply to the collection and use of genetic tissue, and a Coordinating Center that administers the tissue bank, coordinates the scientific and ethics oversight committees, maintains central access to clinical study data linked to the tissue bank, and provides statistical analysis.

Detailed Description
-----------------
Intervention: No intervention. Primary Hypothesis: It is feasible and cost-effective to create a CSP-wide facility for banking genetic tissue in CSP studies. Study Abstract: This is a program-wide genetic tissue databank for the Department of Veterans Affairs Cooperative Studies Program (CSP). The study has five components: a central repository for DNA and other genetic tissue specimens; a Scientific Advisory Committee of individuals with expertise in the genetics and epidemiology of diseases with special importance to the VA (including cardiovascular, neurologic, respiratory, psychological and other disorders); an Ethical Oversight Committee of individuals with expertise in bioethics and the law, as they apply to the collection and use of genetic tissue, A Veteran's Advisory Group, and a Coordinating Center administers the tissue bank, coordinates the three oversight committees, maintains central access to clinical study data linked to the tissue bank, and provides statistical analysis.

Official Title
-----------------
CSP #478 (FeAST-DNA), Genetic Tissue Banking in VA Clinical Research: A Cooperative Studies Program Demonstration Project

Conditions
-----------------
Tissue Banking

Participation Criteria
=================
Eligibility Criteria
-----------------
This DNA Banking substudy piggybacks on VA Cooperative Studies Clinical Trials. All participants who are randomized to selected CSP clinical trials are eligible to participate in the Banking Initiative.

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 |
| --- | --- | --- |
Accuracy of Noninvasive Pulse Oximeter Sensor (LNCS DBI)

Study Overview
=================
Brief Summary
-----------------
In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the percentage of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

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

Intervention / Treatment
-----------------
* Device: LNCS DBI Sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Competent non-smoking adults between the ages of 18 and 40 for each series of tests. Subjects must understand and consent to be in the study. American Society of Anesthesiology Class 1 (Healthy subjects without any systemic disease at all). Exclusion Criteria: Subjects who have any systemic disease at all. Subjects who do not understand the study and the risks. Smokers. Subjects who are pregnant. Subjects having either signs or history of peripheral ischemia. Others deemed ineligible by the clinical staff.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Test Subject<br>All subjects are enrolled into the test group and all subjects received the LNCS DBI Sensor. | Device: LNCS DBI Sensor<br>* Noninvasive Measurement of SpO2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Sensor by Arms Calculation | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value. In order to obtain the Arms value, the blood oxygen saturation measurement is subtracted from the pulse oximeter oxygen saturation measurement for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value. | 1-5 hours |
Comparison of Two Growth Hormone Dosing Methods in Adults With Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
This study tested whether a dose regimen of growth hormone based on body weight is equivalent or better than starting with a low dose and gradually increasing the dose according to individual patient needs. Efficacy of the two regimens were assessed from changes in body fat measured by dual-energy x-ray absorptiometry (DXA) scanning, performed at the beginning of the study and at the completion of the study eight months later.

Detailed Description
-----------------
Dose regimen of growth hormone based on weight: Starting dose was 4.0 micrograms/kg/day for four months, then increased to 8 micrograms/kg/day for two months, and then increased to 12 micrograms/kg/day for a further two months (eight months in total). Dose regimen of growth hormone based on individual patient needs: Starting dose was 200 micrograms/day, then increased by 200 micrograms/day every two months for an additional six months (eight months in total) as needed for optimal treatment results.

Official Title
-----------------
Comparison of an Incremental Weight-Based Dose Regimen With an Individualized Dosage Adjusted According to the IGF-I Response in Adults With Growth Hormone Deficiency

Conditions
-----------------
Hypopituitarism

Intervention / Treatment
-----------------
* Drug: Somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have growth hormone deficiency that started in childhood or adulthood Have not received any growth hormone treatment in the last 12 months Have had a growth hormone stimulation test within the last two years showing abnormally low response Have received adequate and stable hormonal replacement for other hormone deficiencies during the last three months Exclusion Criteria: Presence of clinically significant diseases, such as cancer, lung, heart, liver, kidney, neuromuscular, genetic, or severe psychiatric diseases Recent growth of pituitary tumor or other intracranial tumor History of acromegaly Taking medication to suppress appetite or reduce weight, or antidepressant drugs Poorly-controlled high blood pressure or diabetes

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Somatropin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in total fat mass |  | Eight months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | Eight months |
Study of Genes in Relation to Seasonal Affective Disorder and Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The investigators are looking for volunteers who have a history of Major Depressive Disorder, the Winter Blues, or Seasonal Affective Disorder or healthy volunteers who do not have a history of these disorders for a research study on genetics.

Detailed Description
-----------------
The investigators are looking for volunteers who have a history of Major Depressive Disorder, the Winter Blues, or Seasonal Affective Disorder or healthy volunteers who do not have a history of these disorders for a research study on genetics. Participation involves one 2-3 hour visit involving two diagnostic interviews, DNA collection, and questionnaires.

Official Title
-----------------
Gene Polymorphisms in Mood Disorders

Conditions
-----------------
Seasonal Affective Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SAD or MDD healthy control Exclusion Criteria: drug or alcohol dependence Bipolar Disorder

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Seasonal Affective Disorder<br>Consists of Individuals with Seasonal Affective Disorder | |
| Subsyndromal Seasonal Affective Disorder<br>Consists of individuals who do not meet SAD criteria,but present more symptoms for the disorder than do controls. | |
| Major Depressive Disorder<br>Consists of individuals who have MDD. | |
| Controls<br>Consists of individuals who do not present symptoms of SAD or MDD. | |

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
-----------------
Seasonal Affective Disorder, Major Depressive Disorder, Depression, Winter Blues