linjc16/ctgov huggingface dataset:
HLA-B35 Alleles and AIDS

Study Overview
=================
Brief Summary
-----------------
This study will identify variations in the genome of the human immunodeficiency virus (HIV) early after infection and following the development of AIDS. It will analyze genetic material and clinical data from HIV-positive individuals to assess differences in viral epitopes between patients with two different gene alleles (alternative forms of a gene)-B*3501 and B*3503. (An epitope is a molecular region on the surface of an antigen capable of eliciting an immune response and of combining with the specific antibody produced by such a response.) HIV disease in people with the B*3503 allele progresses significantly faster than it does in people with the B*3501 allele. This study might provide information that is potentially useful in developing a successful HIV vaccine. Blood samples and clinical data for analysis will be obtained from the Johns Hopkins Bloomberg School of Public Health; the University of Pittsburgh; the John H. Stroger, Jr. Hospital of Cook County; the Howard Brown Health Center; Northwestern University; and the University of California at Los Angeles.

Detailed Description
-----------------
The purpose of this study is to identify variations in the genome of HIV early after infection and following the development of AIDS to determine the location of escape mutations that might provide information about potential B*35 epitopes. These data will be useful in explaining the difference in disease progression between individuals possessing B*35 Px alleles and those with B*35 PY alleles. We have previously shown that individuals with B*35 Px alleles progress at a significantly faster rate compared to those with B*35 PY alleles. This study might provide information which is potentially useful in the development of a successful HIV vaccine.

Official Title
-----------------
Comparison of HIV-1 Epitopes That May be Recognized by HLA-B*3501 (PY) and -B*3503 (Px) Early After Seroconversion and After Development of AIDS

Conditions
-----------------
HIV-1, AIDS

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION AND EXCLUSION CRITERIA: Sera and relevant clinical data from properly consented HIV positive seroconverters will be provided to the LGD for analysis. No available subjects will be excluded to maximize power. We will request an accrual ceiling of 100 participants.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Immunity, Mutations, Viral Selection, Disease Progression, RNA
Prevention of Drug Use in Adolescence: Intervening in Parenting Styles

Study Overview
=================
Brief Summary
-----------------
To investigate whether brief motivational intervention is associated with the change of parenting style in parents of teenagers seeking to prevent drug use among their children.

Official Title
-----------------
Prevention of Drug Use in Adolescence: Intervening in Parenting Styles

Conditions
-----------------
Substance-Related Disorders

Intervention / Treatment
-----------------
* Behavioral: Motivational Interviewing for Change of Parenting Styles
* Behavioral: Psicoeducation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of adolescents aged 10-15 years who call for the service call 132 looking for a program to prevent drug use and accept to participate in the study after reading the Statement of Consent Exclusion Criteria: Be excluded individuals that are experiencing difficulty in answering the questions and those who refuse to participate in the study elucidated by IC
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interviewing for Change of Parenting Styles<br>After measured parental style across the scale, the motivational interviewing will be applied in order to modify the parenting styles of risk for involvement with drug use and maintenance of protective factors. This approach will occur in 5 segments . | Behavioral: Motivational Interviewing for Change of Parenting Styles<br> <br> Behavioral: Psicoeducation<br> <br> |
| Sham Comparator: Psicoeducation<br>General information about drugs and ways of prevention | Behavioral: Psicoeducation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the reduction risk factors for the use of drugs | The outcome will be measured by the Parenting Styles Inventory | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Prevention, Substance-Related Disorders, Family
A Randomized Trial to Implement the AHCPR Smoking Cessation Guideline

Study Overview
=================
Brief Summary
-----------------
Among veterans, smoking is the single most important risk factor for preventable mortality and morbidity, and studies suggest a higher prevalence of smoking among veterans than the general population. The VHA has encouraged adoption of the AHCPR Guideline for Smoking Cessation, yet most hospitals have poorly developed smoking cessation programs.

Detailed Description
-----------------
Background: Among veterans, smoking is the single most important risk factor for preventable mortality and morbidity, and studies suggest a higher prevalence of smoking among veterans than the general population. The VHA has encouraged adoption of the AHCPR Guideline for Smoking Cessation, yet most hospitals have poorly developed smoking cessation programs. Objectives: The present study is designed to investigate the effectiveness of an organizational strategy to increase compliance with the AHCPR guideline. Short term goals of the study include increasing the rate of identification of smokers and increasing the delivery of brief smoking cessation interventions. Long term goals include reducing tobacco consumption among veterans. Methods: Twenty VAMC�s with active primary care clinics have been randomly assigned to either control (usual practice; UP) or intervention (organizational support; OS) groups. The intervention hospitals receive staff training and site consultation; all hospitals will receive the AHCPR guideline. Rate of identification of smokers in the medical record, smoking cessation rates, provision of smoking cessation services (e.g., NRT, counseling), and costs of NRT will be determined via telephone interviews with patients, chart review, and electronic records. Status: Baseline data collection is nearly complete, and the intervention period will be complete in September, 2000. We have completed telephone surveys with approximately 4500 veterans. Analysis of study data is ongoing, and manuscript preparation will begin within the next few months.

Official Title
-----------------
A Randomized Trial to Implement the AHCPR Smoking Cessation Guideline

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

Intervention / Treatment
-----------------
* Procedure: Systems Support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be smokers. Exclusion Criteria:
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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Procedure: Systems Support<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Shear-wave Elastography Diffuse Liver Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to correlate between quantitative results of shear wave elastography and CT picture in diffuse liver disease, including liver cirrhosis.

Detailed Description
-----------------
Many pathophysiological processes can lead to diffuse parenchymal liver diseases and the end-result of all chronic liver diseases is healing by fibrosis and regeneration. Liver fibrosis is a slowly progressing disease in which healthy liver tissue is replaced with scar tissue ended with liver cirrhosis, with a variety of causes, including viral, drug induced, autoimmune, cholestatic, and metabolic diseases. Liver biopsy is the gold standard but limited due to its invasiveness, sampling error, and intra- and interobserver variability. Non-invasive tests are preferred in the management of chronic liver diseases. Several serum tests for liver function and markers of liver fibrosis are available and have moderate sensitivity and specificity; however, they are confounded by a wide range of extra-hepatic diseases. Currently, several methods are available for assessing hepatic fibrosis and progression of fibrogenesis including scintigraphy, magnetic resonance diffusion weighted imaging, and magnetic resonance spectroscopy could differentiate between cirrhosis or severe fibrosis and normal liver. However, an accurate staging of fibrosis or diagnosis of mild fibrosis was often not achievable. Shear-wave elastography (SWE) is a real-time freehand ultrasonography-based elastography method for liver stiffness measurement.

Official Title
-----------------
Correlation Between Shear-wave Elastography and CT in Diffuse Liver Disease

Conditions
-----------------
Chronic Hepatic, Chronic Liver Disease and Cirrhosis

Intervention / Treatment
-----------------
* Device: Shearwave elastography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both sexes are included: patients who diagnosed to had chronic liver diseases with or without present hepatic focal lesions. Exclusion Criteria: Lactating and pregnant women Patients known to had high serum creatinine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Shearwave elastography|Shear wave elastography is an ultrasound applied technique used to measure tissue stiffness as a result of a disease. So, it can be used to evaluate liver stiffness as a result of liver cirrhosis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shearwave elastography (SWE) of the liver | Analyze the correlation between SWE of liver and with computed tomography findings. | 1 week |
Dialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion

Study Overview
=================
Brief Summary
-----------------
A unique inside-out-access technique with a new CE certified device (Surfacer (R) Bluegrass Vascular, San Antonio, Tx, USA) enables repetitive and confident right-sided placement of central venous catheters in hemodialysis patients with thoracic central venous occlusion.

Official Title
-----------------
Dialysis Catheter Placement in Patients With Thoracic Central Venous Occlusion

Conditions
-----------------
Central Venous Catheter Thrombosis

Intervention / Treatment
-----------------
* Procedure: inside-out-access technique with inside-out access device (Surfacer (R))
* Procedure: access technique including Sharp recanalization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with thoracic central venous occlusion Exclusion Criteria: pregnancy

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 |
| --- | --- |
| inside-out-access technique with inside-out access device<br> | Procedure: inside-out-access technique with inside-out access device (Surfacer (R))<br>* inside-out-access technique with (Surfacer (R)) with a new CE certified device (Surfacer (R), Bluegrass Vascular)<br>|
| access technique including Sharp recanalization<br> | Procedure: access technique including Sharp recanalization<br>* access technique with Sharp recanalization via interventional radiology<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of dialysis access |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure related complications | infections, bleeding, hematoma or pericardial effusions and intervention related parameters | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thoracic central venous occlusion, Dialysis access
A Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605

Study Overview
=================
Brief Summary
-----------------
A phase 3 study to evaluate efficacy and safety of HCP1401

Detailed Description
-----------------
A randomized, double-blind, multicenter, phase 3 study to evaluate efficacy and safety of HCP1401 for stage 2 hypertension patients not controlled by HCP0605

Official Title
-----------------
A Randomized, Double-blind, Multicenter, Phase 3 Study to Evaluate Efficacy and Safety of HCP1401 for Stage 2 Hypertension Patients Not Controlled by HCP0605

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: HCP1401
* Drug: HCP0605


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertension patient who satisfied below condition at Visit 1. patient who takes antihypertensive drug 140mmHg <= sitSBP <= 200mmHg patient who doesn't take antihypertensive drug 160mmHg <= sitSBP <= 200mmHg 140mmHg <= sitSBP <= 200mmHg at Visit 2 Exclusion Criteria: Patient who have received 4 or more antihypertensive drug Patient with 20mmHg of difference in sitSBP or 10mmHg of difference in sitDBP between 3 times of BP measuring at Visit 1 Patient with sitDBP >= 120mmHg at Visit 2 Patient with secondary hypertension

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>HCP1401 | Drug: HCP1401<br>* amlodipine, Losartan, Chlorthalidone FDC<br>* Other names: amlodipine, Losartan, Chlorthalidone;|
| Active Comparator: Reference<br>HCP0605 | Drug: HCP0605<br>* amlodipine, Losartan FDC<br>* Other names: amlodipine, Losartan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting systolic blood pressure at week 8 |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting diastolic blood pressure at week 2 and week 8 |  | 2 weeks and 8 weeks | 
| Change from baseline in sitting systolic blood pressure at week 2 |  | 2 weeks | 
| Proportion of subjects achieving Blood Pressure control |  | 2 weeks and 8 weeks |
Non-interventional Open Label Study to Investigate the Effect of Quetiapine XR on Patient Satisfaction and Quality of Life in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Since subjective well-being and quality of life (QoL) are increasingly being recognized as important treatment outcomes in patients with schizophrenia (Hofer et al., 2004; Becker et al., 2005), the aim of this study is to investigate the effect of treatment with quetiapine XR on these parameters in the acute hospital and the subsequent ambulant care setting. The study is planned to be conducted in 15 centers all over Austria and, overall, about 150 inpatients with a ICD-10 diagnosis of acute schizophrenia are planning to be enrolled. The duration of the whole trial will be approximately 4 months, whereas 2 visits during hospitalization and two further visits after discharge will be scheduled. At each visit, adverse events and safety parameters, patient satisfaction and effectiveness of the current treatment, as well as concomitant medication and dosing schedules will be assessed and documented.In addition to that, the patients' overall satisfaction with antipsychotic therapy and their current quality of life will be determined using a QoL questionnaire, focussing on the subjective experience with quetiapine XR.

Official Title
-----------------
Patient Satisfaction and Quality of Life Under Treatment With Seroquel XR

Conditions
-----------------
Quality of Life in Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult schizophrenia patients Inclusion according to Summary of product characteristics Exclusion Criteria: Diagnosis other than schizophrenia Patients for which Seroquel XR is not registered (pregnant women, children and adolescents…)

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 |
| --- | --- |
| 1 group, schizophrenia patients<br>Patients with schizophrenia according to ICD-10(diagnostic and statistical manual of mental disorders) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject wellbeing under Neuroleptics scale (Quality of Life) |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BPRS (Brief Psychiatric Rating Scale) |  | 4 months | 
| CGI (Clinical Global Impression) |  | 4 months | 
| All adverse events occurring during the study will be documented |  | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, Patient satisfaction, Schizophrenia, Investigate quality of life in schizophrenia
Observational Study On Compliance Of Statin Treatment Of Patients With High Blood Cholesterol Levels

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to show the compliance rates of the patients to statin treatment and the reasons of non-compliance.

Official Title
-----------------
Assessment Of Statin Treatment Compliance In Dyslipidemia Patients: An Observational Study

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Behavioral: Patient Compliance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with dyslipidemia and taking or planning to take statin treatment. Patients living in the same city of the study center. o Patients aged 18 years and over. Exclusion Criteria: Patients with severe systemic disease Patients with alcohol and drug addiction and/or mental disease Patients nursing or pregnant, or planning to get pregnant during the 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Statins<br>Patients with dyslipidemia who are taking or planning to take a statin treatment (Atorvastatin, Fluvastatin, Prevastatin, Rosuvastatin, Simvastatin or generics). | Behavioral: Patient Compliance<br>* Compliance of patients to statin treatment and reasons of compliance or non compliance will be obtained by Patient Reported Outcomes (PROs) every 3 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Were Compliant With Statin Treatment | The physician asked participants about their compliance with medication use, which was defined as not skipping or forgetting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used. | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Available Lipid Profiles of Compliant and Non-compliant Participants | Available laboratory measurements of participants were recorded in CRFs. | Month 12 | 
| Number of Participants With Reasons of Compliance to Statin Treatment | Compliance with medication use defined as not skipping or forgeting dosing or not delaying the dosing time at least 80 percent (%) of the days in which the medication was used. Participants were called for a final visit . Compliance with drug dosage was recorded. | Month 12 | 
| Number of Participants With Reasons of Non-compliance to Statin Treatment | Participants were called for a final visit and reasons for non-compliance were recorded. | Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Statins, Compliance, Dyslipidemia