linjc16/ctgov huggingface dataset:
Facilitating Shared Decisionmaking About Prostate Cancer Screening

Study Overview
=================
Brief Summary
-----------------
Due to the disputed efficacy of prostate cancer (CaP) screening and treatment, most authorities recommend that providers inform and involve patients in CaP screening decisions.

Detailed Description
-----------------
Background: Due to the disputed efficacy of prostate cancer (CaP) screening and treatment, most authorities recommend that providers inform and involve patients in CaP screening decisions. Objectives: This study evaluated two interventions designed to facilitate this process. Methods: 1152 male veterans age 50+ with no CaP and primary care appointments at four VA medical facilities in VISN 23 were randomly assigned to one of three groups: mailed pamphlet intervention, mailed video intervention, or usual care (control). Intervention materials were mailed two weeks prior to a target primary care appointment and patient telephone surveys were conducted one week (T1) and one year (T2) after the target appointment. Outcomes included: a 10- item validated knowledge index; responses to questions on CaP natural history, treatment efficacy, PSA accuracy, and expert disagreement about the PSA; whether screening was discussed with provider; scores on decision information seeking, participation and satisfaction scales; screening and treatment preferences; and PSA testing rates. Status: Complete

Official Title
-----------------
Facilitating Shared Decisionmaking About Prostate Cancer Screening

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Behavioral: Prostate Cancer Screening Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be male veterans, age 50 and older, with a scheduled primary care appointment at one of 5 VISN 13 medical facilities. Patients diagnosed with prostate cancer will be excluded. Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Behavioral: Prostate Cancer Screening Education<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Rehabilitating Overweight People Back to Working Life

Study Overview
=================
Brief Summary
-----------------
Obesity may have implications on the individual's participation in working life through different mechanisms such as comorbidity and loss of functional level. The investigators also know that when exiting the working force, it is difficult to get back later. As rehabilitation back to working life is often not a very focused aim with weight loss treatment, this study sets this as a primary aim by involvement in a 4 week stay at a rehabilitation clinic followed by 48 weeks work practice programme at one of three different companies.

Official Title
-----------------
Rehabilitating Overweight People Back to Working Life

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 30-47 19-67 years Exclusion Criteria: Pregnancy Significant reduced physical function Drug use Serious mental illness

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 67 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 |
| --- | --- | --- |
| Participation in working life |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | 4 years |
Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether KAI-1678 is effective in the treatment of pain associated with spinal cord injury.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled, Single-Dose Two-Period Crossover Study to Assess the Efficacy of KAI-1678 Administered by Subcutaneous Infusion in Subjects With Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: KAI-1678


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: spinal cord injury at least 1 year prior and nonprogressive ofr at least 6 months central neuropathic pain for at least 3 months or with relapses and remissions for at least 6 months pain score at least 4 on 11-point numerical rating scale (0-10) stable doses of analgesic medications for at least 1 month Exclusion Criteria: history of chronic alcoholism or chronic substance abuse tolerance to opioid analgesics clinically significant abnormality on laboratory tests or ECG

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A1: Placebo<br>Placebo | Drug: Placebo<br>* Placebo IV Infusion<br>|
| Experimental: A2: KAI-1678<br>Experimental | Drug: KAI-1678<br>* KAI-1678 IV Infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of KAI-1678 on mean change from baseline in pain intensity at 6 hours (PID 6). |  | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of KAI-1678 on the proportion of subjects achieving at least a 1 point improvement in pain intensity at 6 hours |  | 6 hours | 
| The effect of KAI-1678 on patient global impression of change |  | 6 hours | 
| The effect of KAI-1678 on symptoms of neuropathic pain assessed by the Neuropathic Pain Scale (NPS) |  | 6 hours | 
| The number of participants with adverse events as a measure of safety and tolerability of KAI-1678 |  | Two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Analgesics. Non-narcotic / therapeutic use, Spinal Cord Injuries, Pain, Pain measurement / drug effect, Pain postoperative / drug therapy
Enhancing Recovery After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Patients recovering from coronary artery bypass graft (CABG) surgery have high rates of depression, and depression is associated with higher risk of complications and death. Recent discoveries show that depression involves changes in certain molecules in the blood, which are also involved in progressive coronary artery disease (CAD) and its complications. This study will evaluate the effects of cognitive behavioral therapy (CBT) as a treatment for depression on these biological markers among CABG patients.

Official Title
-----------------
Enhancing Recovery After Cardiac Surgery

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

Intervention / Treatment
-----------------
* Behavioral: Cognitive Behavioral Therapy (CBT)
* Behavioral: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergone CABG at one of our recruitment sites Exclusion Criteria: Less than 45 years of age Have cognitive impairment or major comorbid psychiatric conditions Have autoimmune disorder or malignancy Currently smoking

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Cognitive Behavioral Therapy (CBT)<br>* Subjects receive CBT in the home for 8 weeks with blood draws every other week during therapy.<br>|
| Active Comparator: 2<br> | Behavioral: Usual Care<br>* Subjects receive Usual Care for 8 weeks followed by CBT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of proinflammatory cytokines (IL-1 and IL-6) |  | at baseline and after 8 weeks (at the completion of the intervention) | 
| The soluble receptor for IL-6 (sIL-6) |  | at baseline and after 8 weeks (at the completion of the intervention) | 
| Inflammatory markers c-reactive protein (CRP and sICAM-1) |  | at baseline and after 8 weeks (at the completion of the intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression symptoms (Beck Depression Inventory) |  | at baseline and after 8 weeks (at the completion of the intervention) | 
| Presence of clinical depression |  | at baseline and after 8 weeks (at the completion of the intervention) | 
| Pain |  | at baseline and after 8 weeks (at the completion of the intervention) | 
| Sleep disturbances |  | at baseline and after 8 weeks (at the completion of the intervention) |
Resection for Multiple Hepatocellular Carcinomas (HCC)

Study Overview
=================
Brief Summary
-----------------
Surgical resection in patients with multiple hepatocellular carcinomas (HCC) remains controversial. The aim of this study was to investigate the outcome of a consecutive cohort of patients resected for multiple HCC, without macrovascular invasion, in order to identify clinically reliable parameters to select patients for surgery.

Official Title
-----------------
Hepatic Resection for Multiple Hepatocellular Carcinoma on Cirrhosis

Conditions
-----------------
Hepatocellular Carcinoma, Multiple Tumors, Cirrhosis

Intervention / Treatment
-----------------
* Procedure: hepatic resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with multiple HCC without macrovascular invasion on liver cirrhosis Exclusion Criteria: macrovascular invasion; normal liver; distant or lymphnodes metastasis
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: hepatic resection<br> | Procedure: hepatic resection<br>* surgical resection of the liver for multiple HCC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival plus multivariate analysis | The primary endpoint of the study was the overall survival of patients resected for multiple HCC, and the univariate and multivariate analyses of prognostic factors for overall survival. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | The secondary endpoint was the disease-free survival. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver resection, hepatic resection, intraoperative ultrasound
PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term Therapy

Study Overview
=================
Brief Summary
-----------------
Non-Ergot Dopamine agonists are meanwhile the drugs of first-choice in the treatment of Parkinson's disease. The receptor profile of the non-ergot dopamine-agonist piribedil is unique. In addition to agonistic effects on dopaminergic D2- and D3-receptors piribedil has adrenergic alpha-2A- and alpha-2C-receptors antagonisic properties. There is evidence from the literature that the antagonistic properties of piribedil are correlated with an improvement of cognitive function and vigilance parameters in parkinson's disease. The aim of the present non-interventional study is to investigate the safety and efficacy of piribedil during long-term therapy of patients with M. Parkinson under consideration of cognitive functions and quality of life.

Official Title
-----------------
Efficacy and Safety of Long-term Therapy With Piribedil (CLARIUM) in Patients With M. Parkinson Under Consideration of Quality of Life Parameters and Cognitive Function

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: piribedil (Clarium)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed or advanced idiopathic Parkinson's disease male and female patients over 18 years of age indication for treatment with piribedil according to Summary of Product Characteristics (SmPC) Exclusion Criteria: in line with piribedil SmPC in particular hypersensitivity to piribedil or to any of the excipients and pregnancy and lactation as stated in the SmPC

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 |
| --- | --- |
| tablet<br> | Drug: piribedil (Clarium)<br>* oral tablets, 50 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event profile during long term therapy with piribedil in patients with Parkinson's disease |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence on quality of life |  | 4 years | 
| Quality of life parameters |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
open, non-intervention, observational
Neonatal Seizures in NICU of Assuit University Children's Hospital

Study Overview
=================
Brief Summary
-----------------
A cross sectional study on neonatal seizures in Assuit University Children's hospital NICU.

Detailed Description
-----------------
An Overview on neonatal seizures in neonatal intensive care unit of Assuit University Children's hospital , a cross sectional study. The aim of this study is to evaluate the clinical seizures during the neonatal period and its prevalence

Official Title
-----------------
An Overview on Neonatal Seizures in Neonatal Intensive Care Unit of Assuit University Children's Hospital, a Cross Sectional Study

Conditions
-----------------
Neonatal Seizure

Intervention / Treatment
-----------------
* Diagnostic Test: blood and CSF studies + neuroimaging studies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ALL neonates (preterm and full-term infants) aged 0 to 28 days who are admitted to the neonatal intensive care unit of Assiut University Children's hospital during the period of the study will be included Exclusion Criteria: Neonates with multiple congenital anomalies (other than CNS anomalies)

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Month

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| neonatal seizures cases<br>Cases of neonatal seizures | Diagnostic Test: blood and CSF studies + neuroimaging studies<br>* blood and CSF studies + neuroimaging studies<br>|
| seizure-free neonates<br>cases that are seizure free | Diagnostic Test: blood and CSF studies + neuroimaging studies<br>* blood and CSF studies + neuroimaging studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of neonatal seizures among neonates admitted to Assiut University children's hospital | prevalence of neonatal seizures among neonates admitted to Assiut University children's hospital during period of study | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with controlled seizures during hospital admission period | Short term outcomes of clinical seizures (if seizures could be controlled during hospital admission period or not) | 1 year |
Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation

Study Overview
=================
Brief Summary
-----------------
Infusion of Mesenchymal Stem Cell (MSC) at day of recovery after bone marrow transplant (BMT) for patients with AL, AA and MM for acute Graft-versus-host Disease (GVHD) prophylaxis and treatment.

Detailed Description
-----------------
Infusion of mesenchymal stem cells at day of recovery after BMT for patients with AL, AA and MM for acute GVHD prophylaxis and treatment. Infusion at dose 1 cells mln/kg at day of white blood cells recovery.

Official Title
-----------------
Pilot Study for Safety and Effectiveness Assessment of Bone Marrow Mesenchymal Stem Cell Infusion for Acute Graft-versus-host Disease Prophylaxis and Treatment After Allogenic Bone Marrow Transplantation

Conditions
-----------------
Graft-versus-host Disease, Relapse

Intervention / Treatment
-----------------
* Biological: Mesenchymal stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: allogenic BMT from related or unrelated donor Exclusion Criteria: Severe infection Relapse admission to ICU refusal of research patients with graft failure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With MSC<br>infusion of Mesenchymal stem cells at dose 1 mln cells per kg | Biological: Mesenchymal stem cells<br>* Mesenchymal stem cells infusion<br>* Other names: Mesenchymal stem cells infusion;|
| No Intervention: Without MSC<br>Without MSC infusion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GVHD |  | Every 30 day for 1 year after BMT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Every 30 day for 1 year after BMT | 
| Relapse-free survival |  | Every 30 day for 1 year after BMT | 
| Infection rate |  | Every 30 day for 1 year after BMT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GVHD, Relapse, Overall Survival
Pharmacogenetics of Antifolate Disease Modifying Anti-Rheumatic Drugs in Rheumatoid Arthritis in Taiwan

Study Overview
=================
Brief Summary
-----------------
Polymorphisms occur in several genes encoding key enzymes in the folate pathway may affect drug metabolism in patients with rheumatoid arthritis. Whether these genetic variations contribute to differential responses to antifolate drug in patients with rheumatoid arthritis (RA) remains to be investigated in the Taiwanese population. Objective. The goal of the present study is to investigate the interactions between genetic variations in folate genes and the efficacy/side effects of anti-folate disease-modifying antirheumatic drug in Taiwan. DESIGN. A cross-sectional study involving 100 patients with RA were enrolled from TCVGH. Genotypes in methylenetetrahydrofolate reductase (MTHFR677C>T), tandem repeat polymorphism in thymidylate synthase enhancer region (TSER) and folylpoly-gamma-glutamate synthetase (FPGS1901T>C) were determined by RFLP or pyrosequencing.

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male/female age >18 Clinical diagnosis of Rheumatoid Arthritis Exclusion Criteria: Must not be pregnant/breastfeeding Other conditions may lead to exclusion from the trial (e.g. Diabetes mellitis, malignant melanoma, cardiac conduction disorders, hepatic/renal insufficiency.

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |