linjc16/ctgov huggingface dataset:
Ion Prostate Irradiation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and feasibility of primary hypofractionated irradiation of the prostate with carbon ions or protons using the raster scan technique.

Detailed Description
-----------------
as published: Habl G, Hatiboglu G, Edler L, Uhl M, Krause S, Roethke M, Schlemmer HP, Hadaschik B, Debus J, Herfarth K: Ion Prostate Irradiation (IPI) - a pilot study to establish the safety and feasibility of primary hypofractionated irradiation of the prostate with protons and carbon ions in a raster scan technique. BMC cancer 2014, 14(1):202. http://www.ncbi.nlm.nih.gov/pubmed/24641841

Official Title
-----------------
Hypofractionated Ion Irradiation (Carbon Ions Versus Protons) of the Prostate

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Procedure: radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histological proven carcinoma of the prostate with Gleason score risk of lymphe node involvement of <15% calculated by the Yale-formula; Risk [%] = [GS -5] x [PSA/3 + 1.5 x T], mit T = 0, 1, and 2 for cT1c, cT2a, und cT2b/cT2c Karnofsky-Index ≥ 70% age between 40 and 80 years PSA Exclusion Criteria: Stadium IV (distant metastases) Lymphogenous Metastases hip replacement former irradiation of the pelvis pacemaker defibrillator

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: protons<br>irradiation 20 x 3,3 GyE protons | Procedure: radiation<br>* radiation with protons or carbon ions<br>|
| Experimental: carbon ions<br>irradiation 20 x 3,3 GyE carbon ions | Procedure: radiation<br>* radiation with protons or carbon ions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proctitis and cystitis | via incidence grade 3-4 toxicity (NCI-CTC-AE) | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA-PFS | by measuring PSA values every 3 months | 3 years | 
| OS |  | 3 years | 
| quality of life | by questionnaire | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate, IPI, hypofractionation, carbon ions, proton
Treatment of Conduct Problems and Depression

Study Overview
=================
Brief Summary
-----------------
Having both depression and conduct problems at the same time has been found to be associated with increased risk for the other and increased risk of negative outcomes. This study will develop an family based cognitive behavioral treatment protocol for youths with both conduct problems and depression, that will take be administered over the course of six months. Youth with comorbid conduct problems and depression will be assigned to the experimental condition or treatment as usual in a community care setting. The treatment manual will be revised as needed. Youth will be assessed before and after treatment to examine program potential. The goal of this research is to develop a more comprehensive outpatient treatment for youth with both conduct problems and depression.

Official Title
-----------------
Treatment of Youth Comorbid Conduct Problems and Depression

Conditions
-----------------
Depression, Oppositional Defiant Disorder, Conduct Disorder

Intervention / Treatment
-----------------
* Behavioral: Integrated Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 8-14 years old Diagnosis of ODD or CD Diagnosis of Depression Speaks English Exclusion Criteria: Developmental/cognitive delays Substance dependence Psychotic disorder or symptoms

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 14 Years

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sequential Treatment<br> | Behavioral: Integrated Treatment<br> <br> |
| Experimental: Integrated Treatment<br> | Behavioral: Integrated Treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Symptoms | Change in depression symptoms from baseline to week 24 will be measured using the Children's Depression Inventory | baseline to week 24 | 
| oppositional symptoms | change in symptoms of oppositionality from baseline to week 24 will be measured using the Disruptive Behavior Disorders Scale | baseline to week 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, conduct problems
Non-interventional-study With Tacrolimus Sandoz© Capsules for Prophylaxis of Renal Graft Rejection

Study Overview
=================
Brief Summary
-----------------
This non-interventional study intends to collect epidemiological data in patients with stable kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the approved indication.

Official Title
-----------------
A Single-site, Prospective Non-interventional-study With Adport Sandoz© Capsules for Prophylaxis of Graft Rejection in Patients With Stable Kidney Function After Renal Allograft.

Conditions
-----------------
Chronic Kidney Insufficiency

Intervention / Treatment
-----------------
* Other: In this observational study no study specific intervention is planned


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: ≥ 18 Post renal transplantation time: ≥ 6 months Stable kidney function ( serum creatinine < 3.0mg/dl; variation < 0.5mg/dl at 2 appointments in minimum distance of 6 days) Stable Tacrolimus Sandoz© dose > 2 weeks before inclusion in this Non Interventional Study (NIS) Written and oral informed consent Exclusion Criteria: Well-known poor compliance with immunosuppressives Acute rejection reaction within the past 3 months or antibody-therapy because of rejection within the past 6 months

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 |
| --- | --- |
| Renal allograft<br> | Other: In this observational study no study specific intervention is planned<br>* Patients with stable kidney function who already receive Tacrolimus Sandoz© capsules before being included in this non-interventional study, are being observed for 6 months by their attending physicians. Routine medical treatment is provided.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Adport Sandoz© trough level |  | Observation time: 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Adport Sandoz© in prevention of renal graft rejection by observing serum creatinine levels |  | Observation time: 26 weeks | 
| Incidence of serious adverse drug reactions |  | Observation time: 26 weeks | 
| Incidence of adverse drug reactions |  | Observation time: 26 weeks | 
| Incidence of serious adverse events |  | Observation time: 26weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Grafting, kidney, Transplantation, kidney
TBE-vaccine to Patients With Rheumatoid Arthritis Who Are Using Immunosuppressive Drugs

Study Overview
=================
Brief Summary
-----------------
The investigators intend to check whether the efficacy of a TBE-vaccine is substantially deteriorated in patients with rheumatoid arthritis who are treated with drugs which suppress the immune system. The investigators aim to detect a difference of at least 10 % compared to healthy individuals (historical controls) in protection when analysed with serology. If the investigators detect a difference, the investigators will continue to explore whether protection can be achieved by additional doses

Official Title
-----------------
Efficacy of TBE-vaccine to Patients With Rheumatic Disease Who Are Treated With Methotrexate and/or TNF-alfa Blocking Drugs

Conditions
-----------------
Rheumatoid Arthritis, Exposed to TBE-virus, Immunosuppression

Intervention / Treatment
-----------------
* Biological: TBE-vaccine
* Biological: TBE-vaccine
* Biological: Vaccination against TBE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rheumatoid arthritis treated with methotrexate and/or TNF-alfa blocking drugs Interest to be vaccinated Written consent Age 18 years or more Exclusion Criteria: Previous TBE-infection Previous Vaccination with TBE Pregnancy Breast feeding Treatment with rituximab the last 9 months Inability to follow study protocol

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccination against TBE<br>Less than 60 years old: Two doses of TBE- vaccine separated by a month and a third dose 12 months after the first dose 60 years and above: Three doses, given at 0+1+3 months and a 4 th dose 12 months after the first dose | Biological: TBE-vaccine<br>* Solution of 0.5 ml for intramuscular use. Given in 2 doses separated by 1 month to healthy individuals less than 60 years old. (3 doses 0+1+3 months to those are 60 and above in Sweden)<br>* Other names: ATC-code J07B A01;Biological: TBE-vaccine<br>* Solution for injection 0.5 ml im. 2 or 3 doses first years, 1 dose next year<br>* Other names: J07B A01;Biological: Vaccination against TBE<br>* 0.5 ml im at 0 and 1 month ( less than 60 years old) or 0 and 1 and 3 months (at least 60 years old)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate | The humoral response to TBE-vaccine | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid arthritis, TBE-vaccine, Immunosuppression
Evaluation of Type 2 Diabetes Treatment

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyze the efficacy of Diabeton 60 MR as intensive sugar-lowering therapy into routine clinical practice, in patients for whom the treating physician has already decided to prescribe this medication. This concerns untreated newly diagnosed patients uncontrolled by diet, and patients uncontrolled by metformin.

Official Title
-----------------
Evaluation of Type 2 Diabetes Treatment in AZERbaijan

Conditions
-----------------
Type2 Diabetes

Intervention / Treatment
-----------------
* Drug: Diabeton 60 MR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Type 2 diabetes patients: Males and females, aged over 35 Currently treated: with diet only, or with metformin therapy for at least 3 months prior to inclusion Who have not been able to achieve target level of glycaemia, with glycated hemoglobin (HbA1c) level exceeding 7%. Exclusion Criteria: Patients with at least one of the following criteria are not included in the study: Type 1 diabetes Severe liver (ALT and AST levels 2.5 times as high as upper level of normal range) or renal insufficiency (creatinin plasma level above 140 µmole/L) Patients who are on insulin therapy, or at risk to receive an insulin treatment in the next 4 months, according to physician judgment. Intolerance to Gliclazide if such prescription was done in the past Pregnancy and breast-feeding Night workers or patients able to skip meals Presence of any contraindication listed in the SmPC.

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- |
| Diabeton MR 60<br> | Drug: Diabeton 60 MR<br>* Administer Diabeton MR 60 mg 1/2 tablet. Increasing dosage of Diabeton MR 60 mg by ½ tablet is recommended if fasting glucose level exceeds 6 mmol/L.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in HbA1c |  | over 4 months | 
| Percentage of patients achieving HbA1c level ≤ 7 % |  | week 16. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of hypoglycemia episodes |  | Week 0, 2, 4, 6, 8 and week 16. | 
| Mean daily dosage of Diabeton MR |  | Week 2, 4, 6, 8 and 16 |
Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients With Alcohol Dependence

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety and the prognosis after achieving reduced alcohol intake in patients with alcohol dependence who received treatment for the reduction of alcohol intake in the routine clinical setting in Japan.

Official Title
-----------------
Nalmefene Hydrochloride Hydrate Tablets 10mg Specified Drug-use Results Survey (the Safety and the Prognosis After Achieving Reduced Alcohol Intake)

Conditions
-----------------
Alcohol Dependence

Intervention / Treatment
-----------------
* Drug: Nalmefene Hydrochloride Hydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Alcohol Dependence Must agree to follow-up during the first year of prescription and publication of survey results Patients whose goal of treatment for Alcohol Dependence is to reduce alcohol consumption Patients receiving psychosocial treatment aiming to promote treatment adherence and reduction of alcohol consumption Patients who have chronic heavy drinking Patients who have confirmed that they are willing to receive treatment to reduce their alcohol consumption Exclusion Criteria: Patients who has ever been treated with nalmefene hydrochloride hydrate Patients who are contraindicated
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nalmefene Hydrochloride Hydrate|Oral administration of nalmefene hydrochloride hydrate|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol Use Disorders Identification Test-Consumption(AUDIT-C) |  | 1 year |
A Preliminary Feasibility Efficacy of Participation in Daily Life Promotion Program

Study Overview
=================
Brief Summary
-----------------
Efficacy of Participation in Daily Life Promotion Program for Patients with Chronic Stroke

Detailed Description
-----------------
The purpose of this three-year research project is to develop an intervention program to promote participation in daily life for patients with chronic stroke and to evaluate its efficacy.

Official Title
-----------------
National Taiwan University Hospital, Taiwan

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: Daily Life Promotion Program
* Other: general rehabilitation treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with stroke after 6 months. Must be able to follow orders and no other cognition impairment, Mini Mental State Examination scale must >20. Exclusion Criteria: Clinical diagnosis of Dementia or Psychosis. Clinical diagnosis of Musculoskeletal disorders or Nervous system diseases. Patient with Congestive Heart Failure, Hypertension, Atrial fibrillation. Could not communication with others. Foreigner.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Daily Life Promotion Program | Other: Daily Life Promotion Program<br>* Daily Life Promotion Program<br>|
| Experimental: control group<br>general rehabilitation treatment | Other: general rehabilitation treatment<br>* general rehabilitation treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Impact Scale(SIS) | quality of life measure | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural Assessment Scale for Stroke patients(PASS) | motor performance measure | one year | 
| Action Research Arm Test(ARAT) | motor performance measure | one year | 
| Fugl-Meyer Assessment(FMA) | motor performance measure | one year | 
| self-rated abilities for health practice scale | self-efficacy factors measure | one year | 
| WHO Quality of Life-BREF (Taiwan version) | quality of life measure | one year | 
| Taiwan Instrumental Activities of Daily Living(TIADL) | self-care ability measure | one year | 
| Barthel Index | self-care ability measure | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Life participation
Study Evaluating Effexor® (Venlafaxine) in Achieving Response and Maintaining Remission

Study Overview
=================
Brief Summary
-----------------
This is a study to determine the utility of Effexor® (venlafaxine) in achieving response, including time to response, maintaining remission, and time to remission as measured by the 17-item Hamilton Rating Scale for Depression (HAM-D) and to determine the utility of Effexor® (venlafxine) on the various cluster of symptom scales in the 17-item HAM-D.

Official Title
-----------------
A Study Of The Utility Of Effexor® (Venlafaxine) In Achieving Response And Maintaining Remission Among Taiwanese Patients With Depression

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

Intervention / Treatment
-----------------
* Drug: Effexor® (Venlafaxine)


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Patients meeting criteria for a diagnosis of major depression, single or recurrent episode as described by the DSM-IV manual (appendix 1). A HAM-D 17 total score of at least 16 at baseline (DSM-IV manual, appendix 2). Patients above 18 years of age who meet the eligibility requirements. EXCLUSION CRITERIA: Patients taking MAOI's within 2 weeks prior to the survey. Patients known to be suffering from bipolar disorder or schizophrenia. Patients who are treatment-resistant, i.e., in the past 3 years have failed (a) three previous adequate trials of greater than or equal to 2 classes of antidepressant medication, or (b) electroconvulsive therapy. Drug or alcohol dependence or abuse in the past 6 months per DSM IV criteria.
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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Effexor® (Venlafaxine)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy variable will be the proportion of patients with remission defined as a HAM-D score of less than or equal to 7 at 8 weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability will be assessed based on adverse events that occurred during the survey for all patients who received at least one dose of Effexor®. |  |  |
PRecIsion Medicine in CardiomyopathY

Study Overview
=================
Brief Summary
-----------------
This is a retrospective cohort study of pediatric hypertrophic cardiomyopathy (HCM) patients using chart and registry review methodology. The studies objective is to develop and validate a sudden cardiac death (SCD) risk calculator that is age-appropriate for children with HCM that includes clinical and genetic factors.

Official Title
-----------------
Development of a Risk Calculator to Predict Sudden Cardiac Death in Children With Hypertrophic Cardiomyopathy

Conditions
-----------------
Hypertrophic Cardiomyopathy, Sudden Cardiac Death

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: phenotype-positive patients diagnosed with hypertrophic cardiomyopathy phenotype-negative, genotype positive patients considered at risk for developing hypertrophic cardiomyopathy Exclusion Criteria: Neuromuscular, metabolic, syndromic (other than Noonan Syndrome and related RAS-opathies) or endocrine (including infants of diabetic mothers) causes of HCM (Other treatable causes of left ventricular hypertrophy (systemic hypertension, anatomic defects causing left ventricular outflow tract obstruction e.g. aortic stenosis, subAS, subaortic membrane, coarctation)

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum 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 |
| --- | --- |
| Hypertrophic Cardiomyopathy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Composite Sudden Cardiac Death Event | The composite SCD event includes post diagnosis SCD, aborted SCD (including ventricular fibrillation, sustained ventricular tachycardia), primary ICD insertion with appropriate shock, secondary ICD insertion | Time to a composite sudden cardiac death event during 5-year follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric, Risk Prediction