linjc16/ctgov huggingface dataset:
Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation.

Detailed Description
-----------------
Prophylactic ICD implantation was recently found to be non-beneficial over usual clinical care in non-ischemic systolic heart failure (LVEF≤35%) and 60-70% percent of SCD cases even occur in individuals with LEVF>35%. A growing evidence, that emphasizes the urgent need to improve the prediction of sudden cardiac death (SCD) in dilated cardiomyopathy (DCM). CMR provides unique information on myocardial mechanics, fibrotic burden, inflammation and microvascular dysfunction, thereby allowing to quantify key substrates for myocardial arrhythmogenic potential. PREDICT-DCM Trial is a multi-centre, prospective observational trial including patients with DCM undergoing cardiac magnetic resonance imaging (CMR) prior to ICD or event recorder implantation. Acquired candidate predictors are among others: Global and regional T1/T2 T1/T2 inhomogeneity Extracellular volume fraction Microvascular dysfunction LA function and filling fraction Global and regional circumferential, radial or longitudinal myocardial strain Biomarkers

Official Title
-----------------
Prediction of Sudden Cardiac Death in Dilated Cardiomyopathy: The PREDICT-DCM Trial.

Conditions
-----------------
Cardiomyopathy, Dilated, Sudden Cardiac Death

Intervention / Treatment
-----------------
* Diagnostic Test: Cardiac Magnetic Resonance Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dilated Cardiomyopathy ICD Indication age ≥ 18 years signed informed consent Exclusion Criteria: severe claustrophobia rest dyspnea tachycardia or severe arrhythmia intolerance to gadolinium-based contrast agent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Dilated Cardiomyopathy<br> | Diagnostic Test: Cardiac Magnetic Resonance Imaging<br>* Patients undergo baseline characterisation including CMR, ECG, blood samples prior to ICD implantation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Combined Endpoint | Sudden Cardiac Death OR sustained VT OR non-sustained, long run VT | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Cardiac Death | 18 months |
Key Aspects of Medical Practice in Patients With Haemophilia A

Study Overview
=================
Brief Summary
-----------------
The KAPPa project has the aim to create an international database in which information about clinical features, therapeutic management, burden of illness and costs of severe and moderate haemophilia A patients from different countries and sites is collected. The aim of this project is to analyse the influence of such different characteristics on medical, psychosocial and economic outcomes in patients over the long-term.

Detailed Description
-----------------
1000 patients with hemophilia A will be enrolled using a webbased registry. Key quality factors that will be registered are : hemophilia joint Health score (HJHS), annual bleed rate, quality of Life (EQ5D), as well as dosing of replacement therapy.

Official Title
-----------------
Key Aspects of Medical Practice in Patients With Haemophilia A

Conditions
-----------------
Joint Disease

Intervention / Treatment
-----------------
* Biological: Factor VIII replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: or forms. severe haemophilia A (factor VIII<1%) moderate (factor VIII<5%) signed informed consent Exclusion Criteria: Not fullfilling inclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Replacement therapy<br>Hemophilia A receiving replacement therapy (prophylaxis or on demand) | Biological: Factor VIII replacement<br>* Patients receive their usual treatment<br>* Other names: factor VIII;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome of factor replacement treatment | Joint disase according to HJHS. Quality of Life. Health economic evalaution. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
haemophilia, joint disease, quality of life
Effects of Xal-Ease on Patient Compliance With Xalatan

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that the Xal-Ease with increase patient compliance with XALATAN

Official Title
-----------------
The Effects of the Xal-Ease Delivery Aid Device on Patient Compliance With Xalatan Eye Drops

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: Xal-Ease device to be used with Xalatan eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 40 to 80 years old Diagnosis warranting treatment with Xalatan eye drops. ambulatory and well functioning Exclusion Criteria: non-ambulatory less than 40 or greater than 80 years old Not using Xalatan eye drops

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

| Intervention/Treatment |
| --- |
|Device: Xal-Ease device to be used with Xalatan eye drops|This intervention is a drop instillation guide to be used in conjunction with the FDA approved Xalatan eye drop.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is compliance with the medication XALATAN using and not using the Xal-Ease delivery aid for their glaucoma treatment. |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if any of the other factors mentioned in the survey affect compliance to their medical regimen |  | six months | 
| To see whether or not the Xal-Ease device helps patients conserve medication. ie - aids in drops not distilled in the eye. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, compliance, eye drops, deliver aid, Patients could range anywhere from 40 to 80 years old, Patients must have diagnosis requiring treatment with Xalatan., Patients will be male or female and from any racial/ethnic background.
Retrospective Treatment Pattern Survey for the Patient With and Without History of Stroke

Study Overview
=================
Brief Summary
-----------------
This study will compare hypertension treatment pattern of stroke patients with non-stroke patients receiving medical care from outpatient clinics at neurology specialty centers in Korea. It will evaluate target BP achievement rate in patients with stroke compared to patients without stroke and investigate factors affecting BP target goal efficacy in these patients.

Official Title
-----------------
A Retrospective, Multi Centre, Non-interventional, Observational Study to Compare Treatment Pattern and Factors That Affect BP Control in Patients With and Without Stroke

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients attending neurology specialty centers, either with or without history of stroke, receiving hypertension medication Exclusion Criteria: Secondary hypertension patients Patients not receiving hypertension medication

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<br>Hypertension patients with history of stroke | |
| 2<br>Hypertension patients without history of stroke | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure, History of stroke, Antihypertensive medication |  | After collecting all Patient Record Form. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure, History of stroke, antihypertensive medication, Classification of stroke, Risk factors, Concomitant medication, etc. |  | After collecting all Patient Record Form. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Stroke, Neurology, JNC7, 2007 ESH-ESC guidelines, survey
Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age

Study Overview
=================
Brief Summary
-----------------
Safety, Tolerability and Immunogenicity of Meningococcal C Conjugate Vaccine to Children 32 to 40 Months of Age

Official Title
-----------------
A Phase IV, Multi-Center, Controlled Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of a Commercially Available Meningococcal C Vaccine When Given as First, Third or Fourth Immunization to Children 32-40 Months of Age

Conditions
-----------------
Meningococcal Infection

Intervention / Treatment
-----------------
* Biological: Meningococcal C conjugate vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children Exclusion Criteria: known hypersensitivity to any vaccine component significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 14 days ascertained or suspected disease caused by N. meningitidis household contact with or intimate exposure to an individual with a positive culture of N. meningitidis serogroup C within the previous 60 days

Ages Eligible for Study
-----------------
Minimum Age: 32 Months
Maximum Age: 40 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Meningococcal C conjugate vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of memory antibody response to Neisseria meningitidis serogroup C after 2 or 3 doses of MenC vaccine given during infancy, as measured by hBCA at day 0 and day 28. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of antibody titers in naïve control subjects. |  |  | 
| Determination of persistence of antibody response after either 2 or 3 doses of MenC vaccine given during infancy and one dose of MenPS A/C vaccine given at 12 months of age. |  |  | 
| Evaluation of the safety and tolerability of a single 0.5 mL intramuscular (IM) injection of MenC Vaccine when given to children approximately three years of age. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention of meningococcal infection
CHP677: I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma: a Phase II Study

Study Overview
=================
Brief Summary
-----------------
131I-metaiodobenzylguanidine (131I-MIBG) is a norepinephrine analog that concentrates in adrenergic tissue and therefore holds promise for cell-specific treatment of neuroblastoma. This is a dual institution, Phase II study of 131I-MIBG administered at the previously defined maximum practical dose of 18 mCi/kg to children with relapsed or refractory neuroblastoma.

Official Title
-----------------
CHP677: I-Metaiodobenzylguanidine (I-MIBG) Therapy for Refractory Neuroblastoma: a Phase II Study

Conditions
-----------------
Neuroblastoma

Intervention / Treatment
-----------------
* Drug: 131I-MIBG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Refractory neuroblastoma with original diagnosis based on tumor histopathology or elevated urine VMA with typical tumor cells in the bone marrow.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 131I-MIBG|nan|

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
-----------------
Relapsed and refractory neuroblastoma
Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized Subjects

Study Overview
=================
Brief Summary
-----------------
Purpose: To provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized Comparison Study Of the Efficacy and Safety of Tigecycline to Imipenem/ Cilastatin to Treat Complicated Intra-Abdominal Infections in Hospitalized Subjects

Conditions
-----------------
Gram-Positive Bacterial Infections, Cross Infection

Intervention / Treatment
-----------------
* Drug: Tigecycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects, ≥ 8 years of age and a weight of ≥ 35 kilograms Subjects with selected culture-positive infections caused by a multiple antibiotic-resistant pathogen presumed to be susceptible to tigecycline Subjects who have failed or are intolerant of other available appropriate antibiotic therapies or whose pathogens are resistant to other available antibiotics Exclusion Criteria: Subjects who are moribund with an expected survival of less than 2 weeks. Subjects who have been designated as Do Not Resuscitate, unless it is anticipated within a reasonable degree of medical certainty that they can achieve benefit from potentially curative antibiotic therapy Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Tigecycline|nan|

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
-----------------
Bacterial Infections
Effect of 2.5 Years of Rasagiline Therapy on Progression of Cognitive Biomarkers Assessed by MRI in Parkinson's Disease.

Study Overview
=================
Brief Summary
-----------------
In this investigator-initiated study, we will compare changes in brain cognitive biomarkers assessed by diffusion tensor imaging over 2.5 years among 12 patients with Idiopathic Parkinson's disease (IPD) receiving rasagiline, 20 IPD patients not receiving MAO-B inhibitors and 25 age-matched healthy controls. Will also compare the changes in Mini-Mental State Exam (MMSE) and Montreal Cognitive Assessment (MoCA) scores and plasma brain-derived neurotrophic factor (BDNF) with changes in brain cognitive biomarkers in all IPD patients and HC over 2.5 years.

Official Title
-----------------
Effect of 2.5 Years of Rasagiline Therapy on Progression of Cognitive Biomarkers Assessed by MRI in Parkinson's Disease.

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

Intervention / Treatment
-----------------
* Drug: Rasagiline


Participation Criteria
=================
Eligibility Criteria
-----------------
IPD or HC subjects who were enrolled in a similar study about 2.5 years ago and for whom Baseline DTI data are available.
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 |
| --- | --- |
| PD-R<br>Parkinson's disease receiving rasagiline | Drug: Rasagiline<br> <br> * Other names: Azilect;|
| PD-NMAO<br>Parkinson's disease not receiving any MAO-B inhibitors | |
| HC<br>Healthy Controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive biomarkers assessed by DTI |  | 2.5 years | 
| Comparison of change in cognitive biomarkers with change in MMSE and MoCA scores |  | 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Baseline plasma BDNF with magnitude of change in brain cognitive biomarkers and MMSE and MoCA scores |  | 2.5 years | 
| Comparison of changes in plasma BDNF with changes in brain cognitive biomarkers and MMSE and MoCA scores |  | 2.5 years |
Reproducibility and Reliability of Epstein-Barr Virus (EBV) DNA/RNA Measures in Nasopharyngeal Swabs

Study Overview
=================
Brief Summary
-----------------
Nasopharyngeal carcinoma (NPC) is a virus-associated cancer that is rare among Caucasians but occurs at an elevated rate among Southern Asians. Rates of NPC are particularly high among individuals with a family history of this disease, but no specific genetic factors have been identified that can serve to guide clinical management of this high-risk population to ensure early detection and treatment of this life-threatening condition.

Official Title
-----------------
Reproducibility and Reliability of Epstein-Barr Virus (EBV) DNA/RNA Measures in Nasopharyngeal Swabs

Conditions
-----------------
Suspect NPC Patients, NPC Multiplex Families

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspect NPC patients Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| positive agreement among the positives, coefficient of variation |  | Four years | 
| positive agreement among the positives, coefficient of variation | CV=SD/mean * 100 | four years |
Cytogenetic Study of Ocular Melanoma

Study Overview
=================
Brief Summary
-----------------
Patients who are diagnosed with choroidal melanoma and undergo I-125 plaque or enucleation surgery consent to participate in the study. A tumor sample taken during surgery is studied in the lab for genetic features. These features and features of subjects' clinical course are recorded. Analysis of the data may identify genetic features that are indicative of prognostic factors including risk of metastasis.

Detailed Description
-----------------
The Jules Stein Eye Institute Ocular Melanoma Research Group is conducting cytogenetic studies of choroidal melanoma to improve the screening of biopsy samples of choroidal melanoma through cytogenetic analysis. Our goal is to identify molecular probes that specifically target regions of chromosomes that undergo changes characteristic of metastatic choroidal melanoma.

Official Title
-----------------
Molecular and Cytogenetic Studies of Ocular Melanoma

Conditions
-----------------
Choroidal Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with diagnosis of ocular melanoma Patient with local treatment plan for ocular melanoma- plaque brachytherapy or enucleation Patient 18 years of age or older Archival enucleation specimens with diagnosis of ocular melanoma Exclusion Criteria: Patient who refuses local melanoma treatment Patient who refuses to participate in this 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?
-----------------
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
-----------------
Choroidal Melanoma, Choroidal Malignant Melanoma, Ocular Melanoma, Uveal Melanoma