linjc16/ctgov huggingface dataset:
Maribavir for Prevention of CMV After Stem Cell Transplants

Study Overview
=================
Brief Summary
-----------------
Cytomegalovirus (CMV) infections remain a significant problem following various types of transplants that are associated with strong immunosuppressive therapy. Maribavir is a new oral anti-CMV drug with a novel mechanism of action compared to currently available anti-CMV drugs. This study will test the safety and anti-CMV activity of different doses of maribavir when given as CMV prophylaxis following stem cell transplants.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Assess the Safety, Tolerability, and Prophylactic Anti-cytomegalovirus Activity of Maribavir in Recipients of Allogeneic Stem Cell Transplants

Conditions
-----------------
Cytomegalovirus Infection

Intervention / Treatment
-----------------
* Drug: Maribavir
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allogeneic stem cell transplant recipient Recipient CMV seropositive Have transplant engraftment Able to swallow tablets Exclusion Criteria: CMV organ disease HIV infection Use of other anti-CMV therapy post-transplant

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Experimental: Maribavir (100 mg twice daily)<br> | Drug: Maribavir<br> <br> |
| Experimental: Maribavir (400 mg twice daily)<br> | Drug: Maribavir<br> <br> |
| Experimental: Maribavir (400 mg once daily)<br> | Drug: Maribavir<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical safety as measured by the recording of treatment emergent adverse events |  | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CMV disease |  | 13 weeks | 
| Incidence of CMV infection |  | 13 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stem cell transplantation, Allogeneic transplantation
Effect of Zinc Supplementation on Appetite and Growth in Primary Malnourished Children

Study Overview
=================
Brief Summary
-----------------
Zinc supplementation effect on appetite and growth of malnourished children

Detailed Description
-----------------
The investigators will do s. Zinc and letting before and after zinc supplementation

Official Title
-----------------
Effect of Zinc Supplementation on Appetite and Growth of Primary Malnourished Children

Conditions
-----------------
Appetite Disorders

Intervention / Treatment
-----------------
* Drug: Zinc sulphate
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary malnourished Exclusion Criteria: zinc supplementation in the previous 3 months Children with chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 10 Years

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

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

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 |
| --- | --- |
| Placebo Comparator: Normal children<br>Placebo | Other: Placebo<br>* Oral syrup placebo<br>|
| Experimental: Malnourished children<br>Oral zinc sulphate syrup | Drug: Zinc sulphate<br>* Oral syrup zinc sulphate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite | Child eating behavior questionnaire | From start of supplementation to the end of the three months of supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Weight | From start of supplementation to the end of the three months of supplementation | 
| Height | Height | From start of supplementation to the end of the three months of supplementation |
Neuron Specific Enolase in Ventricular Assist Device Recipients

Study Overview
=================
Brief Summary
-----------------
An observational study of neuron specific enolase, as a marker of reperfusion injury, in LVAD recipients before and following VAD implantation.

Detailed Description
-----------------
Patients eligible for left ventricular assist device (LVAD) typically have severe heart failure, which is characterized by poor cardiac output. The relatively abrupt increase in cardiac output that follows implant of a LVAD may cause reperfusion injury. Furthermore, selected patients may have particularly severe consequences of such injury, including refractory acidosis and vasoplegia. Neuron specific enolase (NSE) has been established as a biomarker of reperfusion injury. We hypothesize that changes in NSE following LVAD will be greater than the changes in NSE noted in a control population of patients undergoing non-VAD cardiac surgery.

Official Title
-----------------
Neuron Specific Enolase in Ventricular Assist Device Recipients

Conditions
-----------------
Advanced Heart Failure, Left Ventrucular Assist Device

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group 1 - Pre-VAD implantation patients 18 years and older lanning to undergo VAD implantation Group 2 Cardiac Surgery Comparison Group 18 years or older Planning to undergo valve or coronary bypass surgery Exclusion Criteria: Acute cerebrovascular infarction

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 |
| --- | --- |
| LVAD Group<br>18 years and older Planning to undergo VAD implantation | |
| Cardiac Surgery Group<br>18 years or older Planning to undergo valve or coronary bypass surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuron-Specific Enolase |  | Pre and post-surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Left Ventricular Assist Device, Reperfusion Injury, Neuron Specific Enolase
Association Between Cancer and Anti-synthetase Syndrome

Study Overview
=================
Brief Summary
-----------------
Among Idiopathic inflammatory myopathies, antisynthetase syndrome is meant to be rarely associated with cancer. However, clinical evidences of the association of those diseases led to the hypothesis that previous studies might have underestimated the prevalence of cancer in patients with antisynthetase syndrome. The aim of this study was to assess the prevalence of cancer in patients with antisynthetases syndrome in Grand Est and Bourgogne Franche-Comté regions.

Detailed Description
-----------------
Idiopathic inflammatory myopathies area heterogeneous group of disease involving mainly muscles, which paraneoplastic feature has been well characterized, specifically in some subgroups such as dermatomyositis. In contrast, antisynthetase syndrome is thought to be rarely associated with cancer. However, clinical observations of the association of those diseases led us to the hypothesis that previous studies might have underestimated the prevalence of cancer in patients with antisynthetase syndrome. The aim of this study was to assess the prevalence of cancer in patients with antisynthetases syndrome in Grand Est and Bourgogne Franche-Comté regions, describing the type of cancer observed as well as clinical features of patients and diagnostic work-up leading to the diagnosis of cancer.

Official Title
-----------------
Association Between Cancer and Anti-synthetase Syndrome : a Multicenter Study

Conditions
-----------------
Antisynthetase Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients positive antisynthetase antibodies (JO-1,PL12, PL17, EJ, OJ, KS, RS, YRS) Exclusion Criteria: age under 18 opposition to data collection no positive antisynthetase antibodies absence of clinical involvment

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 |
| --- | --- | --- |
| cancer prevalence | prevalence of cancer among patients with antisynthetase syndrome | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| description of cancer type in patients with antisynthetase syndrome | description of the type and stage of cancer in patients with antisynthetase syndrome | baseline | 
| factors associated with cancer | comparison of clinical and paraclinical features associated with cancer in patients with antisynthetase syndrome | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, idiopathic inflammatory myopathies
Retrospective Data Review of ReCap Total Hip Resurfacing

Study Overview
=================
Brief Summary
-----------------
Retrospective Data Review on clinical outcomes and survivorship of ReCap Total Hip Resurfacing

Official Title
-----------------
Retrospective Data Review of ReCap Total Hip Resurfacing

Conditions
-----------------
Osteoarthritis of the Hip

Intervention / Treatment
-----------------
* Device: ReCap Total Hip Resurfacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Patients received ReCap total hip resurfacing

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> | Device: ReCap Total Hip Resurfacing<br>* ReCap Total Hip Resurfacing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate |  | 2 yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score |  | 2yr |
Ripple Mapping for Epicardial Mapping of Brugada Syndrome

Study Overview
=================
Brief Summary
-----------------
Whether a mapping algorithm Ripple-mapping is able to rapidly identify the areas of long-duration multicomponent electrograms which constitute the targets for ablation for an automated strategy remains to be assessed.

Official Title
-----------------
Ripple-Mapping for the Detection of Long Duration Action Potential Areas in Patients With Brugada Syndrome

Conditions
-----------------
Brugada Syndrome

Intervention / Treatment
-----------------
* Procedure: Catheter ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Brugada syndrome patients requiring ablation Exclusion Criteria: Patients not able to consent

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

| Intervention/Treatment |
| --- |
|Procedure: Catheter ablation|Mapping of the epicardium and ablating areas of long fractionated potentials|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication of Brugada syndrome pattern | Disappearance of type 1 Brugada pattern on post-procedure ECG | 24h post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from ventricular arrhythmias | No documentation of sustained ventricular tachycardia or ventricular fibrillation | 12 months post-procedure |
Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE

Study Overview
=================
Brief Summary
-----------------
Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin

Detailed Description
-----------------
Comparison of two kinds of protheses for bridging of the femoropoplitea and/or femorotibiale: PTFE with or without bounded heparin. Evaluation of this comparison by clinical systems: ankle-arm index, duplex echo, follow-up of 2 years

Official Title
-----------------
Multicentric, Prospective, Randomized, Comparing Trial Between Bypass of the Femoropoplitea by PTFE and Heparin Bounded PTFE

Conditions
-----------------
Peripheral Vascular Diseases

Intervention / Treatment
-----------------
* Device: Bridging by PTFE with bounded heparin
* Device: Bridging by PTFE without bounded heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Peripheral Vascular Diseases with complaints of invalidating claudication, rest pain, ucera or gangrene Patients with damage of the arteria femoralis superficialis or poplitea, longer than 6 cm Reasonable outflow arteria Informed consent Patient able to take part in all follow-up examinations Exclusion Criteria: Acute ischemia of the leg Patients with a ipsilateral inflow stenosis of more than 70% which can not be corrected before or during the surgery < 18 years Pregnancy Recent heart attack (< 1 month) Life expectancy less than 12 months Known allergy to heparin Known contrast allergy Known bleeding or coagulation disorder

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>PTFE with bounded heparin | Device: Bridging by PTFE with bounded heparin<br>* Bridging by PTFE with bounded heparin<br>|
| Active Comparator: 2<br>PTFE without bounded heparin | Device: Bridging by PTFE without bounded heparin<br>* Bridging by PTFE without bounded heparin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency after 2 years |  | after 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary patency |  | after 2 years | 
| Limb salvage |  | after 2 years | 
| Mortality |  | after 2 years | 
| Re-intervention |  | after 2 years |
Neoadjuvant Nivolumab for Operable Esophageal Carcinoma

Study Overview
=================
Brief Summary
-----------------
This is a single arm phase II study, in which maximum 3 cycles of nivolumab (240 mg fixed dose every 2 weeks) is administered for T2- or T3-node negative esophageal squamous cell carcinoma, before curative operation.

Official Title
-----------------
Neoadjuvant Nivolumab for Operable Esophageal Squamous Cell Carcinoma

Conditions
-----------------
Esophageal Squamous Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Nivolumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed esophageal squamous cell carcinoma Clinical stage T2N0 (invasion to muscularis propria) or T3N0 (invasion to adventitia) ECOG performance 0 or 1 Age 19 years or older Exclusion Criteria: Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer Ineligibility or contraindication for esophagectomy Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Has severe hypersensitivity and adverse events (≥Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Arm<br>Nivolumab 240 mg fixed dose every 2 weeks, for maximum of 3 cycles | Drug: Nivolumab<br>* Nivolumab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major pathologic response | Viable tumor comprised ≤ 10% of resected tumor specimens | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions | 2 months | 
| Positron Emission Tomography (PET)-CT response | Complete metabolic response is defined as the SUV of 2.5 or less than 2.5 of primary tumor | 2 months | 
| Progression-free survival (PFS) | Time from the enrollment to disease relapse after complete resection or death from any cause | 24 months | 
| Overall survival (OS) | Time from the enrollment to death of any cause | 24 months |
A Multicenter Collaborative Study on the Clinical Features, Expression Profiling, and Quality of Life of Infantile Onset FSHD

Study Overview
=================
Brief Summary
-----------------
This study is an observational study that aims to advance our knowledge on infantile onset FSHD. The study will include 50 participants of all ages who have presented with symptoms of FSHD between birth and 10 years of age. Study participation will involve a single day of assessments at one of the participating CINRG centers (to include physical exam, cognitive testing, eye exam, hearing test, strength testing and speech evaluations). The procedures may be split over additional days for scheduling purposes.

Official Title
-----------------
A Multicenter Collaborative Study on the Clinical Features, Expression Profiling, and Quality of Life of Infantile Onset Facioscapulohumeral Muscular Dystrophy

Conditions
-----------------
Facioscapulohumeral Muscular Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Affected participants must have a clinical diagnosis of FSHD, including the presence of all of the following features based on review of medical records and/or direct examination: Onset of symptoms involving the facial or shoulder girdle muscles Autosomal dominant inheritance in familial cases Contraction of the D4Z4 repeat array from 1-10 (10 - 38 kb) copies in the 4q35 subtelomeric region, based on established molecular genetic techniques Exclusion Criteria: Symptomatic cardiomyopathy or severe cardiac arrhythmia which may limit the ability to complete the study protocol Maternal/mitochondrial mode of inheritance Evidence of an alternative diagnosis based on muscle biopsy or other available investigations
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 |
| --- | --- | --- |
| All Outcome Measures | Establish a standardized muscle testing protocol including both manual and quantitative muscle testing as well as function testing for use in children and adults with infantile onset FSHD. To describe the clinical phenotypes of infantile FSHD; separately in the early infantile group (onset before age 5) and late onset group (onset between 5 and 10 years of age). To evaluate the impact of physical impairment, secondary health conditions, activity limitations and disability caused by FSHD on health-related quality of life and disability across different age groups; as well as to evaluate the utility of the FSHD clinical severity scale. To evaluate potential genetic modifiers of clinical phenotypes and disease progression in infantile FSHD. | Dec 2014 |