linjc16/ctgov huggingface dataset:
Integrative Analysis of Human Glioblastoma Multiforme

Study Overview
=================
Brief Summary
-----------------
Integrative analysis of GBM

Detailed Description
-----------------
The investigators will analyzed proteomes of paired normal brain tissues and GBM, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal brain tissue, primary GBM carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of GBM characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.

Official Title
-----------------
Integrative Analysis of Human Glioblastoma Multiforme

Conditions
-----------------
GBM

Intervention / Treatment
-----------------
* Other: Normal brain tissue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≤ 75 years with histologically proven GBM No severe major organ dysfunction World Health Organization (WHO) performance status of 0 or 1 No prior cancer chemotherapy Exclusion Criteria: Age ≥ 76 Severe major organ dysfunction WHO performance status of >1 Prior cancer chemotherapy

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 |
| --- | --- |
| Normal brain tissue<br>Normal brain tissue from GBM patients | Other: Normal brain tissue<br>* The investigators will extract total protein, DNA and RNA from the samples.<br>|
| GBM tissues<br>GBM tissues from GBM patients | Other: Normal brain tissue<br>* The investigators will extract total protein, DNA and RNA from the samples.<br>|
| Metastasis tissues<br>Metastasis tissues from GBM patients | Other: Normal brain tissue<br>* The investigators will extract total protein, DNA and RNA from the samples.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 years overall survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 years disease-free survival |  | 5 years | 
| 10 years overall survival |  | 10 years | 
| 10 years disease-free survival |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GBM; Integrative Analysis; WES
Effects of Intensive Lipid Lowering and Omega-3 Fatty Acid on Composition of Coronary Atherosclerotic Plaque

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether intensive lipid lowering and Omega-3 fatty acid are effective in the treatment of coronary atherosclerotic plaque.

Official Title
-----------------
Effects of Intensive Lipid Lowering and Omega-3 Fatty Acid on Composition of Coronary Atherosclerotic Plaque: Serial Virtual Histology Intravascular Ultrasound Analysis

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Drug: Intensive lipid lowering plus Omega3-fatty acid
* Drug: Moderate lipid lowering plus Omega3-fatty acid
* Drug: Intensive lipid lowering plus placebo
* Drug: Moderate lipid lowering plus placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute coronary syndrome within 48 hours of symptom onset Have de novo non-culprit coronary artery stenosis 20% to 70% by visual estimation Exclusion Criteria: Cardiogenic shock ST segment elevation myocardial infarction within 1 week Hematologic disorder: neutropenia (neutrophil<3000/mm3), thrombocytopenia (platelet<100,000/mm3) Liver enzyme elevation: serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal Impaired renal function with serum creatinine > 2mg/dL Bleeding diathesis or history of coagulopathy Pregnancy Hypersensitivity to heparin, dye, aspirin, clopidogrel, statin, or fish

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Intensive lipid lowering plus Omega3-fatty acid | Drug: Intensive lipid lowering plus Omega3-fatty acid<br>* Atorvastatin 40mg qd plus Omega3-fatty acid 2.0mg qd<br>|
| Active Comparator: 2<br>Moderate lipid lowering plus Omega3-fatty acid | Drug: Moderate lipid lowering plus Omega3-fatty acid<br>* atorvastatin 10mg qd plus Omega3-fatty acid 2.0mg qd<br>|
| Active Comparator: 3<br>Intensive lipid lowering plus placebo | Drug: Intensive lipid lowering plus placebo<br>* atorvastatin 40mg qd<br>|
| Active Comparator: 4<br>Moderate lipid lowering plus placebo | Drug: Moderate lipid lowering plus placebo<br>* atorvastatin 10mg qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque stabilization using serial virtual histology intravascular ultrasound analysis |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IVUS-VH, Plaque characterization, Omega3-fatty acid, Atorvastatin
Translational Approaches to Septic Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
This translational study will assess the association between septic cardiomyopathy (measured via left ventricular global longitudinal strain) and (a) inflammatory cytokine profiles, and (b) the behavior of cardiomyocytes derived from inducible pluripotent stem cells.

Official Title
-----------------
Translational Approaches to Septic Cardiomyopathy

Conditions
-----------------
Sepsis, Cardiomyopathies, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA At least 18 years of age Admitted to the ICU SEPSIS PATIENTS: Sepsis patients must have: Suspected or confirmed infection AND Organ dysfunction as defined by a SOFA >= 2 above baseline (if no baseline data available, SOFA assumed to be 0) OR SEPTIC SHOCK PATIENTS: AFTER INFUSION OF 20ML/KG CRYSTALLOID OR EQUIVALENT, septic shock patients must have: Suspected or confirmed infection AND Lactate > 2 mmol/L AND Receiving vasopressors EXCLUSION CRITERIA Known pregnancy Primary diagnosis of acute coronary syndrome Known preexisting heart disease Known severe valvular disease (regurgitation or stenosis) Major cardiac dysrhythmia such as: Ventricular tachycardia (V-tach) Ventricular Fibrillation (V-fib) Third degree heart block (complete hear block or complete AV block)

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 |
| --- | --- | --- |
| Correlation of cytokine profile with left ventricular global longitudinal strain | This outcome assesses the correlation between inflammatory cytokines (summarized via PCA) and septic cardiomyopathy, as assessed by left ventricular global longitudinal strain. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adrenergic susceptibility of pluripotent stem cell-derived cardiomyocytes | This is a laboratory-based outcome, using pluripotent stem cell-derived cardiomyocytes, with exposure to adrenergic agonists and antagonists in vitro | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
iPSC, septic cardiomyopathy, Inducible pluripotent stem cell, cytokine
Medical Utilization in Israel During Second Intifada

Study Overview
=================
Brief Summary
-----------------
In this ecological study we examine the impact of stress from repeated terrorist attacks during the second initifada on medical utilization by the Israeli population. We hypothesize that in weeks following serious terror attacks there will be an increase in prescriptions for psychiatric medications and an increased number of unexplained somatic complaints. We will also examine associations with overall medical utlization. We will consider age, gender and effects of geographic poximity to location of attacks.

Official Title
-----------------
Medical Utilization, Psychotropic Prescriptions, and Somatic Complaints in Israel During the Second Intifada: An Ecological Study of the Impact of Stress.

Conditions
-----------------
Anxiety, Depression, Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ecological study We will examine patterns of visits and prescirptions for all participants in two large health provider institutions in Israel. Exclusion Criteria: None - ecological study

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |
Microcirculatory Guided Goal Directed Fluid Therapy in Septic Shock; a Feasibility Study

Study Overview
=================
Brief Summary
-----------------
Prospective single centre study to assess the feasibility of fluid resuscitation guided by macrocirculatory and microcirculation parameters in patients in the early stages of septic shock. The investigators will utilise a novel point of care tool to assess microcirculatory sublingual perfusion in patients with septic shock. This, in combination with conventional haemodynamic monitoring will determine the timing and volume of resuscitative fluid administration. The feasibility of this technique will be determined prior to embarking on a pilot RCT.

Official Title
-----------------
Microcirculatory Guided Goal Directed Fluid Therapy in Septic Shock; a Feasibility Study

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Drug: Intra venous fluid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Within 6 hours of ICU admission Evidence of suspected or confirmed infection Serial Organ Failure Assessment (SOFA) score increase of 2 or more (assuming baseline 0 if no previous measures) Requiring vasopressor therapy to maintain a MAP > 65mmHg Lactate > 2 mmol/l despite initial fluid resuscitation Requirement for advanced haemodynamic monitoring (PiCCO system) in the opinion of the attending clinician Exclusion Criteria: Patients not expected to survive 24 h in whom the intent of treatment is palliative Patients in whom the primary cause of the shock state is cardiogenic -

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
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility study - single arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GDT feasibility<br>Patients undergoing microcirculatory goal directed therapy | Drug: Intra venous fluid<br>* Volume of intra venous fluid administered during GDT protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to acquire POEM score | Feasibility measure of point of care test | 6 hours | 
| Effect of POEM score on clinical decision making | Feasibility outcome measure | 6 hours |
Interleukine 6 as a Predictor of Outcome in Mechanically Ventilated Patients With Covid 19

Study Overview
=================
Brief Summary
-----------------
Serum IL-6 levels will be determined by enzyme-linked immunosorbent assay according to the manufacturer's instructions and the normal range is <10 pg/mL , Patients' medical records will be carefully reviewed and analyzed. Patient data regarding demographics, comorbidities, signs and symptoms, laboratory results and complications will be collected. The occurrence of complications will be confirmed according to the following criteria: acute respiratory distress syndrome (ARDS) defined according to the Berlin definition

Official Title
-----------------
Serum Interleukine 6 as a Predictor of Outcome in Mechanically Ventilated Patients With Covid 19

Conditions
-----------------
Mechanical Ventilation Duration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: •Age: more than 20 years. Gender: both males and females will be included. Mechanically Ventilated patients. COVID 19 confirmed diagnosis Exclusion Criteria: •Immunocompromised patients. Oxygen saturation more than 95% without ventilation. Malignancy. Patients refuse to be enrolled in the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| detection of acute respiratory distress syndrome | hypoxia, incresed plateau pressure | 2 weeks |
Phase II Pilot Study of Cytarabine for Refractory Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the toxicity of cytarabine in patients with refractory systemic lupus erythematosus. II. Evaluate objective disease parameters, including serum complement levels, anti-DNA antibody titers, sedimentation rate, and the systemic lupus activity measure in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: Subcutaneous cytarabine is given for 5 days. Patients are re-treated every 4 weeks for a maximum of 3 courses; those who relapse prior to the second course are re-treated every 3 weeks.

Conditions
-----------------
Lupus Erythematosus, Systemic

Intervention / Treatment
-----------------
* Drug: cytarabine


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Disease Characteristics Clinically documented active systemic lupus erythematosus demonstrating at least 4 revised diagnostic criteria Unresponsive to conventional therapy with nonsteroidal anti-inflammatory drugs (NSAIDs), topical corticosteroids, and antimalarials Intolerable side effects from corticosteroids or other immunosuppressive drugs Failure on immunosuppressives not required No life-threatening disease, e.g.: Lupus cerebritis Rapidly progressive glomerulonephritis Prior/Concurrent Therapy No concurrent other DNA synthesis inhibitors, NSAIDs, and prednisone continued on study Patient Characteristics Hematopoietic: WBC at least 2000; Platelets at least 100,000 Renal: Creatinine clearance at least 20 mL/min Other: No major infection within 2 weeks prior to entry Negative pregnancy test required of fertile women Effective contraception required of fertile women. Advised for men during and for 75 days after therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cytarabine|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
-----------------
arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus
Multiple Oral Doses Of PH-797804 In Healthy Japanese Adult Subjects

Study Overview
=================
Brief Summary
-----------------
Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when administered to healthy Japanese subjects once a day (QD) for 10 days.

Official Title
-----------------
APhase 1, Placebo-Controlled, Randomized, Parallel Group, Subject- And Investigator-Blind, Sponsor-Open Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PH-797804 Following Multiple Escalating Oral Doses In Healthy Japanese Adult Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: 1 mg
* Drug: 5 mg
* Drug: 10 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers Japanese Exclusion Criteria: Subjects with clinically significant skin lesions Subjects with known tuberculosis infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>PH-797804 | Drug: 1 mg<br>* 1 mg or placebo a material sparing tablet per day for 10 days<br>|
| Experimental: Cohort 2<br>PH-797804 | Drug: 5 mg<br>* 5 mg or placebo as material sparing tablet per day for 10 days<br>|
| Experimental: Cohotr 3<br>PH-797804 | Drug: 10 mg<br>* 10 mg or placebo as a material sparing tablet per day for 10 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities. |  | Day 1 to Follow-up | 
| Mean change from baseline in vital signs (blood pressure and heart rate) measurements |  | Baseline to Follow-up | 
| Mean change from baseline in 12-lead ECG parameters |  | Baseline to Follow-up | 
| Plasma PH-797804 Cmax, Cmin, Cavg(ss), Tmax, AUC(0-last), AUC(0-inf), AUC(0-tau), t1/2, CL/F, Vz/F, Rac, and Rac, Cmax |  | Days 1 and 10 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PH-797804, Japanese, Phase 1, multiple dose study
Post Stroke Psychological Distress

Study Overview
=================
Brief Summary
-----------------
Neuro-psychological, cognitive and biochemical assessment matched with MR-Imaging in acute and chronic poststroke conditions.

Detailed Description
-----------------
The study design relates to affective symptomatology, particularly poststroke depression and posttraumatic stress symptoms as well as to cognitive decline due to stress-related hypercortisolemia in the early phase after stroke. Extended MRI studies including a functional connectivity (fc-MRI) paradigm have been incorporated to study on subacute midbrain neurodegeneration as a possible morphological correlate of functional and clinical findings.

Official Title
-----------------
Depression and Posttraumatic Stress Disorder in Stroke Patients: an Observational Study of Neuro-psychiatric, Cognitive, and MR-Changes Over Time After Stroke

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stroke in MCA/AchA territory of striato-capsular (at least 125mm³) or non-striatal (10-100cm³) involvement MR-imaging can be conducted 24-48 hours of onset preserved communication skills Exclusion Criteria: Patients with psychiatric conditions or medication in the last 4 weeks severe medical conditions limited prognosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Non-striatal lesion group<br>acute ischemic Stroke in MCA territory of 10-100 cm³ with sparing of striatocapsular structures | |
| Striatal lesion group<br>acute ischemic stroke in MCA/AchA territory with involvement of at least 125 mm³ of striatocapsular structures | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurence of depression (GDS, SKID) | Geriatric Depression Scale, Structured Clinical interview for DSM-IV | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in saliva cortisol | measurement of saliva cortisol levels | 90days | 
| change in serumcholine | measurement of serumcholine | 90days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke