linjc16/ctgov huggingface dataset:
Effect of Ocrelizumab on Cortical Lesion Accumulation in Patients With PPMS (ORATORIO-Cortical)

Study Overview
=================
Brief Summary
-----------------
The goal of this non-interventional, observational study is to determine whether cortical pathology can be slowed down by use of ocrelizumab.

Detailed Description
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To study the effect of ocrelizumab on cortical lesion accumulation in patients with primary-progressive multiple sclerosis participating in the ORATORIO: a post-hoc analysis of a double-blind, randomized, phase 3, placebo-controlled study.

Official Title
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Effect of Ocrelizumab on Cortical Lesion Accumulation in Patients With Primary-progressive Multiple Sclerosis Participating in the ORATORIO: a Post-hoc Analysis of a Double-blind, Randomized, Phase 3, Placebo-controlled Study

Conditions
-----------------
Primary Progressive Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Ocrelizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient participating in the ORATORIO study MRI scans available at baseline Presence of T2-weighted image (WI) (FLAIR, T2/PD), and 2D/3D T1-WI at baseline Exclusion Criteria: - None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Ocrelizumab|Non-interventional|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortical lesion number accumulation | Cortical lesion accumulation as measured using MRI between subjects on placebo and subjects who took ocrelizumab. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortical lesion number accumulation and disability. | Cortical lesion number accumulation as measured by MRI for subjects who developed disability over the course of the placebo-controlled phase of the study. | 5 years |
Assessment of the Association Between Metabolic Associated Fatty Liver Disease (MFLD) and Biopsy Proved Cases of GN

Study Overview
=================
Brief Summary
-----------------
Fatty liver disease is a global health concern with a prevalence of about 25% amongst United States. Its increased prevalence is attributed to increase in patients with obesity and metabolic syndrome (1). Diabetes mellitus (DM),obesity, hyperinsulinemia are predisposing factors for fatty liver disease(2). Glomerulonephritis (GN), a complex syndrome encompassing a variety of individual disorders, is associated with significant morbidity and mortality(3). Given its association with hyperlipidaemia, metabolic syndrome and long-term use of steroid there is concern that patients with GN may be at increased risk of fatty liver disease Patients with NS are frequently found to have fatty liver disease even when adjusting for common risk factors(1). It is known that obesity is an independent risk factor for CKD and it is associated with the development of proteinuria and pathologic findings of podocyte hypertrophy and focal segmental glomerular sclerosis even in the absence of diabetes and hypertension . In addition, studies have shown that obesity as well as metabolic syndrome is a strong predictor of the development of fatty liver disease (4) . Hence, clinicians should maintain a high index of suspicion regarding presence of NAFLD in patients with NS

Official Title
-----------------
Assessment of the Association Between Metabolic Associated Fatty Liver Disease MFLD and Glomerulonephritis

Conditions
-----------------
Assessment of Patients With Biopsy Proven Primary Glomerulonephritis Above 18 Years of Age for MFLD Development

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with biopsy proven primary glomerulonephritis. Age >18 years Exclusion Criteria: Patients with e-GFR<60ml/min/1.73m2 Patients with secondary glomerulonephritis Patients with body mass index >35 kg/m2 Patients known to be diabetic. Patients known to be hypertensive. Patients with HCV or HBV infection either acute or chronic Patients with acute hepatitis whatever the aetiology Patients with autoimmune diseases

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Assessment of the association between MFLD and GN | Assessment of the association between MFLD and GN | Within 1 year |
The Effect of Interpersonal Psychotherapy on Quality of Life Among People Living With HIVAIDS

Study Overview
=================
Brief Summary
-----------------
Quality of life (QOL) is a significant importance for people living with HIV/AIDS by modifying the adverse psychosocial consequences that accompany the disease. In Ethiopia, interpersonal psychotherapy (IPT) has never been tried for people living with HIV/AIDS for quality of life. The objective of the study was to assess the effects of interpersonal psychotherapy on quality of life among PLWHA at Mettu Karl referral and Bedele hospital, southwest Ethiopia, 2022.

Official Title
-----------------
The Effect of Interpersonal Psychotherapy on Quality of Life Among People Living With HIVAIDS at Mettu Karl Referral and Bedele Hospital, Southwest Ethiopia, 2022: A Quasi-experimental Study

Conditions
-----------------
Breif Description: Patients' Quality of Life of

Intervention / Treatment
-----------------
* Behavioral: Interpersonal Psychotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PLWHA who were 18 years of age or above were included in the study Exclusion Criteria: PLWHA who are either currently or previously used IPT and acute physical or mental disturbances will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>intervention group were took interpersonal psychotherapy | Behavioral: Interpersonal Psychotherapy<br>* Intervention Group were took interpersonal psychotherapy<br>|
| Experimental: Control group<br>control group didn't took interpersonal psychotherapy | Behavioral: Interpersonal Psychotherapy<br>* Intervention Group were took interpersonal psychotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of Interpersonal Psychotherapy on quality of life among people living with HIVAIDS | Quality of Life measured by World Health Organization Health Related Quality of Life (WHOQOL- BREF). | two months |
Clinico-immunological Characterization and Immune Tolerance Breakdown in HU-autoimmunity

Study Overview
=================
Brief Summary
-----------------
Phenotypic characterization of patients with Hu-Abs, including the different neurological presentation and the presence or not of an underlying cancer. Analysis and clinical correlation of the diagnostic techniques for Hu-Abs detection (immunofluorescence, immunodot/Western blot, and CBA) in serum and/or CSF. Genomic and transcriptomic features of tumors (histological and immune infiltrate characteristics, transcriptomic profile, mutational status).

Official Title
-----------------
Clinico-immunological Characterization and Immune Tolerance Breakdown in HU-autoimmunity

Conditions
-----------------
Immune Tolerance

Intervention / Treatment
-----------------
* Other: Description of clinical, immunological and tumor features of patients harboring Hu Abs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria * : Patient with neurological disorder Patient with Hu antibody in sera or CSF Exclusion Criteria * : Patient with no data Patient without neurological disorder Patient without Hu antibody in sera/CSF
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Hu Abs<br>Patients harboring Hu Abs and a neurological syndrome | Other: Description of clinical, immunological and tumor features of patients harboring Hu Abs<br>* This observationnal study involves clinical data and bio. samples (DNA and tumors block). Demographic and clinical data already in French Reference Center on PNS database will be reviewed. Additional data will be obtained from the referral physicians. The results of diagnostic tests performed to detect Hu-Abs in the patients are already in this database and will be retrospectively analyzed. In addition, the 4 available techniques (immunofluorescence, commercial immunodot, Western blot, and CBA) will be performed from Jan. 2022 to Dec. 2022.Tumor samples from 2 cohorts will be analyzed: (i) tumors of patients with Hu-Abs and PNS, and (ii) tumors of patients without PNS (mostly SCLC). After selecting patients, the study will involve 3 steps: (i) pathological confirmation; (ii) DNA sequencing and CNV analysis (panel of genes involved in anti-Hu autoimmunity; mainly ELAVL1 to 4, encoding for HuA to HuD, the 4 main proteins of the Hu family); and (iii) whole-genome RNA sequencing.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale (mRs) | Application of modified rankin scale | At 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PARANEOPLASTIC NEUROLOGICAL DISORDERS, LUNG CANCER, HU AUTOIMMUNITY, IMMUNE TOLERANCE BREAKDOWN
Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

Study Overview
=================
Brief Summary
-----------------
The goal of this observational registry is to assess the use and performance of Galvanize PEF technology in a real-world setting. The main questions it aims to answer are: PEF utilization and performance Monitor safety outcomes and inform future generation devices. Participants will undergo the PEF procedure and be followed per institutional standard of care.

Detailed Description
-----------------
This is a multi-center, observational registry that follows patients for a total of 2 years from the date of the Pulsed Electric Field (PEF) procedure with the FDA cleared Galvanize Technology. Patients will be enrolled and followed prospectively or enrolled retrospectively with prospective, longitudinal follow up. Enrollment for this study will include up to 200 patients throughout the US who underwent or are scheduled to undergo PEF energy delivery.

Official Title
-----------------
Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry

Conditions
-----------------
Soft Tissue Lesion

Intervention / Treatment
-----------------
* Device: PEF ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 years of age Subject will undergo or has undergone PEF energy delivery utilizing Galvanize technology Subject is expected to be available for follow-up per the enrolling physician's standard care practices Signed informed consent is obtained, if required by IRB Exclusion Criteria: None

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 |
| --- | --- |
| Aliya PEF ablation<br>Patients will undergo PEF ablation per institutional standard of care | Device: PEF ablation<br>* Pulsed Electric Field (PEF) Ablation per institutional standard of care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthesia Type Usage for PEF Procedure | Anesthesia type usage | PEF procedure | 
| PEF Target Location | PEF procedural target location | PEF procedure | 
| PEF Target Size | PEF target size (cm) | PEF procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of SAEs | Incidence of SAEs (Registry device and/or procedure related) | within 30 days of PEF energy delivery | 
| Unanticipated [not listed in the Instructions for Use (IFU)] adverse events | Unanticipated [not listed in the Instructions for Use (IFU)] adverse events (device-related) | within 30 days of PEF energy delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulsed Electric Fields
The Use of Thrombin Generation Assay in Detection of Central Line Related Thrombosis (CRT) in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
To study thrombin generation parameters in critically ill patients with and without central line related thrombosis (CRT).

Official Title
-----------------
The Use of Thrombin Generation Assay in Detection of Central Line Related Thrombosis (CRT) in Critically Ill Patients

Conditions
-----------------
Central Line Complication, Thrombosis, Venous

Intervention / Treatment
-----------------
* Diagnostic Test: Thrombin generation assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≧ 18; AND Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital in Hong Kong; AND Clinically indicated for central catheter insertion, which includes central venous catheters and dialysis catheters; AND Expected to have the central catheter in place for at least 5 days in their ICU stay. Exclusion Criteria: Patients known to have active venous thromboembolism including deep venous thrombosis or pulmonary embolism; Patients known to have hypercoagulable states, e.g., hereditary thrombophilia, antiphospholipid syndrome; OR Patients with active solid organ or hematological malignancies; OR Patients already receiving therapeutic anticoagulation prior to study recruitment; OR Patients with thrombosis detected in the insertion site before central catheter insertion; OR Patients with a central venous catheter already in place prior to ICU admission; OR Patients admitted to the ICU for post-operative care; OR Patients admitted to the ICU for trauma care; OR Patients requiring extra-corporeal life support (ECLS); OR Patients with poor window or inaccessible for ultrasonographic examination; OR Pregnancy/post-partum within 6 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Thrombin generation assay|Thrombin generation parameters in patients receiving central catheter insertion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in peak thrombin generation (nM) between patients with and without central line related thrombosis | The primary outcome measure is the difference in peak thrombin generation (nM) between patients with and without central line related thrombosis | From the time of CVC insertion to the time of CVC removal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thrombin generation, Central line related thrombosis
Pattern of Chronic Disease in Adult attendantsabove18years Old in New Vally Elkharga Family Medicine Clinic

Study Overview
=================
Brief Summary
-----------------
Globally one in three of all adult suffer from multible Chronic condition six in ten adult has achronic disease and four in ten adult have twoor more.It has been calculated that 58million death in2005 approximately 35million will be aresult of chronic disease health damaging behavior tobbaco use, poor physical activity and poor eating habbits are major contributors to the leading chronic diseases the leading chronic diseases in developed countries including arthritis, cardiovascular diseases,heart attacks,stroke,cancer, diabetes,breast&colonic cancer , Aging increasing the risk of chronic diseases like dementia ,heart diseases,cancer these are the nation's leadingdrivers of illness,disability,death and health care costs.

Detailed Description
-----------------
In2008 more than1,2million people died from non communicable diseases accounting for nearly 60% of all death inthe region with wide several outbreaks of hospital acquired infection in the midlle east have occurredwith substantial morbidity and mortality.Egypt currently has the third highest prevelance of obesity inMena region after saudi arabia and Emirates similar to the Hispanic and native.American population central adiposity is particularly common among egyptienand is probably inherited the Egyptian national survey individual have central obesity.this be found strongly associated with increase risk of dm and cardiovascular diseases

Official Title
-----------------
Pattern of Chronic Diseases in Adults Above 18years Old

Conditions
-----------------
Chronic Wasting Disease of Elk and Deer, Injury; Knee, Meniscus, Old Injury or Tear

Intervention / Treatment
-----------------
* Diagnostic Test: Urine analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Attendands above18years Exclusion Criteria: Attendants below18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Chronic diseased attendants above 18years old<br> | Diagnostic Test: Urine analysis<br>* Diagnostic test<br>|
| Healthy attendants<br> | Diagnostic Test: Urine analysis<br>* Diagnostic test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidities | morbidities among adults above 18 years old | 6 months |
Multicenter Symphony IL-6 Monitoring Sepsis ICU Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to establish an IL-6 concentration cutoff and optimal time point(s) for using Symphony IL-6 that predict 28-day mortality in patients who are admitted or are intended to be admitted to the intensive care unit (ICU) diagnosed with sepsis or septic shock.

Official Title
-----------------
Multicenter Symphony IL-6 Monitoring Sepsis ICU Pilot Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (≥22 years of age) Diagnosis of sepsis or septic shock based on: the Third International Consensus Definitions (Sepsis-3 criteria) defined as at least one of the following criteria as determined by a treating physician or study physician investigator. Admitted or intended to be admitted to the ICU At least 0.4ml plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 12 hours of the earliest diagnosis of sepsis or septic shock. Exclusion Criteria: Prisoners or imprisonment at time of enrollment Prior enrollment into this study Informed consent as approved by IRB is unable to be obtained.

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- | --- |
| 28-day all-cause mortality | Participants will be followed up for 28 days for all-cause mortality | Within 28 days after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality up to 28 days | Participants will be followed up for 28 days for in-hospital mortality | Within 28 days after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Interleukin-6, IL-6, Risk Stratification, Infections, Toxemia, Systemic Inflammatory Response Syndrome, Inflammation, Pathologic Processes, Sepsis, Septic Shock, Shock