linjc16/ctgov huggingface dataset:
Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the safety and efficacy of mesenchymal stromal cells as treatment for steroid-refractory chronic graft-versus-host disease.

Official Title
-----------------
Mesenchymal Stromal Cells as Treatment of Chronic Graft-versus-host Disease

Conditions
-----------------
Graft-Versus-Host Disease

Intervention / Treatment
-----------------
* Biological: Mesenchymal stromal cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic graft-versus-host disease, grade moderate or severe despite at least 3 months treatment with calcineurin inhibitors and steroids OR Chronic graft-versus-host disease, grade moderate or severe, where full treatment with calcineurin inhibitors and steroids is impossible due to intolerable side-effects Exclusion Criteria: Active malignancy Fulfilling criteria for previously initiated study for treatment of chronic graft-versus-host disease

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stromal cell treatment<br> | Biological: Mesenchymal stromal cells<br>* Allogenous mesenchymal stromal cells, to be injected intravenously at a dose of 1-2 million/kg at a frequency of once a month (frequency may be changed during the study if deemed appropriate by investigators) for 6-9 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in disease activity according to National Institute of Health criteria | Patients are evaluated according to NIH criteria at 3, 6 and (if applicable) 9 months after initialising MSC treatment, and the score compared to baseline score. | Baseline to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in disease activity as measured by histological examination |  | Baseline to 9 months | 
| Change in self-assessed disease activity and quality of life |  | Baseline to 9 months | 
| Safety (Adverse events, infections and relapse) | Frequency of complications, infections and relapse | 21 months | 
| Freedom from steroids at 1 year after MSC treatment | Proportion of patients free from corticosteroids at 1 year after finishing MSC treatment. | 1 year after finishing treatment |
Retrospective Analysis on Relapsed/Refractory Aggressive Non Hodgkin Lymphoma Treated With Z-BEAM Plus ASCT

Study Overview
=================
Brief Summary
-----------------
Evaluate if Y90 Ibritumomab Tiuxetan Radioimmunotherapy in addition to standard high dose chemotherapy followed by autologous stem cell transplant could improve prognosis in patients affected by relapsed/refractory aggressive non Hodgkin lymphoma

Official Title
-----------------
Retrospective Collection of Data on Patient With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma Treated With Y90 Ibritumomab Tiuxetan Radioimmunotherapy Plus High-Dose Chemotherapy and Autologous Stem Cell Transplant

Conditions
-----------------
Refractory B-Cell Non-Hodgkin Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High Risk Relapsed/refractory aggressive non-hodgkin lymphoma defined as: Progressive disease Early relapse (within 12 months from response) Recurrent relapse Treated with salvage chemotherapy followed by Y90 Ibritumomab Tiuxetan plus high-dose chemotherapy and Autologous stem cell transplant Age > 18 years Previous treatment with Rituximab Written informed consent Exclusion Criteria: Patient with no complete data available for collection

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Overall Survival | Time to last follow-up or death | Date of last follow-up for at least 18 months (up to 78 months) | 
| Progression Free Survival | Time from last response to nearest relapse or follow-up | From first response to last follow-up for at least 18 month (up to 78 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aggressive B-cell non-Hodgkin Lymphoma, Relapsed, Refractory, Zevalin, Y90 Ibritumomab Tiuxetan, Autologous stem cell transplant, BEAM, Recurrent
A Trial of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are: Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamic (PD) effects of a range of doses of IW-1701 tablets administered orally to healthy subjects over 7 days of repeated dosing Stage 2: To assess the safety, tolerability, PK profile and PD effects of IW-1701 tablets administered orally to healthy subjects, in fed and fasted states, in an open-label, single-dose, 2-period, 2-sequence crossover study.

Official Title
-----------------
A 2-Stage Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 Tablets in Healthy Subjects in a Double-blind, Placebo-controlled, Multiple-ascending-dose Stage and an Open-label, Single-dose, Crossover Food-effect Stage

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

Intervention / Treatment
-----------------
* Drug: IW-1701
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is an ambulatory male or female between 18 and 55 years old at the screening visit Subject's body mass index score is > 18.5 and < 30.0 kg/m2 at the screening visit Women of childbearing potential must have a negative pregnancy test at the time of check-in and must agree to use double-barrier contraception throughout the duration of the study Subject is in good health and has no clinically significant findings on a physical examination Other inclusion criteria per protocol Exclusion Criteria: History of any clinically significant medical conditions Other exclusion criteria per protocol

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IW-1701<br>IW-1701 tablets administered orally in multiple ascending dose. | Drug: IW-1701<br>* IW-1701 Tablet<br>|
| Placebo Comparator: Placebo<br>Matching placebo tablets administered orally. | Drug: Placebo<br>* Matching Placebo Tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Emergent Adverse Event |  | 47 Days | 
| Maximum observed plasma concentration [Cmax] | Maximum observed Plasma Concentration | 47 Days | 
| Area under the plasma concentration time curve during a dosing interval [AUC] | Area under the plasma concentration time curve during a dosing interval | 47 Days | 
| Time of maximum observed plasma concentration [Tmax] | Time of maximum observed plasma concentration | 47 Days | 
| Blood Pressure |  | 47 Days |
Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology

Study Overview
=================
Brief Summary
-----------------
Rotator Injury: Strength/range of Motion ASES, VAS

Detailed Description
-----------------
The addition of a nutritional therapy to a standardized physical therapy program, may expedite recovery from shoulder injury. An attractive feature of this approach is the development of an efficacious adjunct therapy that is economically superior to traditional therapy modalities and logistically feasible.

Official Title
-----------------
Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology

Conditions
-----------------
Rotator Cuff/Shoulder Structure and Function

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo (maltodextrin)
* Dietary Supplement: Multi-nutrient Blend


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 18-65 years old Diagnosed with rotator cuff injury that will not be treated surgically Exclusion Criteria: Have received a previous injection therapy (platelet-rich plasma or corticosteroid injection) within previous 6 months Have used the following supplements in the previous 2 weeks: Vitamin C or D, or protein supplements Have poorly controlled type I or type II diabetes (HgB A1C > 9.5%) or renal insufficiency (GFR < 60 ml/min). Have an inability to participate in rehabilitation exercises. Are diagnosed with arthritis, rheumatoid arthritis, or any other autoimmune or rheumatologic disease Have musculoskeletal pathology in a neighboring joint or structure Have an allergy to any component of the nutritional supplement Are consuming warfarin

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo (maltodextrin)<br>Maltodextrin | Dietary Supplement: Placebo (maltodextrin)<br> <br> |
| Active Comparator: Multi-Nutrient Blend<br>Blend of vitamins, minerals, and amino acids, given twice daily | Dietary Supplement: Multi-nutrient Blend<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in shoulder function, pain, strength and range of motion |  | Change from baseline to four, six, and twelve weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shoulder, Supplement, Amino Acids, Collagen, Standard of Care
Observational Study of Keratoconus and Post-keratoplasty Eyes

Study Overview
=================
Brief Summary
-----------------
A prospective observational study on keratoconus and post-keratoplasty will be conducted. We will enroll 50 subjects in each of 3 groups: keratoconus, post-PK, and post-DSAEK. The Optovue anterior segment OCT prototype will be used to perform 3-D corneal scans. These scans will be used to measure corneal thickness (pachymetry), corneal topography (anterior and posterior) and epithelial thickness maps. The ultrahigh-speed MIT OCT prototypes will also be used when they become available. A comprehensive eye examination, Placido-ring corneal topography, ultrasound pachymetry, and Scheimpflug camera imagery, will be performed for comparison. In some post-PK and post-DSAEK cases, vision will be primarily affected by regular astigmatism, myopia, or hyperopia, rather than HOA. These cases can be corrected by standard PRK (not OCT guided) with adjunctive mitomycin C treatment to prevent haze formation.107, 108 In these cases PRK will be performed according to the standard of care and will not be a part of the study protocol. The postoperative results will be observed at the 3-4 month visit with UCVA, manifest refraction, BSCVA, OCT scanning, Placido topography, ultrasound pachymetry, and Scheimpflug camera imagery

Official Title
-----------------
Observational Study of Keratoconus and Post-keratoplasty Eyes

Conditions
-----------------
Keratoconus and Post-keratoplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Adults (18 & older) with keratoconus, keratoplasty, DSAEK procedures Exclusion Criteria: Inability to give informed consent. Inability to maintain stable fixation for OCT imaging. Inability to commit to required visits to complete the study.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| keratoconus<br> | |
| post-keratoplasty<br> | |
| post-DSAEK<br>Descemet's stripping automated endothelial keratoplasty (DSAEK) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| validate OCT anterior topography | The primary goal of this observational study is to validate OCT anterior topography by comparison with standard Placido-ring corneal topography | 3-4 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
keratoconus, post-keratoplasty
Effect of Intravitreal Ranibizumab Injection With Retinal Vein Occlusion (RVO)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of intravitreal Lucentis® (Ranibizumab) and investigate the anatomical and functional improvement following this treatment in patients with macular edema due to retinal vein occlusion (RVO).

Official Title
-----------------
An Open-label, Nonrandomized, Phase IIIb, Single Dose Study to Evaluated the Changes in Optical Coherence Tomography (OCT) and Fluorescein Angiography (FA) After Intravitreal Injection of Lucentis® in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)

Conditions
-----------------
Macular Edema, Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Drug: ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Patients with macular edema due to RVO (confirmed by fundus photography, fluorescein angiography, OCT) Male and female aged from 18 to 70 Baseline best-corrected visual acuity (BCVA) in the study eye was from 20/400 to 20/30 using ETDRS chart Exclusion Criteria: Additional eye disease that could compromise VA Ocular inflammation Intraocular surgery ≤ 1 month before day 0 Uncontrolled glaucoma Prior treatments with laser photocoagulation or other intervention for macular edema due to BRVO Patients aged under 18 or over 71 Female patient in pregnancy or breast feeding Not suitable to regular follow up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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: ranibizumab|ranibizumab 0.5mg (0.05ml volume), intravitreal injection first 3 injection every 4 weeks additional injection (optional) according to the judgement of doctor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in ETDRS visual acuity letter scores from baseline. The change in the 1-mm central retinal thickness as measured by OCT from baseline. |  | every 4 weeks (up to 52 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intraretinal structure changes in OCT. Progression of avascular area by FA. Number of additional treatments. Intraocular safety (endophthalmitis, uveitis, increase in intraocular pressure, etc). |  | every 4 weeks (up to 52 weeks) |
Open-Label, Single- and Multiple-Dose Pharmacokinetic Study of Diazoxide Choline

Study Overview
=================
Brief Summary
-----------------
This is a single-center, randomized, open-label, single- and multiple-dose, five-treatment, two-period, four-way parallel study comparing the pharmacokinetics (PK) of Diazoxide Choline Controlled-Release Tablet (DCCR) administered orally under fed and fasting conditions at two dose levels.

Official Title
-----------------
A Randomized, Open-Label, Single- and Multiple-Dose, Four-Way Parallel Study Comparing the Fed and Fasted Pharmacokinetics of Two Dose Levels of Diazoxide Choline Controlled-Release Tablet (DCCR) in Healthy VolunteersVOLUNTEERS

Conditions
-----------------
Hypertriglyceridemia

Intervention / Treatment
-----------------
* Drug: Diazoxide choline
* Drug: Diazoxide choline high dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Healthy adults Fasting glucose ≤ 125 mg/dL and HbA1C ≤ 6.5 Fasting triglyceride ≥150 mg/dL and ≤ 500 mg/dL Exclusion Criteria: Known CAD, DM, uncontrolled HTN Pregnancy or unable to complaint with the birth control method required

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Single dose of low dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR | Drug: Diazoxide choline<br>* A single dose low dose DCCR then re-randomized to either multiple dose low dose DCCR or high dose DCCR<br>|
| Experimental: Sequence 2<br>Single dose of high dose DCCR followed by a 14 day washout, then re-randomized to either low or high multiple dose DCCR | Drug: Diazoxide choline high dose<br>* A single dose high dose DCCR then re-randomized to either low or high multiple doses of DCCR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the single-dose and steady-state, fed and fasting PK profiles of two dose levels of diazoxide administered as DCCR |  | 35 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the impact of dosing in the absence of food on the steady-state pharmacokinetic profiles of two dose levels of diazoxide administered orally as DCCR under fed conditions |  | 35 days |
Knowledge and Practices of ADR Reporting in LMICs

Study Overview
=================
Brief Summary
-----------------
The reported literature suggests that knowledge about pharmacovigilance is on a lower side and ADR reporting is not common in developing countries. This survey may help us to identify the common gaps in knowledge and practices about pharmacovigilance so that we can devise the strategy on the basis of outcome.

Detailed Description
-----------------
Safety evaluation of a product in a market is like a moving ball which need re-evaluation as the data gather in its life cycle.(1) As per the definition of International society of harmonization and World Health Organization, adverse reaction is Adverse drug reaction (ADR) is defined as A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function. (2) Adverse reaction and adverse event are interchangeable use in pharmacovigilance sector by knowing the difference is that ADR term used when drug is causing the effect (1). The frequency of ADR is getting higher due to the increasing prevalence of chronic disease with the growing trend of combination drugs (3). The non-profitable organization of pharmacovigilance is playing tremendous role in disseminating the awareness of proper usage of drug globally.(3) According to Uppsala database statistics, approximately 3 million reports were listed as suspected ADRs. (4) Nearly 6.7% of hospitalizations were due to serious ADRs (5)

Official Title
-----------------
Knowledge and Practices of Adverse Drug Reaction Reporting Among Healthcare Professionals in Low and Middle-income Countries: a Cross-sectional Survey.

Conditions
-----------------
Adverse Reaction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Participants who would like to voluntarily fill the survey form Exclusion Criteria: Students Other than Health care professionals (including but not limited to Physicians, Doctors, Nurses and/or pharmacist)

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 |
| --- | --- | --- |
| Country-wise Analysis on knowledge of HCPs | Number of HCPs had knowledge about AR in their own country | 2 years | 
| Country-wise Analysis on practices of HCPs | Number of HCPs practicing AR reporting in their own country | 2 years |