linjc16/ctgov huggingface dataset:
Patients With Chronic Hepatitis B and Low Viremia Not Receiving Antiviral Therapy

Study Overview
=================
Brief Summary
-----------------
This observational long-term follow-up study will evaluate demographic, clinical, histological, biochemical, and virological parameters of patients with chronic hepatitis B and low viremia who do not require antiviral therapy according to current guidelines. Liver stiffness values as detected by FibroScan and ARFI will also be collected if available. All data will be collected at yearly intervals (minimum). Patients included in the study are followed for up to 10 years. The target sample size is <1000.

Official Title
-----------------
A Multicenter, Prospective, Observational, Long-Term Follow-Up Study of Subjects With Chronic Hepatitis B and Low Viremia Who Do Not Receive Antiviral Therapy

Conditions
-----------------
Hepatitis B, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patient, age 18-79 chronic hepatitis B HBV-DNA < 100.000 IU/ml ALT ≤2 x ULN recent liver histology and/or FibroScan measurement willingness to sign informed consent Exclusion Criteria: current or past antiviral therapy for hepatitis B chronic hepatitis B in immune tolerance phase (HBeAg positive, high viral load) co-infection with HIV, HCV malignant disease HCC or other liver tumor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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 |
| --- | --- | --- |
| Indication for Antiviral Treatment |  | 10 years | 
| Development of hepatocellular carcinoma (HCC) |  | 10 years | 
| Progression of Liver Fibrosis |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV-DNA |  | 10 years | 
| Quantitative HBsAg |  | 10 years | 
| Serum ALT |  | 10 years | 
| Serum AFP |  | 10 years | 
| FibroTest/ActiTest |  | 10 years |
Iris Shelf Technique for Intraocular Foreign Bodies Removal

Study Overview
=================
Brief Summary
-----------------
Intraocular foreign body (IOFB) injury is a common potentially serious form of ocular trauma. Metallic IOFB is the most common type of IOFB injury. Apart from the associated ocular tissue damage, Metallic IOFB may cause permanent visual impairment due to retinal toxicity and endophthalmitis. When presenting posteriorly, the approach of IOFB removal is challenging. Several techniques had been described for posterior IOFB removal. All of these techniques aimed to remove IOFB with the least possible collateral damage. This study aims to describe Iris shelf technique for posterior IOFB removal through a clear corneal incision combined with phaco-vitrectomy and report its outcomes.

Conditions
-----------------
Eye Injuries

Intervention / Treatment
-----------------
* Procedure: Iris shelf technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - posterior segment metallic IOFB who underwent combined phacovitrectomy with IOFB removal through a clear corneal incision using Iris shelf technique Exclusion Criteria: Any other surgical technique for posterior segment IOFB removal

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Iris shelf technique|Removal of posterior segment intraocular foreign bodies through corneal incision combined with phaco-vitrectomy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corrected distance visual acuity |  | 1 month |
Bevacizumab Versus Ranibizumab for the Treatment of Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the morphological and visual acuity outcomes associated with 1.5 mg bevacizumab versus 0.5 ranibizumab intravitreal injections for treatment of diabetic macular edema.

Official Title
-----------------
Bevacizumab Versus Ranibizumab for Refractory Diabetic Macular Edema

Conditions
-----------------
Diabetic Retinopathy, Macular Edema

Intervention / Treatment
-----------------
* Drug: Bevacizumab
* Drug: Ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Center-involving Diabetic macular edema unresponsive to LASER therapy performed at least 3 moths prior to inclusion; Best corrected visual acuity equal or worse than 20/40 and better than 20/800; Central subfield macular thickness greater than 300 µm Exclusion Criteria: Aphakia High-risk proliferative diabetic retinopathy Previous treatment for DME in the past three months

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab<br>Treatment of macular edema with intravitreal Bevacizumab | Drug: Bevacizumab<br>* Bevacizumab, 1.5 mg, intravitreal, throughout the study<br>* Other names: Avastin;|
| Experimental: Ranibizumab<br>Treatment of macular edema with intravitreal Ranibizumab | Drug: Ranibizumab<br>* Ranibizumab, 0.5 mg, intravitreal, throughout the study<br>* Other names: Lucentis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central subfield macular thickness (CSFT) change | Central subfield macular thickness (CSFT) measured with spectral-domain optical coherence tomography (OCT) | Monthly from baseline to Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity change | Best-corrected visual acuity using ETDRS charts | Monthly from baseline to week 48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Retinopathy, Macular Edema, Bevacizumab, Ranibizumab
Retinal Endo Vascular Surgery for Central Retinal Vein Occlusion

Study Overview
=================
Brief Summary
-----------------
Patients with Central Retinal Vein Occlusion will undergo vitrectomy, a small needle of about 71 micron will enter a branch retinal vein and TPA will be injected into the obstracted vein.

Detailed Description
-----------------
Patients with Central Retinal Vein Occlusion less than 6 month duration and reduction of vision to 6/21 will go OCT and FANG examinations. Patient will be operated vitrectomy, and a branch retinal vein will be punctured by small needle and rTPA 200mcg/ml will be injected to the vein.

Conditions
-----------------
Central Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Procedure: Retinal endo vascular surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: crvo less than 6 month Visual Acuity less than 6/21 No prior eye surgery except cataract. Exclusion Criteria: Retinal/iris neovascularization

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Retinal endo vascular surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  |  | 
| Amount of macular edema. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retinal vein occlusion, rTPA
Efficacy, Safety and Tolerability of Repeated Dosis of Intravitreous Bevacizumab in Uveitic Macular Oedema

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether intravitreous bevacizumab or intravitreous triamcinolone acetonide are effective and safe in the treatment of uveitic macular oedema

Official Title
-----------------
Open , Randomized Study About Efficacy, Safety and Tolerability od Repeated Dosis of Intravitreous Bevacizumab in Patients With Uveitic Macular Oedema

Conditions
-----------------
Uveitis

Intervention / Treatment
-----------------
* Drug: bevacizumab
* Drug: triamcinolone acetonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients with uveitis or retinal vasculitis with unilateral or bilateral macular oedema with macular thickness > 250 micra using OCT visual acuity at least 20/200 with stable treatment with oral prednisone at least during 3 months, either oral ciclosporin or other immunomodulator to treat intraocular inflammatory disease patient that can follow study's requirements patient who consents to participate Exclusion Criteria: presence of corneal or crystalline opacity preventing observation of fundus of eye patients requiring ocular surgery in next 3 months one-eyed pregnancy and child breastfeeding previous history of glaucoma on treatment woth an experimental ocular drug previous thromboembolism or receiving oral anticoagulant treatment vitrectomy patients with proved tractional macular pathology associated to macular oedema

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bevacizumab<br>intravitreous bevacizumab 2,5 mg at baseline, week 4 and 8. reinjection is required. | Drug: bevacizumab<br>* 2.5mg at baseline, week 4 and 8. Beyond this initial period if needed reinjection criteria are described in protocol<br>|
| Experimental: triamcinolone acetonide<br>intravitreous triamcinolone 2 mg, frequency: 3 months | Drug: triamcinolone acetonide<br>* 2 mg at baseline; frequency every three months if needed. reinjection criteria are described in protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular Thickness Measurements Using Stratus Optical Coherence Tomography |  | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity |  | 48 weeks | 
| intraocular pressure |  | 48 weeks | 
| opacity crystalline |  | 48 weeks |
Regenerative Stem Cell Therapy for Stroke in Europe

Study Overview
=================
Brief Summary
-----------------
Stroke is the second leading cause of death in the world population. When not fatal, stroke often results in disability, and secondary health problems affecting not only patients but also their families. Building on emerging preclinical and pilot clinical evidences, RESSTORE will focus on the clinical assessment of regenerative cell therapy to improve stroke recovery and patients quality of life.

Detailed Description
-----------------
RESSTORE European multicentre randomised phase IIb will explore the efficacy (functional recovery) and safety of intravenous infusion of allogenic adipose tissue derived mesenchymal stem cells (ADSC) in 400 stroke patients. Therapeutic effects of ADSCs will be assessed and monitored in patients using clinical rating scales, multimodal MRI and blood biomarkers. The European regenerative therapy capacities (France, Spain, Finland, United Kingdom and Czech Republic), developed in RESSTORE will cover the full value chain in the field (large scale GMP cell production, clinical testing, biomarkers discovery, understanding of the restoring mechanisms, biobanking...).

Official Title
-----------------
Regenerative Stem Cell Therapy for Stroke in Europe

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

Intervention / Treatment
-----------------
* Other: Adipose Derived Stem Cells
* Other: Vehicle media


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemispheric ischemic stroke (>1.5cm) Inclusion from 1 to 4 days post-stroke NIHSS > or = 7 No craniectomy Able to follow a rehabilitation program Modified Rankin scale = 0 before stroke onset Exclusion Criteria: Coma Severe leucoariosis Previous stroke Active endocarditis, pneumonia, AIDS, active hepatic disease due to HBV or HCV History of cancer Pregnancy, breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Adipose derived Stem Cells ADSC<br>ADSC, single IV, 1.106 cells/kg | Other: Adipose Derived Stem Cells<br> <br> * Other names: ADSC;|
| Sham Comparator: Vehicle media<br>IV infusion of cell excipients, 1ml/kg | Other: Vehicle media<br> <br> * Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between-group difference of NIHSS (stroke severity score) |  | 6 months after stroke onset | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cell therapy, stem cell, transplantation, graft, recovery, repair, stroke, mesenchymal stem cell, regenerative
Comparison of Point of Care to Lab INR in Dialysis Patients on Warfarin

Study Overview
=================
Brief Summary
-----------------
To determine whether point of care (POC) International Normalized Ratio (INR) test results correlate with plasma INR measures in hemodialysis patients.

Detailed Description
-----------------
37 chronic hemodialysis patients being anticoagulated with warfarin require INR monitoring routinely.

Official Title
-----------------
Correlation of Point of Care INR to Laboratory INR in Hemodialysis Patients Taking Warfarin

Conditions
-----------------
Anticoagulation in Dialysis Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic dialysis patients on chronic warfarin anticoagulation. Exclusion Criteria: On warfarin for less than 1 month.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| 37 dialysis patients<br>37 chronic hemodialysis patients on warfarin requiring Laboratory INR monitoring for anticoagulation management. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether Point of Care INR testing would be suitable in the management of dialysis patients on chronic warfarin therapy |  | Not an intervention study, but observational in this cohort | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether Point of Care INR devices maintain test accuracy in dialysis patients who are temporarily anemic (HCT <32%) according to their CBC |  | Not an intervention study, but observational in the cohort (statistics completed 1.5 yrs) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anticoagulation in dialysis patients, chronic anticoagulation, warfarin, hemodialysis, INR, Point of Care
Gepirone vs Placebo in Treatment of Cocaine Dependence - 3

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test antidepressant medication, gepirone, as a pharmacotherapy for cocaine dependent subjects.

Official Title
-----------------
Gepirone vs Placebo in Treatment of Cocaine Dependence

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Gepirone


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
Sexes Eligible for Study
-----------------
Male

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

| Intervention/Treatment |
| --- |
|Drug: Gepirone|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
-----------------
Cocaine Dependence, Gepirone
Observatory on Emergency Care for Acute Coronary Syndrome in Grand Est of France

Study Overview
=================
Brief Summary
-----------------
The purpose is to build up a data observatory of individuals with thoracic pain evoking acute coronary syndrome (ACS). The aim is the characterization of this population of patients consulting at emergency department, the evaluation of therapeutic strategies with regard to guidelines and the becoming of patients including severe complications and mortality.

Official Title
-----------------
Observatory on Emergency Care for Acute Coronary Syndrome in Grand Est of France

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Resident in Grand Est of France (Lorraine, Champagne Ardenne) under medical care at the emergency room or outside of hospital or in cardiology: Outside of hospital: for thoracic or epigastric pain with suspicion of ACS Emergency: for thoracic pain for which the doctor will prescribe troponin or troponin kinetics Affiliation to social security Exclusion Criteria: Patient affected by ACS with ST segment elevation Patient with traumatic thoracic pain Patient with thoracic pain of parietal origin Patient with consciousness troubles

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 |
| --- | --- |
| Patients with thoracic pain and suspicion of ACS<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 30 days | 
| Mortality |  | 1 year | 
| Severe complications |  | 30 days | 
| Severe complications |  | 1 year | 
| Benefit/risk ratio of treatments |  | day 0 | 
| Benefit/risk ratio of treatments |  | 30 days | 
| Benefit/risk ratio of treatments |  | 1 year |
Effect of Pyridorin in Patients With Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate the safety, tolerability and efficacy of Pyridorin (pyridoxamine dihydrochloride) up to 250 mg given orally twice daily in patients with diabetic kidney disease.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Escalating Dose, Pilot Study to Evaluate the Safety, Tolerability and Biologic Activity of Pyridorin (Pyridoxamine Dihydrochloride) in Patients With Diabetic Nephropathy Associated With Type 1 or Type 2 Diabetes

Conditions
-----------------
Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: Pyridorin (pyridoxamine dihydrochloride)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and Females (non-pregnant and non-lactating) between 18 and 70 years of age with type 1 or type 2 diabetes Sitting blood pressure of <=170/100 mm Hg at weeks -2 and -1 Hemoglobin A1C <=12% at week -2 Patients with diagnosis of diabetic nephropathy as defined by Serum Creatinine <=2.0 mg/dL at weeks -2 and -1 (PYR-205) Serum Creatinine >2.0 mg/dL but <=3.5 mg/dL at weeks -2 and -1 (PYR-207) Urinary albumin excretion >=300 mg/24 hours at week -2 No other known or suspected etiology for nephropathy Voluntary written consent to participate in this study Exclusion Criteria: History of allergic or adverse response to any B vitamin History of major cardiovascular or cerebrovascular events History of cancer except adequately treated basal or squamous cell carcinoma of the skin History of diabetic ketoacidosis Autoimmune diseases History of significant peripheral neuropathy

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pyridorin (pyridoxamine dihydrochloride)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Serum Creatinine from baseline to week 26 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic nephropathy, Advanced Glycation Endproduct Inhibitor, Pyridorin, Pyridoxamine