linjc16/ctgov huggingface dataset:
Evaluation of Neuroprotective Effect of Minocycline

Study Overview
=================
Brief Summary
-----------------
This process appears as a incredible and progressive event that will not stop till reattachment of RPE and neurosensory retina happened . Process of degeneration begins from first hours of RD (Retinal Detachment) establishment Neuroprotection of photoreceptor following RD is a novel and debatable discussion encountered in recent years . How to stop this phenomena and neuroprotective agent role in this issue are a new interest of researcher. In the study the investigators are planning to perform a clinical trial to demonstrate the minocycline neuroprotective effect in a double blind design as this impact has been implicated previously in a animal study

Official Title
-----------------
Evaluation of Minocycline Neuro Protective Role in Retinal Detachment Surgery

Conditions
-----------------
Retinal Detachment

Intervention / Treatment
-----------------
* Drug: placebo
* Drug: Minocycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 8 years old gender of both sex normal liver and renal function informed consent received from all patients no pregnancy and no lactation minimal sun exposure Exclusion Criteria: old RD diabetic retina previous retinal surgery CRF& liver disfunction RD + PVR > B Hyper sensitivity to tetracycline History previous MPC or PRP Patients unsuccessful SB (retina is off )

Ages Eligible for Study
-----------------
Minimum Age: 8 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>100mg- | Drug: placebo<br>* 100mg,BD, fo three month<br>|
| Placebo Comparator: minocyclin<br> | Drug: Minocycline<br>* 100mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA | outcome method of measurement: Snellen chart | changes of BCVA in 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| finding of ERG changes | outcome method of measurement: ERG( testes) | 3 months | 
| finding of OCT changes | outcome method of measurement: OCT | 3 months | 
| finding of FAF changes | outcome method of measurement: FAF( testes) | 3 months |
Comparison of the 3-month Strut Coverage After Coronary Stenting by Optical Coherence Tomography; Cilotax and DESyne

Study Overview
=================
Brief Summary
-----------------
We will compare the stent coverage at 3 months by optical coherence tomography (OCT) between the Cilotax and DESyne drug-eluting stents (DES). The extent of the strut uncoverage has not been evaluated yet for both the Cilotax and DESyne and we first sought to decide the reference intervals using 40 samples (total 44 patients for each group considering 10% drop-out rate) as the pilot study.

Conditions
-----------------
Patients in the Treatment of Subjects With All-comer Who Are to Undergo PCI

Intervention / Treatment
-----------------
* Device: Cilotax drug-eluting stents implantation
* Device: DESyne drug-eluting stents implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 20 years old Patients in the treatment of subjects with all-comer who are to undergo PCI Exclusion Criteria: Pregnant women or women with potential childbearing Life expectancy < 1 year

Ages Eligible for Study
-----------------
Minimum Age: 20 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: 1 CILOTAX arm<br>Cilotax drug-eluting stents implantation | Device: Cilotax drug-eluting stents implantation<br> <br> |
| Active Comparator: 2 DESyne arm<br>DESyne drug-eluting stents implantation | Device: DESyne drug-eluting stents implantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent coverage | The percentage of stent uncoverage measured by OCT | up to 3 months after stent implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Optical coherence tomography, Drug-eluting stent, Strut coverage
A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.

Detailed Description
-----------------
To evaluate two different preparations of a pancreatic enzyme in subjects with chronic pancreatitis, exocrine pancreatic insufficiency, and chronic abdominal pain.

Official Title
-----------------
Single Center Randomized Single Blind Crossover Group Active Control Study to Evaluate Safety and Efficacy of EUR-1066 a Pancreatic Enzyme Product in Patients With Chronic Pancreatitis Exocrine Pancratic Insufficiency,Chronic Abdominal Pain

Conditions
-----------------
Chronic Pancreatitis

Intervention / Treatment
-----------------
* Drug: EUR-1066-A
* Drug: Zenpep
* Drug: EUR-1066-B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Chronic Pancreatitis Exocrine Pancreatic Insufficiency Chronic abdominal pain Exclusion Criteria: Acute pancreatitis Active alcohol consumption Uncontrolled diabetes

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EUR-1066-A<br>Treatment with Eur-1006-A. | Drug: EUR-1066-A<br>* Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.<br>* Other names: EUR-1066;|
| Experimental: EUR-1066-B<br>Treatment with Eur-1066-B | Drug: EUR-1066-B<br>* Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.<br>* Other names: EUR-1066;|
| Active Comparator: Zenpep<br>Control Group: Consist of treatment with Zenpep | Drug: Zenpep<br>* Capsules taken for daily for 28 days during treatment period 2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing frequency and severity of pain | Patient diary | up to 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fat malabsorption | Assess the coefficient of fat absorption | up to 124 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Abdominal Pain, Exocrine Pancreatic Insufficiency
Outpatient Cardiac Rehabilitation in Austria

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective trial is the manifestation of guidelines developed for outpatient cardiac rehabilitation in Austria. The evaluation of prospective and retrospective data is supposed to give evidence on morbidity and/or mortality advantages compared to patients not participating in cardiac rehabilitation programs. The database created in this context is supposed to pave the way as instrument to document and comprehend quality and cost effectiveness of outpatient cardiac rehabilitation in Austria as a key for quality management.

Conditions
-----------------
Heart Disease

Intervention / Treatment
-----------------
* Other: Physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: heart disease Exclusion Criteria: participation in another study within the previous 6 months Medical conditions which prevent patients from complying with the exercise program Acute infections Hypertrophic cardiomyopathy Pulmonary artery embolism or phlebothrombosis within the previous 6 months Unstable angina pectoris Heart failure (NYHA IV) Hemodynamically unstable arrhythmia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Physical activity|50min of endurance training combined with 45min of calisthenics; 1-3x/week; 6-24 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical work capacity (PWC) | PWC is measuered by gradded exercise test on cycling ergometer before and after rehabilitation. | 6 weeks |
Prospective Study to Assess DES Re-endothelization in BMS Restenosis and De-novo Lesions

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that strut coverage occurs earlier when a DES is implanted to treat a BMS restenosis compared with atherosclerotic de-novo lesion. This hypothesis is supported by two different observations: first, when a DES is implanted to treat a BMS restenosis, stent struts are deployed and drugs are eluted on a soft tissue mostly characterized by extracellular matrix with a regular surface. In this case stent malposition is less likely to occur compared to atherosclerotic lesion whose surface is often more irregular and rich in calcium. Second, patients who develop in-stent restenosis after BMS implantation are likely to show a more pronounced neointima hyperplasia and, when a DES is implanted to treat restenosis, reendothelialization is likely to occur earlier. If this hypothesis was verified, duration of dual antiplatelet therapy could be shortened after DES implantation on BMS restenosis with a clinical advantage in terms of bleeding risk. Furthermore, a higher bleeding risk is often a reason for choosing a BMS instead of a DES; thus, patients presenting with BMS restenosis are likely to have a higher bleeding risk and to benefit from a shorter period of dual antiplatelet therapy.

Official Title
-----------------
Des Re-Endothelization for In-StEnt ResTenosis. The DESERT Study

Conditions
-----------------
Stable Coronary Artery Disease, Silent Myocardial Ischemia, In-stent(BMS)Restenosis, De-novo, Atherosclerotic, Coronary Lesions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suitable for implantation of everolimus-eluting stents (Xcience V, Xience Prime) because of stable/unstable angina or silent myocardial ischemia due to: Group A: single BMS restenosis (> 50% of luminal diameter) Group B: single de-novo lesion (> 50% of luminal diameter) Exclusion Criteria: contraindications to dual antiplatelet therapy acute myocardial infarction within the previous 48 hours significant left main coronary artery disease reference vessel diameter < 2.5 mm, hemodynamic instability chronic kidney disease with serum creatinine > 2 mg/dl pregnancy allergy to contrast agent, everolimus, aspirin, clopidogrel life expectancy < 24 months patients with possible low adherence to medical therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| In-stent (BMS) restenosis<br> | |
| De-novo coronary lesion<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of uncovered struts evaluated by OCT analysis at six-month follow-up. |  | Measured will be assessed six-month after coronary angioplasty |
Robson Classification of Indications of Cesarean Section at MUH

Study Overview
=================
Brief Summary
-----------------
Robson classification of Cesarean section rates and indications allows evaluation and comparison of the contributors to the Cesarean section rate and their impact. It also allows comparison between institutions, regions, and countries that adopt this classification Robson's system classifies all deliveries into one of ten groups on the basis of five parameters: obstetric history (parity and previous cesarean section), onset of labor (spontaneous, induced, or cesarean section before onset of labor), fetal presentation or lie (cephalic, breech, or transverse), number of neonates, and gestational age (preterm or term; panel This study evaluates C.S rates and indications according to Robson classification in a University Hospital in a year (2016) to compare with international standards

Official Title
-----------------
Robson Classification of Indications of Cesarean Section at a University Hospital in Egypt

Conditions
-----------------
Indication of Cesarean Section

Intervention / Treatment
-----------------
* Procedure: cesarean section


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all cases who underwent CS at Mansoura University Hospital inpatients and emergency cases Exclusion Criteria: non
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cesarean section|assessment of the indications of cesarean section according to Robson criteria|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of C.S rates and indications according to Robson classification | comparison of the results with the international standards | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
robson classification, Egypt
CLBS201 in Patients With Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM)

Study Overview
=================
Brief Summary
-----------------
CLBS201 will evaluate the safety, tolerability, and therapeutic effect in subjects with CKD and T2DM.

Official Title
-----------------
A Phase 1 Open-Label, Proof-of-Concept Study to Evaluate the Safety and Efficacy of CLBS201 Autologous Peripheral Blood-Derived CD34+ Cells in Subjects With Chronic Kidney Disease and Type 2 Diabetes Mellitus

Conditions
-----------------
Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Drug: CLBS201


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18 to 75 years, inclusive Documented diagnosis of type 2 diabetes eGFR of 30 to <45 mL/min/1.73m at the screening visit. UACR 300 mg/g to ≤ 5000 mg/g Exclusion Criteria: Hemoglobin < 10 g/dL Hemoglobin A1c ≥8% at the time of screening Acute kidney injury within 6 months prior to screening

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

Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLBS201<br>CLBS201 will be administered in an open-label fashion via intra-renal-arterial infusion in 6 subjects followed by 6 months of observation. | Drug: CLBS201<br>* 1 x 10^6 to 300 x 10^6 autologous CD34+ cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events | Proportion of patients with a treatment-emergent serious adverse event | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Glomerular Filtration Rate (eGFR) | Change in eGFR from baseline | 6 Months | 
| UACR & UPCR | Change in UACR & UPCR from baseline | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney disease, Type 2 Diabetes Mellitus, Diabetic Kidney disease
Contrast-Enhanced Whole-Heart Coronary Magnetic Resonance Angiography at 3.0-T: A Multicenter Trial

Study Overview
=================
Brief Summary
-----------------
The multicenter study evaluates the diagnostic performance of 3.0 T contrast-enhanced whole-heart coronary MRA in patients with suspected coronary artery disease.

Detailed Description
-----------------
This is a multicenter trial evaluated the diagnostic ability of 3.0 T contrast-enhanced whole-heart coronary MRA to detect significant coronary artery stenosis among patients with suspected CAD. A total of 272 patients will be prospectively enrolled from 8 cities in China.

Official Title
-----------------
Contrast-Enhanced Whole-Heart Coronary Magnetic Resonance Angiography at 3.0-T: A Multicenter Trial

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected CAD, scheduled for DSA Sinus rhythm Exclusion Criteria: Contraindications to MR examination: pacemaker, intraauricular implants, intracranial clips, thoracotomy, claustrophobia, orthopnea Acute coronary syndrome Atria fibrillation Coronary stents Bypass grafts Renal insufficiency (estimated glomerular filtration rate assessed by creatinine clearance <60 ml/min/1.73 m2)

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery, Magnetic Resonance Angiography, Coronary Artery disease, Multicenter Trial, Cardiac MRI
Safety and Efficacy of Octreotide Long Acting Release (LAR) in Treatment Naïve Acromegalic Patients

Study Overview
=================
Brief Summary
-----------------
Currently, the first line treatment for acromegaly is surgery, in order to remove the adenoma causing overproduction of growth hormone which leads to acromegaly. Octreotide LAR is approved for treatment of acromegaly after surgery if the disease is not controlled. This study was aimed to test the safety and efficacy of octreotide LAR in acromegalic patients who did not have any previous treatment for acromegaly.

Official Title
-----------------
Safety and Efficacy of Octreotide LAR in Treatment Naïve Acromegalic Patients

Conditions
-----------------
Acromegaly

Intervention / Treatment
-----------------
* Drug: Octreotide LAR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed or previously untreated acromegalic patients Lack of suppression of growth hormone (GH) nadir to <1.0 µg/L, after oral administration of 75g of glucose (oral glucose tolerance test [OGTT]) Insulin-like growth factor-I (IGF-I) levels above the upper limits of normal, i.e. 97th percentile (adjusted for age and gender) Exclusion Criteria: Requires surgery for recent significant deterioration in visual fields or other neurological signs, which are related to the pituitary tumor mass No evidence of pituitary adenoma on magnetic resonance imaging (MRI) Symptomatic cholelithiasis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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: Octreotide LAR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean GH and IGF-I at baseline, week 12, 24 and 48 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor volume at baseline, week 24 and 48 |  |  | 
| Signs and symptoms of acromegaly at baseline, week 12, 24 and 48 |  |  | 
| Safety and tolerability at any time on treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acromegaly, untreated, newly diagnosed, octreotide LAR