linjc16/ctgov huggingface dataset:
Safety and Effectiveness of the Opira AIOL in Comparison to Commercial IOLs in Patients Undergoing Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
This is a clinical trial comparing an investigative accommodative IOL and two commercial IOLs in patients with cataracts undergoing primary cataract surgery.

Detailed Description
-----------------
This is a prospective, multicenter clinical study comparing the safety and performance of the Opira accommodative IOL, a commercial monofocal IOL, and a commercial multifocal IOL. Eligible patients with bilateral cataracts will undergo cataract surgery implanting one of three study lenses, and will be followed postoperatively for 24 months

Official Title
-----------------
Evaluation of the Visual Performance and Safety of the Investigational Opira AIOL, A Commercial Multifocal IOL, and a Commercial Monofocal IOL

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: Cataract Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects aged 50-75 with bilateral cataracts, good potential vision, and clear intraocular media other than lens opacity Exclusion Criteria: Comorbidities affecting visual acuity, IOP > 22mmHg, congential cataract

Ages Eligible for Study
-----------------
Minimum Age: 50 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opira AIOL<br> | Device: Cataract Surgery<br>* The surgical procedure in which the natural crystalline lens is removed and replaced with a lens implant.<br>|
| Active Comparator: Monofocal AIOL<br> | Device: Cataract Surgery<br>* The surgical procedure in which the natural crystalline lens is removed and replaced with a lens implant.<br>|
| Active Comparator: Multifocal AIOL<br> | Device: Cataract Surgery<br>* The surgical procedure in which the natural crystalline lens is removed and replaced with a lens implant.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity |  | 6 Months | 
| Adverse event rates |  | 12 Months |
Predictive Factors on the Results of Epidural Adhesiolysis in Patient With Chronic Spinal Pain

Study Overview
=================
Brief Summary
-----------------
The primary aim of this exploratory study was to determine the demographic, clinical, and technical factors associated with treatment outcome, to create a better select treatment candidates.

Official Title
-----------------
Predictive Factors on the Results of Percutaneous Epidural Adhesiolysis in Patient With Chronic Spinal Pain

Conditions
-----------------
Pain, Chronic

Intervention / Treatment
-----------------
* Procedure: Percutaneous adhesiolysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients in whom percutaneous epidural lysis of adhesions was performed Exclusion Criteria: nonadhesiolytic procedure lack of follow-up incomplete outcome data

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

| Intervention/Treatment |
| --- |
|Procedure: Percutaneous adhesiolysis|Percutaneous adhesiolysis is a minimally invasive technique which involves the use of a spring-wound catheter, ideally placed in the ventrolateral aspect of the epidural space for the lysis of adhesions.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity | The visual analog scale is a numerical scale from 0 to 10; with 0 representing no pain and 10 representing the worst pain imaginable. | baseline to 12 months post-procedure |
Treatment of Relapsed Low-Grade or Follicular Lymphoma With Rituximab (Also Known as Rituxan, IDEC-C2B8, IDEC-102)

Study Overview
=================
Brief Summary
-----------------
Rituximab is an antibody made in a laboratory. It binds to lymphoma cells and kills them. Treatment of recurrent B-cell lymphoma with rituximab may delay or prevent relapses. A total of 166 patients with recurrent B-cell lymphoma were given intravenous rituximab once a week for 4 weeks. The patients' tumors were measured before and after treatment. Ten patients had a complete response and 70 patients had a partial response to rituximab. The median duration of response was 11.2 months.

Official Title
-----------------
Pivotal Phase III Multi-Center Study to Evaluate the Safety and Efficacy of Once Weekly Times Four Dosing of IDEC-C2B8 (IDEC-102) in Patients With Relapsed Low-Grade or Follicular B-Cell Lymphoma

Conditions
-----------------
Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma

Intervention / Treatment
-----------------
* Drug: rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of relapsed, low-grade or follicular B-cell lymphoma CD20-positive lymphoma Progressive, measurable disease Sign informed consent 3 weeks beyond standard therapy Good performance status Adequate hematologic, renal, and hepatic function Exclusion Criteria: Chronic lymphocytic leukemia Lesions greater than or equal to 10 cm in diameter CNS lymphoma AIDS-related lymphoma Pleural effusions or ascites secondary to lymphoma Active, opportunistic infection Serious nonmalignant disease Prior investigational therapies, including prior anti-CD20 therapy Recent major surgery

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rituximab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to disease progression |  |  | 
| progressive disease-free interval |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rituximab, Rituxan, B-cell lymphoma, low-grade, follicular, anti-CD20 monoclonal antibody
A Multi-centre, Double-blinded, Randomized, Placebo-controlled Trial on the Efficacy and Safety of Lopinavir / Ritonavir Plus Ribavirin in the Treatment of Severe Acute Respiratory Syndrome

Study Overview
=================
Brief Summary
-----------------
The study aims to examine whether the combination of Lopinavir/Ritonavir plus Ribavirin for treatment of severe acute respiratory syndrome (SARS) is superior to placebo.

Official Title
-----------------
A Multi-centre, Double-blinded, Randomized, Placebo-controlled Trial on the Efficacy and Safety of Lopinavir / Ritonavir Plus Ribavirin in the Treatment of Severe Acute Respiratory Syndrome

Conditions
-----------------
Severe Acute Respiratory Syndrome

Intervention / Treatment
-----------------
* Drug: Lopinavir / Ritonavir plus Ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female over the age of 18 with a diagnosis of SARS and with valid consent will be recruited. Exclusion Criteria: Subjects with medical conditions that makes the prescription of study medications unsafe are excluded.

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

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

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: Lopinavir / Ritonavir plus Ribavirin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of severe SARS |  | Any time during the acute illness | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | Throughout the illness period | 
| SARS-CoV Viral load |  | Throughout the illness period | 
| Immunological profile |  | Throughout the illness period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Severe acute respiratory syndrome
Sympathetic Nerve Activity in Renal Failure

Study Overview
=================
Brief Summary
-----------------
The primary purpose is to assess the role of sympathetic activation for the development and progression of chronic renal failure. Using microneurography sympathetic activity will be registered in various stages of kidney affection or failure and hypertension. A sympatholytic agent will be compared with a non-sympatholytic drug to asses the effect sympathetic activation and on the progression of kidney disease. The effects of a sympatholytic agent on cardiovascular reactivity to various stressors wil be examined.

Official Title
-----------------
Role of the Sympathetic Nerve System for the Pathogenesis and Progression of Chronic Kidney Failure

Conditions
-----------------
Chronic Kidney Disease, Hypertension

Intervention / Treatment
-----------------
* Drug: Rilmenidine
* Drug: Nitrendipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic renal failure stages I-IV Exclusion Criteria: pregnancy and lactation severe heart failure or ischemic heart disease patients with NYHA III-IV

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Rilmenidine as a sympatholytic agent for three months | Drug: Rilmenidine<br>* 1 mg Rilmenidine per day versus<br>* Other names: Hyperium;|
| Active Comparator: Arm 2<br>Nitrendipine as a non-sympatholytic agent for three months | Drug: Nitrendipine<br>* 20 mg Nitrendipine per day<br>* Other names: Bayotensin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sympathetic activation for the development and progression of chronic renal failure |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects of a sympatholytic agent on cardiovascular reactivity to various stressors |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sympatholytic treatment, sympathetic nerve activity
Fetal Viability Estimation in Egypt

Study Overview
=================
Brief Summary
-----------------
Due to the discrepancy between the Egyptian and the conventional definition of miscarriage or live birth, there seemed to be a need for a study that ends up with reaching a definition for the mentioned terms. live birth is known to be for fetus born after 20 weeks or of weight more than 500 grams, while in Egypt, this is not applicable. basically the neonate has a chance of survival if the weight is more than 1000 grams or of gestational age more than 26 weeks.

Official Title
-----------------
Correlation Between Fetal Gestational Age, Viability and Survival Rates in Egypt

Conditions
-----------------
Premature Birth, Miscarriage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant females age from 18- 40 years old preterm delivery before completing 38 weeks of gestation singleton or multiple gestation fetuses with congenital anomalies Exclusion Criteria: refusal to get enrolled in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| determination of age of fetal viability according the survival rate percentage |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| most common causes for premature delivery in Egypt |  | 6 months | 
| the mode of delivery of preterm cases in Egypt |  | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
miscarriage, fetal viability, prematurity
AVACEN Treatment Method and Postprandial Blood Glucose

Study Overview
=================
Brief Summary
-----------------
A double-blind crossover randomized controlled trial to investigate the effects of the AVACEN device on postprandial blood glucose. The AVACEN device creates negative pressure around the hand while heating the palm. Two sham devices, one providing heat but no vacuum and one providing neither heat nor vacuum were also used. Each subject will use each of these three devices during the first hour of a 2-hour oral glucose tolerance test on separate visits. Subjects arrived in the morning following an overnight fast. Fasting blood glucose, blood pressure, tympanic temperature, and subjective thermal ratings were measured before and throughout the 2-hour oral glucose tolerance test.

Official Title
-----------------
AVACEN Treatment Method and Postprandial Blood Glucose

Conditions
-----------------
Postprandial Hyperglycemia

Intervention / Treatment
-----------------
* Device: AVACEN 100
* Device: AVACEN 100 heat only
* Device: AVACEN 100 sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals Exclusion Criteria: Diagnosis of diabetes, diabetes medication, hypertension medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heat and Vacuum<br>AVACEN 100 applies heat and vacuum to hand | Device: AVACEN 100<br>* The AVACEN 100 pulls a -30mmHg vacuum around the hand from the wrist down and applies heat (108 Fahrenheit) to the palm<br>|
| Active Comparator: Heat Only<br>AVACEN 100 applies heat only | Device: AVACEN 100 heat only<br>* The AVACEN 100 applies heat (108 Fahrenheit) to the palm<br>|
| Sham Comparator: Sham<br>AVACEN 100 applies neither heat nor vacuum | Device: AVACEN 100 sham<br>* The AVACEN 100 does not provide heat or vacuum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial Blood Glucose | Measuring peak postprandial blood glucose with Contour Next glucometer | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure | Measuring blood pressure with automated cuff | 30 minutes | 
| Tympanic Temperature | Measuring tympanic temperature with infrared thermometer | 30 minutes | 
| ASHRAE 7 point thermal sensation scale | Measuring subjective temperature with thermal sensation scale | 30 minutes |
Talonavicular Arthrodesis and Surgical Treatment of Ankle and Varus Foot

Study Overview
=================
Brief Summary
-----------------
This study should refine our surgical indications and to establish a decision tree of medical and surgical treatment of this common and troublesome strain functionally which is equino-varus.

Official Title
-----------------
Interest of Talonavicular Arthrodesis on Walking Speed at Brain Lesion Patients Who Benefit of a Surgical Treatment of Ankle and Varus Foot : Randomized Study

Conditions
-----------------
Orthopedic Equine Varus Deformity

Intervention / Treatment
-----------------
* Procedure: arthrodesis talonavicular
* Procedure: tendon gestures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemiparesis secondary to a lesion of the central nervous system, regardless of the etiology dated within 6 months Orthopedic equine-varus deformity of the foot and ankle requiring surgery Patient able to move by walking preoperatively at least 2 meters with or without technical assistance or may earn postoperative walking ability Exclusion Criteria: History of foot surgery the side to be operated Significant deformation set foot and ankle (requiring treatment with triple arthrodesis) Bilateral surgery Progressive neurological disease Dystonic movements or movement disorders Realization of a botulinum toxin injection in the 6 months preceding gesture Important cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 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 |
| --- | --- |
| Experimental: arthrodesis talonavicular<br>arthrodesis talonavicular in addition to tendon gestures | Procedure: arthrodesis talonavicular<br> <br> Procedure: tendon gestures<br> <br> |
| Active Comparator: tendon gestures<br>tendon gestures only | Procedure: tendon gestures<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| walking speed at one year |  | 12 months after surgery intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| walking speed at 3 and 6 months |  | 3 months and 6 months after surgery intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemiparesis, deformity of the foot and ankle
The Expression of Aquaporin 3, 8 and 9 in Placenta in Normal and Preeclamptic Pregnancies: Perinatal and Neonatal Outcomes.

Study Overview
=================
Brief Summary
-----------------
The etiologic agent responsible for the development of preeclampsia remains unknown. Aquaporins, members of integral membrane proteins, are responsible of water molecules movements through the plasma membrane channels, energy metabolism and associated with changes in cellular volume during apoptosis. İn such placental pathology as preeclampsia, characterized with superficial implantation and increased apoptosis leading to a relative hypoxia between mother and fetus, the hypothesis of aquaporins important role in energy homeostasis and apoptosis maybe suggested.

Detailed Description
-----------------
The investigators are carrying out a study of 210 pregnant women , from whom 105 will have pregnancy complicated with preeclampsia and 105 with normal pregnancy. The investigators aim is to investigate the role of the placenta, umbilical cord and amniotic membrane aquaporin expression in etiopathogenesis of preeclampsia. The investigators will compare aquaporin levels in preeclamptic and normal placentas, umbilical cords and amniotic membranes , and investigate relation between aquaporin levels and perinatal ( maternal blood pressure, proteinuria, maternal-fetal doppler ultrasound, amniotic fluid index, fetal intrauterine growth) and neonatal ( Apgar score, biometry, complications) finding.

Official Title
-----------------
The Expression of Aquaporin 3, 8 and 9 in Placenta, Umbilical Cord and Fetal Membranes in Normal Pregnancies and Pregnancies Complicated by Preeclampsia: Perinatal and Neonatal Outcomes.

Conditions
-----------------
Preeclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preeclamptic pregnants Normal non-complicated pregnants Exclusion Criteria: -Pregnants with another obstetric complications

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preeclamptic pregnants<br>pregnants with preeclampsia | |
| Normal pregnants<br>pregnants without obstetric complications | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunohistochemistry | Compare aquaporin levels in normal and preeclamptic placentas | up to 2 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistical analysis | Correlate aquaporin expression with perinatal and neonatal outcomes | up to 2 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preeclampsia, Aquaporins, Placenta