linjc16/ctgov huggingface dataset:
Effect of Vitamin Supplementation in Glaucoma Patients

Study Overview
=================
Brief Summary
-----------------
The impact of targeted vitamin supplementation on retinal venous pressure (RVP) and steady state pattern ERG (SSpERG) in patients with RVP 15mmHg or more above intra-ocular pressure (IOP) and serum homocystein 12µmol/l or more, with signs of progression in spite of adequate IOP control, as evidenced by SSpERG abnormality with or without structural progression or visual field progression,

Detailed Description
-----------------
Provided the inclusion criteria were met, RVP measurement was repeated, and a 1 capsule/day regimen of Ocufolin® forte was subsequently carried out for a duration of 3 months, after which repeat measurements of IOP, SSpERG, and RVP were performed, along with dilated fundoscopy. .

Official Title
-----------------
The Effects of Vitamin Supplementation Containing L-Methylfolate (Ocufolin® Forte) on Retinal Venous Pressure and Homocysteine Plasma Levels in Patients With Glaucoma

Conditions
-----------------
Glaucoma, Homocysteinemia, Elevated Retinal Venous Pressure, Abnormal Steady State Pattern Electroretinography

Intervention / Treatment
-----------------
* Dietary Supplement: Ocufolin forte


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: glaucoma and/or ocular vascular disease in at least on eye abnormal SSpERG RVP measured using an ophthalmodynamometer at least 15 mmHg higher than intra-ocular pressure (IOP), fasting serum Hcy level > 12 µmol/l stable and well-controlled IOP (with or without IOP-lowering treatment) Exclusion Criteria: starting other systemic or ocular medications with potential impacts on RVP within a month before entering the study or during the course of the study starting or changing the dosage of other medications with potential impact on SSpERG within 3 months before entering the study or during the course of the study non-adherence to the follow-up schedule inability to perform a proper RVP measurement using ophthalmodynamometry.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Ocufolin forte|start of ocufolin forte 1 dd after RVP measurement, till 90 tablets are finished (3 months)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RVP effect | measurement of RVP lowering effect | 3 months | 
| SSpERG effect | measurement of improvement of SSpERG | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, homocysteine plasma levels, L-methylfolate, ophthalmodynamometry, retinal venous pressure (RVP), steady state pattern electroretinography
AZD7325 Single Ascending Dose Study in Healthy Male Japanese Subjects

Study Overview
=================
Brief Summary
-----------------
This is a Phase I randomized double-blind, placebo-controlled, single centre study to assess the safety, tolerability and pharmacokinetics of AZD7325 following single ascending dose administration to healthy male Japanese volunteers.

Official Title
-----------------
A Phase I,Single-Center,Randomised,Double-Blind,Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7325 in Healthy Male Japanese Subjects

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: AZD7325
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) : 18 to 27 kg/m 2 Exclusion Criteria: Clinically relevant disease and/or abnormalities (past or present) Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis at screening as judged by the investigator Use of any medication or herbal preparation within 14 days of Study day 1 through the Follow-up Visit other than paracetamol (up to 3 g/day) Smoking in excess of 5 cigarettes per day or the equivalent within 28 days prior to the first study day or inability to refrain from smoking during the study confinement period

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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: 1<br> | Drug: AZD7325<br>* Capsule for oral, single dose<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo capsule for oral, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerabilityThe nature and incidence of adverse events (AEs), vital signs,physical examinations,electrocardiograms (ECGs)and laboratory assessments. |  | During the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters for AZD7325 |  | During residential period | 
| Genetic analysis of the genes involved in the pharmacokinetics and safety and tolerability to AZD7325 treatment may be performed. Participation in the exploratory genetic study is optional for the subjects. |  | During the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AZD7325, Japanese Healthy Volunteers, Phase I study, Single Ascending Dose
Post-Infectious Irritable Bowel Syndrome (PI-IBS)

Study Overview
=================
Brief Summary
-----------------
Purpose: identification of factors predisposing for Post-Infectious Irritable Bowel Syndrome (PI-IBS) development after an episode of traveler's diarrhea identification of systemic (serum) and local (biopsy) changes in infectious and immunological activity during infection and correlation with Irritable Bowel Syndrome (IBS) symptoms, persisting after traveler's diarrhea Design: 4 study visits: before traveling, 2 weeks after traveling, 6 months after traveling, 12 months after traveling at each study visit following investigations: blood collection, stool collection, questionnaires, rectal biopsy

Official Title
-----------------
Post-Infectious Irritable Bowel Syndrome (PI-IBS)

Conditions
-----------------
Irritable Bowel Syndrome With Diarrhea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: traveling to South-America, Africa, South-East Asia 18-70 years traveling for 1-10 weeks Exclusion Criteria: Chronic diarrhea Pregnant Colitis Ulcerosa Morbus Chrohn IBS Coeliakie Gastrointestinal malabsorption microscopic colitis diverticulitis immune deficiency use of antibiotics/corticosteroids 2 weeks before travelling

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| travelers to tropical destinations<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postinfectious IBS symptoms (ROME III criteria) 1 year after travelers diarrhea episode |  | 1 year after traveling | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post-Infectious Irritable Bowel Syndrome, PI-IBS
Postoperative Sleep Disturbances Role in Cognitive Test Results After Fast-track Hip and Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate sleep cycle before and after fast-track arthroplasty (3 days before and 10 days after) combined with cognitive testing preoperatively, on postoperative day 1,2,10.

Official Title
-----------------
Postoperative Sleep Disturbances Role in Cognitive Test Results After Fast-track Hip and Knee Arthroplasty

Conditions
-----------------
Postoperative Cognitive Abilities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: above 60 ASA classification I-IV Exclusion Criteria: general anaesthesia within 90 days daily use of sedatives, hypnotics og anxiolytics alcohol abuse insufficient written and verbal Danish severe hearing loss and poor sight Parkinsons Disease or other functional neurological deficits Mini mental status < 24 Shift work

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| Stroop colour word test result on the first postoperative morning compared to preoperatively. |  | 4 days on average between preoperative and postoeperative testing |
Embryoscope and Reproductive Outcome

Study Overview
=================
Brief Summary
-----------------
cases with embyos cultured in the standard incubator and evaluated only by morphology are compared to cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model

Detailed Description
-----------------
cases with embyos cultured in the standard incubator and evaluated only by morphology (control group) are compared to cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model(study group)

Official Title
-----------------
Does Embryoscope Improve Reproductive Outcome in ICSI Patients

Conditions
-----------------
Invitro Fertilization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age:25-40 years old BMI:18-30 patients with first or second ICSI trial Exclusion criteria: AMH <1 severe male factor(total motile sperm <1 million) frozen embryo transfer cycles patients with endocrinopathies or thrombophilia patients on medical treatment which may interfere with results hydrosalpinx

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 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 |
| --- | --- |
| embryoscope group<br>cases with embryos continuously monitored by the embryoscope followed by embryo selection based on a multivariable model | |
| control group<br>cases with embyos cultured in the standard incubator and evaluated only by morphology | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | transvaginal ultrasound done to assess the gestational sac | 14 days after embryo transfer |
MR Textural Analysis in Low Grade Gliomas

Study Overview
=================
Brief Summary
-----------------
WHO classification of low grade gliomas now relies on tumoral molecular patterns, especially on IDH mutation and 1p/19q co deletion status. Textural analysis on medical imaging is studied in several fields, and could provide help in patients with brain tumor due to possible complications of brain biopsy. The purpose of this study is to determine if specific textural signature on MR imaging could be found for low grade gliomas. The investigators included patients with LGG diagnosed at CHU of Nice abd whose first MRI was available on the PACS of the CHU. Textural data are extraxted by tumoral contouring and specific logiciel (LifeX) and histopathologic data are assessed for each patient. Then the investigators analyze it to dtermine if textural indices can predict molecar status.

Official Title
-----------------
Textural Analysis in Low Grade Gliomas on Pre Operative MRI Exams to Determine Molecular Status : a Retrospective Study

Conditions
-----------------
Glioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LGG diagnosed at CHU of Nice abd whose first MRI was available on the PACS of the CHU Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 77 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 |
| --- | --- | --- |
| review of MRI images to find clues that can predict molecular status |  | 9 years |
Short Daily Versus Conventional Hemodialysis for COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
Treatment of dialysis patients involved with COVID-19 with short daily hemodialysis has been supposed to improve short term outcome. It is unclear if short daily dialysis would optimize mortality or ICU admission in routine dialysis patients with COVID-19. Also the potential variants according with worse outcomes remain to be fully elucidated.

Detailed Description
-----------------
investigators undertook a randomized trial in ESRD patients infected with COVID-19 to determine: 1) if short-daily hemodialysis is associated with a reduction in mortality and ICU admission in one weak period and; 2) the potential effective variants in worst outcome. . Paperwork for the trial was submitted to the shaheed beheshti university of medical sciences in June 2021 for registration . The protocol for this trial and supporting CONSORT checklist are available. The SBMU Ethics Board approved the study and all amendments. The study was conducted according to the Declaration of Helsinki.

Official Title
-----------------
Short Daily Versus Conventional Hemodialysis for COVID-19 Patients: A Randomized Study

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Other: Short daily dialysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ESRD patients >3months on hemodialysis admitted for COVID-19 Exclusion Criteria: ESRD patients <3 months on hemodialysis infected with COVID-19
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 |
| --- | --- |
| Other: short daily dialysis<br>7 days 2hours dialysis | Other: Short daily dialysis<br>* 7 days 2hours dialysis<br>|
| No Intervention: conventional dialysis<br>3 times weekly 4hours dialysis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | discharged or dead | From date of randomization until the date of first documented progression or date of death | 
| ICU add | admission to ICU or not | From date of randomization until the date of first documented progression or date of death | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dialysis
Pediatric Pulmonary and Cardiovascular Complications of Vertically Transmitted HIV Infection (P2C2)

Study Overview
=================
Brief Summary
-----------------
To determine the prevalence and natural history of pulmonary and cardiac complications associated with HIV infection in utero, in infancy, and during early childhood.

Detailed Description
-----------------
BACKGROUND: In 1982, a year after the discovery of AIDS in adults, cases were described in children. Subsequent reports clearly indicated that pulmonary and cardiac diseases contributed significantly to morbidity and mortality in children infected with the human immunodeficiency virus. The initiative was developed by the staff of the Division of Lung Diseases and the Division of Heart and Vascular Diseases after consultation with members of the pulmonary, cardiology, and pediatric communities. The Request for Proposals was released in August 1988 and awards made in May 1989. DESIGN NARRATIVE: In this prospective natural history study, research was conducted on the response of the immature lung to Pneumocystis carinii and other opportunistic lung infections, as well as on the etiology and pathogenesis of lymphocytic pulmonary disorders. The types, incidence, course, outcome, and origin of cardiac disorders were also determined. In addition to the pulmonary and cardiovascular measurements, data on the effects of co-infection with other viruses, CMV and EBV, were obtained. Enrollment of participants began in May 1990 and continued through April 1993 in Group I and through January 1994 for Group II. The cohort was followed at specified intervals for an additional three years beyond the end of recruitment for clinical examination, cardiac, pulmonary, immunologic, and infectious studies and for intercurrent illnesses (The cohorts were followed through January 1997). Follow-up ranged from 2.5 to 6.6 years. The study ends in July 2002. Analysis of the database, preparation of manuscripts and follow-up of adult type pulmonary function studies in infants currently followed at sites conducting the Womens & Infants Transmission Study (WITS) continue through July 2002

Conditions
-----------------
Acquired Immunodeficiency Syndrome, Lung Diseases, Cardiovascular Diseases, Heart Diseases, Heart Failure, HIV Infections, Cytomegalovirus Infections, Pneumocystis Carinii Infections, Ebstein-Barr Virus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Study Evaluating Etanercept 25mg or 50mg Administered Subcutaneously to Healthy Chinese Male Subjects

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to assess the pharmacokinetics of etanercept in healthy Chinese male subjects. Safety and tolerability data will also be obtained.

Official Title
-----------------
A Randomized, Open-Label, Single-Dose Administration, Parallel-Group Study of the Pharmacokinetics of Etanercept, 25mg or 50 mg, Administered Subcutaneously to Healthy Chinese Male Subjects

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

Intervention / Treatment
-----------------
* Drug: Enbrel (etanercept)


Participation Criteria
=================
Eligibility Criteria
-----------------
Men, aged 18 to 45 years, of Chinese descent and living in China. Body mass index in the range of 18.0 to 30.0 kg/meter squared and body weight equal to or greater than 50 kg. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, chest x-ray, and 12-lead electrocardiogram (ECG). Have a high probability for compliance with and completion of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enbrel (etanercept)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetics of etanercept in healthy Chinese male subjects. |  |  |
Plasma Transfusion in Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the clinical efficacy of three types of plasma secured on the viral level either by quarantine or by chemical treatment in patients undergoing liver transplantation.

Detailed Description
-----------------
Three types of plasma are transfused in bleeding patients undergoing liver transplantation: quarantined plasma, methylene blue treated plasma, solvent/detergent plasma. The main purpose is to show that the volume of methylene blue treated plasma consumed intraoperatively is equivalent to that of the 2 other types of plasma. In addition, the correction of coagulation abnormalities are studied.

Official Title
-----------------
Plasma Transfusion in Liver Transplantation : a Randomized, Double Blind, Multicenter Trial of Methylene Blue, Solvent/Detergent and Quarantined Plasma.

Conditions
-----------------
Bleeding in Liver Transplantation

Intervention / Treatment
-----------------
* Other: plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 yo and above consent is signed, liver transplantation is indicated, plasma is transfused Exclusion Criteria: multiorgan transplantation (except combined kidney and liver transplantation) allergy to methylene blue.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quarantined FFP<br>Quarantined FFP | Other: plasma<br>* transfusion of more than 15 mL/Kg of plasma<br>|
| Active Comparator: Methylene blue FFP<br>Methylene blue FFP | Other: plasma<br>* transfusion of more than 15 mL/Kg of plasma<br>|
| Active Comparator: Solvent detergent FFP<br>Solvent detergent FFP | Other: plasma<br>* transfusion of more than 15 mL/Kg of plasma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of transfused plasma during surgery |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correction of coagulation abnormalities |  | 5 years | 
| immediate and delayed adverse events |  | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bleeding, plasma, liver transplantation