linjc16/ctgov huggingface dataset:
EyeConic: Qualification for Cone-Optogenetics

Study Overview
=================
Brief Summary
-----------------
This study aims to prepare for the first-in-human clinical trial of cone optogenetics vision restoration. As a first step, this worldwide multicenter ocular imaging study (EyeConic Study) is performed to identify eligible patients.

Detailed Description
-----------------
In a subset of patients with inherited retinal dystrophies (IRDs), cones lose their light-sensitive outer segments but remain alive in a dormant stage. This creates an opportunity to resensitize them through targeted optogenetic tools. However, the true proportion of low vision patients harboring dormant, non-functional cones, is currently unknown. The worldwide multicenter retrospective study (EyeConic) aims to estimate the proportion of low vision patients with remaining cone cell bodies for the first time.

Official Title
-----------------
Qualification for Cone-Optogenetics (EyeConic)

Conditions
-----------------
Retinal Dystrophies

Intervention / Treatment
-----------------
* Diagnostic Test: OCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (patients): Diagnosis of generalized IRD Low vision as defined as visual acuity worse or equal to 0.05 (or 20/400) in the study eye Availability of macular optical coherence tomography (OCT) Inclusion Criteria (controls): Normal ophthalmic findings Availability of macular optical coherence tomography (OCT) Exclusion Criteria (all): Other eye diseases with a significant effect on vision or retinal structure Extraocular disease affecting retinal structure such as neurodegenerative diseases
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 |
| --- | --- |
| Patients<br>-Availability of macular optical coherence tomography (OCT) | Diagnostic Test: OCT<br>* Macular optical coherence tomography (OCT)<br>|
| Controls<br>-Availability of macular optical coherence tomography (OCT) | Diagnostic Test: OCT<br>* Macular optical coherence tomography (OCT)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT - Central retinal volume | Number of participants with preserved central retinal volume | Baseline (about 10 minutes) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Generalized retinal dystrophies, Cone-Optogenetics, Rod-cone Dystrophy, Cone-rod Dystrophy, Inherited retinal disease
Green Tea in Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Prognostic factors for breast cancer beyond stage at diagnosis and tumor characteristics have not been well studied. Of special interest are lifestyle factors that can be modified by women after diagnosis to increase disease-free survival. Green tea is rich in polyphenols consisting primarily of epicatechins, epigallocatechin, epicatechin gallate, and epigallocatechin gallate (EGCG). The investigators hypothesize that there will be a reduction in proliferation and/or an increase in apoptosis in association with short-term EGCG treatment.

Official Title
-----------------
Green Tea Supplement in Women With Incident Breast Cancer

Conditions
-----------------
Incident Breast Cancer

Intervention / Treatment
-----------------
* Dietary Supplement: tea capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal (at least 2 years since last menstrual period) or age 55 or older if prior hysterectomy Non-current (not with past 6 months) user of menopausal hormones Mammographic abnormality consistent with any type of incident breast cancer necessitating a diagnostic biopsy (BIRAD IV(b), (c) or V) will be sufficient to draw baseline LFT and complete screening questionnaire. Unless the biopsy confirms incident breast cancer, such subjects will not be included in further research interventions and they will not serve as EGCG treated or control subjects. Diagnosed with incident breast cancer on the diagnostic biopsy is required for inclusion in the EGCG or control treatment groups. Non-green tea drinker (less than monthly) - this criteria does not apply to black tea or herbal tea Provided written informed consent Exclusion Criteria: Green tea drinker (once per month or more) History of breast cancer or other cancer including a prior diagnosis of any type of incident breast cancer. Known allergy to tea Abnormal liver enzymes (plus or minus 10% of the normal ranges).

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tea capsules<br>3 tea capsules daily for 3 weeks | Dietary Supplement: tea capsule<br>* 3 tea capsules daily for 3 weeks<br>* Other names: Green Tea Mega EGCG, ProHealth, Inc;|
| No Intervention: Control<br>No tea capsules | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of reduction in proliferation or increase in apoptosis in association with short-term EGCG |  | At surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postmenopausal women, Suspicious for breast ca
CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE)

Study Overview
=================
Brief Summary
-----------------
The key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three groups of patients will be compared.

Detailed Description
-----------------
Key of this prospective study is to identify a potentially increased cardiovascular risk in patients with systemic Lupus erythematodes, with and without renal affection. Three group of patients will be compared as followed. First group are patients with known systemic Lupus erythematodes without renal affection, second group are patients with known systemic Lupus erythematodes with renal affection and the third group are patients with a non-autoimmun chronic kidney disease

Official Title
-----------------
CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE): Studie Zur Detektion Des kardiovaskulären Risikos in Patienten Mit Systemischem Lupus Erythematodes

Conditions
-----------------
Systemic Lupus Erythematosus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with systemic Lupus erythematosus Exclusion Criteria: Patients without systemic Lupus erythematosus

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 |
| --- | --- |
| Systemic lupus erythematosus with renal affection<br>30 patients will be investigated suffering from a known systemic lupus erythematosus with renal affection | |
| Systemic lupus erythematosus without renal affection<br>30 patients will be investigated suffering from a known systemic lupus erythematosus without renal affection | |
| Non-autoimmune kidney disease<br>Patients with non-systemic, non-autoimmune kidney disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of cardiovascular risk in patients with systemic Lupus Erythematodes | Identification of cardiovascular risk in patients with systemic Lupus Erythematodes | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lupus erythematosus, cardiovascular risk
The Acute Effects of Low-dose TNF-α on Glucose Metabolism and β-cell Function in Humans

Study Overview
=================
Brief Summary
-----------------
Type 2 diabetes is characterized by increased insulin resistance and impaired insulin secretion. In addition, type 2 diabetes is associated with low grade inflammation indicated by increased levels of proinflammatory cytokines such as TNF-α. TNF-α has previously been shown to impair peripheral insulin signaling in vitro and in vivo. However, it is unclear whether TNF-α may also affect endogenous glucose production (EGP) during fasting and glucose stimulated insulin secretion (GSIS) in vivo. We hypothesized that low dose TNF-α would increase EGP and attenuate GSIS. Recombinant human TNF-α or placebo was infused in healthy, non-obese and non-diabetic young men (n=10) during a 4-hour basal period followed by an intravenous glucose tolerance test (IVGTT).

Official Title
-----------------
The Acute Effects of Low-dose TNF-α on Glucose Metabolism and β-cell Function in Humans

Conditions
-----------------
Diabetes Type 2

Intervention / Treatment
-----------------
* Other: Low-dose TNF-alpha


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men Age 20-35 Exclusion Criteria: obesity (BMI>25) diabetes chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Low-dose TNF-alpha|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beta-cell function | Insulin levels (pg/ml) in blood measured continually before and after Intravenous glucose tolerance test. Glucose bolus infused in healthy young men after a 4 hour basal period. Subsequent measurements og insulin and glucose levels in peripheral blood | Measurements at 0h, 1h, 2h, 3h and 4h during basal period. After glucose bolus infusion, measurements every 1 min for the first 30 min and every 3 mins for the next hour. Last measurement 1,5 hours post- IVGTT |
The Effect of Endurance Training on Body Composition and Insulin Sensitivity in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to investigate if endurance training can be used as a therapeutic action against the adverse metabolic disturbances and unfavourable changes in body composition that accompany the androgen deprivation therapy (ADT) treatment in prostate cancer patients.

Official Title
-----------------
The Effect of Endurance Training on Body Composition and Insulin Sensitivity in Prostate Cancer Patients Receiving ADT

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Behavioral: Endurance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prostate cancer patients receiving ADT for at least 3 months Healthy age and BMI matched controls Exclusion Criteria: severe cardiovascular disease severe arthritis severe neuropathy severe hypertension therapy with antidiabetic agents VO2max > 30.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADT group<br> | Behavioral: Endurance training<br>* 12 weeks of endurance training 3 times per week<br>|
| Experimental: Control group<br> | Behavioral: Endurance training<br>* 12 weeks of endurance training 3 times per week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body composition and insulin sensitivity in response to training |  | Body composition and insulin sensitivity are measured at baseline and after 12 weeks of endurance training | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, ADT, Endurance training
Genetic Basis of Non Syndromic Congenital Diaphragmatic Hernia

Study Overview
=================
Brief Summary
-----------------
In isolated congenital diaphragmatic hernia (CDH), recurrent risk is low suggesting the occurrence of novo mutations (dominant or recessive). Our objective is to test this hypothesis by combining the search for pathogenic genomic alteration and intragenic mutations through whole exome sequencing in a homogenous group of patients.

Detailed Description
-----------------
To elucidate the genetic basis of non syndromic congenital diaphragmatic hernia in a sub group of individuals with similar phenotype: Isolated CDH presenting with postero-lateral-left diaphragmatic defect with good perinatal outcome (n=16) To establish the prevalence of the identified gene(s) in a cohort of identical patients (n=30) Two complementary approaches will be used: Search for pathogenic genomic alterations using microarrays ( 2.106 markers (SNP and CNV) in 16 trios (affected child and 2 parents). Sequencing of the whole exome from patient genomic DNA (n=16) Selection of unknown or very rare variants according to different criteria: recessive or dominant model, prediction of their pathogenicity, filtered on genes already known in CDH or involved in diaphragmatic development and non annotated CNV or variants of new gene(s) shared by different patients. Variants will be validated by Sanger sequencing (for intragenic variants) or quantitative PCR (for CNV) on CDH cases and their parents as well as their absence on 100 controls.

Official Title
-----------------
Genetic Basis of Non Syndromic Congenital Diaphragmatic Hernia

Conditions
-----------------
Isolated Non Syndromic Left CDH With Postero Lateral Diaphragmatic Defect With Good Perinatal Outcome

Intervention / Treatment
-----------------
* Genetic: Blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Families with one (or more) non syndromic CDH child Signed consent form Exclusion Criteria: Syndromic CDH or associated with a known karyotype anomaly No signed consent form Not affiliated to French social security

Ages Eligible for Study
-----------------
Minimum Age: 3 Months

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 and Families with isolated non syndromic CDH cases<br> | Genetic: Blood sample<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| genes responsible for isolated CDH |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of new identified genes in a cohort of CDH |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Isolated non syndromic CDH
Physical Activity in People With Sequelae of Poliomyelitis

Study Overview
=================
Brief Summary
-----------------
People with disabilities are less physically active than the general population. At present, the physical activity level of people with poliomyelitis sequelae and their barriers to physical activity are unknown. The aim of this study is to describe the physical activity level of people with poliomyelitis sequelae and their barriers to physical activity.

Detailed Description
-----------------
This is a cross-sectional, monocentric, cohort study of subjects with poliomyelitis sequelae followed in a Physical Medicine and Rehabilitation Department. All consecutive eligible outpatient subjects consulting to the Physical Medicine and Rehabilitation Department of our university hospital will be included. Data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological and physiological examinations. It is an ancillary study to the NO-AGING study.

Official Title
-----------------
Physical Activity in People With Sequelae of Poliomyelitis : a Cross-sectional Study

Conditions
-----------------
Poliomyelitis

Intervention / Treatment
-----------------
* Other: standard of care for patients with poliomyelitis sequelae


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consulting to the Physical Medicine and Rehabilitation Department of our university hospital Having poliomyelitis sequelae No opposition to be enrolled in the study from the patient Affiliation to a social security scheme Exclusion Criteria: Disability that does not allow the completion of questionnaires Acute intercurrent medical situation Use of electric wheelchair Under court protection.

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 |
| --- | --- |
| All subjects with poliomyelitis sequelae<br> | Other: standard of care for patients with poliomyelitis sequelae<br>* clinical examination, radiological, biological and physiological examinations.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity level | Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) Questionnaire | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers of physical activity | Barriers to Physical Activity Questionnaire for People with Mobility Impairments (BPAQ-MI) | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Disabled persons, Rehabilitation, Cross sectional studies, Social inclusion
Prospective Assessment of the Rockall Risk ScoringSystem in Patients With Upper Gastrointestinal Hemorrhage

Study Overview
=================
Brief Summary
-----------------
This study aimed to Assess the validity of the Rockall score for the prediction of rebleeding and death in patients with upper gastrointestinal bleeding.

Detailed Description
-----------------
This present study aimed to evaluate: Assess the validity of the Rockall score for the prediction of rebleeding and death in patients with upper gastrointestinal bleeding. 1- Technical Design: The technical design included research design, setting, subject and tools for data collection. Research design: A descriptive exploratory design was followed to achieve the aim of the study. Study setting: This study was conducted between Tropical department in AinShams university and Gastroenterology and Hepatology department in TheodorBilharz Research Institute. Sample size: EPI - INFO program version 6 was used for sample size calculation guided by power of the test = 80% - confidence level =95% and accepted margin of error = 5% and risk ratio = 5.5 - total sample minimum accepted = 50 This study included 50 recipients and done Tropical department in Ain Shams university and Gastroenterology and Hepatology department in . Theodore Bilharz Research Institute

Official Title
-----------------
Prospective Assessment of the Rockall Risk ScoringSystem in Patients With Upper Gastrointestinal Hemorrhage

Conditions
-----------------
Gastrointestinal Bleeding

Intervention / Treatment
-----------------
* Other: Upper gastrointestinal endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Egyptian patients. Patients with acute upper G.I hemorrhage. Informed consent. Exclusion Criteria: Refuse to participate in this study.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Upeer gastrointestinal bleeding<br>Adult Egyptian patients. Patients with acute upper G.I hemorrhage. Informed consent. | Other: Upper gastrointestinal endoscopy<br>* Upper gastrointestinal endoscopy, if stigmata of recent hemorrhage are seen, varices are either injected with ethanolamine or banded, depending on the clinical setting and availability .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical condition of the patients with accute upper gastrointstinal bleeding after 48 hours from endoscopy |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with variceal bleeding and other causes of upper gastrointestinal bleeding regarding the clinical condition after 48 hours |  | 48 hours |