linjc16/ctgov huggingface dataset:
Enhanced External Counterpulsation on Delayed Onset Muscle Soreness

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effects of Enhanced External Counterpulsation on delayed onset muscle soreness. The primary outcomes will be duration of delayed onset muscle soreness, WBC count, CRP count, CPK count, and pain tolerance.

Official Title
-----------------
Effects of Enhanced External Counterpulsation on Delayed Onset Muscle Soreness, a Pilot Study

Conditions
-----------------
Muscle Tightness

Intervention / Treatment
-----------------
* Device: Enhanced External Counterpulsation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy active Duty or DoD beneficiaries between 25 and 59 years old Exclusion Criteria: Not on a physical profile Not taking any OTC or prescription pain medications or workout supplements

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 59 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: EECP for DOMS<br>All enrolled subjects will receive EECP treatment Delayed Onset Muscle Soreness. | Device: Enhanced External Counterpulsation<br>* Enhanced External Counterpulsation<br>* Other names: Lumenair Enhanced External Counterpulsation Therapy System, Vasomedical;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in delayed onset muscle soreness over time. | Likert pain surveys | At 3, 6, 9, 12, 15, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain tolerance | Pain tolerance measured by mmHg pressure required to elicit a delayed-onset muscle pain response. | Baseline, 24 hours, 2 days 3 days 4 days 33 days | 
| Bio-markers for muscle inflammation | Bio-markers for muscle inflammation: C-reactive protein, creatine phosphokinase, and white blood cell count. | Baseline, 24 hours, 2 days 3 days 4 days 33 days |
Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity.

Study Overview
=================
Brief Summary
-----------------
Evaluate the feasibility and effectiveness of a multi-component school-based intervention to promote healthy eating and physical activity with school children ages 9 to 11 years in Lebanon.

Official Title
-----------------
Interventions to Promote Healthy Eating and Physical Activity in Lebanese School Children Targeting Overweight and Obesity.

Conditions
-----------------
Childhood Obesity

Intervention / Treatment
-----------------
* Other: Health-E-PALS-


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schoolchildren Aged 9 to 11 years Exclusion Criteria: - no exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 11 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group- Health-E-PALS<br>Group of students receiving the school-based intervention: Health-E-PALS, it consists of in class activities and lessons. | Other: Health-E-PALS-<br>* Intervention to promote Healthy Eating and Physical Activity in Lebanese School-Children It comprises in class-activities, meetings with parents, improvement of school food service<br>|
| No Intervention: Control group<br>Group of students not receiving any intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in knowledge score | Change in the knowledge scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and -post assessment phases | One school year | 
| Change in dietary habits | Change in the percentage of children consuming sugary drinks, unhealthy and healthy snacks, fruits and vegetables/change in the percentage of children's physical activity frequency (self-reported in the questionnaires during pre- and -post assessment phases) | One school year | 
| Change in self-efficacy score | Change in the self-efficacy scores (the sum of correct answers) based on a scored questionnaire delivered during pre- and -post assessment phases | One school year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
School-based intervention
Long-Term Follow-Up Gene Therapy Study for Leber Congenital Amaurosis OPTIRPE65 (Retinal Dystrophy Associated With Defects in RPE65)

Study Overview
=================
Brief Summary
-----------------
This study is a longer-term follow-up study for patients who have been administered AAV2/5-OPTIRPE65 in the Phase I/II, open label, non-randomised, two-centre, dose escalation trial in adults and children with retinal dystrophy associated with defects in RPE65.

Detailed Description
-----------------
The follow up study is designed to collect data on longer-term safety and efficacy of AAV2/5-OPTIRPE65 administration in the OPTIRPE65 trial.

Official Title
-----------------
Long-term Follow-up Study of Participants Following an Open Label, Multi-centre, Phase I/II Dose Escalation Trial of an Adeno-associated Virus Vector (AAV2/5-OPTIRPE65) for Gene Therapy of Adults and Children With Retinal Dystrophy Owing to Defects in RPE65 (LCA2)

Conditions
-----------------
Leber Congenital Amaurosis (LCA), Eye Diseases, Eye Diseases, Hereditary, Retinal Diseases

Intervention / Treatment
-----------------
* Biological: AAV OPTIRPE65


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Were enrolled and treated in the prior open-label, Phase I/II, dose escalation study involving intraocular administration of AAV2/5-OPTIRPE65 Exclusion Criteria: Individuals will be excluded if they are unwilling or unable to meet with the requirements of the study.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 100 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 |
| --- | --- |
| Low dose AAV OPTIRPE65<br>subretinal administration of a single low dose of AAV RPE65 | Biological: AAV OPTIRPE65<br>* comparison of different doses of AAV RPE65<br>|
| Intermediate dose AAV OPTIRPE65<br>subretinal administration of a single intermediate dose of AAV RPE65 | Biological: AAV OPTIRPE65<br>* comparison of different doses of AAV RPE65<br>|
| High dose AAV OPTIRPE65<br>subretinal administration of a single highdose of AAV RPE65 | Biological: AAV OPTIRPE65<br>* comparison of different doses of AAV RPE65<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events related to the treatment | Safety is defined as the absence of ATIMP-related safety events | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the retinal function | Improvements in visual function as assessed by visual assessment | 5 years | 
| Improvement in the visual function | Improvements in retinal function as assessed by visual assessment | 5 years | 
| Improvement in quality of life | Improvement in the participant's quality of life which is measurable by QoL questionnaire | 5 years |
Evaluation of Orlistat as Adjuvant Treatment of Obesity in Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate efficacy of orlistat 60 mg as adjuvant treatment of Obesity in adults.

Official Title
-----------------
A Prospective Study, Parallel, Double-blind, Multicenter for Evaluation of Efficacy of Orlistat 60 mg as Adjuvant Treatment of Obesity in Adults

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Orlistat 60 mg
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent; Adults Male and Female ≥ 18 years old; Obesity (BMI ≥ 30kg/m2 or ≥ 27 Kg/m2 with associate risk); Exclusion Criteria: Pregnancy and Lactation or women without effective contraception; Relevant clinical diseases; Obesity associated to genetic syndrome; Decompensated Diabetes; Psychiatric disorders; Alimentary disorders; Use of: anorectics, herbal weight loss and/or constipation and laxatives, in the past 30 days; Patients using cyclosporine or amiodarone; Patients with bowel disease; Prior bariatric surgery; Anemia; Hemoglobinopathies and coagulopathy; History of cancer in the past five years; Use of corticosteroids, oral or injectable, in the last 30 days.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Orlistat 60 mg<br> | Drug: Orlistat 60 mg<br>* 1 tablet 3 times a day<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* 1 tablet 3 times a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Orlistat 60 mg associated with diet and exercise in relation to placebo associated with diet and exercise in obesity treatment based on weight loss. |  | 112 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated by the adverse events occurrences |  | 112 days |
Angiogenesis With Positron Emission Tomography (PET) Tracer Uptake

Study Overview
=================
Brief Summary
-----------------
Purpose: L-[3-18F]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for PET. We have conducted a clinicopathologic study to elucidate the correlation of angiogenesis with 18F-FMT and 18F-FDG uptake in the patients with non-small cell lung cancer (NSCLC). Method: Thirty-seven NSCLC patients were enrolled in this study, and a pair of PET study with 18F-FMT and 18F-FDG was performed. Uptake of PET tracers was evaluated with standardized uptake value. VEGF, CD31, CD34, LAT1 and Ki-67 labeling index of the resected tumors were analyzed by immunohistochemical staining, and correlated with the clinicopathologic variables and the uptake of PET tracers.

Official Title
-----------------
Correlation of Angiogenesis With 18F-FMT and 18F-FDG Uptake in Non-Small Cell Lung Cancer

Conditions
-----------------
Angiogenesis, Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent a thoracotomy within 4 weeks after 18F-FMT PET and 18F-FDG PET study Histology is non-small cell lung cancer Exclusion Criteria: Patient who received neoadjuvant chemotherapy or radiotherapy before surgery Patients who have insulin-dependent diabetes
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| I<br>L-[3-18F]-α-methyltyrosine (18F-FMT) is an amino-acid tracer for PET. We have conducted a clinicopathologic study to elucidate the correlation of angiogenesis with 18F-FMT and 18F-FDG uptake in the patients with non-small cell lung cancer | |
| Nuclear<br> | |

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
-----------------
Fluorine-18-α-methyltyrosine,, Positron emission tomography,, Fluorine-18-fluorodeoxyglucose,, Lung cancer,, Angiogenesis, The median VEGF rate was 45% (range, 10-78%)., High expression was seen in 30 patients (81%, 30/37)., VEGF expression was statistically associated with progressively growing microvessel count.
Retrospective Study on Anosmias and Ageusias Linked to Infection by Covid-19

Study Overview
=================
Brief Summary
-----------------
Odor and taste disturbances have increased dramatically during this time of the COVID-19 pandemic. Currently, we have very little information on the demographic and clinical characteristics of the affected population, on the severity and course of the olfactory / taste loss. The main objective of this research is to analyze the epidemiological, demographic and clinical characteristics of patients suspected or already confirmed of infection with SARS-Cov2 presenting with anosmia and / or ageusia.

Official Title
-----------------
Retrospective Study on Anosmias and Ageusias Linked to Infection by SARS-Cov 2

Conditions
-----------------
Covid-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major subject (≥18 years old) Subject having had a loss of smell and / or taste that occurred during the period of the Covid-19 epidemic with or without other symptom (s) suggestive of a Covid infection -19 Subject with suspected or confirmed Covid-19 infection Subject taken care of by the ENT service Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research. Exclusion Criteria: Subject having expressed opposition to participating in the study Subject under guardianship or guardianship Subject under safeguard of justice

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Retrospective analysis of demographic and clinical characteristics of patients with suspected or already confirmed SARS-Cov2 infection with anosmia and / or ageusia |  | The files analysed retrospectily from February 01, 2020 to June 03, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid-19, Odor disturbance, Taste disturbances, SARS-Cov2, Anosmia, Ageusia
Cerebrospinal Fluid Movements Through Interventricular Foramina in Phase Contrast Magnetic Resonance Imaging (PC-MRI)

Study Overview
=================
Brief Summary
-----------------
Assess the reproductibility of PC-MRI for cerebrospinal fluid movements through the interventricular foramina on volunteer subjects.

Detailed Description
-----------------
It is a monocentric interventional prospective study. Each subject will have to pass two MRI. Phase contrast MRI (PC-MRI) will be calibrated for each subject by assessing the optimal encoding velocity. Three sequences including the aqueduct and the two interventricular foramina (IVF) will be done. The signal will be analysed by syngo.via software after defining by two different investigators the region of interest (ROI) which correspond to the IVF or the aqueductal lumen. Descriptive statistics will test the intra-individual and inter-observer consistency based on 4 flow parameters.

Official Title
-----------------
Cerebrospinal Fluid Movements Through Interventricular Foramina in Phase Contrast Magnetic Resonance Imaging (PC-MRI)

Conditions
-----------------
Mri, CSF Circulation Disorder, Foramen; Monro, Obstruction

Intervention / Treatment
-----------------
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mini-Mental State Examination score > 28/30 Exclusion Criteria: MRI contraindication Medical or surgical history related to following pathologies: nervous system disease, cardiac arrhythmia, cardiac or respiratory insufficiency. Long-term medical treatment Ongoing pregnancy

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cerebral magnetic resonance imaging x2<br>Cerebral MRI performed at enrolment visit and at +6 weeks (maximum) | Device: MRI<br>* Reproductibility test assessed with MRI for cerebrospinal fluid movements<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PC-MRI procedure reproductibility | Test-retest reproducibility of double measures (2nd measure at +48 hours minimum +6 weeks maximum) of 4 cerebrospinal liquid (CSL) flow parameters during PC-MRI. CSL flow through interventricular foramina will be measured within healthy volunteers, and 4 intraclass correlation coefficients (ICC) will be calculated. The test-retest coefficient will be considered satisfactory if > or = to 0.75 . | week 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CSF, PC-MRI, interventricular foramina
Effect of CACICOL20 on Corneal Epithelial Healing After Cross-linking in Patients With Keratoconus

Study Overview
=================
Brief Summary
-----------------
CACICOL20 is an ophthalmic solution based on the technology of RGTAs (ReGeneraTingAgents). It consists of large biopolymers, imitating the structure of heparansulphate. The protecting effect on different biological tissues and enhancement of wound healing has been described in several studies. Keratoconus is a relatively common disease, with incidences ranging from 1.3 to 25 per 100,000 per year across different populations. Corneal collagen cross-linking represents a treatment option for these patients, aiming to prevent progression of the disease via stabilization of corneal microstructure. Corneal epithelial removal prior to the ultraviolet A/riboflavin cross-linking procedure significantly improves the outcome of the intervention, due to ameliorated distribution of riboflavin. The aim of the present study is to investigate the effect of CACICOL20 on corneal epithelial wound closure after collagen cross-linking in patients with keratoconus. Results may lead to an improved management and pain reduction of patients with corneal epithelial defects.

Official Title
-----------------
Effect of CACICOL20 on Corneal Epithelial Healing After Cross-linking in Patients With Keratoconus

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Device: RGTA OTR 4120 (CACICOL20)
* Device: Genteal HA eye drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged over 18 years Presence of keratoconus Scheduled for corneal cross linking No ophthalmic surgery in the 3 months preceding the study Exclusion Criteria: Participation in a clinical trial in the previous 3 weeks Topical use of aminoglycosid antibiotics Use of therapeutic or refractive contact lenses after surgery Known hypersensitivity to any component of the study medication or heparinoids or heparin Active ocular infection Presence of any abnormalities preventing reliable measurements as judged by the investigator Pregnancy, planned pregnancy or lactating

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RGTA OTR 4120 (CACICOL20)<br> | Device: RGTA OTR 4120 (CACICOL20)<br> <br> |
| Active Comparator: Genteal HA<br> | Device: Genteal HA eye drops<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to closure of the epithelial wound |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cross-linking, RGTA OTR4120 (CACICOL20)