linjc16/ctgov huggingface dataset:
Assessment of Device for Treatment of Amblyopia

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the effect of Reviview™, a dichoptic video display device for administrating a novel treatment protocol for Amblyopia (lazy eye) in kids. The effect of the treatment will be measured by the change from baseline in Visual acuity and in Stereoscopic Vision; and to assess the ease of use of and compliance by the patients.

Conditions
-----------------
Amblyopia

Intervention / Treatment
-----------------
* Device: Daily watching videos using Reviview™, a dichoptic video display device, for 60 min


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refractive or Strabismic Amblyopia, with best corrected visual acuity. (1) Refractive Amblyopia, visual acuity score <6:15 (worse then) or (2) Strabismic Amblyopia, visual acuity score between 6:15 and 6:30 Exclusion Criteria: Diagnosed with epilepsy, recently treated with occlusion or penalization therapy

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 8 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Daily watching videos using Reviview™, a dichoptic video display device | Device: Daily watching videos using Reviview™, a dichoptic video display device, for 60 min<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in VA in amblyopic eye |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amblyopia
The Comparison of the Two Simulators for ACLS Training

Study Overview
=================
Brief Summary
-----------------
Compared two different training simulators(the computer screen-based simulator versus the full-scale mannequin-based simulator) with respect to training effectiveness in ACLS training.At the same time,evaluate the effectiveness of combination of these two simulators(screen-based simulation followed by mannequin-based simulation),so that to find out a new simulation format for ACLS training.

Detailed Description
-----------------
A prospective,single-blinded,randomized controlled study was used.30 first-year residents were randomized to Computer screen-based simulator group(C group),full scale Mannequin-based group(M group) and screen+Mannequin combing group(SM group).After a 30min ACLS lecture and 30min integrated CPR hands-on training,all groups received a pretest.The C group was exposed to two ACLS computer scenarions,M group was exposed to two ACLS mannequin scenario.Each scenario took 10min and followed by 20min debriefing with simulation educator.After the training session,each participant completed by modified'megacode'checklist.

Official Title
-----------------
The Comparison of the Two Simulators for ACLS Straining:Does the Computer Simulator Have the Same Effectiveness as the Mannequin Simulato

Conditions
-----------------
Computer Simulator and Mannequin Simulator

Intervention / Treatment
-----------------
* Other: computer simulator and mannequin simulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - training doctors,intern Exclusion Criteria:Standardized training of doctors，Medical students -
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: computer simulator<br>training students ACLS by one computer simulator | Other: computer simulator and mannequin simulator<br>* compared two different training simulators with respect to training effectiveness in ACLS training.<br>|
| Other: mannequin simulator<br>training students ACLS by one mannequin simulator | Other: computer simulator and mannequin simulator<br>* compared two different training simulators with respect to training effectiveness in ACLS training.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effection of the two different simulators for ACLS training. | If all the groups have improvement in konwledge,ACLS and non-technical skills.Compared with C group,M group，the scores of each group were compared | six months |
Long-term Result of Placing Intracorneal Rings in Keratoconus Using Laser

Study Overview
=================
Brief Summary
-----------------
Intracorneal rings are indicated in patients whose central cornea does not present opacity and whose visual acuity is not satisfied despite correction with lenses or linked to an intolerance to lenses. Surgeries such as crosslinking and intracorneal rings placement are alternatives to corneal transplantation with the expected effects: stabilization of the disease for corneal collagen crosslinking and visual rehabilitation by the placement of intracorneal rings. The main objective of this study is to evaluate visual benefit1 year after placement of intracorneal rings using laser in keratoconus

Official Title
-----------------
Long-term Result of Placing Intracorneal Rings in Keratoconus Using Laser

Conditions
-----------------
Intracorneal Ring, Keratoconus, Laser

Intervention / Treatment
-----------------
* Procedure: Intracorneal rings placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient having received the information notice/non-objection Adult man or woman (over 18) Failure of a lens fitting adaptation Patient with a diagnosis of keratoconus Patient operated at Somain institute with the placement of intra-corneal rings Exclusion Criteria: Minor Post-lasik ectasia Iatrogenic Keratoconus Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision

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 |
| --- | --- |
| Patient operated at Somain institute with the placement of intracorneal rings<br>patient operated in the last 10 years on one or both eyes | Procedure: Intracorneal rings placement<br>* Intracorneal rings placement in keratoconus using laser<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity (BCVA) evolution. Visual acuity will be expressed in logMAR. | Evolution of the best corrected visual acuity (BCVA) 1 year after the installation of intra-corneal rings compared to the preoperative value. Visual acuity will be expressed in logMAR. | 1 year |
Early DHA Supplementation in Very Low Birth Weight Infants

Study Overview
=================
Brief Summary
-----------------
This clinical trial will evaluate the effects of giving supplements of PUFA to premature infants.

Official Title
-----------------
Early DHA Supplementation in Very Low Birth Weight Infants

Conditions
-----------------
Prematurity

Intervention / Treatment
-----------------
* Other: Low dose PUFA
* Other: High dose PUFA
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Very low birth weight infants weighing less than 1500 grams Consent signed within 72 hours of life Exclusion Criteria: Infants with know metabolic disorder Infants with known congenital GI anomaly Infants who are deemed to be inappropriate for enrollment per attending neonatologist

Ages Eligible for Study
-----------------
Maximum Age: 3 Days

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose PUFA<br> | Other: Low dose PUFA<br>* Low dose PUFA<br>|
| Experimental: High dose PUFA<br> | Other: High dose PUFA<br>* High dose PUFA<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red Blood Cell polyunsaturated fatty acids (PUFA) levels |  | 2 weeks of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red Blood Cell PUFA levels |  | 8 weeks of age | 
| Feeding tolerance | Full enteral feed of 120 kcal/kg/day | 8 weeks | 
| Incidence of necrotizing enterocolitis |  | 8 weeks | 
| Incidence of bronchopulmonary dysplasia |  | 8 weeks |
Mass Balance Study of MT-1303

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the absorption, metabolism and excretion of MT-1303 in healthy subjects.

Official Title
-----------------
An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C] MT-1303 After a Single Oral Dose to Healthy Male Subjects.

Conditions
-----------------
Relapsing-remitting Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: MT-1303


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian male aged 30 to 65 at Screening. Body weight of ≥60 kg, and a BMI ranging from 18.0 to 32.0 kg/m2 at Screening and Day -1. Normal or not clinically significant ECG as defined by a HR between 50 and 100 bpm inclusive at Screening, Day -1 and pre-dose. Vital signs within the following ranges at Screening and Day -1,Body temperature: 35.0 to 37.5 °C,SBP: 90 to 140 mmHg,DBP: 50 to 90 mmHg. Regular daily bowel movements. Exclusion Criteria: Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study. Previous medical history of tuberculosis, or in the opinion of the Investigator, a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections or fungal infections. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardise the subject in case or participation in the study. The investigator should be guided by evidence of any of the following: history of inflammatory bowel syndrome,gastritis, ulcers, gastrointestinal or rectal bleeding; history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-1303<br>[14C] MT-1303 after a single oral dose | Drug: MT-1303<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total radioactivity in urine and faeces |  | up to 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK of total radioactivity in plasma |  | up to 10 weeks |
Developement and Evaluation of Serological Assays for COVID-19

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study aims to evaluate serological assays of virus Covid-19.

Detailed Description
-----------------
This is a retrospective monocentric study, which will include the patients who have hospitalized in Ambroise Paré Hospital and have sampling sent to the Laboratory of Microbiology of the hospital between the 15 March 2020 and 30 september 2020.

Official Title
-----------------
Developement and Evaluation of Serological Assays for COVID-19

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient ≥ 18 years; Have molecular diagnosis of positive or negative result in Covid-19 virus by the Laboratory of Microbiology in Ambroise Paré Hospital; Have diagnosed of a viral infection in respiratory. Exclusion Criteria: - Patient refusal.

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 |
| --- | --- | --- |
| Sensibility and specificity | Determination of sensibility and specificity of serological testing in SARS-CoV-2 virus in patients with acute respiratory symptoms. | Throughout of the study, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay between the first symptoms and the positive serological result | Delay between the first symptoms and the positive serological result of SARS-CoV-2 virus. | Throughout of the study, an average of 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, serological assay
NANOTECH RCC Biomarkers

Study Overview
=================
Brief Summary
-----------------
The incidence of renal cell carcinoma (RCC or kidney cancer) in men exceeds that of pancreatic cancer or leukemia. In women, the incidence of RCC is similar to that of leukemia, ovarian, or pancreatic cancer; thus, RCC is significant health issue. This study focuses on identifying specific molecules [biomarkers] of RCC that can be used to develop a reliable low-cost screening method at the point of service. If successful, our method would provide a diagnostic test to distinguish benign kidney masses from malignant ones, eliminating the need to surgically remove a kidney with a benign tumor.

Official Title
-----------------
Nanotech Biomarkers For Renal Cancer Intervention: Clinical Validation & Utility

Conditions
-----------------
Renal Cell Carcinoma, Renal Cell Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age and older undergoing surgery. Patient samples are divided into 2 groups based on their surgery: Patients with an imaged renal mass, encompassing about 300 patients/year (about 1200 total) of both malignant (about 80-85% of time) and benign (about 15-20% of time), and patients with non-kidney cancers, encompassing about 6,000 patients/year (about 24,000 total), Exclusion Criteria: Age <18 years and prisoners.

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 |
| --- | --- |
| Imaged renal mass cohort<br>Subjects undergoing surgery for an kidney tumor identified radiologically. | |
| control cohort<br>Subjects undergoing surgery for any kind of cancer other than kidney. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine AQP1 | Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes. | 28 days | 
| PLIN2 concentration | Assay results will be compared to the pathology report for the excised renal mass and the ICD10 codes. | 28 days |
Breath Analysis Based Disease Biomarkers of COVID-19 and Other Diseases

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.

Detailed Description
-----------------
The study will seek to collect and analyze breath samples from a broad range of patients to develop reference ranges and to refine the testing methods. Protocols for breath sample collection and algorithms for analysis will be developed. Samples will be collected from normal volunteers, persons with documented liver disease, organ transplant or with known COVID-19 test results.

Official Title
-----------------
Development of a Breath Analysis Test for Disease Diagnosis and Prognosis

Conditions
-----------------
Liver Diseases, Liver Cancer, COVID19

Intervention / Treatment
-----------------
* Diagnostic Test: Collection of breath sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide informed consent Exclusion Criteria: None

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal<br>No known medical conditions | Diagnostic Test: Collection of breath sample<br>* Analysis of volatile organic compounds in breath<br>|
| Liver Cirrhosis<br>Clinically diagnosed with cirrhosis | Diagnostic Test: Collection of breath sample<br>* Analysis of volatile organic compounds in breath<br>|
| COVID-19 tested<br>Persons with known test results for COVID-19 RNA | Diagnostic Test: Collection of breath sample<br>* Analysis of volatile organic compounds in breath<br>|
| Other<br>Persons with other medical diagnosis, no known liver disease, negative for COVID-19 | Diagnostic Test: Collection of breath sample<br>* Analysis of volatile organic compounds in breath<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breath volatile organic compound profiles | Analysis of profiles of volatile organic compounds present in exhaled breath | 1 day | 
| Utility of breath profiles for disease diagnosis or prognosis | Diagnosis or prognostic utility of breath volatile organic compound profiles | 14 days |
A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response

Study Overview
=================
Brief Summary
-----------------
Trial design: Prospective observational study Target population: 200 NSCLC patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who consent for study participation and meet the study selection criteria Primary objective: To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR We will also assess the correlation of EGFR mutations and c-MET with clinical outcome (Overall Response Rate, Progression Free survival ) Duration of Trial Recruitment: 2 years

Official Title
-----------------
Phase 4 Study of Response to EGFR-TKI and Correlation With C-met Expression and EGFR Gene Mutation in NSCLC Patients Treated With Erlotinib

Conditions
-----------------
Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Recurrent

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent 19 80 year old male or female Histologically proven advanced or metastatic NSCLC Failed to 1st line chemotherapy Tumor tissue for genetic analysis Evaluable target lesion by RECIST v1.1 ECOG performance from 0 to 3 Expected survival more than 12 weeks Exclusion Criteria: Previous treatment of EGFR-tyrosine kinase inhibitors Severe hypersensitivity to erlotinib Residual toxicities (above grade 2) after previous chemotherapy Total bilirubin more than 1.5x of upper normal limit Liver function tests more than 2.5x of upper normal limits

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 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 |
| --- | --- |
| Erlotinib treatment<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rates of C-met expression/amplification and EGFR gene mutations | To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib : C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR | Average of 1 year |