linjc16/ctgov huggingface dataset:
Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin in Patients in Type 2 Diabetes Mellitus (T2DM)

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy and safety of combination therapy of vildagliptin/metformin in patients with T2DM inadequately controlled with metformin 1,000 mg/day.

Official Title
-----------------
Multi-center, Open-label, 24-week Study to Demonstrate the Efficacy and Safety of Combination Therapy of Vildagliptin/Metformin 50/500 or 50/1000 mg Twice Daily in Patients With T2DM Inadequately Controlled With Metformin

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

Intervention / Treatment
-----------------
* Drug: vildagliptin/metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes mellitus patients who are treated with metformin monotherapy 1,000 mg daily for at least 3 months The patient is required to have HbA1c 6.5-11.0% BMI in the range of 22-48 kg/m2 Exclusion Criteria: Severe or uncontrolled Type 2 diabetes mellitus (HbA1c> 11.0%) Acute metabolic diabetes complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months Congestive heart failure requiring pharmacologic treatment Any of following within past 6 months: (1) myocardial infarction; (2) unstable angina (3) coronary artery bypass surgery or percutaneous coronary intervention Liver disease such as cirrhosis or chronic active hepatitis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 Years

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

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: Vildagliptin/metformin<br> | Drug: vildagliptin/metformin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c reduction |  | 24 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who achieve target of HbA1c<6.5% at the end of study |  | 24 weeks after treatment | 
| To evaluate the effect of combination therapy of vildagliptin (50 mg) plus metformin (500 or 1000 mg) twice daily on FPG and BMI, safety and tolerability profiles |  | 24 weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes Mellitus, vildagliptin, metformin
Capsule Endoscopy Delivery at sCale Through Enhanced AI anaLysis Study

Study Overview
=================
Brief Summary
-----------------
The CESCAIL study tests the use of Artificial Intelligence (AI) on a video taken from a minimally-invasive imaging device, to improve efficiency and accuracy of the detection of polyps, which are little outgrowths within the lining of the bowel.

Detailed Description
-----------------
Participants will be continuing to follow their standard care pathway, and there are no additional requirements of the participants other than providing consent for their pseudonymised capsule video and data to be used to test the AI system. The participant's final diagnosis will only be determined by the clinician's standard analysis pathway and not influenced by the AI enabled analysis pathway. All data is de-identified before a video is created and re-identified only once the standard final report is signed-off by the referring clinician. Therefore, the risk of patient harm due to exposed data is minimised.

Official Title
-----------------
Capsule Endoscopy Delivery at sCale Through Enhanced AI anaLysis Study

Conditions
-----------------
Bowel Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 or over Patients who have been selected by overseeing clinician meeting NHS England criteria to undergo colon capsule endoscopy as part of their standard of care Exclusion Criteria: Patients unable to provide consent to take part in the study

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 |
| --- | --- |
| Lower Gastrointestinal Symptoms<br>Participant aged over 18 with referred lower gastrointestinal symptoms | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of polyp detection in AI enabled CCE reporting | Sensitivity and specificity of polyp detection in AI enabled CCE reporting | 11 months | 
| Time taken to read video by clinicians and AI tool | Time taken to read video by clinicians and AI tool | 11 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AI, bowel, cancer
Maintenance Treatment of Chidamide in Stage IV or Relapsed/Refractory Extranodal NK/T-cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
Extranodal natural killer/T-cell lymphoma, nasal type (NKTCL) is a highly aggressive peripheral T-cell lymphoma (PTCL). Patients with newly diagnosed stage IV and relapsed/refractory have poor prognosis. 5-year progression-free survival was reported only 55%. Chidamide is a selective histone deacetylase inhibitor which was approved by FDA in treating relapsed or refractory PTCL. In phase I and II studies of chidamide, patients with relapsed or refractory NKTCL achieved a higher overall remission. Patients who obtained complete or partial remission had much favourable duration of remission. Thus, the invesgator design this study to evaluate the role of maintenance treatment of chidamide for induction chemotherapy-responded newly-diagnosed advanced and relapsed/refractory NKTCL patients.

Official Title
-----------------
Maintenance Treatment of Chidamide in Chemotherapy-responded Stage IV or Relapsed/Refractory Extranodal Natural Killer/T-cell Lymphoma, Nasal Type

Conditions
-----------------
Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Intervention / Treatment
-----------------
* Drug: chidamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of NKTCL with typical morphology and immunophenotype, according to the 2008 World Health Organization classification of lymphomas; newly-diagnosed stage IV disease or relapsed or refractory disease； age ≥ 18 years; ECOG performance status 0-2; at least one measurable lesion; adequate hematological, hepatic, and renal functions; e.g., absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, total bilirubin ≤ 1.5 × upper limit of normal, alanine transaminase and aspartate transaminase ≤ 2 × upper limit of normal, and creatinine ≤ 1.5 mg/dl; life expectancy of more than 3 months. Exclusion Criteria: Patients with newly-diagnosed stage I-II disease; pregnancy or lactation; any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.

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: chidamide|For those who responded to induction chemotherapy, chidamide will be given OR orally 30mg biw for at least half a year|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | PFS was defined as the period from the date of treatment till the date of disease progression, relapse, or death from any cause. | 1 year |
Managerial and Environmental Risk for COVID 19 in French Long Term Care Institutions

Study Overview
=================
Brief Summary
-----------------
REMPAR EHPAD study addresses environmental and managerial factors associated with an outbreak of COVID 19 in French Long Term Care Institutions in the spring of 2020. The survey used a mixed methodology, combining qualitative and quantitative approaches, with a questionnaire send to all identified institutions (n=501) and qualitative interviews with facility directors (n=21).

Detailed Description
-----------------
Declarative retrospective survey : A questionnaire was e-mailed to all identified institutions, with 3 reminders in one month. It included 39 questions concerning : morbidity and mortality linked with COVID-19 structural features of the facility (location, architecture, residents characteristics) human resources crisis management (visits and circulation restrictions, personal protective equipment) A statistical analysis by logistic regression will be made, to identify explanatory variables for the occurrence of at least one COVID 19 infection among the residents. Qualitative survey : The investigators conducted semi-directed face-to-face interviews with facility directors. The investigators realized a purposive sample to assure maximal variability of the facilities (location, size, status, severity of the outbreak). The interview guide focused on structural, organizational, and human factors at stake in outbreak management, to identify incentives and obstacles associated with an easier crisis management.

Official Title
-----------------
Managerial and Environmental Risk for COVID 19 in French Long Term Care Institutions_COVID-19

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Long Term Care Institution (EHPAD) in Britain, France, Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire|A questionnaire was e-mailed to all identified institutions, with 3 reminders in one month. It included 39 questions concerning : morbidity and mortality linked with COVID-19 structural features of the facility (location, architecture, residents characteristics) human resources crisis management (visits and circulation restrictions, personal protective equipment)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| case of COVID 19 | Number of case (confirmed or probable) of COVID 19 in each facility | 01 september 2020, survey closing date | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid19, Elderly, Long term care, Crisis Management, France
Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections

Study Overview
=================
Brief Summary
-----------------
This study randomizes women using long-acting reversible methods of contraception to home-based STD screening through the mail compared to screening available in a clinical setting. We hypothesize that women randomized to home-based screening will be more likely to complete screening.

Official Title
-----------------
Randomized Trial of Home Versus Clinic-based Screening for Sexually Transmitted Infections in Long-Acting Reversible Contraceptive Users

Conditions
-----------------
Chlamydia, Gonorrhea

Intervention / Treatment
-----------------
* Behavioral: Home screening
* Behavioral: Clinic screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant in Contraceptive CHOICE cohort study Using a long-acting reversible method of contraception Completed baseline clinical survey in the Contraceptive CHOICE cohort study Exclusion Criteria: Living outside the United States at time of annual STI screening

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 45 Years

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home<br>Home-based STI screening using self-obtained vaginal swabs and postal return of samples. | Behavioral: Home screening<br> <br> |
| Active Comparator: Clinic<br>Receive STI screening in a clinical setting such as a private physician or clinic. | Behavioral: Clinic screening<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of tests received |  |  |
Fluorophotometry Evaluation of Lubricant Eye Drops

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the safety and efficacy of exaggerated use of Lubricant Eye Drops in a population of normal subjects by measuring corneal epithelial permeability to fluorescein.

Official Title
-----------------
Fluorophotometry Evaluation of Lubricant Eye Drops FID 105783

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

Intervention / Treatment
-----------------
* Other: Systane Free lubricant eye drops
* Other: Visine Tears Lubricant Eye Drops
* Other: Refresh Liquigel Lubricant Eye Drops
* Other: Refresh Plus Lubricant Eye Drops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 and over Exclusion Criteria: No sodium fluorescein corneal staining at Screening Visit

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FID 105783<br> | Other: Systane Free lubricant eye drops<br> <br> |
| Active Comparator: Visine<br> | Other: Visine Tears Lubricant Eye Drops<br> <br> |
| Active Comparator: Refresh Liquigel<br> | Other: Refresh Liquigel Lubricant Eye Drops<br> <br> |
| Active Comparator: Refresh Plus<br> | Other: Refresh Plus Lubricant Eye Drops<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epithelial permeability to fluorescein |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tear turnover rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Normal, healthy eyes (other than correction for visual acuity)
Prevalence and Spectrum of Cancer Susceptibility Among Patients With Advanced Colorectal Polyps

Study Overview
=================
Brief Summary
-----------------
The study is being conducted to determine the prevalence and risk factors for germline cancer susceptibility genetic mutations among patients with advanced colorectal polyps.

Official Title
-----------------
Prevalence and Spectrum of Germline Cancer Susceptibility Gene Mutations Among Patients With Advanced Colorectal Polyps

Conditions
-----------------
Colorectal Neoplasm

Intervention / Treatment
-----------------
* Genetic: Multi-Cancer Cancer Panel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision to sign and date the consent form Stated willingness to comply with all study procedures and be available for the duration of the study Be a male or female aged 18-89 Undergone colonoscopy At least one advanced colorectal polyp, defined as having any of the following: Any polyp ≥ 1cm (adenoma or serrated polyp) Any polyp with villous architecture Any polyp with high-grade dysplasia Sessile serrated polyps with any dysplasia Traditional serrated adenoma Exclusion Criteria: Known hereditary cancer syndrome Personal history of inflammatory bowel disease Personal history of colorectal cancer Polyp histology or size unavailable or not documented

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: Multi-Cancer Cancer Panel|Eligible patients will receive genetic testing to determine germline cancer predisposition.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of germline pathogenic/likely pathogenic variants in cancer predisposition genes in patients with advanced colorectal polyps |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for germline pathogenic/likely pathogenic variants in patients with advanced colorectal polyps |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
genetics, polyps, cancer, multi-gene panel
Development of a Biomarker for Dietary Furanocoumarins

Study Overview
=================
Brief Summary
-----------------
Certain plant foods are high in furanocoumarins. Test tube and animal studies suggest that furanocoumarins may help prevent cancer. It is difficult to determine in humans if furanocoumarins do prevent cancer because there isn't an objective way to tell who has eaten these compounds. This study will develop a urine test to determine if an individual ate foods that contain furanocoumarins.

Official Title
-----------------
Development of a Biomarker for Dietary Furanocoumarins

Conditions
-----------------
Cancer, Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Cooked parsnips with parsley


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be at least 18 years of age Healthy Exclusion Criteria: History of gastrointestinal, hepatic or renal disorder Currently taking any prescription or over-the-counter medication Currently taking any herbal supplement Pregnant or lactating Allergies to foods that will be used (parsnips and parsley)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Furanocoumarin<br>Includes participants first refraining from eating foods with furanocoumarins for one week, followed by 2 weeks of increasing furanocoumarin consumption. Participants will be asked to consume cooked parsnips and parsley. | Dietary Supplement: Cooked parsnips with parsley<br>* Beginning on Day 9 participants will be given cooked parsnips with parsley at a dose of 2 grams total apiaceous vegetable/kilogram body weight for period 1, and 4 gram/kilogram body weight for period 2.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Biomarker Results for Dietary Furanocoumarins | determine the optimal conditions for furanocoumarin identification and quantification in human urine | Week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Concentration of Dietary Furanocoumarin in Urine | Determine dose response of dietary furanocoumarin in urine - Comparison of Pre-Dose, Low-Dose and High Dose diet of furanocoumarin in subjects' urine collected (ng/ml). | Week 1, 2 and 3 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteer
Escitalopram in Schizophrenia in OCD- Open Label Study

Study Overview
=================
Brief Summary
-----------------
SSRI's has been demonstrated to be partially effective in schizophrenia and OCD. We therefore suggest that Escitalopram up to 20 mg /d in those patients could be effective in reducing obsessive compulsive symptomatology

Official Title
-----------------
Escitalopram in the Treatment of Patient Suffering From Scizophrenia and Obsessive Compulsive Disorder- an Open Label Study

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Escitalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who suffer from schizophrenia and OCD Exclusion Criteria: Substance abuse, Serious medical condintions, Being on SSRI treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |