linjc16/ctgov huggingface dataset:
Effectiveness of Cervico-isthmic Cerclage

Study Overview
=================
Brief Summary
-----------------
This study compares the rate of live births before and after cervico-isthmic cerclage in 3 hospitals in the last 10 years. The hypothesis is that cerclage significantly increases the rate of live births in women with cervical insufficiency.

Official Title
-----------------
Effectiveness of CERvico-isthmic CErclage in Increasing the Rate of Live Births in Case of a History of Late Miscarriage and/or Premature Delivery

Conditions
-----------------
Cerclage, Cervical, Cervical Insufficiency

Intervention / Treatment
-----------------
* Procedure: Cervico-isthmic cerclage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of premature delivery or late miscarriage unrelated to maternal pathology, chorioamnionitis, fetal or placental pathology Patient aged over 18 at the time of the phone call Cerclage performed according to the Benson technique verified on the operative report Cerclage performed in one of the 3 obstetric gynecology departments of the CHU de Lyon (Lyon Sud, Croix Rousse and HFME) between January 1, 2010 and April 1, 2019 Exclusion Criteria: History of trachelectomy Surgical technique not specified or not deductible from the operating report Refusal to participate in the study Patient under legal protection

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Cervico-isthmic cerclage<br>Are included in this group the women who underwent cervico-isthmic cerclage between January 1, 2010 and April 1, 2019, in 3 hospitals of the Hospices Civils de Lyon, respecting the inclusion and exclusion criteria, to assess the primary and secondary outcomes before and after performing the cerclage. | Procedure: Cervico-isthmic cerclage<br>* There is no intervention in this study. It's an observational retrospective study, before/after.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of live birth ≥ 24 weeks of gestation or before 24 weeks of gestation with active neonatal intensive care, among pregnancies progressing after 14 weeks of gestation. | We collect the data necessary to assess the outcomes in the medical charts. When data is missing, we will call patients (telephone interview) and ask them a few questions related to their gynecological and obstetric history. | Day 0 (At Inclusion) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cervico-isthmic cerclage, cerclage, cervico-isthmic, cervical insufficiency, miscarriage, prematurity
Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and immunogenicity of booster dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 365-569 days of age

Official Title
-----------------
A Phase III Observer Blind Single-Coordinating Center Pediatric Study in China Comparing a Booster Dose of Vaxem™ Hib to HIBERIX® When Given as Part of a Local Dosing Regimen in Infants

Conditions
-----------------
Haemophilus Influenzae Type b (Hib) Infection

Intervention / Treatment
-----------------
* Biological: Haemophilus influenzae type b (Hib) vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants 365-569 days of age. Exclusion Criteria: Subjects who already received a booster dose of Hib vaccine. History of serious reaction(s) following vaccination. Any vaccination within 7 days of study vaccination. Known or suspected immune impairment.

Ages Eligible for Study
-----------------
Minimum Age: 365 Days
Maximum Age: 569 Days

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Biological: Haemophilus influenzae type b (Hib) vaccine<br>* Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines<br>|
| Active Comparator: Arm 2<br> | Biological: Haemophilus influenzae type b (Hib) vaccine<br>* Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-PRP (polyribosyl-ribitol-phosphate) antibody levels at day 31 post last vaccination |  | 30 days after last vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) |  | 30 days post last vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Haemophilus influenzae type b (Hib), Vaccine, Anti-PRP antibody
Insulin Resistance and Vessel Function After Meals: Does Early Intervention Make a Difference?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether attenuation/normalization of elevated blood sugar after meals ameliorates vessel wall (endothelial) function in individuals with insulin resistance.

Detailed Description
-----------------
Background:Insulin Resistance (IR) is accompanied by a high incidence and prevalence of cardiovascular disease. IR is present in individuals with pre-diabetes/ type 2 diabetes. Epidemiological data demonstrate a tight relationship between postprandial blood sugar, insulin resistance and cardiovascular disease (CVD). Endothelial dysfunction seems to be the very first sign of CVD. Purpose: We propose to determine whether attenuation /normalization of post-prandial hyperglycaemia, through the administration of an oral hypoglycaemic agent of ultra rapid action (nateglinide), ameliorates endothelial function in the IR. We extrapolate that a better endothelial function in the brachial artery reflects regression of atherosclerotic changes in the coronary system. Method and Study Design: Prospective, open, parallel, group comparison study of 1 intervention group, 1 intervention control group and 1 disease control group. The intervention group and the intervention control group each consist of 30 individuals with IR. Individuals in the intervention group receive an individually adjusted dose of nateglinide 3 times daily during 12 weeks. The third group consists of 10 healthy, young individuals. All groups are followed during 3 months with an otherwise unchanged lifestyle. Endothelial function is measured with the Flow Mediated Dilation method before and after the intervention/observation period.

Official Title
-----------------
Insulin Resistance and Postprandial Endothelial Function: Does Early Intervention Make a Difference?

Conditions
-----------------
Insulin Resistance, Impaired Fasting Glucose

Intervention / Treatment
-----------------
* Drug: Nateglinide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insulin resistance, impaired glucose tolerance Exclusion Criteria: unstable chronic disease, acute disease

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 75 Years

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic function |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postprandial endothelial function
Effects of Acu-Transcutaneous Electrical Nerve Stimulation (Acu-TENS) on Post-exercise Blood Lactate and Excessive Post-exercise Oxygen Consumption (EPOC)

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the effect of Acu-TENS on post-exercise blood lactate level and EPOC

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Device: Transcutaneous electrical nerve stimulation (TENS)
* Device: Transcutaneous electrical nerve stimulation (TENS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: with normal health (no known history of cardiovascular, pulmonary, metabolic or musculoskeletal diseases) Exclusion Criteria: unable to communicate and follow the exercise procedures

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acu-TENS<br>Application of TENS over acupuncture points | Device: Transcutaneous electrical nerve stimulation (TENS)<br>* Application of TENS over acupuncture points<br>|
| Placebo Comparator: Placebo-TENS<br>Application of Acu-TENS but with no electricity | Device: Transcutaneous electrical nerve stimulation (TENS)<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood lactate level | Finger pick method - measured by Lactate Plus (Nova Biomedical, USA) | Before exercise | 
| Blood lactate level | Finger pick method - measured by Lactate Plus (Nova Biomedical, USA) | Immediately post exercise | 
| Blood lactate level | Finger pick method - measured by Lactate Plus (Nova Biomedical, USA) | 15 minutes post exercise | 
| Oxygen consumption | measured by K4b2 (Cosmed, Italy) | Measurements continued during exercise and until heart rate returned to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | measured by Polar heart rate monitor (RS800CX, Polar Electro, Finland) | Measurements continued during exercise and until heart rate returned to baseline |
The Effect of Nicorandil on Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion

Study Overview
=================
Brief Summary
-----------------
Background Nicorandil is recommended as a second-line treatment for stable angina, but randomized-controlled trials (RCTs) to evaluate the benefit of nicorandil for patients with chronic total occlusion (CTO) are still lack. Objective To determine whether nicorandil can improve left ventricular myocardial strain in patients with CTO. Methods Patients with CTO were included and were randomized to the nicorandil group and the control group. Nicorandil was given orally 15 mg/day for 3 months in the nicorandil group. 3-dimentional-speckle tracking echocardiography (3D-STE) and the Seattle angina questionnaire (SAQ) survey were performed at baseline and at 3 months. Participants were randomized according to an IBM SPSS23.0-generated randomization schedule, with a 1:1 allocation to the nicorandil group or the control group.

Official Title
-----------------
The Effect of Nicorandil on Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: nicorandil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18 and 80 years;1 or more CTO vessels (≥2mm in diameter) Exclusion Criteria: successful PCI for all CTO lesions; ST segment elevation myocardial infarction (STEMI) during the past 3 months; planed coronary artery bypass grafting (CABG) within 3 months; valvular heart disease or congenital heart disease; cardiomyopathy; heart failure with NYHA (New York Heart Association) class III or above; persistent atrial fibrillation or complete left bundle branch block; severe liver, kidney, or lung diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nicorandil group<br> | Drug: nicorandil<br>* Patients in the nicorandil group were also given nicorandil (Tohoku Nipro Pharmaceutical Corporation, Japan) orally 5 mg three times per day for 3 months<br>|
| No Intervention: control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total area strain |  | 3 months |
Evaluation of the Colonoscope With Vision to 330 ° (Full Spectrum Endoscopy) in the Detection of Colorectal Adenomas

Study Overview
=================
Brief Summary
-----------------
The coloscopy is considered as the gold standard for screening and resection of colorectal adenomas. However the literature reports that the rate of omitted adenoma is still high (24 to 41%). The development of the FUSE system (Endochoice, USA) allows a larger field of view with a projection onto 3 screens (330° vision). A pilot study and a randomized multicentre has demonstrated the feasibility with a significant improvement of the rate of detected adenomas. This first study in France concerning this technology has the objectives to demonstrate the feasibility in France, the safety and to compare the rate of detected adenomas with data of the literature.

Official Title
-----------------
Evaluation of the Colonoscope With Vision to 330 ° (Full Spectrum Endoscopy) in the Detection of Colorectal Adenomas

Conditions
-----------------
Colorectal Adenoma

Intervention / Treatment
-----------------
* Device: FUSE-TM colonoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Diagnostic colonoscopy Exclusion Criteria: Colorectal cancer Colic surgery Preparation of average or poor quality Rectal polyp of hyperplastic type <2 mm

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

| Intervention/Treatment |
| --- |
|Device: FUSE-TM colonoscope|Colonoscopy in conditions of normal security including patient clinical examination before leaving the hospital. Data collection by each operator.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Cecal intubation rate | 1 day | 
| Efficacy | Absence of necessity to change of endoscope in case of progression, visualization, biopsy or resection | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity | Serious adverse events (perforation, uncontrolled bleeding) | 1 day |
Uveitis in Relation to Perceived Stress: A Prospective Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct a prospective analysis to determine the relationship between disease activity of noninfectious uveitis and stress.

Detailed Description
-----------------
Patients presenting at The New York Eye and Ear Infirmary (NYEEI) who meet the inclusion criteria will be recruited prospectively. Patients diagnosed with non-infectious uveitis will be asked to self-administer the Perceived Stress Scale (PSS) - 10, following informed consent. Patient demographics will also be collected. The presence of inflammation will be then be assessed by the investigator. Patients will be asked to complete the PSS-10 again at all subsequent standard-of-care visits within a 6-month timeframe. PSS-10 scores are obtained by reversing the scores on the four positive items (4, 5, 7 and 8), then summing across all 10 items. Patient and the investigator will be masked to the PSS scores.

Official Title
-----------------
Uveitis in Relation to Perceived Stress: A Prospective Study

Conditions
-----------------
Uveitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age with a diagnosis of non-infectious uveitis Able to self-administer the Perceived Stress Scale (PSS) - 10 Exclusion Criteria: Diagnosis of infectious uveitis

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 |
| --- | --- |
| Noninfectious Uveitis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Influenza Vaccination in Bone Marrow Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether influenza vaccination protects patients who receive a certain type of bone marrow transplantation.

Detailed Description
-----------------
Patients who receive bone marrow transplantation are at high risk for complications from influenza infection. It is not whether influenza vaccination protects patients who undergo a type of bone marrow transplantation called nonmyeloablative, or reduced intensity bone marrow transplantation. This study compares the response to influenza vaccination in a group of these patients to that in healthy people.

Official Title
-----------------
Immunogenicity of Influenza Vaccination (Flu Vac) in Patients Receiving Nonmyeloablative Allogeneic Peripheral Blood Stem Cell Transplantation (NM Allo PBSCT) Compared to Healthy Controls

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: inactivated split-virus influenza vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were included if they had received RIC allo HSCT 3 months or more prior to enrollment, and were between the age of 18 and 65 years. Controls were health care providers at our institution, between the ages of 18 and 65 years, who were in good health, and who are routinely offered influenza vaccination. Exclusion Criteria: Patients were excluded if they failed to engraft, or had relapse of the underlying disease requiring chemotherapy or immunotherapy. Patients and controls were also excluded if they had history of egg allergy, acute febrile illness at the time of vaccination, or influenza-like illness within 4 weeks prior to vaccination.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: inactivated split-virus influenza vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is the influenza vaccine immunogenic in patients receiving nonmyeloabalative allogeneic PBSCT compared to healthy controls as judged by their humoral antibody response? |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral blood stem cell transplantation, Non-myeloabalative, Influenza vaccination, Humoral immune response, Immunogenicity
Consequences of DNA Repair and Telomere Defects on the Function of the Immune System: Application to CVID and Immune Deficiencies With Dysmorphic Syndromes

Study Overview
=================
Brief Summary
-----------------
The molecular mechanisms participating in the various aspects of the DNA Damage Response (DDR) are absolutely essential to maintain the genome dynamics essential to all living organisms. The most commonly studied consequence of faulty DDR is genome instability participating in cancer onset. In the present proposal, we wish to explore another aspect of DDR, not relevant to cancer, which is its absolute requirement at several key steps of the development, maturation, and function of the immune system. The most spectacular consequences of faulty DNA repair processes with respect to the immuno-hematopoietic tissue are the complete block of B and T lymphocytes maturation owing to defective DNA joining phase during V(D)J recombination resulting in patients with Severe Combined Immune Deficiency (SCID). The objectives of this study are to increase our knowledge on the role of the various DNA repair processes in the development, the maintenance, and the function of the immune system and thus, to better understand why and how dysfunctions of these DNA repair processes result in human severe conditions such as CVID, LOCID or other manifestations of immune disorders such as autoimmunity. The explorations of DNA repair mechanisms in the patients will allow us to establish the genetic diagnosis in some patients with until now undefined molecular diagnosis. This is of immediate importance for the patients and their families, as it not only contributes to a better understanding of the patients' condition, but also allows providing genetic counseling for the families.

Official Title
-----------------
Consequences of DNA Repair and Telomere Defects on the Function of the Immune System: Application to CVID and Immune Deficiencies With Dysmorphic Syndromes

Conditions
-----------------
Immune Deficiency and Early BMF in Childhood

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Immune Deficiency and early BMF in childhood Common Variable Immunodeficiency (CVID) Genetic patients Exclusion Criteria: Refusal to consent.
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 |
| --- | --- | --- |
| DNA abnormailities |  | 1 day |