linjc16/ctgov huggingface dataset:
Acute Cardiac Ischemia in Women in the ACI/TIPI Trial

Study Overview
=================
Brief Summary
-----------------
To conduct a series of five inter-related studies on acute cardiac ischemia (ACI) in women.

Detailed Description
-----------------
BACKGROUND: Acute cardiac ischemia (ACI), including acute myocardial infarction (AMI) and unstable angina pectoris, is the leading cause of death in women in the US. Despite growing interest in ischemic (coronary) cardiac disease in women, little research has focused on women in the most common site of ACI initial evaluation and care: the emergency department (ED). Improving medical care quality and outcomes for ACI in women will require an understanding of gender's influence on initial ED presentation, diagnosis, triage, treatment, and outcomes.The detail of prospectively-collected data and number of patients available for this project with the resulting large statistical power (while savings the cost of the $1.8 million ACI-TIPI Trial data collection effort) and the experience of the CCHSR in over a decade of related studies of factors influencing the triage, treatment, and outcome of ED patients with ACI, provide this project with substantial promise of new and useful results. DESIGN NARRATIVE: The five studies included. STUDY I: Were women's emergency department (ED) presentations of ACI different from men's? STUDY II: Were there differences between women and men in the ED diagnosis and triage of patients with chest pain and other symptoms suggestive of ACI? STUDY III: Were there differences between women and men in the use of non-invasive and invasive treatments among patients presenting to the ED with ACI? STUDY IV: Were there significant differences between women and men in medical outcomes during the acute event and within 30 days following ED presentation with ACI? STUDY V: Had differences between women and men in their ED presentation, diagnosis, and/or triage for chest pain or other symptoms compatible with ACI changed over the past 10-15 years? In studying the impact of gender, these studies also included analyses for primary and interaction effects related to patient sociodemographic features, ED presenting clinical features, physician type and training, hospital type and ED setting, health insurance type, and include adjustments for patients' probabilities of having ACI as well as their likelihood of acute cardiac mortality. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Heart Diseases, Cardiovascular Diseases, Angina Pectoris, Myocardial Ischemia

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
The Norepinephrine Transporter: A Novel Target for Imaging Brown Adipose Tissue

Study Overview
=================
Brief Summary
-----------------
This study seeks to assess a novel imaging technique to image brown adipose tissue utilizing the norepinephrine transporter.

Official Title
-----------------
The Norepinephrine Transporter: A Novel Target for Imaging Brown Adipose Tissue

Conditions
-----------------
Brown Adipose Tissue

Intervention / Treatment
-----------------
* Radiation: PET imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-30 yrs BMI < 24 kg/m2 Caucasian Exclusion Criteria: Current neuro-psychiatric illness substance abuse medical or neurological illnesses likely to affect physiology or anatomy, i.e., uncontrolled hypertension, cardiovascular disorders current pregnancy current breast feeding suicidal ideation or behavior use of medications which potentially affect NET binding within 2 weeks of the PET scans.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy subjects<br>Healthy subjects (male, female) | Radiation: PET imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of brown adipose tissue based on PET imaging |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
brown adipose tissue
ATEZOLIZUMAB - BEVACIZUMAB in the Treatment Hepatocellular Carcinoma Inoperable or

Study Overview
=================
Brief Summary
-----------------
Evaluation of the efficacy and safety of the combination ATEZOLIZUMAB - BEVACIZUMAB in the treatment of locally advanced inoperable or metastatic hepatocellular carcinoma in Finistère

Detailed Description
-----------------
Patients treated by ATEZOLIZUMAB and BEVACIZUMAB for an Advanced hepatocellular carcinoma will be followed to observed their safety and the efficacy of this treatment, and to identify prongnosis factors

Official Title
-----------------
Evaluation of the Efficacy and Tolerance of the Association ATEZOLIZUMAB - BEVACIZUMAB in the Treatment of a Locally Advanced Hepatocellular Carcinoma Inoperable or Metastatic in Finistère

Conditions
-----------------
Advanced Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hepatocellular carcinoma locally advanced or metastatic, non able to be resectable, with no prior systemic treatment Child Pugh A and ECOG 0 or 1 upper digestiuve endoscopy less than 6 months, if esophageal varcices : must be treated non eligible to receive a locoregional therpay or progressive after this kinf of treatment with informed consent Exclusion Criteria: refuse to participate under legal protection exclusion criteria from the tempory utilisation authorization

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| predictive factor for progression-free survival | progression-free survival = time between treatment initiation and rediologic or clinical progression | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ATEZOLIZUMAB, BEVACIZUMAB , Advanced hepatocellular carcinoma
Airway Dysfunction and Remodelling in Athletes Following Swimming Training in Chlorinated Pools

Study Overview
=================
Brief Summary
-----------------
Swimmers show the highest prevalence of asthma among elite athletes, certainly due to chlorine exposure. The consequences of a chronic exposure to chlorine compounds by swimmers and the mechanisms of asthme in this population are still poorly documented. Specific diagnostic criteria have been proposed by the International Olympic Committee - Medical Council (IOC-MC) and World anti-doping agency (WADA) to determine the presence of asthma in athletes. Using the more specific bronchial provocation tests, our aims are to compare the prevalence of asthma in swimmers and control subjects to analyze the Influence of chlorine exposure on bronchial inflammatory processes in swimmers versus control subjects to study the time-course of changes in airway symptoms, responsiveness, inflammation and remodeling after cessation of training

Official Title
-----------------
Airway Dysfunction and Remodelling in Athletes Following Swimming Training in Chlorinated Pools

Conditions
-----------------
Asthma, Airway Hyperresponsiveness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 14 to 35 years old To swim at least 10h per week For control subjects, non-competitive healthy subjects Exclusion Criteria: any disease that may interfere with the tests for the controls Triathletes are excluded Smokers Obese or with a BMI more than 29 Former athletes (control group)

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 35 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 |
| --- | --- |
| 1<br>Swimmers without AHR | |
| 2<br>Swimmers with asymptomatic AHR | |
| 3<br>Swimmers with symptomatic AHR and use only of beta-2 adrenargic | |
| 4<br>Swimmers with asthma and inhaled corticosteroids | |
| 5<br>Healthy Subjects | |
| 6<br>Healthy subjects with AHR | |
| 7<br>Healthy subjects with symptomatic AHR (asthma) but without treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma and airway hyperreactivity prevalence in swimmers |  | 3 measurements in the year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway inflammation and remodeling in swimmers |  | 3 measurements in the year and a bronchial biopsy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Airway hyperresponsiveness, Swimmers, Airway inflammation, Airway remodelling
Surgical Activity During the Covid-19 Pandemic: Results for 112 Patients in a French Tertiary Care Center

Study Overview
=================
Brief Summary
-----------------
Background After the emergence of Covid-19 in China, Hubei Province, the epidemic quickly spread to Europe. France was quickly hit and the Croix-Rousse hospital at the Hospices Civils de Lyon was one of the first French university hospital to receive patients infected with Sars-COV2. The predicted massive influx of patients motivated the cancellation of all elective surgical procedures planned to free hospitalization beds and to free intensive care beds. Nevertheless, patients who had to be canceled had to be properly selected to avoid a life threatening. The retained surgical indications were surgical emergencies, oncologic surgery and organ transplantation. The objective was to describe the organization of the Croix-Rousse hospital to allow the continuation of these surgical activities while limiting the exposure of patients to the Sars Cov2.

Official Title
-----------------
Surgical Activity During the Covid-19 Pandemic: Results for 112 Patients in a French Tertiary Care Center: A Retrospective Observational Cohort Study

Conditions
-----------------
Digestive Cancer, Gynaecological Cancer, Head and Neck Cancer

Intervention / Treatment
-----------------
* Biological: Screening test for covid ( RT PCR and CT Chest)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgical management > 18 years old Exclusion Criteria: < 18 years old

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 |
| --- |
|Biological: Screening test for covid ( RT PCR and CT Chest)|Each patient was screened before surgery with RT PCR and CT Chest. Post operatively, if symptoms, patients are tested with RT PCR and CT Chest|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of Covid after surgery | Patients are tested with RT PCR and CT Chest if they declare symptoms after surgery | Screening test are performed if the patient becomes symptomatic up to 14 days after surgery. In case of symptoms patients are tested within 24 hours. |
Myocardial Protection and Clinical Outcome in Patients Undergoing Tetralogy of Fallot Repair : A Randomized Study of Two Different Cardioplegia Technique

Study Overview
=================
Brief Summary
-----------------
Myocardial protection and clinical outcome in patients Undergoing tetralogy of fallot repair: a randomized study of Two cardioplegic techniques.

Detailed Description
-----------------
Del Nido cardioplegia has not been used for myocardial protection and clinical outcome in patients undergoing tetralogy of Fallot repair, so the investigators hypothesized that a del Nido cardioplegia technique may be beneficial in the pediatric patients undergoing tetralogy of fallot repair.

Official Title
-----------------
MYOCARDIAL PROTECTION AND CLINICAL OUTCOME IN PATIENTS UNDERGOING TETRALOGY OF FALLOT REPAIR: A RANDOMIZED STUDY OF TWO CARDIOPLEGIC TECHNIQUES

Conditions
-----------------
Myocardial Protection in TOF Repair

Intervention / Treatment
-----------------
* Other: blood cardioplegia
* Other: del nido cardioplegia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Tetralogy of fallot Exclusion Criteria: TOF with absent pulmonary valve , TOF with pulmonary atresia

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: blood cardioplegia<br>these patients received blood cardioplegia | Other: blood cardioplegia<br> <br> |
| Active Comparator: del nido cardioplegia<br>these patients received del nido cardioplegia | Other: del nido cardioplegia<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inotropic score |  | First 24 hours | 
| Creatine kinase MB level baseline preoperative and postoperative 0, 6, 24, and 72 hours |  | 72hrs | 
| resumption of spontaneous rhythm after aortic cross clamp off |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of mechanical ventilation in hours |  | 48 hours | 
| ICU stay |  | 7 days | 
| hospital mortality |  | 30 days | 
| echocardiographic assessment |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tetralogy of fallot, cardioplegia
Impact of Weight Loss Following Bariatric Surgery on Pulmonary Function in Patients With Morbid Obesity

Study Overview
=================
Brief Summary
-----------------
Increase in body mass index (BMI)is associated with a decrease in expiratory flows.Obesity is also associated with an increased prevalence of asthma.Consequences of obesity on respiratory function and on bronchial responsiveness are still to be documented. This study aims to evaluate, before and after surgery, the impact of a bariatric surgery (biliopancreatic diversion with duodenal switch)on respiratory function in patients with morbid obesity . Our hypothesis is that weight loss following bariatric surgery will induce significant improvements in pulmonary function and airway responsiveness, and, as a consequence, a reduction in respiratory symptoms,these changes being correlated with a reduction in systemic markers of inflammation. Maintenance of weight loss after one year will permit the persistence of these improvements

Detailed Description
-----------------
Patients will be evaluated before the surgery (time zero), 6 months and one year after their surgery. A control group of patients on a waiting list for bariatric surgery will be evaluated at time zero and after 6 months and one year. At each visit,patients will: fill a standardized respiratory questionnaire and a questionnaire on sleep apnea; questionnaires on asthma control will be completed by patients with asthma. have a spirometry, pulmonary volumes measures by body plethysmography and methacholine inhalation test with evaluation of symptoms perception. an induced sputum will be performed. A blood sample will be drawn to evaluate inflammation and measure C-reactive protein concentration in plasma. An allergy skin prick test will be done at time zero.

Official Title
-----------------
Impact of Weight Loss Following Bariatric Surgery on Pulmonary Function in Patients With Morbid Obesity

Conditions
-----------------
Bariatric Surgery, Obesity, Respiratory Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index >or= 35 kg/m2 Non-smokers or ex-smokers (<10 packs-year) Exclusion Criteria: Previous bariatric surgery previous vagotomy no compliance to visits subjects unable to provide an informed consent or to understand the questions included in questionnaires Patients with cardiac pacemaker hemodynamically significant valvulopathy

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 |
| --- | --- |
| bariatric surgery<br>patients with morbid obesity undergoing a bariatric surgery | |
| No bariatric surgery<br>patients with morbid obesity on a waiting list for a bariatric surgery but who will have their surgery in more than one year. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of Wear Experience With a Water Surface Daily Disposable Contact Lens

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the wear experience of existing wearers of a monthly replacement contact lens after they have been fit with a daily disposable contact lens that has water surface treatment.

Official Title
-----------------
Evaluation of Wear Experience With a Water Surface Daily Disposable Contact Lens

Conditions
-----------------
Contact Lens

Intervention / Treatment
-----------------
* Device: Comfilcon A Toric contact lenses
* Device: Verofilcon A for Astigmatism Daily Disposable contact lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be a current wearer of Comfilcon A contact lenses Distance visual acuity of 20/25 or better with current contact lenses Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI) Ability to give informed consent Willing to spend time for the study, which includes attending three study visits and be willing to wear contact lenses on days between study visits. Either gender. Any racial or ethnic origin. Exclusion Criteria: No current ocular inflammation or infection. Not currently pregnant or lactating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: All participants<br>All participants have habitual Comfilcon A Toric lenses optimized for wear over 2 weeks. Then all participants are fit with the Verofilcon A study daily disposable lenses with water surface treatment for astigmatism. | Device: Comfilcon A Toric contact lenses<br>* Monthly replacement contact lenses<br>Device: Verofilcon A for Astigmatism Daily Disposable contact lenses<br>* Daily disposable contact lenses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Assessment of Overall Comfort With Verofilcon A Daily Disposable Lenses for Astigmatism | Participants will complete a Visual Analog Scale survey of overall comfort (0-100 Scale with 0 anchored with Poor Comfort and 100 anchored as Excellent Comfort) | 3 weeks |
Eeva™ Pregnancy Pilot Study (PPS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical investigation is to gather pilot data to evaluate the impact of using Eeva™, a time-lapse enabled embryo test, in combination with traditional morphology on clinical pregnancy rates.

Official Title
-----------------
Eeva™ Pregnancy Pilot Study (PPS)

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Device: Eeva™ results


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women undergoing fresh in vitro fertilization treatment using their own eggs ≤ 40 years ≥ 4 diploid embryos (i.e. having 2 PNs) ≤ 3 Prior ART cycles (IVF, ICSI and related procedures) All 2PN embryos (for all 3 arms) must be imaged by Eeva Subject willing to comply with study protocol and procedures Subject willing to provide written informed consent Exclusion Criteria: Preimplantation genetic diagnosis or preimplantation genetic screening Planned freeze all cycle (eggs or embryos) Asherman's Syndrome Donor egg Gestational carrier Presence of Hydrosalpinx on ultrasound Concurrent participation in an interventional clinical study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Day 3 eSET combined with Eeva<br>Traditional Morphology + Eeva™ results | Device: Eeva™ results<br> <br> |
| Active Comparator: Day 5 eSET combined with Eeva<br>Traditional Morphology + Eeva™ results | Device: Eeva™ results<br> <br> |
| No Intervention: Day 5 eSET with Traditonal Morphology<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Pregnancy |  | 7-8 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate |  | 8-12 week gestation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
In Vitro Fertilization