linjc16/ctgov huggingface dataset:
Ovarian Reserve and Embryo Implantation

Study Overview
=================
Brief Summary
-----------------
Compare, in young patients with In vitro fertilization (IVF), the rate of embryo implantation by early culture transfer (J2-J3) between 2 groups of patients: normo responders vs. poor responders.

Official Title
-----------------
Ovarian Reserve and Embryo Implantation

Conditions
-----------------
Ovarian Reserve, IVF

Intervention / Treatment
-----------------
* Other: no intervention. observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IVF patient managed with or without ICSI between 01/01/2014 and 30/06/2015 in one of the two study centres Age < 35 years old Fresh transfer of at least one embryo between D2 and D6 patients who have already received one or more transfer attempts. Exclusion Criteria: No fresh transfer (Freeze All, segmentation failure, stimulation failure) Double successive embryo transfer (e. g. J3-J5). We did not retain these cases because if only one of the 2 embryos is implanted, it is not possible to know which transfer it corresponds to. Maternal serum FSH determination < 4 IU/ml at D3 in the baseline balance sheet (hypogonadotropic hypogonadism)

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- |
| normo responders<br>that have an AMH dosage greater than or equal to 1.2 ng/mL | Other: no intervention. observational study<br>* no intervention. observational study<br>|
| poor responders<br>with a dosage of less than 1.2 ng/mL | Other: no intervention. observational study<br>* no intervention. observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The embryo implantation rate at 5 weeks after transfer is defined by the presence of an embryo with objective cardiac activity by ultrasound | The embryo implantation rate corresponds to the number of embryos with cardiac activity found on the number of embryos transferred | 5weeks |
An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity

Study Overview
=================
Brief Summary
-----------------
Evaluate the association between level of decreased corneal sensitivity and diabetic retinopathy severity scale

Detailed Description
-----------------
This study is assessing the association between neurotrophic keratopathy and diabetic retinopathy severity by examining subjects with diabetic retinopathy to associate DRSS and disease characteristics with corneal desensitization. In addition, to better understand the relationship of disease duration, HbA1c, and status of concurrent systemic therapies and diabetic retinopathy treatments, predictive modelling will be performed to determine predictive factors of patients at highest risk of developing reduced corneal sensitivity.

Official Title
-----------------
An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity

Conditions
-----------------
Diabetic Retinopathy, Neurotrophic Keratitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have Type 1 or Type 2 diabetes with DRSS of 3 or higher Be willing and able to sign the informed consent form (ICF) Be at least 18 years of age Be literate and able to complete questionnaires independently Have provided verbal and written informed consent Exclusion Criteria: Have a history of vitrectomy Have a history of cornea, eyelid, glaucoma, or retina surgery Have a history of previously diagnosed neurotrophic keratopathy or other cranial nerve V pathology, such as trigeminal neuralgia Have a history of ocular herpes simplex virus infection Have a history of herpes zoster ophthalmicus Have a history of ocular chemical trauma Have a history of underlying corneal dystrophies Have had cataract surgery less than 3 months prior Have a history of pan-retinal photocoagulation (PRP) Have current Stage 2 or 3 neurotrophic keratopathy Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint | • To associate the Diabetic Retinopathy Severity Scale level 3 or higher (as confirmed by masked reading center) with the level of decreased corneal sensitivity in patients with Type 1 and Type 2 diabetes | 3months |
Strabismus Measurements Using Automated 3D Video Oculography

Study Overview
=================
Brief Summary
-----------------
Measuring ocular motility and alignment is important for diagnosing different causes of strabismus, following patients recovering from cranial nerve palsies, preparing patients for strabismus surgery and follow-up post surgery. The current clinical gold standards for measuring ocular alignment are the Hess screen and the Harms tangent screen. These tests are accurate, but require patient cooperation, and are not objective because the patient has to indicate the position of the light he sees on the screen. Our objective is to develop an accurate and easy to use goggles system to measure ocular alignment and motility using 3D video oculography.

Official Title
-----------------
Strabismus Measurements Using Automated 3D Video Oculography

Conditions
-----------------
Strabismus

Intervention / Treatment
-----------------
* Device: strabismus video goggles


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 11 years or older congenital strabismus acquired strabismus paretic strabismus (oculomotor, abducens and trochlear nerves) before and after strabismus surgery normal controls Exclusion Criteria: Patients unable to sign informed consent Patients with significantly impaired vision Patients unable to cooperate with standard strabismus workup (including Hess and Harms tests) For sub-study: intolerance to scleral search coils

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: strabismus video goggles<br> | Device: strabismus video goggles<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of video goggles against Hess/Harms screen | Measurement of squint angle with 3D video goggles vs. Hess/Harms screen. | initial visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of video goggles in comparison to scleral search coils | Measurement of squint angle with 3D video goggles vs. scleral search coils. | initial visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oculomotor palsy, abducens palsy, trochlear palsy, strabismus
Study to Evaluate Safety and Pharmacokinetics of UB-421 Antibody in HIV-1 Infected Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this Phase I study is to determine whether the antibody (UB-421), targeting the HIV-1 receptor on the CD4 molecule (domain 1) of T-lymphocytes and monocytes, is safe and well tolerated when administered to asymptomatic HIV-1 infected adults by intravenous infusion and to assess pharmacokinetic parameters of the antibody in blood and on cells. The neutralizing activity of UB-421 blocks HIV-1 from binding to its receptor on CD4-positive cells; thus, UB-421 functions as an immunotherapeutic intervention to prevent HIV-1 infection.

Official Title
-----------------
A Phase I, Open-label, Single-dose, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of the UB-421 Antibody in Asymptomatic HIV-1 Infected Adults

Conditions
-----------------
HIV-1 Infection in Adults (Asymptomatic)

Intervention / Treatment
-----------------
* Drug: Antibody UB-421


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptomatic, treatment-naive, HIV-1 seropositive CD4+ T cell count >350 cells/cubic millimeter HIV-1 viral load >5,000 copies/mL Other inclusion criteria apply Exclusion Criteria: Active infection requiring immediate therapy (except HIV-1) Prior participation in any HIV vaccine trial Previous exposure to a monoclonal antibody Use of immunomodulating drugs or systemic chemotherapy Other exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Antibody (UB-421)<br> | Drug: Antibody UB-421<br>* Single intravenous infusion at day 0 of a liquid dose of 1, 5, 10 or 25 mg/kg body weight.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety and tolerability of a single intravenous infusion at escalating doses of UB-421. |  | Screen, treatment & follow-up: 62 to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine pharmacokinetic parameters of a single intravenous infusion at escalating doses of UB-421. |  | Screen, treatment & follow-up: 62 to 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1, CD4, antibody, immunotherapy
Evaluating the Effect of Surgical Safety Checklists on Perioperative Complications in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if the surgical safety checklist is associated with a reduction in perioperative complications for children undergoing surgery in Ontario, Canada.

Official Title
-----------------
Evaluating the Effect of Surgical Safety Checklists on Perioperative Complications in Children

Conditions
-----------------
Intraoperative Complications, Postoperative Complications

Intervention / Treatment
-----------------
* Other: Surgical Safety Checklist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgical admission, with a noncardiac surgical interventions Aged between >28 days and <18years on the day of the surgical intervention Exclusion Criteria: Non-surgical admission Surgical interventions with <10 per group Cardio-thoracic and interventional cardiology procedures

Ages Eligible for Study
-----------------
Minimum Age: 28 Days
Maximum Age: 17 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 |
| --- | --- |
| Pre-checklist<br>Surgical interventions performed for children before the introduction of the surgical safety checklist in Ontario, from October 2008 to September 2009. | |
| Post-checklist<br>Surgical interventions performed for children after the introduction of the surgical safety checklist in Ontario, from October 2010 to September 2011. | Other: Surgical Safety Checklist<br>* An Ontario hospital-wide introduction of a surgical safety checklist based on the WHO guidelines, as mandated by the Ontario Ministry of Health<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative complications | Composite outcome, complications included were death (all-causes), acute renal failure, cardiac arrest, complications of implants or grafts, decubitus ulcer, deep vein thrombosis, disruption of wound, electrolyte or acid-base abnormality, hemorrhage or hematoma, pulmonary embolism, pulmonary collapse or pneumonia, surgical site infection, sepsis, shock, stroke, and vascular graft failure | 30-days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare utilization - proportion of Emergency Room visits | Number of Emergency Room visits | 30-days after surgery | 
| Healthcare utilization - rate of unplanned return to the operating room | Unplanned return to the operating room | 30-days after surgery | 
| Healthcare utilization - length of hospital stay | Length of hospital stay | 30-days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgical safety checklist, perioperative complications, pediatric
Use of a Point-of-Care Platelet Function Assay for the Prediction of Atherothrombotic Events

Study Overview
=================
Brief Summary
-----------------
To evaluate the role of VerifyNow test as prognostic marker in routine clinical practice using drug-eluting stents. To determine the add-on-effect of VerifyNow test beyond on conventional risk factors (clinical, lesions, or procedural factors). To compare the prognostic utility of VerifyNow test with several biomarkers.

Detailed Description
-----------------
Predictive role of a point-of-care assay (VerifyNow test) has not been well evaluated in large number of patients receiving drug-eluting stents as a routine practice. In addition, additional predictive effect of a point-of-care assay, as compared to conventional clinical factors or other biomarkers, might be clinically interesting and important.

Official Title
-----------------
Use of a Point-of-Care Platelet Function Assay to Improve the Prediction of Atherothrombotic Events After Implantation of Drug-Eluting Stents: ASAN-VerifyNow Registry

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients with established coronary artery disease receiving PCI with stent implantation Exclusion Criteria: Cardiogenic shock Patients using concomitant medication known to affect platelet function other than aspirin (i.e. nonsteroidal antiinflammatory agents, dipyramidole, upstream glycoprotein IIb/IIIa inhibitors) patients with a known platelet function disorder or a whole blood platelet count of less than 150000/μL.

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 |
| --- | --- |
| patients receiving drug-eluting stents<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of all-cause death, myocardial infarction, stent thrombosis, and stroke |  | at median 2 year after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death (all-cause and cardiovascular) |  | at median 2 year after enrollment | 
| myocardial infarction |  | at median 2 year after enrollment | 
| stent thrombosis |  | at median 2 year after enrollment | 
| stroke |  | at median 2 year after enrollment | 
| Thrombolysis In Myocardial Infarction (TIMI) major/minor bleeding |  | at median 2 year after enrollment | 
| target-vessel revascularization |  | at median 2 year after enrollment | 
| Composite of cardiovascular death, MI, stent thrombosis, or stroke |  | at median 2 year after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary disease, platelet reactivity, drug-eluting stent
A Single-Dose Study of LY3471851 in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to estimate how much LY3471851 gets into the blood stream and how long it takes the body to remove it when administered under the skin in healthy participants. The study will also evaluate the safety and tolerability of LY3471851. The study is expected to last up to 87 days for each participant.

Official Title
-----------------
A Phase 1, Randomized, Open-Label, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Healthy Participants

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

Intervention / Treatment
-----------------
* Drug: LY3471851


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overtly healthy males or females, as determined by medical history and physical examination. Body weight greater than 55 kilograms (kg) and body mass index (BMI) within the range of 19 to 30 kilograms per meter squared (kg/m²) Exclusion Criteria: Have evidence of clinically significant active infection, including fever 100.5ºF (38ºC) or above, within 28 days of dosing or Day 1 (before dosing) Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening. Examples include but are not limited to infections requiring intravenous antibiotics, hospitalization, or prolonged treatment Are immunocompromised per investigator judgment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3471851 (Abdomen)<br>LY3471851 administered subcutaneously (SC) into the abdomen. | Drug: LY3471851<br>* Administered SC.<br>|
| Experimental: LY3471851 (Thigh)<br>LY3471851 administered SC into the thigh. | Drug: LY3471851<br>* Administered SC.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3471851 | PK: Cmax of LY3471851 | Predose up to 56 days postdose | 
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3471851 | PK: AUC of LY3471851 | Predose up to 56 days postdose |
Predictive Factors of Clinical, Laboratory and Imaging Findings Routinely Used in Diagnosing Thyroid Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the correlation between the cytohistology exam of patients undergoing thyroid surgery, and the predictive values of: suspicious clinical findings, preoperative thyroid imaging, and the incidence of thyroid cancer in cytologically negative nodes.

Official Title
-----------------
Defining Predictive Factors of Clinical, Laboratory and Imaging Criteria Routinely Used in the Diagnosis of Thyroid Cancer: Observational, Prospective Multicentered Study

Conditions
-----------------
Thyroid Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients presenting for thyroid disease (palpable nodules) Indication for surgery Age > 18 years Signed informed consent for surgery Signed informed consent for data collection Exclusion Criteria: Concurrent condition that contraindicates surgery Clinical or radiologic evidence of locally advanced tumor Clinical or radiologic evidence of metastatic lymph nodes or distant metastases Nonpalpable nodes

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 |
| --- | --- | --- |
| positive predictive value of preoperative suspicious clinical, laboratory and imaging findings |  | at baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fine needle aspiration, diagnosis, nodules
Serum Zinc, Peptic Ulcer Disease and H. Pylori Infection

Study Overview
=================
Brief Summary
-----------------
Fifty consecutive patients with symptoms suggestive of peptic ulcer disease were included. All underwent complete clinical evaluation, laboratory investigations, upper gastrointestinal endoscopy and rapid urease test. Measurement of serum zinc level was done for all the included patients in addition to twenty five age and sex matched healthy control subjects.

Conditions
-----------------
Peptic Ulcer Disease

Intervention / Treatment
-----------------
* Procedure: Upper gastrointestinal endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms suggestive of peptic ulcer disease like epigastric pain, dyspepsia, heartburn Exclusion Criteria: Patients who received zinc supplementation, proton pump inhibitors (PPI), non-steroidal anti-inflammatory drugs (NSAIDs) Those presented with hematemesis or melena Those with chronic liver disease, renal failure, malabsorption or previous gastric surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Case Group<br> | Procedure: Upper gastrointestinal endoscopy<br>* Thorough examination of the esophagus, stomach and duodenum to the second part was done to all patients using Olympus CV-150 or Pentax EPM-3500.<br>|
| Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of positive upper GIT endoscopic findings |  | upon endoscopy |