linjc16/ctgov huggingface dataset:
Risk Stratification in Severe Treatment-naive, Tricuspid Regurgitation

Study Overview
=================
Brief Summary
-----------------
This registry is aimed to characterize patients with severe tricuspid regurgitation for the purpose of patient selection for interventional treatment and identify factors related to adverse outcomes.

Official Title
-----------------
Risk Stratification in Patients With Severe Tricuspid Regurgitation: Insights From the TRicuspid Regurgitation rEgistry (TRuE)

Conditions
-----------------
Functional Tricuspid Regurgitation

Intervention / Treatment
-----------------
* Diagnostic Test: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe functional tricuspid regurgitation Exclusion Criteria: prior surgery or congenital heart diseases with involvement of the tricuspid valve

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 |
| --- |
|Diagnostic Test: No Intervention|No Intervention planed|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Mortality due to all causes | 1 year | 
| All-cause mortality | Mortality due to all causes | 5 years | 
| All-cause mortality | Mortality due to all causes | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality | Mortality due to cardiovascular causes | 1 year | 
| Cardiovascular mortality | Mortality due to cardiovascular causes | 5 years | 
| Cardiovascular mortality | Mortality due to cardiovascular causes | 10 years | 
| Number of hospitalizations | Number of hospitalizations due to right heart failure | 1 year | 
| Number of hospitalizations | Number of hospitalizations due to right heart failure | 2 years | 
| Number of hospitalizations | Number of hospitalizations due to right heart failure | 5 years | 
| Number of hospitalizations | Number of hospitalizations due to right heart failure | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tricuspid regurgitation, tricuspid valve, percutaneous treatment, right ventricle
Optimal Timing For Embryo Transfer For Low Responder Patients

Study Overview
=================
Brief Summary
-----------------
Women undergoing in vitro fertilization (IVF) therapy, who are low responder and agree to enter the trial will be randomized to a study group, for whom embryo transfer will be done on the same day as oocyte aspiration and fertilization; and a control group for whom embryo transfer will be performed 48 to 72 hours later, as is the current accepted practice.

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

Intervention / Treatment
-----------------
* Other: Embryo Transfer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing IVF Number of mature oocytes equal to or lesser than the maximum number of embryos intended for transfer Exclusion Criteria: Patient nor consenting

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Day 0 Embryo Transfer<br>Embryo transfer will be performed on the same day as oocyte aspiration and fertilization | Other: Embryo Transfer<br>* In the study group embryo transfer will be performed on the day of oocyte aspiration and fertilization while in the control group it will be done 2 or 3 days later as is common practice.<br>|
| Active Comparator: Day 2,3 Embryo Transfer<br>Embryo Transfer will be performed 2 or 3 days after oocyte aspiration and fertilization | Other: Embryo Transfer<br>* In the study group embryo transfer will be performed on the day of oocyte aspiration and fertilization while in the control group it will be done 2 or 3 days later as is common practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, Low Responder, IVF, Embryo Transfer
Impact of Combined of Lantus(Insulin Glargine) and Lyxumia (Lixisenatide) on Insulin Secretion and Gastric Emptying

Study Overview
=================
Brief Summary
-----------------
Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying

Detailed Description
-----------------
Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying

Official Title
-----------------
A Bicentric Open-label, Randomized, Two-parallel-group Study Investigating the Impact of Combined Lantus Insulin Glargine) and Lyxumia(Lixisenatide) on Insulin Secretion and Gastric Emptying in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled on Diet and Oral Antidiabetic Medication

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Luyxumia versus Lantus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes mellitus diagnosed at least one year before the screening visit not previously treated with glitazones, insulin or GLP-1 agonists Inadequately controlled diabetes mellitus Exclusion Criteria: Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lyxumia<br>4 weeks Luxumia plus another 4 weeks combination | Drug: Luyxumia versus Lantus<br> <br> |
| Other: Lantus<br>4 weeks Lantus plus another 4 weeks combination | Drug: Luyxumia versus Lantus<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCISEC(0-10min) |  | Within 0 to 10 min after iv glucose challenge |
Safety and Effectiveness of Nintedanib in Korean Patients

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to monitor the safety and effectiveness of Ofev in Korean patients in a routine clinical practice setting.

Official Title
-----------------
A Regulatory Required Non-interventional Study to Monitor the Safety and Effectiveness of Ofev(Nintedanib 150mg/100mg BID) in Korean Patients

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Drug: Nintedanib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have been started on Ofev in accordance with the approved label in Korea Patients who have signed on the data release consent form Exclusion Criteria: Patients for whom nintedanib is contraindicated according local label of Ofev Patients with known hypersensitivity to Ofev, peanut or soya, or to any of the excipients Women who are pregnant or nursing Patients with moderate(Child pugh B) and severe(Child Pugh c) hepatic impairment
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 treated with Nintedanib<br> | Drug: Nintedanib<br>* Nintedanib<br>* Other names: Ofev;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events in patients who take at least one dose of Ofev |  | up to 24 weeks | 
| Change from baseline in Forced Vital Capacity) (FVC) (mL) after 12, 24 weeks of treatment |  | at baseline, at week 12, at week 24 |
Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether orotracheal intubation in morbidly obese patients is faster, gentler and safer using the GlideScope videolaryngoscope than with the Macintosh direct laryngoscope.

Official Title
-----------------
Orotracheal Intubation of Morbidly Obese Patients. A Randomised Controlled Trial Comparing the GlideScope Videolaryngoscope to the Macintosh Direct Laryngoscope.

Conditions
-----------------
Intubation, Endotracheal, Anesthesia, General, Obesity

Intervention / Treatment
-----------------
* Device: GlideScope
* Device: Macintosh direct laryngoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Approved for elective bariatric surgery at Glostrup University Hospital, Copenhagen. Body Mass Index at least 35 kg/m2 Written informed consent to participate Exclusion Criteria: Mental illness Abuse of alcohol or other substances Previous difficult tracheal intubation Considered non-eligible for safety-reasons by the anesthetist in charge

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GlideScope<br>Orotracheal intubation using the GlideScope videolaryngoscope | Device: GlideScope<br>* Orotracheal intubation<br>|
| Active Comparator: Macintosh<br>Orotracheal intubation using the Macintosh direct laryngoscope | Device: Macintosh direct laryngoscope<br>* Orotracheal intubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to intubate |  | Measured during intubation (seconds) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intubation attempts |  | Measured during intubation (seconds) | 
| Lowest arterial oxygen saturation during intubation |  | Measured during intubation (seconds) | 
| Subjective difficulty of intubation |  | Measured during intubation (seconds) | 
| Cormack-Lehane Score |  | Measured during intubation (seconds) | 
| Airway mucosal trauma |  | Measured during intubation (seconds) | 
| Dental injury |  | Measured during intubation (seconds) | 
| Post-procedure sore throat |  | One hour post-operative | 
| Post-procedure hoarseness of voice |  | One hour post-operative |
Plastic Surgery Training in Europe

Study Overview
=================
Brief Summary
-----------------
Survey study to evaluate plastic surgery training in European countries.

Detailed Description
-----------------
National delegates of 30 European countries - the 27 member countries of the European Union (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Spain and Sweden) and Norway, Switzerland and the United Kingdom were invited to complete a questionnaire on plastic surgery training.

Official Title
-----------------
Plastic Surgery Training in Europe

Conditions
-----------------
Plastic Surgery Training

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Countries of the European Union (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Spain and Sweden) and Norway, Switzerland and the United Kingdom Countries must organise plastic surgery training Exclusion Criteria: Countries other than member states of the European Union, Norway, Switzerland and United Kingdom Countries that do not provide plastic surgery training
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organisation of training | Organisation of training (e.g. centralised or decentralised, number of training centres, number of trainees, etc) | 2019-2020 | 
| Scope of practical training curriculum | Scope of practical training curriculum (e.g. number of clinical rotations, number of surgical procedures, types of surgical procedures, etc) | 2019-2020 | 
| Scope of theoretical courses | Scope of theoretical courses (e.g. topics that are included in theoretical courses, hours of theoretical courses, etc) | 2019-2020 | 
| Evaluation of trainees | Evaluation of trainees (e.g. number of oral examinations, number of MCQ examinations, number of written examinations, etc) | 2019-2020 |
Phenotyping Diabetic Retinopathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate and characterize phenotypes of diabetic retinopathy (DR) progression based on available clinical data (demographic, systemic and ophthalmic data).

Detailed Description
-----------------
This study aims to validate and characterize phenotypes of diabetic retinopathy (DR) progression using ophthalmic and systemic data from type-2 diabetic subjects followed at the AIBILI Clinical Trial Center in the last 10 years. Macular Edema (ME) development during the study period, mainly Clinically Significant ME (CSME) needing treatment, will be the primary indicator for DR progression. CSME will be considered as the primary end-point and will be used to identify phenotypes (and risk markers) of DR progression.

Official Title
-----------------
Observational Study of Type-2 Diabetic Subjects to Validate Diabetic Retinopathy Phenotypes

Conditions
-----------------
Diabetic Retinopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of DR. Females or Males; Age over 18 years; Signed Informed Consent; Previous follow-up with regular systemic and ophthalmic assessments. Exclusion Criteria: Cataract or other eye disease that may interfere with fundus examinations; Vitreous syneresis or posterior vitreous detachment; Dilatation of the pupil < 5 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DR<br>Type-2 diabetic subjects diagnosed with diabetic retinopathy (DR). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSME |  | 1 year |
Modulated Accelerated RAdiotherapy in Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This trial was a retrospective study on postoperative accelerated hypofractionated IMRT (MARA-1) in patients with early stage breast carcinoma, to compare late toxicity after this treatment and standard fractionated RT delivered with 3D-CRT.

Detailed Description
-----------------
The aim of this study was to evaluate the clinical results in terms of late skin and subcutaneous toxicity of accelerated hypofractionated forward-planned IMRT in patients with early stage BC. Results were compared with a historical control group (CG) of patients treated with 3D-conformal postoperative RT delivered with conventional fractionation.

Official Title
-----------------
Postoperative Modulated Accelerated RAdiotherapy (MARA-1) for Early Stage Breast Cancer: a Retrospective Analysis

Conditions
-----------------
Breast Cancer, Radiation Toxicity

Intervention / Treatment
-----------------
* Radiation: accelerated hypofractionated RT
* Radiation: conventional fractionated RT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed histologic evidence of pTis-pT3 breast cancer breast conservative surgery post menopausal status clear surgical margin Exclusion Criteria: pT4 positive or close resection margins 3 or more metastatic axillary nodes nodal irradiation M1
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MARA-1: accelerated hypofractionated RT<br>A forward planned IMRT technique was used and the prescribed dose to the breast was 40 Gy in 16 fx with a concomitant boost of 4 Gy. | Radiation: accelerated hypofractionated RT<br> <br> |
| CG: conventional fractionated RT<br>In the CG, the whole breast received 50.4 Gy in 28 fractions (fx) delivered with 3D-RT, followed by a sequential boost on the tumour bed of 10 Gy in 4 fx delivered with electrons | Radiation: conventional fractionated RT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-related late adverse events | late toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-related acute adverse events | acute toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients | 6 months | 
| local control | absence of locoregional relapse | 5 years | 
| overall survival | defined as the time from diagnosis to death | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, radiotherapy, cutaneous toxicity, subcutaneous toxicity, IMRT
Effects of TT301 on Cytokine Levels Post Endotoxin Challenge

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.

Detailed Description
-----------------
The LPS human endotoxemia model results in a well characterized, transient acute inflammatory response. The model has been widely used for decades as a system to study new therapeutic agents for inflammation before wider clinical studies are undertaken. This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.

Official Title
-----------------
A Phase 1 Double-blind, Randomized, Placebo-controlled Study Evaluating the Effects of a Single Intravenous Dose of TT301 on LPS-induced Changes in Blood Cytokine Levels in Healthy Male Volunteers

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Drug: TT301
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 18 to 40 years, inclusive 55 - 95 kg, inclusive Exclusion Criteria: Evidence of any clinically significant disease History of cancer History of syncope or severe vasovagal events Antibiotic treatment within 60 days of Day 1 Surgical procedure within 60 days of Day 1 Hepatitis C, Hepatitis B Tuberculosis HIV Requirement for medications (prescription/OTC) during the study Donated > 250 mL blood within 30 days of Day 1 Donated > 750 mL blood within 60 days of Day 1 In a clinical trial of an immunosuppressive drug within 6 months of Day 1 Received any vaccination within 6 months of Day 1 Any clinically important allergy Known allergy/sensitivity to lactose and/or polyethylene glycol

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TT301<br>Investigational drug TT301 | Drug: TT301<br>* Single iv dose of TT301<br>* Other names: TT301 iv;|
| Placebo Comparator: Placebo<br>Normal saline | Drug: Placebo<br>* Single iv dose of 0.9% sodium chloride for injection USP<br>* Other names: 0.9% sodium chloride for injection USP;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine levels post LPS challenge |  | Measured up to 12h post-LPS |
Effects of a Computer Game on Activity Choices

Study Overview
=================
Brief Summary
-----------------
The study seeks to discover whether peer rejection increases the value of food relative to peer interaction in overweight individuals. After playing a computer game that randomly simulates peer rejection or peer acceptance, participants will play another computer game that will assess the value of food and social interactions. Overweight individuals may be more likely to resort to food in moments of distress and less likely to choose to interact with a peer to reestablish their sense of belongingness.

Conditions
-----------------
Overweight

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ages 18-50 Adults with a BMI greater than or equal to 18.5 Adults must report at least a moderate liking of study foods used Exclusion Criteria: Adults should have no psychopathology Adults should have no developmental disabilities Adults should have no cold or upper respiratory distress that could influence their activities Adults should have not be taking medications that could affect their food intake Adults should have no dietary restrictions Adults should have no food allergies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- | --- |
| amount of food chosen amount of social time chosen |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peer rejection, obesity, amount of food chosen, amount of social time chosen