linjc16/ctgov huggingface dataset:
Assuring and Defining Outcomes Through Procedural Training Using a Proctorship Model That Collects Patient Outcomes A Single-Arm, Case-Series to Determine the Feasibility of Safe Skills Transfer for Laparoscopic Ventral Hernia Repair Utilizing a Hands-On Proctorship Model.

Study Overview
=================
Brief Summary
-----------------
The objective of the Project ADOPT- Ventral Hernia case-series is to collect clinical outcome data following the completion of a hands-on proctorship training model in laparoscopic ventral hernia repair.

Detailed Description
-----------------
The ADOPT- Ventral Hernia project is designed as a prospective, single arm, case series. The proctor will select a limited number of licensed surgeon trainees (up to 5) as agreed upon by Covidien and the proctor. The proctor will then train through clinical immersions, hands on proctorship and video training for proper technique on minimally invasive surgical (MIS) repair of ventral hernia. After the training, the data will be collected on the trainee's next 10 MIS ventral hernia repair cases, pending subject consent to collect data. Procedural and Post-Operative details will be captured for each of these subjects who have undergone the laparoscopic ventral hernia repair.

Official Title
-----------------
A Single-Arm, Case-Series to Determine the Feasibility of Safe Skills Transfer for Laparoscopic Ventral Hernia Repair Utilizing a Hands-On Proctorship Model.

Conditions
-----------------
Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Determined by surgeon's standard of care Exclusion Criteria: Determined by surgeon's standard of care
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 |
| --- | --- | --- |
| Number of complications during independent cases post proctorship | collect clinical outcome data following the completion of a hands-on proctorship training model in laparoscopic ventral hernia repair | up to 30 days |
Austrian Left Atrial Appendage Closure Registry

Study Overview
=================
Brief Summary
-----------------
Left atrial appendage (LAA) occlusion (LAAC) has been introduced to treat patients with indication of oral anticoagulation (OAC) for atrial fibrillation (AF) with contraindication to OAC. This registry aims to document all LAAC procedures in Austria.

Official Title
-----------------
Austrian Left Atrial Appendage Closure Registry

Conditions
-----------------
Atrial Fibrillation, Left Atrial Appendage Closure

Intervention / Treatment
-----------------
* Device: LAAC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received LAAC in Austria Exclusion Criteria: Absence of informed consent

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: LAAC|Left atrial appendage closure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with successful left atrial appendage closure, as defined by European Society of Cardiology Guidelines |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with death, stroke or bleeding |  | 5 years | 
| Number of participants with procedure-related adverse events |  | 30 days |
Analysis of Cases of Sexual Assault in Taiwan

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to analyze victims, assailants, assaults, evidentiary examinations and treatment characteristics of cases of sexual assault sought emergency care at Far Eastern Memorial Hospital、National Cheng Kung University Hospital、Taoyuan General Hospital, Department of Health, Executive Tuan, R.O.C.、National Taiwan University Hospital Yun-Lin Branch、Hospital and National Taiwan University Hospital.

Conditions
-----------------
Sexual Assault

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all cases Exclusion Criteria: nil

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

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

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 |
| --- | --- | --- |
Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus.

Study Overview
=================
Brief Summary
-----------------
Obesity is a growing epidemic throughout the world and is followed by increasing incidence of type 2 diabetes that accounts for 90-95% of all cases of diabetes. Weight loss is a major objective, although difficult to achieve with medical treatments. Many recent studies demonstrated that bariatric surgery has the potency to achieve marked and sustained weight loss, and is also associated with a significant improvement in control of type 2 diabetes. The principal aim of this study is to compare two types of bariatric procedures, the Roux-en-Y gastric bypass (RYGBP) and sleeve gastrectomy (SG). The study hypothesis is that these procedures have equal efficacy with regard to resolution of type 2 diabetes.

Official Title
-----------------
Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus. Randomised Controlled Trial

Conditions
-----------------
Bariatric Surgery, Obesity, Type 2 Diabetes

Intervention / Treatment
-----------------
* Procedure: Roux-en-Y gastric bypass
* Procedure: sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus BMI between 35 and 50kg/m2. Males and females Age between 18 and 60 years. Exclusion Criteria: Severe ongoing psychiatric disorder, alcoholism and substance abuse. Redo operations after previous bariatric procedures. Type 1 diabetes or other non-type 2 forms of diabetes End stage renal disease, retinopathy, neuropathy

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 |
| --- | --- |
| Active Comparator: RYGBP<br>Roux-en-Y gastric bypass | Procedure: Roux-en-Y gastric bypass<br>* RYGBP=Roux-en-Y gastric bypass<br>|
| Active Comparator: SG<br>sleeve gastrectomy | Procedure: sleeve gastrectomy<br>* SG = sleeve gastrectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of resolution of type 2 diabetes |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative complications | Post-operative (within 30 days) bleeding, staple line/anastomotic leakage, infection, deep venous thrombosis, pulmonary embolism, resubmission. Questionnaires for health related quality of life (SF-36), gastroesophageal reflux symptoms (Carlsson-Dent), gastrointestinal symptom rating scale (GSRS) and food intake (SOS food questionnaire), recorded pre-operatively and at 6 weeks to 60 months post-operatively. | 5 years |
Observational Study of Type 1 and Type 2 Diabetes Patients Having Switched From Human Premixes to NovoMix®30

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoMix® 30 for treatment of type 1 and type 2 diabetes under normal clinical practice conditions in Romania.

Official Title
-----------------
A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Type 1 and Type 2 Diabetes Mellitus in Romania

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 and type 2 diabetics who are treated with human premix insulin (the selection of the subjects will be at the discretion of the individual physician). Exclusion Criteria: Subjects currently being treated with biphasic insulin aspart 30 Subjects who were previously enrolled in this study Subjects with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients Women who are pregnant or have the intention of becoming pregnant within next 6 months Children below 10 years of age

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 75 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 |
| --- | --- |
| A<br> | Drug: biphasic insulin aspart 30<br>* Start dose and frequency prescribed by the physician as a result of a normal clinical evaluation<br>* Other names: NovoMix® 30;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline |  | For the duration of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5% |  | after 12 weeks and 24 weeks of treatment | 
| Change in FPG (glucose variability) |  | after 12 weeks and 24 weeks of treatment | 
| Change in PPG (postprandial control) |  | after 12 weeks and 24 weeks of treatment | 
| Change in insulin dose and number of injections |  | at 12 weeks and 24 weeks of treatment | 
| Change in oral antidiabetic drug therapy |  | after 12 weeks and 24 weeks of treatment | 
| Change in body weight |  | at 12 weeks and 24 weeks of treatment | 
| Change in number of hypoglycaemic events |  | during 4 weeks proceeding routine visits at 12 weeks and 24 weeks of treatment | 
| Number of adverse drug reactions (ADR) |  | after 12 weeks and 24 weeks of treatment |
Adipokines and Ghrelin Concentrations in Different Stages of Anorexia Nervosa

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine serum concentrations of adiponectin (ApN), leptin and ghrelin in different stages of anorectic patients and to evaluate their relationships between biochemical, hormonal and anthropometric parameters.

Detailed Description
-----------------
Objective: The aim of this study is to determine serum concentrations of adiponectin (ApN), leptin and ghrelin in different stages of anorectic patients and to evaluate their relationships between biochemical, hormonal and anthropometric parameters. Design: The study group is composed of four groups. Group1: Treatment-naïve patients with a recent diagnosis of AN (n:19), Group 2: The weight recovered (10 % increase in body weight compared with baseline weight) subgroup of group 1 at the end of a mean 117.72±98.14 days of follow-up (n: 12), Group 3: Recovered patients with a previous history of AN but normal menstrual cycles and body weight at the present time (n:10), Group 4: Control group: constitutionally thin healthy young women with normal menstrual cycles (n:10). Venous blood was obtained for measurements of biochemical parameters, ApN, leptin and ghrelin and body composition was determined by bioimpedance analysis.

Official Title
-----------------
Adipocytokine and Ghrelin Concentrations in Different Stages of Anorexia Nervosa

Conditions
-----------------
Anorexia Nervosa, Adipokines

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of anorexia nervosa for Group 1-3 Constitutionally thin healthy subjects for Group 4 Exclusion Criteria: Medical or psychiatric diagnosis other than anorexia nervosa, History of gastrointestinal disease for Group 1-3 History of eating disorder or gastrointestinal or psychiatric disease for control group

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 32 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Treatment-naïve patients with a recent diagnosis of anorexia nervosa | |
| 2<br>The weight recovered subgroup of group 1 | |
| 3<br>Recovered patients with a previous history of anorexia nervosa but normal menstrual cycles and body weight at the present time | |
| 4<br>Control group | |

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anorexia nervosa, Adipokines, Ghrelin, Fat mass
Assessment of End-tidal Carbon Dioxide Levels in Respiratory Disease

Study Overview
=================
Brief Summary
-----------------
The investigators aim to evaluate the correlation between PetCO2, PaCO2, and PtcCO2 in patients with respiratory diseases. The investigators also evaluate the correlation between PetCO2, PaCO2, and PtcCO2 changes over time.

Detailed Description
-----------------
Partial pressure of carbon dioxide(PCO2) is mainly evaluated by partial pressure of arterial carbon dioxide (PaCO2), and is used as an index for prognosis and NPPV introduction in chronic respiratory failure. Arterial blood gas analysis for PaCO2 measurement is the most accurate test value, but it is invasive and frequent tests are difficult and cannot be performed at home. The transcutaneous PCO2 (PtcCO2) is a non-invasive measurement and its measured value is close to PaCO2, and it can be measured continuously, which is useful for monitoring patients with chronic respiratory failure. However, PtcCo2 has not been applied at home due to technical problems (necessity of calibration, periodic drift, etc.). The end-tidal pressure of expired CO2 (PetCO2) can be measured non-invasively, easily and continuously. PetCO2 is mainly used for patients undergoing mechanical ventilation, and its accuracy and stability have been evaluated. The investigators decided to investigate whether PetCO2 is useful for monitoring respiratory status in patients with respiratory disorder.

Official Title
-----------------
Validity Assessment of End-tidal Carbon Dioxide Levels in Respiratory Disease

Conditions
-----------------
Respiratory Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with respiratory disorder. Subjects who are clinically stable for the last 2 weeks Exclusion Criteria: Subjects who required treatment with antibacterial agents or oral/intravenous steroids for pneumonia or exacerbation of respiratory disease in the last 2 weeks. Subjects with severe complications such as cardiovascular disease, liver disease, renal disease, and neurological disease.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Correlation between PetCO2, PaCO2, and PtcCO2 |  | One to three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of changes over time between PetCO2, PaCO2 , and PtcCO2 |  | One to three months | 
| Relationship between PetCO2 and respiratory symptoms evaluated by The COPD Assessment Test (CAT) and mMRC (modified British Medical Research Council) |  | One to three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PetCO2
Virtual Reality in Electrophysiology Laboratory (EP)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the use of virtual reality (VR) technology as adjunct to routine anesthesia care for patients undergoing electrophysiology (EP) procedures.

Official Title
-----------------
Use of Virtual Reality as An Adjunct for Anesthesia During Procedures in the Electrophysiology Laboratory: A Pilot and Feasibility Study

Conditions
-----------------
PVC - Premature Ventricular Complex, Ablation

Intervention / Treatment
-----------------
* Other: Virtual reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old. Patients scheduled for electrophysiology procedure with MAC. Subject willing to participate and able to provide informed consent. Exclusion Criteria: Age < 18 years old. History of motion sickness or blindness.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Virtual reality<br> | Other: Virtual reality<br>* Use of Virtual reality goggles during procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virtual reality as distractor | Evaluate patients' experience and satisfaction with using virutal reality during electrophysiology procedures | Up to 2hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of virtual reality use on pharmacological therapy | Evalute the amount of medications use during the procedure | Up to 2 hours | 
| Impact of virtual reality on electrophysilogy procedure | Evaluate success rate of completing ablation while patient is utilizing virtual reality | Up to 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
virtual reality
ESCAPE Study : Validation of a Specific Tool Scoring Residents at Risk of Escaping/Elopement From Nursing Homes (ESCAPE)

Study Overview
=================
Brief Summary
-----------------
Residents' escapes occur even if most of the nursing homes (NH) have set up specific devices to prevent from this risk. Therefore, the need to develop and validate a specific tool to assess the risk of escaping was obvious to the working group, aim at emphasizing patient centered-care by the nurses' staff and help to develop personalized devices. Aim of the study: develop and validate a specific tool to score the risk of escaping in NH residents Study design: Observational prospective multicentered cohort study Nursing homes volunteer to participate Location: Provence Alpes Cotes d'Azur Region ( South East of France) Population: 4050 NH residents. Duration: two years, each resident included is followed up for one year Measures: Nursing homes characteristics, residents characteristics ( social and from medical record); Escape Scale (25 items with a Yes/no answer; filled up during a nurses staff meeting for each resident and every three months; 3 sub scales: resident environmental items, social items, and medical items.

Official Title
-----------------
ESCAPE STUDY : A Specific Tool for Detecting Nursing Home Residents (With or Without Dementia) at Risk of Escaping for the Use of Caregivers: Psychometric Properties and Definition of Risk Levels

Conditions
-----------------
Elopement or Escaping of Nursing Home Resident With or Without Dementia

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every resident of Nursing home participating to the study Living in the NH for three months or more With a living prognosis longer than 3 Months Exclusion Criteria: Prognosis less than three months Bedridden (not able to move alone from bed to chair) Nursing home short stay scheduled < 3 months
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|develop and validate a specific tool to score the risk of escaping in Nursing Homes residents|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Escape/elopement occurence | Each Event occurrence is notify by the nurses staff at any time | 2 years |