linjc16/ctgov huggingface dataset:
Web-based, Interactive Professional Education for Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
This study involves the development and evaluation of a web-based, interactive education program on chronic obstructive pulmonary disease (COPD) for primary care clinicians. The research questions that this proposal addresses include: Can an interactive, web-based COPD course be developed to disseminate evidence-based, best practice recommendations to primary care clinicians? Can assessment tools be developed to evaluate the impact of the program on clinician behavior in clinical practice and on patient care?

Official Title
-----------------
Assessment of an Interactive Education Tool to Disseminate Best Practice Recommendations on Chronic Obstructive Pulmonary Disease to Primary Care

Conditions
-----------------
Education of Primary Care Clinicians

Intervention / Treatment
-----------------
* Other: Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary care clinicians in training willing to participate Exclusion Criteria: Specialists

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Usual curriculum education program<br>Third year internal medicine residents | Other: Education<br>* The third year internal medicine residents completed the usual curriculum for COPD and took one pretest and two posttests to validate the questions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical practice |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician knowledge and comprehension |  | 9 months | 
| Clinician self-confidence |  | 9 months |
Exploratory Study in Healthy Elderly Subjects to Collect Urine for Development of Assays to Detect S. Pneumoniae

Study Overview
=================
Brief Summary
-----------------
GSK Biologicals is working on the development of a vaccine to protect elderly people from pneumococcal infection. For the future studies in that project, it would be useful to have some easy non invasive tests to detect infection by the bacteria. Some tests on urine are already on the market but need to be improved in the laboratory. For that purpose, some urine samples from healthy subjects aged 65 years or above and who have not suffered from pneumonia nor have been administered pneumococcal vaccination in the past 3 months are needed. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007

Official Title
-----------------
An Exploratory Study in Healthy Elderly Subjects to Collect Urine for the Development of Assays to Detect Streptococcus Pneumoniae.

Conditions
-----------------
Infections, Streptococcal

Intervention / Treatment
-----------------
* Procedure: Urine sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. A male or female between, and including, 65 and 85 years of age at the time of the study. Written informed consent obtained from the subject Healthy subjects as established by medical history and clinical examination before entering into the study Exclusion Criteria: Previous vaccination against Streptococcus pneumoniae in the 3 months before study start, History of pneumonia confirmed by documented radiology or any other diagnostic method within 3 months prior to study start

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Group A<br>Non-pneumococcal infected healthy elderly volunteers | Procedure: Urine sample collection<br>* Urine samples will be collected and tested for the presence of S. pneumoniae<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive or negative result using Binax NOW S. pneumoniae Test |  | within one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive or negative result using the test to be developed for typing of S. pneumoniae |  | within one day | 
| Positive or negative result using the test to be developed for detection of non-typable Haemophilus influenzae (NTHi) |  | within one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Invasive Pneumococcal Diseases, Pneumonia
Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results

Study Overview
=================
Brief Summary
-----------------
Weight regain after Laparoscopic Sleeve Gastrectomy (LSG) is nowadays a growing concern. Sleeve dilatation and loss of food restriction is considered the main mechanism. The placement of a silicon ring around the gastric tube seems to give benefits in the short-term. The Investigators evaluate the efficacy of banded sleeve gastrectomy compared to standard sleeve in the mid-term. Fifty patients were randomized between LSG and Laparoscopic Banded Sleeve Gastrectomy (LBSG), and they underwent a mean follow-up of 4 years. Patients' management was exactly the same, apart from the band placement. After surgery differences in weight loss, operative time, complication rate and mortality were analyzed.

Official Title
-----------------
Banded Sleeve Gastrectomy Improves Weight Loss Compared to Non-banded Sleeve: Mid-term Results From a Prospective Randomized Study

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Procedure: sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morbid obesity Failure of medical treatment >18yrs; <60 yrs Exclusion Criteria: Previous bariatric or GI surgery Psychiatric disease Pregnancy Contraindication to laparoscopy

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: Laparoscopic banded sleeve gastrectomy<br>Group undergoing banded sleeve | Procedure: sleeve gastrectomy<br>* Comparison of banded and not-banded sleeve gastrectomy<br>|
| Active Comparator: Laparoscopic sleeve gastrectomy<br>Group undergoing standard sleeve | Procedure: sleeve gastrectomy<br>* Comparison of banded and not-banded sleeve gastrectomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | comparison of weight loss between the two procedures | from surgery to 4 years follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Short and mid-term complications | from surgery to 4 years follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleeve gastrectomy, banded sleeve, obesity surgery
Risk of Recurrent Venous Thromboembolism After Provoked Venous Thromboembolism

Study Overview
=================
Brief Summary
-----------------
Venous thromboembolism (VTE) is a common disease with an incidence of 1-2/1000 persons per year. VTE is a chronic disease with a considerable risk of recurrence. Patients with unprovoked VTE, i.e. VTE in the absence of a temporary risk factor including surgery, cancer or immobilisation, have a high recurrence risk and indefinite anticoagulation is generally recommended. The recurrence risk of patients with VTE provoked by a transient risk factor is regarded as low. Discontinuation of anticoagulation after three months is recommended because the benefit of reducing the recurrence risk further by prolonged anticoagulation is outweighed by the bleeding risk. However, the newer direct oral anticoagulants are potentially associated with a lower bleeding risk than vitamin K antagonists. Because they are also meanwhile widely available and are convenient there is a trend towards prolonging anticoagulation also in patients with a VTE after a transient provoking factor. However, the definition of transient provoking factors is imprecise and a distinct categorization according to the risk of recurrence is lacking. Preliminary evidence suggests that the recurrence risk varies considerably between the different transient provoking factors. In a prospective cohort study, the investigators will include patients with a deep vein thrombosis or pulmonary embolism provoked by a transient risk factor defined according to Guidance of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis (Kearon et al., J Thromb Haemost 2016; 14: 1480-3) after discontinuation of anticoagulation. The study endpoint is recurrent symptomatic VTE.

Official Title
-----------------
Risk of Recurrent Venous Thromboembolism in Patients With Provoked Deep Vein Thrombosis of the Leg and/or Pulmonary Embolism: a Prospective Cohort Study

Conditions
-----------------
Recurrent Venous Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic uni- or bilateral proximal or distal deep vein thrombosis of the leg and/or symptomatic pulmonary embolism provoked by a temporary risk factor Scheduled to be treated with anticoagulants for at least 3 months Exclusion Criteria: Need for long-term anticoagulation Poor patient compliance No consent to participate VTE during pregnancy

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 |
| --- | --- | --- |
| recurrent venous thromboembolism |  | 2 years |
Study of Mental Care in Spain

Study Overview
=================
Brief Summary
-----------------
Non-interventional, multicenter, cross-sectional study to evaluate the mental care received by schizophrenic patients and their caregivers in Spain irrespective of the drug prescribed.

Official Title
-----------------
Study of Mental Care in Spain

Conditions
-----------------
Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schizophrenia (DSM-IV criteria) Attended to the mental care units for the first time in 2006 Exclusion Criteria: Participation in another clinical trial Other criteria that according to the medical criteria make difficult the normal development of the study

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 |
| --- | --- | --- |
| Camberwell's scale of Needs Analysis (CAN) |  | Once | 
| Caregiver Needs Questionnaire(CNF) |  | Once | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health of the Nation Outcome Scales (HoNOS) |  | Once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, medical mental care, caregiver, Sapin
Cost-Effectiveness and Patients Satisfaction of Conventional vs Robotic-Assisted Laparoscopy in Gynecologic Oncologic Indications

Study Overview
=================
Brief Summary
-----------------
Laparoscopic surgery is gaining currency in the field of oncologic care, particularly for colorectal and gynecologic cancers. This innovation could be used either for staging purpose and therefore could steer global therapeutic options or for surgical management only. Increase knowledge and skills lead to an increase in the number and rate of the women this innovation could be offered. The project team observed a shift from traditional surgical management (abdominal radical surgery) towards laparoscopic with a focus on lymphadenectomy. This innovation however increases some costs (the surgical stage) but decrease some others (the post surgical stage). Foreseeing the pace of the dissemination needs to have objective and reliable data about who had access to laparoscopic surgery and who didn't (and why) and accurate assessment of related costs. This program will focus on uterine cancer (both cervix and corpus).

Conditions
-----------------
UTERINE CERVICAL NEOPLASMS, ENDOMETRIAL NEOPLASMS

Intervention / Treatment
-----------------
* Procedure: Laparoscopy in Gynecologic Oncologic Indications
* Procedure: Conventional surgery (abdominal radical surgery)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years Endometrial or cervical cancer Exclusion Criteria: -

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Uterine oncologic Indications for surgery<br> | Procedure: Laparoscopy in Gynecologic Oncologic Indications<br> <br> Procedure: Conventional surgery (abdominal radical surgery)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost comparison between Conventional vs Robotic-Assisted Laparoscopy | The following costs were included:Equipment costs,Instrument costs,Operating room costs,Hospital stay | 2 years | 
| Comparison of the effectiveness of procedures (Conventional vs Robotic-Assisted Laparoscopy) | Comparison of the effectiveness of procedures will take into account conversion rate, complications rate, metastatic and pelvic relapse | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic surgery, Uterine Neoplasms
Simplified Assessment of Left Ventricular Systolic Function in Septic Shock Patients

Study Overview
=================
Brief Summary
-----------------
The assessment of left ventricular systolic function is based on the measurement of left ventricular ejection function (LVEF) by the Simpson biplane method. More recently, left ventricular global longitudinal strain (GLS) has been developed to detect abnormalities of cardiac contractility in patients with preserved myocardial contractility. However, both tools are not always easy to collect in practice. This is why other ultrasound parameters have been proposed in the literature as a substitute for LVEF and GLS such as the Doppler tissue imaging (DTI)-derived mitral annular systolic peak S-wave velocity (S'), the mitral annular plane systolic excursion (MAPSE) and the longitudinal wall fractional shortening index (LWFS). The purpose of this project is to propose an algorithm using simple parameters (S' wave, lateral MAPSE, septal MAPSE, mean MAPSE and LWFS) to predict LVEF and GLS in order to diagnose patients with impaired systolic function and preserved ejection.

Official Title
-----------------
Simplified Assessment of Left Ventricular Systolic Function in Septic Shock Patients

Conditions
-----------------
Left Ventricular Systolic Dysfunction, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients hospitalized in the Medical Intensive Care Department of the Amiens-Picardie University Hospital for the management of septic shock. Septic shock is defined by sepsis with a need for vasopressor amines to maintain a mean arterial pressure higher than or equal to 65 mmHg, and associated with hyperlactatemia (higher than 2 mmol/L). A transthoracic echocardiography should be performed within 72 hours of the diagnosis of septic shock. Exclusion Criteria: Patient with cardiac arrhythmias, patients with severe mitral or aortic valve disease, patients with fused mitral Doppler flow, patients with insufficient echogenicity to allow a correct assessment of left ventricular systolic function.

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 |
| --- | --- | --- |
| Concordance between LVEF and echocardiographic algorithm | left ventricular ejection function = LVEF The echocardiographic parameters used are: lateral S' wave; septal, lateral and mean MAPSE; and LWFS. | 3 months | 
| Concordance between GLS and echocardiographic algorithm | left ventricular global longitudinal strain = GLS The echocardiographic parameters used are: lateral S' wave; septal, lateral and mean MAPSE; and LWFS. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Left ventricular systolic function, global longitudinal strain, Septic Shock
Effectiveness of Parenting Intervention for Improving Child Mental Health

Study Overview
=================
Brief Summary
-----------------
In this study, effectiveness of a group parenting intervention was assessed in a community setting, for its impact on child behaviour problems and parental mental health.

Official Title
-----------------
Effectiveness of Parenting Intervention for Improving Child Mental Health: Randomised Single Blind Controlled Trial

Conditions
-----------------
Behavior Problem, Conduct Disorders in Children, Mental Health Wellness 1

Intervention / Treatment
-----------------
* Behavioral: Samarthan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents who consented to join the trial Children aged 2-8 years Mean score on the Eyberg Intensity Scale for clinical issues Exclusion Criteria: Any comorbid psychiatric condition in parents or children Substance abuse or diagnosed clinical somatic condition influencing ability to consent or follow intervention

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 8 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parenting Intervention Group(Samarthan)<br>Parenting intervention was designed as group program, training parents in cognitive-behavioural techniques for managing child's difficult behaviour and issues. Program was focused on parent-child problem solving method and positive interaction. | Behavioral: Samarthan<br>* Samarthan intervention was designed as group program, training parents in cognitive-behavioural techniques for managing child's difficult behaviour and issues. Program was focused on parent-child problem solving method and positive interaction.<br>|
| No Intervention: Wait list Control group<br>wait list control group was given no intervention for the trial period. They were offered sam intervention after the intervention was completed in experimental group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Problem Behaviour | Child problem behaviour was assessed using Eyberg Child Behavior Inventory which evaluates parental report of behavioral problems | Change from baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Health Questionnaire | Parents general health was assessed using General Health questionnaire | Changes from baseline to 8 weeks | 
| Parenting stress | Parenting Stress Index measured parenting stress | Changes from baseline to 8 weeks | 
| Self-esteem | Self-esteem in parents were measured using Self-esteem score | Changes from baseline to 8 weeks |
Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to to monitor the peripheral intravenous (PIV) site on subjects receiving continuous IV fluids for infiltration and extravasation events. Infiltration is an indication that the PIV is leaking fluids outside of the vascular system. The study hypothesis is to demonstrate that changes in the optical signals of the non-invasive monitoring medical device will detect infiltration and extravasation events.

Official Title
-----------------
Non-invasive Optical Medical Device for Monitoring and Detecting Peripheral Intravenous Infusion Sites for Infiltration and Extravasation in Subjects Receiving Continuous Fluids

Conditions
-----------------
Infiltration, Extravasation, IV Infiltration, IV Extravasation, Extravasation of Diagnostic and Therapeutic Materials

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed consent patient age under 12 PIV with continuous fluids Exclusion Criteria: no consent patient age over 12 PIV fluids not continuous

Ages Eligible for Study
-----------------
Maximum Age: 12 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 |
| --- | --- | --- |
| Test performance of optical device for monitoring intravenous infusion site for infiltration. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infiltration, Extravasation, Leaking, PIV Infiltration, IV Infiltration, Optical Detection of Infiltration, Optical Monitoring