linjc16/ctgov huggingface dataset:
Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Kids Device

Study Overview
=================
Brief Summary
-----------------
This is a post market clinical follow-up study and devices will carry the CE mark once the study is initiated. The investigational device is SenSura® Mio Kids, which is a flat ostomy device. The device is comprised by a baseplate connected to a bag. The coupling between baseplate and bag can be either welded together, referred to as a 1-piece (1P) system, or assembled as separate parts, referred to as a 2-piece (2P) system.

Detailed Description
-----------------
The purpose of this research is to gather more information about how well the SenSura® Mio Kids ostomy device works, and how safe it is. This device has already been studied and approved to be used in the United States. It has a European CE-mark, which means it has met European health and safety requirements. SenSura® Mio Kids is a flat ostomy device that is made to be used for kids from 6 months up to 4 years of age. The reason for this study is to find out how well the new SenSura® Mio Kids device works compared to the standard of care device. We can learn about this by asking people who have used it about how well it worked and how comfortable it was. The Investigator/study nurse will decide whether the subject would benefit from switching to SenSura® Mio Kids and if so, the subject will be invited to take part in the study. The study design is observational. That means that the ostomy device, and the skin around the stoma, will be observed while receiving the stoma care they normally would. This study design will help the researchers see how well the device works when it is used in the usual way, and makes it easier for the people who are participating in the study.

Official Title
-----------------
A Multi-Centre Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Kids Device in Subjects With a Stoma

Conditions
-----------------
Stoma Ileostomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a colostomy, ileostomy, urostomy, loop stoma, or two stomas placed closely together Have given written informed consent (the legal authorized representative of the subject) Group 1 subjects should use a competitor device Exclusion Criteria: 1) Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (as-sessed by the investigator)

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 4 Years

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 |
| --- | --- | --- |
| Median wear time | of 8 baseplate changes | 2-3 weeks |
Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy

Study Overview
=================
Brief Summary
-----------------
Blood loss was reported as a prognostic risk factor of morbidity and overall survival after hepatic resection. The aim of this study prospective randomized was compare the efficacy of the administration of tranexamic acid versus placebo to reduce perioperative bleeding after major hepatectomy (> 3 hepatic segments).

Official Title
-----------------
Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy : a Prospective Randomized Double-blinding Study

Conditions
-----------------
Blood Loss, Surgical

Intervention / Treatment
-----------------
* Drug: acid tranexamic
* Drug: Nacl 0.9%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signature of the consent form Patients with hepatic lesion needing a major hepatectomy (≥ 3 hepatic segments) Exclusion Criteria: Absence of signature of the consent form Patient with cirrhosis Minor hepatectomy (< 3 hepatic segments) Hepatectomy associated with vascular resection Contraindication of tranexamic acid : history of arterial or venous thrombosis , disseminated intravascular coagulation, severe renal insufficiency, history of epilepsies , intrathecal or intraventricular injection Pregnant or lactation

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

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acid tranexamic<br>acid tranexamic | Drug: acid tranexamic<br>* 10 mg/kg Iv after randomization of the patient in the study,follow-up by continuous infusion of 10 mg/kg/h up to the end of the intervention.<br>|
| Placebo Comparator: 2<br>Nacl 0.9% | Drug: Nacl 0.9%<br>* 10 mg/kg Iv after randomization of the patient in the study,follow-up by continuous infusion of 10 mg/kg/h up to the end of the intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The volume of compensated blood loss with the formula: [TBV x (initial hematocrit - final hematocrit ) + number of transfused RBC unit] with TBV=Total Blood Volume and RBC= red blood cell (1 RBC unit = 500 ml with hematocrit=30%). |  | at day 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Specify the primary condition or disease being studied Major Hepatectomy
The Influence of Muscle Contraction on the Cardiac Autonomic System

Study Overview
=================
Brief Summary
-----------------
Population: 16 children with cerebral palsy, GMFCS 1-3.16 children typically developed, matched for age. All children aged 6-12 yrs who understand simple commands. Tools: Polar monitor to record heart rate, attached to chest, in use throughout testing Dynamometer- for assessing muscle strength. Weights Method: Each child will be tested once. Both tools will be demonstrated and tried out before actual testing. With Polar watch attached: 5 min sitting at rest, knee muscle strength assessment with the dynamometer, 15 minutes rest Isometric and isotonic knee muscle contraction at 30% of childs' maximal strength as has assessed by the dynamometer. The child will asked to perform each for 3 minutes, with 5 minutes rest in-between All will be perform in both legs.

Official Title
-----------------
The Influence of Muscle Contraction on the Cardiac Autonomic System at Rest and Activity

Conditions
-----------------
Cerebral Palsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GMFCS I-II Unilateral CP Exclusion Criteria: Heart problems

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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 |
| --- | --- |
| cerebral palsy<br>Age 6-12 years Gross Motor Function Classification System I-II | |
| control<br>Age 6-12 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  | 40 minutes | 
| Heart rate variability |  | 40 minutes |
Single Embryo Transfer Versus Double Embryo Transfer

Study Overview
=================
Brief Summary
-----------------
The aim of this project is to study the best number (1 or 2)and day (3 vs 5)of embryo transfer in good prognosis patient.

Official Title
-----------------
Single Embryo Transfer Versus Double Embryo Transfer in Day 3 or Blastocyst Stage

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

Intervention / Treatment
-----------------
* Procedure: Double Embryo Transfer (DET)
* Procedure: Single Embryo Transfer (SET)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:G Good prognosis IVF patients Exclusion Criteria: Bad prognosis IVF patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 37 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SET on day 3<br>Single embryo transfer on day 3 of embryo development | Procedure: Single Embryo Transfer (SET)<br>* A single embryo is transferred during an IVF treatment<br>|
| Experimental: DET on day 3<br>Double embryo transfer on day 3 of embryo development | Procedure: Double Embryo Transfer (DET)<br>* Two embryos are transferred during an IVF treatment<br>|
| Experimental: SET on day 5<br>Single embryo transfer on day 5 of embryo development | Procedure: Single Embryo Transfer (SET)<br>* A single embryo is transferred during an IVF treatment<br>|
| Experimental: DET on day 5<br>Double embryo transfer on day 5 of embryo development | Procedure: Double Embryo Transfer (DET)<br>* Two embryos are transferred during an IVF treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live-birth delivery rate |  | End of pregnancy (nine months after last transfer) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple live-birth rate |  | End of pregnancy (nine months after last transfer) | 
| Acceptance of assigned randomised group |  | Day of randomisation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, SET, DET, Blastocyst, IVF
Nalmefene Smoking Cessation Study

Study Overview
=================
Brief Summary
-----------------
To determine if nalmefene is safe and effective in smoking cessation.

Detailed Description
-----------------
Single centered, randomized, placebo-controlled,double-blind, outpatient pilot study to evaluate the efficacy, safety and tolerability of 2 doses of nalmefene on smoking cessation.

Official Title
-----------------
A Single Center Evaluation of Nalmefene HCl Versus Placebo on Smoking Cessation

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: nalmefene
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Smokers in good general health self reporting more than 15 cigarettes per day Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Nalmefene 40 mg | Drug: nalmefene<br>* Nalmefene HCl film-coated tablets administered orally, twice daily, for total daily dosage of 40 or 80 mg, for 5 weeks (following a 2-week titration period).<br>|
| Experimental: 2<br>Nalmefene 80 mg | Drug: nalmefene<br>* Nalmefene HCl film-coated tablets administered orally, twice daily, for total daily dosage of 40 or 80 mg, for 5 weeks (following a 2-week titration period).<br>|
| Other: 3<br>Placebo | Other: Placebo<br>* Placebo tablets, administered orally, twice daily for 5 weeks (following a 2-week titration period).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of 2 doses of nalmefene relative to placebo |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and tolerability of 2 doses of nalmefene |  |  |
Psychosocial Wellbeing Following Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this feasibility study is to develop and initially test a dialogue-based psychosocial intervention aimed at promoting coping and psychosocial wellbeing following an acute stroke. The intervention is carried out by primary care registered nurses or other appropriate health professionals. The intervention included persons with and without aphasia.

Official Title
-----------------
Psychosocial Wellbeing Following Stroke: Developing and Testing a Psychosocial Nursing Intervention for Primary Care

Conditions
-----------------
Coping, Psychosocial, Narrative, Quality of Life

Intervention / Treatment
-----------------
* Behavioral: Psychosocial support and counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or above acute stroke 4-8 weeks poststroke Exclusion Criteria Other serious disease

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

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychosocial support and counselling<br>There is only one arm as this is a pilot and feasibility study. | Behavioral: Psychosocial support and counselling<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39) |  | baseline and 2 weeks after end of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39) |  | baseline and 12 months after end of intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, psychosocial, intervention, quality of life
Thromboembolic Events in Severe COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to describe the incidence of thromboembolic events in a population of patients hospitalized in intensive care units in France for severe COVID-19. The secondary objective of this study is to describe the evolution of hemostasis parameters during the first two weeks of intensive care hospitalization and to evaluate the influence of different anticoagulation regimens on these parameters and on the incidence of thromboembolic events

Official Title
-----------------
Incidence of Thromboembolic Events and Prognosis of COVID-19 Patients Hospitalized in Intensive Care Units in France

Conditions
-----------------
Pulmonary Thromboembolism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed infection with the Sars-CoV-2 virus (RT-PCR) Hospitalization in Intensive Care Unit Age over 18 years Old Exclusion Criteria: Refusal of the patient to participate in data collection

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 |
| --- | --- | --- |
| Analysis of incidence of thromboembolic events in patients with Sars-CoV-2 |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid-19, Thrombosis, D-Dimers, Anticoagulation
Effects of Body Contouring Surgery in Obese Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is twofold; 1) to assess the psychometric properties of the Finnish version of the BODY-Q questionnaire, 2) to assess the effects of body contouring surgery using patient-reported outcome measures.

Detailed Description
-----------------
The BODY-Q is translated into Finnish through forward and backward translation and a committee review. The preliminary version is pilot tested with 20 participants undergoing body contouring surgery. The study is of longitudinal design gathering data from participants undergoing body contouring surgery due to obesity. Data collection takes place in the Department of Plastic Surgery, Helsinki University Central Hospital, Helsinki, Finland. The participants fill in three patient-reported outcome measures. The outcomes of the three patient-reported outcome measures are compared with each other and internal validity assessed. Test-retest reliability is assessed after two weeks from the first completion of the questionnaires. With validated questionnaires the effects of body contouring surgery is assessed.

Official Title
-----------------
Effects of Body Contouring Surgery in Obese Patients: a Prospective Study

Conditions
-----------------
Validation Study, Quality of Life

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body contouring surgery due to: A) massive weight loss B) Postbariatric weight loss Patient age over 18 years Exclusion Criteria: Patient age under 18 years No body contouring surgery Surgical intervention performed in another hospital than Helsinki and Uusimaa Hospital District No obesity

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 |
| --- | --- | --- |
| Validity of the Finnish version of the BODY-Q questionnaire | The psychometric properties of the BODY-Q patient-reported outcome measure are measured | 6 months | 
| Health-related quality of life after body contouring surgery in obese patients | Health-related quality of life is assessed with a questionnaire | 0.5 to 3 years | 
| Depression after body contouring surgery in obese patients | Depression is assessed with a questionnaire | 0.5 to 3 years | 
| Body image after body contouring surgery in obese patients | Body image is assessed with a questionnaire | 0.5 to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 15-Dimensions health-related quality of life instrument | Assessment of health-related quality of life | 0.5 to 3 years | 
| The BODY-Q questionnaire | Assessment of health-related quality of life and body image | 0.5 to 3 years | 
| The Raitasalo Beck Depression Index questionnaire | Assessment of depression | 0.5 to 3 years |
AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood

Study Overview
=================
Brief Summary
-----------------
The AQUA© questionnaire developed in 2008 is a validated tools for the screening of allergic diseases in adult athletes. The objective of the present study is to develop and validate a modified version of the AQUA© questionnaire to be used in childhood. In this phase, the validation is intended to assess the reliability of the information collected through the AQUA© modified version: question difficulty and response patterns with respect to children characteristics (in particular age, sex and physical activity). In particular, the focus will be on the core questions, i.e. the indicators of allergic disorders. This is a cross-sectional study on 1264 healthy schoolchildren aged 8 to 14 years.

Official Title
-----------------
AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aforementioned sex and age criteria. Exclusion Criteria: Respiratory infections in the previous 3 weeks; Immunological or metabolic systemic disease; Major malformations of the upper airways; Active smoker.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 14 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1264 healthy schoolchildren<br>There is only one study group consisting of 1264 children recruited at school. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Question difficulty | Comprehensibility (or difficulty) of the questions, especially the core questions, will be assessed by the percentages of non-response possibly stratified by children characteristics (in particular age, sex and physical activity). | Study end (4 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patterns of missing response | Possible tendency to skip consecutive questions will be assessed by studying the association between the presence of missing (0 = answer missing, 1 = answer given) in sequence (tetrachoric correlation). | Study end (4 months) | 
| Patterns of non-missing responses | Analysis of the distribution of non-missing responses, possibly stratified by children characteristics (in particular age, sex and physical activity). | Study end (4 months) |