linjc16/ctgov huggingface dataset:
The Six-minute Stepper Test as an Outcome Measure of Exercise Tolerance During Pulmonary Rehabilitation in With Chronic Obstructive Pulmonary Disease (COPD) Patients(STEPPER)?

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to show if the six-minute stepper test (ST6) is a sensible marker of exercise tolerance evolution during a pulmonary rehabilitation program in people with all stages of severity of Chronic Obstructive Pulmonary Disease (COPD).

Detailed Description
-----------------
Currently, the reference test in assessing functional capacity in COPD patients during pulmonary rehabilitation is the six-Minute Walking Test (6MWT). However, the realization of the 6MWT requires a 30m-long corridor, according to the American Thoracic Society Guidelines. Lack of sufficient space can prevent the realization of 6MWT, especially for private practitioner pulmonologists, and also in hospitals. The six-minute stepper test (ST6) which can be performed in a normal room, should be an interesting alternative.

Official Title
-----------------
The Six-minute Stepper Test : Marker of Exercise Tolerance's Evolution During Pulmonary Rehabilitation in Patients With COPD ?

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Procedure: Pulmonary rehabilitation assessed with six-minute walk test and six-minute stepper test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with COPD wtih all stages of severity Hospitalized in the pulmonary rehabilitation unit in the hospital of Morlaix, with a 3 weeks pulmonary rehabilitation course Exclusion Criteria: Pneumonectomy, Lobectomy less than 6 months orthopedic problem Balance disorder Weight > 110kg

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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The six minute Stepper Test<br>Experimental : The six minute Stepper Test with a Conventional respiratory rehabilitation | Procedure: Pulmonary rehabilitation assessed with six-minute walk test and six-minute stepper test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of steps to The Six-minute Stepper Test (ST6) | Assess the difference in the number of steps in ST6 before and after pulmonary rehabilitation | 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, ST6: The six minute Stepper Test, Conventional respiratory rehabilitation, Pulmonary rehabilitation
Image Guided Radiation Therapy For Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
During the 7 to 8 weeks of conformal radiotherapy for prostate carcinoma, the prostate has an intra-pelvic motion which is not detectable by the conventional portal imaging. This prostate motion may lead to a mistargeting, which possibly decreases the local control. On the other hand, the new 3D on board imaging (3D OBI) allows to localize the target but is expensive. The cost/effectiveness ratio is not well established, as well as the frequency of using such imaging during the course of radiation.

Official Title
-----------------
Economic Evaluation of Image Guided Radiation Therapy For Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Control position by 3DOBI before the fraction
* Procedure: Standard imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: prostate adenocarcinoma intermediate / high risk group N0 or N - treatment by conformal radiotherapy (including or not IMRT), with or without androgen deprivation Exclusion Criteria: pelvic irradiation metal objects in the pelvis
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Experimental: Control position by 3DOBI daily<br> | Procedure: Control position by 3DOBI before the fraction<br> <br> |
| Active Comparator: Standard imaging<br> | Procedure: Standard imaging<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate position under the LINAC is checked by 3D OBI (mainly cone-beam imaging, CBI) performed before the fraction. |  |  | 
| To validate the optimal strategy of IGRT for prostate adenocarcinoma based on 2 and 5 year-disease free survival rates (events= biochemical failure or death). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rectal and bladder, acute and late toxicities (CTCAE, SOMA-LENT) |  |  | 
| Cost comparison and cost/effectiveness analysis |  |  | 
| 2 and 5 years clinical relapse free survival rates |  |  | 
| Lack of dose in the prostate in case of decreasing the CBI frequency (using the 1rst arm for testing) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate adenocarcinoma treated by radiotherapy
Placenta Accreta&Its Complications in Placenta Previa Cases

Study Overview
=================
Brief Summary
-----------------
Cases of previous cesarean with placenta previa anterior underwent cesarean section. Placenta accreta is diagnosed during cesarean section &confirmed by pathology. All complications are monitored in cases with placenta accreta and without.

Detailed Description
-----------------
100 cases of gestational age 30 weeks or more with placenta previa anterior with previous one or more cesarean section will be enrolled. History,examination &routine investigations will be taken. Colour doppler will be done to diagnose cases with suspected placenta accreta. Pre & postoperative Hb concentration will be taken. Cases with nonseparation of the placenta will be diagnosed as accreta & confirmed by pathology. Operative time & complications like bladder or intestinal injury will be noted. All data will be analyzed.

Official Title
-----------------
Incidence of Placenta Accreta & it's Complications in Cases of Previous Cesarean With Placenta Previa Anterior

Conditions
-----------------
Placenta Accreta in Placenta Previa Anterior

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all pregnant women more than 30 weeks with previous one or more cesarean section with placenta previa anterior Exclusion Criteria: pregnant with unscarred uterus scars other than cesarean section
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 |
| --- | --- | --- |
| Number of patients with placenta accreta. |  | 3 months | 
| Number of patients with bladder injury. |  | 3 months | 
| Number of patients with intestinal injury. |  | 3 months | 
| Number of patients with cesarean hysterectomy. |  | 3 months | 
| Number of deaths. |  | 3 months |
Validation of an Allergic Rhinitis Control Test in Children

Study Overview
=================
Brief Summary
-----------------
Allergic rhinitis is a common condition that affects adults as well as children and adolescents, often with impaired quality of life. Patients often report a poor level of satisfaction with the effectiveness of their treatment and are always looking for more drug combinations to improve their symptom. Several tools exist for assessing control of allergic rhinitis, but none has been validated in teenagers or in children. A study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitis (ARCT) in patients from 12 years of age. We propose to adapt ARCT adult to pediatric population from 5 to 11 years old.

Official Title
-----------------
Validation of an Allergic Rhinitis Control Test in Children

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Other: Self Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 5 to 11 years old, consulting a practitioner for an allergic rhinitis Parents formulated their study participation agreement by signing the consent form. Exclusion Criteria: Patients that are already treated for the actual episode of allergic rhinitis and are satisfied of the treatment.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 11 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>questionnaire for allergic rhinitis control children from 5 to 11 years old who complete a self questionnaire regarding allergic rhinitis control during the consultation and after 15 days | Other: Self Questionnaire<br>* self questionnaire for allergic rhinitis control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of the allergic rhinitis control self questionnaire | Score of the allergic rhinitis control self questionnaire in teenagers from 5 to 11 years old. | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic rhinitis
IMPEDE and IMPEDE-FX Embolization Plug Registry

Study Overview
=================
Brief Summary
-----------------
EMBO-PMS is a prospective, multicentre, registry study of the IMPEDE and IMPEDE-FX Embolization Plug Systems

Official Title
-----------------
Post Market Registry of the IMPEDE and IMPEDE-FX Embolization Plugs

Conditions
-----------------
Peripheral Vascular Embolization

Intervention / Treatment
-----------------
* Device: IMPEDE, IMPEDE-FX or IMPEDE-FX RapidFill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study participant is ≥18 years of age Study participant is considered a candidate for arterial or venous embolization of the peripheral vasculature Exclusion Criteria: Study participant has an inability to provide written informed consent Study participant/treatment outside of the approved study device labeling, instructions for use (IFU) Study participant is a prisoner or member of other vulnerable population

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: IMPEDE, IMPEDE-FX or IMPEDE-FX RapidFill|Peripheral vascular embolization|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety - Rate of freedom from serious adverse events | Rate of freedom from serious adverse events related to the study devices and/or procedure, per review and adjudication by medical monitor | 30 days | 
| Efficacy - Rate of technical success (embolization of target vessel) | Technical success, defined as embolization of the target area after deployment of the study device | Immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - Rate of recurrence of clinical symptoms, based on original complaint | Number of participants free of recurrent clinical symptoms, based on clinical symptoms of original complaint | 90 days | 
| Efficacy - Rate of treated vessel occlusion | Treated vessel occlusion, measured per study site standard of care for the original condition treated | 90 days | 
| Safety - Rate of freedom from serious adverse events | Rate of freedom from serious adverse events related to the study devices and/or procedure, per review and adjudication by medical monitor | 90 days |
Low Field Magnetic Resonance Imaging Assessment With Outpatients

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to perform imaging assessments of an early stage magnetic resonance imaging (MRI) system on patients using low field magnetic strength.

Official Title
-----------------
Low Field Magnetic Resonance Imaging Assessment With Outpatients

Conditions
-----------------
Conditions Requiring a Brain Magnetic Resonance Imaging, Head Computerized Tomography, or Head Ultrasound

Intervention / Treatment
-----------------
* Diagnostic Test: Hyperfine MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Outpatients at CMH Adele Hall Radiology ages 0 days to 22 years are eligible for enrollment. Exclusion Criteria No additional sedation will be given as part of this study and that sedation, if already administered, will not be altered for study purposes. Any patient who has a contraindication to having an MRI, such as: Non-MRI conditional implanted device or device that is not able to be removed for MRI examination

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 22 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperfine<br>For patients that have standard of care head imaging, we will do a secondary analysis to compare their standard of care MRI, CT and/or US exams with Hyperfine MRI exams. | Diagnostic Test: Hyperfine MRI<br>* Patients who have a standard of care MRI, CT or US will undergo a low-field MRI utilizing Hyperfine either at the patient's bedside or in the department of Radiology. Results of the Hyperfine MRI will not be used for clinical care and will only be available to members of the research team for review.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US | Sensitivity and specificity of hyperfine MRI versus conventional MRI, CT and/or US | Through study completion, an average of 3 years |
Sleep Disorders in Children With ADHD

Study Overview
=================
Brief Summary
-----------------
ADHD is often associated with sleep difficulties. Attention-deficit/hyperactivity disorder (ADHD) is the most common problem presented to children mental health services. The disorder affects approximately 5 % of school-age children. The core symptoms of this disorder include varying degrees of inattention, impulsiveness and restlessness. In addition to the core symptoms, ADHD is associated with other problems (e.g. academic underachievement, poor social relations and sleep disturbances). Despite clinical observations of sleep problems in children with ADHD, there is little empirical research on this topic. The prevalence, type of sleep problems, and significance of these sleep disturbances in children with ADHD remain undocumented. The objective is to determine the relationship of sleep problems to attention deficit/hyperactive disorder, comorbid disorders, and the effect of stimulant treatment.

Official Title
-----------------
Sleep Disorders in Children With ADHD

Conditions
-----------------
Attention Disorder With Hyperactivity (ADHD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - We will compare a group of children with ADHD, other psychiatric disorder, and a healthy group of children age 5 - 10 Exclusion Criteria: mental retardation -

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Attention disorder with hyperactivity, sleep, stimulants, actigraphy
A Randomized Controlled Trial To Evaluate The Use Of Botox In Breast Reconstruction With Tissue Expanders

Study Overview
=================
Brief Summary
-----------------
Investigation of whether injection of the pectoralis muscle with 100 units botulinum toxin during breast reconstruction with tissue expanders results in decreased pain using a blinded, randomized, controlled trial.

Official Title
-----------------
A Randomized Controlled Trial To Evaluate The Use Of Botox In Breast Reconstruction With Tissue Expanders

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Bilateral mastectomy with reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral mastectomy with immediate tissue expander reconstruction Exclusion Criteria: Unwilling to receive study injections

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
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral mastectomy with reconstruction<br>The trial was a comparison between each breast in a single patient undergoing bilateral mastectomy with reconstruction | Procedure: Bilateral mastectomy with reconstruction<br>* In each patient enrolled in the study, botulinum toxin was injected into one pectoralis muscle while saline placebo was injected on the opposite side in a randomized blinded fashion<br>* Other names: Botulinum toxin (botox) injection;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between preoperative and postoperative pain scale | Patients reported pain in each breast on a visual analog scale of 1-10 at each clinic visit | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tissue expanders, Botulinum toxin, Botox
Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.

Study Overview
=================
Brief Summary
-----------------
The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.

Official Title
-----------------
A Six Month, Multi-centre, Open-label, Parallel Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes on a Basal-bolus Regimen.

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

Intervention / Treatment
-----------------
* Drug: Insulin detemir
* Drug: NPH insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated informed consent obtained before any trial-related activities Type 1 diabetes diagnosed and classified according to aetiology Duration of type 1 diabetes equal to or more than 12 months Glycosylated haemoglobin less than or equal to 12 percent based on analysis from central laboratory Able and willing to perform self-blood glucose monitoring Exclusion Criteria: Proliferative retinopathy Total basal insulin dose of more than 100 IU per day Recurrent major hypoglycaemia - that would interfere with trial participation (as judged by the investigator) Known unawareness of hypoglycaemia Previous treatment with insulin detemir

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 |
| --- | --- |
| Experimental: Insulin detemir<br> | Drug: Insulin detemir<br> <br> |
| Active Comparator: NPH insulin<br> | Drug: NPH insulin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the level of glycosylated haemoglobin(HbA1c) |  | From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26) |