linjc16/ctgov huggingface dataset:
BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)

Study Overview
=================
Brief Summary
-----------------
The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep Apnoea (OSA).

Official Title
-----------------
A Multicentre, Prospective, Open-label, Non-randomized, Single Arm Treatment Study to Assess the Safety, Performance and Initial Efficacy Trends of the Genio(TM) Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea.

Conditions
-----------------
Obstructive Sleep Apnea of Adult

Intervention / Treatment
-----------------
* Device: Genio(TM) bilateral hypoglossal nerve stimulation system


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Body mass index ≤32 kg/m2 Patients who do not tolerate or do not accept positive airway pressure (PAP) treatments. Obstructive apnoea-hypopnea index (AHI) of 20-60 events/hour Main Exclusion Criteria: Unable or incapable of providing informed written consent Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires Significant co-morbidities making the patient unable or inappropriate to participate in the trial

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genio(TM) system therapy<br> | Device: Genio(TM) bilateral hypoglossal nerve stimulation system<br>* Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Four (4) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4 and 6 month(s) after implantation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Incidence of serious device-related adverse events) | Incidence of serious device-related adverse events | 6-months post implantation | 
| Performance | Change from baseline to 6-month post implantation in the apnoea-hypopnea index (AHI) | 6-months post implantation |
Impact of Asthma Treatments on Daily Activities

Study Overview
=================
Brief Summary
-----------------
The primary objective of this web-based, cross-sectional study is to assess and compare the ability to sleep, work or go to school, and to participate in leisure activities among subjects who are receiving Xolair treatment and subjects who were eligible to receive Xolair, but instead have been using Advair for at least 1 year.

Official Title
-----------------
Study on Asthma Treatments on Daily Activities as Reported by Patients (STAR)

Conditions
-----------------
Asthma, Allergies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have asthma and allergies Currently taking Xolair® or Advair® Started Xolair® treatment within the last 4 to 12 months OR have been taking Advair® for at least 12 months Between 18 and 55 years of age A non-smoker for at least 6 months Have internet access

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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
-----------------
asthma, allergies, Xolair, Advair
Therapeutic Variables in Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare patient outcomes in following cataract surgery in patients randomized to one of two surgical kits.

Conditions
-----------------
Cataract Surgery

Intervention / Treatment
-----------------
* Drug: Gatifloxacin
* Drug: Ketorolac LS
* Drug: Pred Forte
* Drug: Moxifloxacin
* Drug: Nepafenac
* Drug: EconoPred Plus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females scheduled to undergo cataract surgery Patients can be receiving monofocal IOLs only Likely to complete all study visits and able to provide informed consent Visual potential of 20/25 or better Exclusion Criteria: Known contraindications to any study medication or ingredients Active ocular diseases or uncontrolled systemic disease Active ocular allergies
Sexes Eligible for Study
-----------------
All

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gatifloxacin|nan|
|Drug: Ketorolac LS|nan|
|Drug: Pred Forte|nan|
|Drug: Moxifloxacin|nan|
|Drug: Nepafenac|nan|
|Drug: EconoPred Plus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
PreAsthmaControl (PAC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the ability of budesonide, given during episodes of troublesome lung symptoms to reduce further symptoms in infants and young children at risk of developing asthma

Official Title
-----------------
Prevention of Asthma in Infants/Young Children - PAC

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Pulmicort (budesonide) pMDI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children of asthmatic mothers form the COPSAC birth cohort study Exclusion Criteria: Children born more than 4 weeks preterm children with other systemic illness that atopy/allergy Children requiring mechanical ventilation at any time since birth.

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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

| Intervention/Treatment |
| --- |
|Drug: Pulmicort (budesonide) pMDI|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom free days |  |  | 
| days with no use of bronchodilator |  |  | 
| days with no use of bronchodilator and no symptoms |  |  | 
| number of treated episodes |  |  | 
| number of treatment with add-on medication |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| asthma status |  |  | 
| time to start of algorithm treatment |  |  | 
| the total steroid dose |  |  | 
| First treatment episode: |  |  | 
| number of symptom days |  |  | 
| number of days with use of bronchodilator |  |  | 
| number of patients who needed add-on medication |  |  | 
| BMD |  |  | 
| height |  |  | 
| serious adverse events |  |  |
Comparison of In-lab PSG to WP200 for Assessing Sleep Parameters

Study Overview
=================
Brief Summary
-----------------
The WP200 and/or WP200U will be compared with a PSG system which is a digital physiological recorder system, cleared for use for clinical sleep studies. The manual scoring of the PSG data, performed by a trained and authorized scorer, according to the AASM (American Academy of Sleep Medicine) guidelines, serves as a gold standard for all determinations of efficacy.

Official Title
-----------------
Testing for Sleep Apnea in Adolescence Subjects With the WP200/WP200U Compared to an In-lab Overnight PSG Testing

Conditions
-----------------
Sleep

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 12-17 Subjects with a legal guardian that is able to read understand and sign the informed consent form Willing to sleep with the WP200/WP200U and PSG simultaneously in the sleep lab Exclusion Criteria: Permanent pacemaker: atrial pacing or VVI without sinus rhythm. Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study)

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 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 |
| --- | --- |
| PSG and WatchPAT200 in subjects age12-17<br>Adolescents refered to a sleep lab for sleep lab for full night PSG | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity, specificity, obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the gold standard |  | 1 night | 
| correlation obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the gold standard |  | 1 night | 
| Agreement obtained by the WP200/WP200U device automatic-computerized analysis as compared to the manual scoring of the PSG that is considered the gold standard |  | 1 night | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diagnosing sleep
Norepinephrine for Spinal-induced Hypotension

Study Overview
=================
Brief Summary
-----------------
Norepinephrine (NE) infusion is used prophylactically to counteract the vasodilator effect of spinal anesthesia. prophylactic use of NE infusion is expected to decrease bouts of hypotension, vomiting and increase patient satisfaction

Official Title
-----------------
Prophylactic Norepinephrine Infusion for Spinal-induced Hypotension

Conditions
-----------------
Spinal Anesthesia

Intervention / Treatment
-----------------
* Drug: Norepinephrine infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients scheduled for elective surgery under spinal anesthesia Exclusion Criteria: ischemic heart disease uncontrolled hypertension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br> | |
| Experimental: NE group<br> | Drug: Norepinephrine infusion<br>* Norepinephrine infusion (5miclml) is immediately started after spinal anesthesia. Rate starts at 30 ml/h and modified according to hemodynamic state<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of hypotension | intraoperative decrease of patient blood pressure by more than 20% from its basal reading | intraoperative |
Descriptive Study on the Evaluation of Well-being in Relation to Diet and Nutrition and Comparison Between Three Care Units in the Dijon University Hospital Centre

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to qualify patient well-being in relation to diet. The notion of dietary well-being is believed to be subjective and we wish to base it on tangible parameters (presentation of meals, variety of menus, social interaction, environment, convenience, pleasure...) in order to establish a score of dietary well-being that we will then correlate to the patient's nutritional status. This tool can then be used more widely as an assessment tool within health institutions.

Official Title
-----------------
Descriptive Study on the Evaluation of Well-being in Relation to Diet and Nutrition and Comparison Between Three Care Units in the Dijon University Hospital Centre

Conditions
-----------------
Hospitalization in Cardiology, Orthopaedic Surgery or Endocrinology Departments

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: person who has given oral consent adult persons admitted to cardiology, orthopaedic surgery and endocrinology units absence of cognitive problems oral food intake Exclusion Criteria: no affiliation to a national health insurance scheme current pregnancy blended diet

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 |
| --- | --- |
| Patients hospitalized in the cardiology unit<br> | Other: Questionnaire<br>* Questionnaire evaluating well-being in relation to diet and nutrition<br>|
| Patients hospitalized in the orthopedic surgery unit<br> | Other: Questionnaire<br>* Questionnaire evaluating well-being in relation to diet and nutrition<br>|
| Patients hospitalized in the endocrinology unit<br> | Other: Questionnaire<br>* Questionnaire evaluating well-being in relation to diet and nutrition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire evaluating well-being in relation to diet and nutrition |  | Baseline |
A 12 Week Physical Training Programme for Patients With Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether water based or land based group training is more effective for people with COPD.

Detailed Description
-----------------
COPD is a more common diagnosis today compared to 20 years ago, and the group is growing fast. The suffering caused by COPD and the financial cost to society is on the increasing. The principal causes of COPD are smoking and inactivity. So far it is poorly understood wich form of exercise is the most effective in training this condition.

Official Title
-----------------
A 12 Week Physical Training Programme for Patients With Chronic Obstructive Pulmonary Disease (COPD)-a Comparison of Water Based and Land Based Group Training

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

Intervention / Treatment
-----------------
* Behavioral: Training in water
* Behavioral: Training on land


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD GOLD II Not taking part in physical activity during the last year Exclusion Criteria: COPD GOLD I, III, IV Pain in the legs that make activity difficult

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B1<br>B1 - training in water | Behavioral: Training in water<br>* 45 minutes interval training in water, submaximal intensity, twice a week<br>|
| Experimental: S1<br>S1 - training on land | Behavioral: Training on land<br>* 45 minutes interval training on land, submaximal intensity, twice a week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2 peak |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Obstructive Pulmonary Disease, COPD, Physical group training, Water exercise, Cardiorespiratory fitness, Functional exercise capacity, Health related quality of life
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
This study describes a controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem-cell implants by minithoracotomy in patients with dilated cardiomyopathy and cardiac failure class III or NYHA.

Official Title
-----------------
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy: Randomized Clinical Trial

Conditions
-----------------
Dilated Cardiomyopathy

Intervention / Treatment
-----------------
* Procedure: intramyocardial bone marrow stem cells implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis made at more than one year and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy Left ventricular ejection fraction (LVEF) less than 35% by echocardiogram Age below 70 years Absence of neoplasm Abscence of hematologic disease or systemic disease No previous cardiac intervention Exclusion Criteria: Episodes of tachycardia or ventricular fibrillation Severe or moderated mitral insufficiency Any other valvulopathies Previous cardiac surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Interventional | Procedure: intramyocardial bone marrow stem cells implantation<br>* Control group: the patients will be monitored with regular medical visits. Echocardiography: baseline,3,6,9 months. Cardiac NMR at baseline, 3 and 9 months. Interventional group: Bone-marrow was collected from in the anterior-superior iliac crest and mononuclear stem cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5ml), in the anterior, lateral, posterior and apical faces of the LV ((average 9.6±2.6 x 10[7] cells). After the procedure, the patients were kept in the p.o. for a minimum period of 24hrs. They were released from the hospital in a period that varied from 5-7 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of the ejection function of the left ventricle |  | twelve months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiomyopathy, stem cell, cardiac failure
An Extension Trial to Evaluate Long-term Safety of SABER™-Bupivacaine for Pain Following Shoulder Surgery

Study Overview
=================
Brief Summary
-----------------
This is an extension to a previous research trial testing SABER™-Bupivacaine (an experimental pain-relieving medication). The purpose of this extension trial is to assess whether treatment with SABER™-Bupivacaine or SABER™-Placebo has had any effect on healing of the participant's shoulder, wound, or the skin near their scar. This trial will also assess safety (side effects).

Detailed Description
-----------------
This research trial will involve all available subjects who received treatment in DURECT Protocol C803-017. All subjects will have the same follow-up safety assessments performed. No experimental treatment will be given in this trial. Subjects, Investigators, and caregivers will remain blinded to the treatment subjects received in the previous trial.

Official Title
-----------------
A Multi-Center, Prospective, Observational, Extension Trial Following DURECT Protocol C803-017 to Investigate the Long-term Safety of SABER™-Bupivacaine Following Arthroscopic Shoulder Surgery

Conditions
-----------------
Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must have provided written consent to participate in the trial prior to any trial procedures and understand that they are free to withdraw from the trial at any time. Participants must be able to read and understand the consent form, complete trial-related procedures, and communicate with the trial staff. Participants must have participated in DURECT Protocol C803-017 and received SABER™-Bupivacaine or SABER™-Placebo approximately 18 months before enrolling in this trial. Exclusion Criteria: Participants who participated in any other trial with an investigational drug or device since their participation in DURECT protocol C803-017.

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 |
| --- | --- |
| Group 1: SABER™-Bupivacaine<br>Received 5.0 mL SABER™-Bupivacaine in previous C803-017 trial | |
| Group 2: SABER™-Placebo<br>Received 5.0 mL SABER™-Placebo in previous C803-017 trial | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Summaries: Pain Intensity on Movement Evaluation; Surgical Site Healing and Local Tissue Evaluation; Shoulder Examination; MRI; Medical History Update; Adverse Events; and Concomitant Medications |  | 18 months post-dose in C803-017 trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Long-term Safety, Shoulder Surgery, bupivacaine