linjc16/ctgov huggingface dataset:
Cardiovascular Impairments and Obstructive Sleep Apnea Syndrome

Study Overview
=================
Brief Summary
-----------------
Which are the anthropometric parameters and/or of severity of the syndrome of apnea of sleep (SAS) which make it possible to anticipate occurred of vascular anomalies, anatomical and/or functional precociously found among patients SAS? Secondary objectives: Which are the anthropometric parameters and/or of severity of SAS allowing to anticipate occurred of early of the cardiac function and/or rhythmic anomalies found among patients SAS? Do there exist biological markers who allow to anticipate the early vascular lesions or the anomalies beginners of the cardiac function? Which are the cardiovascular effects of a treatment of SAS by Continuous Positive Pressure (PC) after 3 to 6 months of treatment? Do the identified early cardiovascular attacks and/or the biological anomalies make it possible to predict occurred of cardiovascular events in this population of patients carrying SAS (followed longitudinal at 5 years)?

Official Title
-----------------
Subclinical Cardiovascular Impairments in Patients With Obstructive Sleep Apnea Syndrome

Conditions
-----------------
Subclinical Cardiovascular Impairments, Obstructive Sleep Apnea Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female from 18 to 78 years old Patients with obstructive sleep apnea syndrome (Apnea/Hypopnea index > 15) ambulatory patients patients who have signed the inform consent form patients with health insurance Exclusion Criteria: Body Mass Index upper or equal to 30 cardiovascular pathology except blood pressure hypertension known or treated diabetes pathologies with consequence on blood pressure regulation drugs intakes with consequence on blood pressure regulation patient with chronic obstructive pulmonary disease atrial fibrillation or more than 10/minute extrasystoles bedridden patients or patients with decreased mobility patients working at night or with shift work patients with carotid stenting or surgery history patients unable to sign the inform consent form patients already treated by cPAP or dental appliance for OSAS in the last 6 months pregnant or suckling female patients under supervision or trusteeship patients taking part in another clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiovascular risks, Oxidative stress, Systemic inflammation, Endothelial function, Peripheral Arterial Tone, Positive Airway Pressure
Respiratory Management of Children Under Anaesthesia

Study Overview
=================
Brief Summary
-----------------
Ventilation management in paediatric anaesthesia remains difficult because of the wide range of age and weight, and therefore practices are heterogeneous. In adults, protective ventilation during anesthesia is now a standard of care but in children there is no level of evidence to recommend it. The aim of the study was to describe current practice and the factors associated with the use of high tidal volume during anaesthesia in children in France.

Official Title
-----------------
Respiratory Management of Children Under Anaesthesia: a French Prospective Multicentre Observational Study

Conditions
-----------------
Anesthesia, Peroperative Complication

Intervention / Treatment
-----------------
* Other: Respiratory management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children less than 18 years of age Admitted in one of the participating centers over 2 days (21 and 22 June 2017) Exclusion Criteria: Children extracorporeal circulation Children who required ventilation with lung exclusion Opposition of the parents or legal guardians

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- |
| Children <18 years, admitted for a general anesthesia.<br>Children <18 years, admitted for a general anesthesia. | Other: Respiratory management<br>* Data on respiratory management were collected at different time: data regarding the induction period, ventilatory parameters set and measured during a stable period, ventilatory change made during anaesthesia, use of recruitment manoeuvres, data regarding weaning and extubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients receiving a tidal volume higher than 10 milliliters/kilogram (ml/kg) of actual body weight | Number of patients receiving a tidal volume higher than 10 milliliters/kilogram (ml/kg) of actual body weight | up to 1 hour (during a stable period in anaesthesia) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, Respiratory
Evaluation of Drug Display in Critical Care Setting

Study Overview
=================
Brief Summary
-----------------
To assess the clinical utility of the graphical medication monitor, results of the anesthetics for which the display was present will be compared to the results of the anesthetics in which there was no display.

Detailed Description
-----------------
This study has two objectives: First, before the medication monitor is shown to anesthesiologists in a clinical setting, the PKPD models must be validated to assess the clinical reliability of the model-based predictions for patients undergoing general anesthesia. Second, once the PKPD models have been successfully validated, presenting it to anesthesiologists during administration of anesthesia will assess the impact of the graphical medication monitor. Differences in performance and patient care will be determined by comparing anesthesiologists who are presented with the monitor to those who care for patients without the monitor.

Official Title
-----------------
Evaluation of Drug Display in Critical Care Setting

Conditions
-----------------
Decision Making

Intervention / Treatment
-----------------
* Device: medication monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Board certified attending anesthesiologists at the University of Utah Health Sciences Center and supervised anesthesiology residents and have been trained on the graphic display Exclusion Criteria: Board certified attending anesthesiologists at the University of Utah Health Sciences Center and supervised anesthesiology residents that have not been trained on the graphic display

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 |
| --- | --- |
| 1<br>For the phase of the study in which the utility of the graphical medication monitor is assessed, the monitor will not be shown to anesthesiologists placed in the control condition. | |
| 2<br>In the experimental condition, anesthesiologists will be shown the medication monitor to aid their expertise and decision-making. | Device: medication monitor<br>* the medication monitor will aid in expertise and decision-making.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess differences between medication administration data and patient information with and without the use of the graphical medication monitor. |  | preoperative, intraoperative and postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
decision making, graphic display
Fiber-enriched Buckwheat Pasta and Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease

Study Overview
=================
Brief Summary
-----------------
The intervention was preceded by a 1-week run-in period during which participants underwent continuous glucose monitoring (CGM) and filled in a 7-day dietary record to optimize basal infusion rate and insulin-to-glycemic load ratio. The study had a randomized crossover design with each subject studied on 2 occasions at least 1 week apart. Participants were assigned to consume, in random order, two test meals with the same amount of carbohydrates (50g): a meal containing fiber-enriched buckwheat pasta (FBP) or corn pasta (CP), used as control. Over the experimental period, participants underwent CGM, wearing their sensors 7 days/week.

Official Title
-----------------
Fiber-enriched Buckwheat Pasta Reduces Daily Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease: an Acute Randomized Controlled Trial

Conditions
-----------------
Type 2 Diabetes Mellitus, Celiac Disease

Intervention / Treatment
-----------------
* Other: Acute test meal with fiber-enriched buckwheat pasta
* Other: Acute test meal with corn pasta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 20-50 years Documented history of celiac disease and type 1 diabetes. Exclusion Criteria: Pregnancy/breast feeding Serious microvascular and macrovascular diabetes complications Any other chronic or acute disease apart from diabetes seriously affecting health status

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fiber-enriched buckwheat pasta<br>Acute test meal | Other: Acute test meal with fiber-enriched buckwheat pasta<br>* Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)<br>|
| Active Comparator: Corn pasta<br>Acute test meal | Other: Acute test meal with corn pasta<br>* Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glucose response | Incremental area under the curve | 6 hours |
Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
Patients were randomly assigned into 2 groups: those patients undergoing RYGB with a BPL of 70cm and those ones undergoing RYGB with a BPL of 120 cm. Excess BMI loss 5 years after surgery was investigated

Detailed Description
-----------------
Patients were randomly assigned into 2 groups: those patients undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 70cm and those ones undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 120 cm. Alimentary limb was constant in both groups (150cm). Excess BMI loss 5 years after surgery was investigated

Official Title
-----------------
Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric

Conditions
-----------------
Weight Loss

Intervention / Treatment
-----------------
* Procedure: BP limb 70cm
* Procedure: BP limb 120cm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >40 Kg/m2 BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity Age older than 18 years Exclusion Criteria: Patients undergoing other bariatric techniques than RYGB Patients undergoing RYGB with different BPL or AL lengths than that reported for this study Any other surgical procedure added to the bariatric surgery Impossibility to comply with pre-established clinical follow-up.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BP limb 70cm<br>Patients underwent a RYGB with a biliopancreatic limb of 70cm | Procedure: BP limb 70cm<br>* Performance of RYGB with a BP limb of 70cm<br>|
| Experimental: BP limb 120cm<br>Patients underwent a RYGB with a biliopancreatic limb of 120cm | Procedure: BP limb 120cm<br>* Performance of RYGB with a BP limb of 120cm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Weight loss was evaluated | 5 years after surgery |
Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Biliary Cirrhosis.

Official Title
-----------------
A Phase 2, Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Pharmacodynamic Activity of NGM282 in Combination With Ursodeoxycholic Acid (UDCA) Administered for 28 Days in Patients With Primary Biliary Cirrhosis

Conditions
-----------------
Primary Biliary Cirrhosis

Intervention / Treatment
-----------------
* Biological: NGM282
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females, between 18 and 75 years of age, inclusive PBC diagnosis consistent with AASLD and EASL guidelines Stable dose of UDCA Exclusion Criteria: Chronic liver disease of a non-PBC etiology Evidence of clinically significant hepatic decompensation

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NGM282 Dose 1<br>NGM282 Dose 1 | Biological: NGM282<br> <br> |
| Experimental: NGM282 Dose 2<br>NGM282 Dose 2 | Biological: NGM282<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Biological: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in plasma ALP from Baseline to Day 28 |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in bilirubin from Baseline to Day 28 |  | 28 days |
Effect of Hydrocortisone Iontophoresis Versus Hydrocortisone Phonophoresis On Post Surgical Scar

Study Overview
=================
Brief Summary
-----------------
The purpose of this study will be to compare the effect of hydrocortisone iontophoresis and hydrocortisone phonophoresis on the treatment of surgical scar and overall scar appearance.

Detailed Description
-----------------
Scar contractures develop and extend to the underlying connective tissue and then muscles, leading to reduction in joint range of motion and affecting the day-to-day activities. Most patients (irrespective of age, gender and ethnicity) believe that even a small improvement in scarring is worthwhile , any research that may help improve scar outcome is meaningful. The need of this study has developed from the rarity of information about the difference between the effectiveness of iontophoresis and phonophoresis in enhancing the overall appearance of surgical scar.

Official Title
-----------------
Effect of Hydrocortisone Iontophoresis Versus Hydrocortisone Phonophoresis On Post Surgical Scar

Conditions
-----------------
Scar, Hydrocortisone, Iontophoresis, Phonophoresis

Intervention / Treatment
-----------------
* Other: Iontophoresis
* Other: Phonophoresis
* Other: traditional PT program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both genders same approach of medications scar size varies from 5-15 cm Exclusion Criteria: have cardiac / pacemakers have significant health problems obese patients (BMI more than 30) uncooperative patients

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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: Iontophosresis group<br> | Other: Iontophoresis<br>* Hydrocortisone iontophoresis<br>Other: traditional PT program<br>* Ultrasound and deep friction massage<br>|
| Experimental: Phonophoresis group<br> | Other: Phonophoresis<br>* Hydrocortisone Phonophoresis<br>Other: traditional PT program<br>* Ultrasound and deep friction massage<br>|
| Experimental: Traditional group<br> | Other: traditional PT program<br>* Ultrasound and deep friction massage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar pliability | assessment of change in Scar pliability by using tonometer device | at baseline and after 3 months of intervention |
Intravitreal Bevacizumab for Neovascular Glaucoma

Study Overview
=================
Brief Summary
-----------------
Several studies have confirmed high levels of vascular endothelial growth factor (VEGF) in eyes with neovascular glaucoma (NVG). The role of VEGF inhibitors in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic macular edema has been described. We aim to evaluate the effect of three intravitreal injections of bevacizumab (Avastin) 2.5 mg versus a sham procedure for treatment of NVG. Outcome measures include intraocular pressure and extent of iris neovascularization. Both study arms will receive conventional treatment for NVG.

Official Title
-----------------
Intravitreal Bevacizumab for Neovascular Glaucoma; a Randomized Placebo Controlled Clinical Trial

Conditions
-----------------
Neovascular, Glaucoma

Intervention / Treatment
-----------------
* Other: subconjunctival normal saline
* Drug: Avastin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of NVG Vision less than 20/200 age 10-80 years Exclusion Criteria: Uncontrolled Blood Pressure History of thromboembolism Congestive Heart Failure Renal Failure Pregnancy or Lactation Active ocular or periocular infection No light perception

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 80 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 |
| --- | --- |
| Sham Comparator: 2<br> | Other: subconjunctival normal saline<br>* 0.1cc normal saline injection in the subconjunctival space repeated twice at monthly intervals<br>|
| Experimental: 1<br> | Drug: Avastin<br>* intravitreal injection of avastin 2.5mg repeated twice at monthly intervals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intraocular pressure |  | 6 months | 
| Change in extent of iris neovascularization |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neovascular, Glaucoma, Bevacizumab, Avastin, Intravitreal, IOP