linjc16/ctgov huggingface dataset:
Type 2 Diabetes and Exercise - A Pilot Study

Study Overview
=================
Brief Summary
-----------------
A randomised, cross-over trial targeting a small sample of older (age 45-65 years) overweight adults with type 2 diabetes the aims of this pilot study are to: Determine the feasibility of investigating the acute effects of prolonged sedentary behaviour (sitting) in this target group. Compare the acute effects of a single prolonged (8 hour) bout of sedentary behaviour (sitting) on glucose and triglyceride concentrations and key muscle and adipose regulatory enzymes to a similar bout of sedentary behaviour combined with intermittent bouts of light-intensity activity.

Detailed Description
-----------------
The proposed study will involve a randomised cross-over experimental trial conducted in the laboratory setting in older overweight adults with type 2 diabetes. Participants will receive both of the acute testing conditions in a randomised manner. Study design: Randomised cross-over pilot trial of 20 overweight/obese older adults with diet-controlled type 2 diabetes involving 2 acute treatment conditions, with a one-week wash-out period between testing conditions (Figure 1 a). Setting: Acute, supervised laboratory setting within the Alfred and Baker Heart Institute Medical Unit. Outcomes: We will measure acute responses in laboratory-measured plasma glucose & triglyceride levels (every 60 mins) and glucose concentrations determined from continuous glucose monitoring (CGMS).

Official Title
-----------------
Understanding the Acute Effects of Prolonged Sedentary Behaviour (Sitting) on Post-meal Glucose and Lipids - A Pilot Study

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diet controlled Diabetes Overweight (BMI > 27 kg/m2 but <50 kg/m2) Exclusion Criteria: Hypoglycaemic Agents Lipid Lowering Agents

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 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 |
| --- | --- | --- |
Medical and Medico-economic Evaluation Comparing the Follow-up of Patients Undergoing Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
Study design : Prospective, longitudinal, observational (non-interventional), multicenter, comparative medico-economic study - RIPH2, with direct matching to SNDS data (National Health Data System) Main objective : To evaluate the effectiveness of a multidisciplinary, pre- and post-operative, care course for patients undergoing bariatric surgery

Official Title
-----------------
Medical and Medico-economic Evaluation Comparing the Follow-up of Patients Undergoing Bariatric Surgery (SPOC Study (Suivi Parcours Obésité en Chirurgie))

Conditions
-----------------
Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Other: Follow-up of patients undergoing bariatric surgery : integrated pathway


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria for the Integrated group (SPOC) Patient, male or female, at least 18 years old; Patient undergoing bariatric surgery after the implementation of the integrated pathway (date depending on the deployment of the integrated pathway); Patient informed and not objecting to this research; Subject affiliated to or benefiting from a social security program. Inclusion criteria for the control group Patient, male or female, at least 18 years old; Patient undergoing bariatric surgery before the implementation of the integrated pathway (date depending on the deployment of the integrated pathway); Patient informed and not objecting to this research; Subject affiliated to or benefiting from a social security program. Exclusion Criteria: • Protected patient : adult under tutorship, curatorship or other legal protection, deprived of his freedom by judiciary or administrative decision; Patient hospitalised without consent

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 |
| --- | --- |
| Integrated group (SPOC)<br> | Other: Follow-up of patients undergoing bariatric surgery : integrated pathway<br>* Integrated pathway : multidisciplinary, pre- and post-operative, care course for patients undergoing bariatric surgery<br>|
| Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bariatric revision surgery at 5 years follow-up | Proportion of subjects who will have a bariatric revision surgery at 5 years follow-up | 5 years after the first surgery |
Bispectral Index (BIS) on Ventilated Patients in the Prehospital Setting

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of use of the bispectral index for monitoring of depth of sedation in ventilated patients during their prehospital management by a physician- staffed EMS. Hypothesis: there is a correlation between BIS and sedation scores.

Detailed Description
-----------------
The protocol compares BIS values to the RAMSAY score, which is the validated sedation scoring system in the prehospital setting.Ventilated patients receiving sedatives drugs can be included during primary prehospital interventions or interhospital transfers. During primary prehospital interventions, the protocol starts before endotracheal intubation. Depth of sedation is assessed every 5 minutes by the physician of EMS team. Blinded BIS monitoring is performed at the same time and recorded by the nurse at the end of out-of-hospital management. Data are analysed secondarily by the principal investigator.

Official Title
-----------------
Use of Bispectral Index to Assess Depth of Sedation in Ventilated Patients in the Prehospital Setting

Conditions
-----------------
Ventilation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 Ventilated patient Exclusion criteria: None

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 |
| --- | --- | --- |
| Correlation between BIS values and RAMSAY score |  | Instantaneously | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between BIS values and ATICE score |  | Instantaneously | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bi spectral Index, Sedation depth monitoring, Out of hospital ventilated patients
Gastrointestinal Microcirculation During Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
O2C is a diagnostic device for non-invasive determination of oxygen supply in microcirculation of blood perfused tissues. The optical sensor is easy to handle and guarantees reproducible examinations of local oxygen supply of tissues in clinics as well as in research. The examinations are without any strain for your patient. Determines by use of a glass fibre probe: Blood Flow in Microcirculation Capillary-Venous Oxygen Saturation Blood Filling of Microvessels Blood Flow Velocity This device makes it possible to supervise the local oxygen supply of organs and tissue. With it is possible to measure locally the amount of oxygen which is transported into the region of interest and to diagnose local oxygen consumption of an organ. O2C's novelty is monitoring the energetic metabolism of cells by measuring the oxygen uptake with an optical sensor probe. Pathological O2-supply, which can lead to angiogenesis or cell-death and subsequently to organ failure, now can be detected in an early state by use of the new sensor system. One of these new developed sensors are used to place in rectal position during extracorporeal circulation to determine the microcirculation.

Conditions
-----------------
MeSH Heading Cardiac Surgical Procedures, Tree Number E04.100.376, Tree Number E04.928.220

Intervention / Treatment
-----------------
* Procedure: Heart Lung machine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients on extracorporeal circulation Exclusion Criteria: Haemorrhoidal lesions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Extracorporeal circulation<br>all patients were measured by microcirculation device O2C | Procedure: Heart Lung machine<br>* measurement of microcirculation with O2C device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Flow in Microcirculation |  | 3 hours |
Appetite Regulation in Children With Failure to Thrive

Study Overview
=================
Brief Summary
-----------------
Failure to thrive (FTT) is an expression for inadequate growth in the early childhood and thus, a sign of undernutrition. This study will include children with FTT, and compare with existing data from children with normal and excessive growth. The overall aim of this study is to explore whether 1) children who develop FTT with no organic explanation differ from healthy normal weight and overweight children in their basal level of appetite-regulating hormones and 2) if inadequate, normal and excessive growth in children can be partly predicted by variation in their gut microbiome and metabolome.

Official Title
-----------------
Appetite-regulating Hormones, the Gut Microbiome and the Metabolome in Children With Failure to Thrive

Conditions
-----------------
Failure to Thrive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with failure to thrive Weight for height > 1.9 SD below the median by use of the WHO Child Growth Standards Age between 12-36 months Exclusion Criteria: Cancer Inflammatory bowel disease Celiac disease Immunodeficiency Other somatic disease that can explain the growth failure

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 36 Months

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 |
| --- | --- | --- |
| Appetite-regulating hormones (ghrelin, PYY, leptin) measured by fasting blood samples |  | At subject enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota composition measured by fecal samples |  | At subject enrollment | 
| Metabolome measured by urine samples |  | At subject enrollment | 
| Metabolic markers (insulin, glucose) measured by fasting blood samples |  | At subject enrollment | 
| Body weight measured in kilograms |  | At subject enrollment | 
| Height measured in centimeters |  | At subject enrollment | 
| Head circumference measured in centimeters |  | At subject enrollment | 
| Waist circumference measured in centimeters |  | At subject enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Growth, Children, Appetite-regulating hormones, Gut Microbiota
Comparison of McCoy Laryngoscope and C-MAC D-blade Video Laryngoscope in Obese Patients

Study Overview
=================
Brief Summary
-----------------
Obesity is associated with difficult intubation rate of 30%, and this study was performed to compare the use of McCoy laryngoscope and C-MAC D-blade video laryngoscope for intubation in obese patients. A total 104 patients with body mass index (BMI) ≥ 35kg/m² scheduled for general anesthesia were randomly assigned to be intubated with McCoy laryngoscope or C-MAC D-blade video laryngoscope. The primary outcome was intubation time, and secondary outcomes were mask ventilation scale, intubation difficulty scale (IDS), percentage of glottis opening (POGO) score, and hemodynamic variables including mean arterial pressure, heart rate and saturation.

Official Title
-----------------
Comparison of McCoy Laryngoscope and C-MAC D-blade Video Laryngoscope in Obese Patients

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: McCoy laryngoscope
* Device: C-MAC D-blade video laryngoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American society of anesthesiologists physical status of I-II patients with BMI ≥ 35 kg/m² scheduled for general anesthesia Exclusion Criteria: patients with tracheal diseases, sore throat, neck pain and loose tooth.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: McCoy group<br>Patients were intubated with McCoy laryngoscope. | Device: McCoy laryngoscope<br>* Patients scheduled for general anesthesia were intubated with McCoy laryngoscope.<br>|
| Experimental: C-MAC group<br>Patients were intubated with C-MAC D-blade video laryngoscope. | Device: C-MAC D-blade video laryngoscope<br>* Patients scheduled for general anesthesia were intubated with C-MAC D-blade video laryngoscope.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | Timing measurement began when the laryngoscope blade was inserted in patients' mouth and ended when end tidal carbon dioxide tracing was detected in the monitor. | The patients were excluded in this study if intubation time was over 90 seconds. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, intubation, laryngoscopes
Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous

Study Overview
=================
Brief Summary
-----------------
Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous is a prospective randomized controlled trial comparing 24 hour intravenous antibacterial therapy to 24 hour oral antibacterial therapy after surgery in complicated appendicitis.

Official Title
-----------------
Short Post-operative Antibacterial Therapy in Complicated Appendicitis: Oral Versus Intravenous

Conditions
-----------------
Acute Appendicitis Without Peritonitis, Acute Appendicitis With Appendix Abscess, Appendicitis; Perforation, Appendicitis Perforated, Appendicitis Acute, Acute Appendicitis, Acute Appendicitis With Rupture

Intervention / Treatment
-----------------
* Other: Oral versus intravenous administration of antibacterial treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with acute appendicitis and are candidates for laparoscopic appendectomy. Exclusion Criteria: Patients with compromised immune system (HIV, diabetes), ongoing or completed radio-chemotherapy in past 5 years, prosthetic heart valve, vascular prosthesis, pregnancy.

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 24 hour intravenous antibacterial therapy<br>S.Augmentin 1,2g x 3 i/v | Other: Oral versus intravenous administration of antibacterial treatment<br>* Mode of administration of antibacterial treatment<br>|
| Experimental: 24 hour oral antibacterial therapy<br>T.Augmentin 1g x 3 p/o | Other: Oral versus intravenous administration of antibacterial treatment<br>* Mode of administration of antibacterial treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious complications |  | 30 days |
Evaluation of Organisational Changes to Promote Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The Department of Family Practice at Michigan State University partnered with BCBSM with a grant from the Robert Wood Johnson Foundation to recruit primary care practices for a 3 year study designed to assess smoking cessation referral rates by primary care physicians in Michigan.

Detailed Description
-----------------
There are two main research questions to our study: 1) Whether provider referral rates to smoking cessation services and quitline counseling are enhanced by comparative feedback profiles to individual providers and provider groups (Study 1) and 2) Whether health plan members who receive pharmacotherapy for smoking cessation have higher participation rates in smoking cessation services if they receive proactive, invitational phone calls (Study 2).

Official Title
-----------------
Evaluation of Organisational Changes to Promote Smoking Cessation

Conditions
-----------------
Adult Smokers

Intervention / Treatment
-----------------
* Behavioral: Feeback group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary care practice and thier Adult smokers Exclusion Criteria: Non somkers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 2<br>No intervention | Behavioral: Feeback group<br>* The intervention practices received a quarterly comparative feedback performance report based on the Achievable Benchmarks of Care (ABC) research conducted by Kieffe (YEAR).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate and provide a model of smoking cessation interventions |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult smokers
Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome

Study Overview
=================
Brief Summary
-----------------
This research study will determine if esomeprazole, when administered twice daily at 40, 80, or 120 mg doses, can control excessive stomach acid secretion.

Official Title
-----------------
A Phase III, Multicenter, Open-Label Study To Evaluate the Control of Gastric Acid Secretion With Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome For 12 Months

Conditions
-----------------
Zollinger-Ellison Syndrome

Intervention / Treatment
-----------------
* Drug: Esomeprazole magnesium (Nexium)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females at least 18 years of age. Diagnosis of Zollinger-Ellison Syndrome or idiopathic hypersecretion Exclusion Criteria: Pregnant or lactating females History of drug addiction or alcohol abuse within 12 months prior to Screening. History of intolerance to any proton pump inhibitors or any ingredient in their formulation.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Esomeprazole magnesium (Nexium)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the gastric acid secretory rate at the final study visit. |  |  | 
| Control is defined as gastric acid secretory rate below 10 mEq/h or below 5 meq/h for patients with prior gastric acid reducing Surgery |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The status (controlled or not controlled) of gastric acid secretory rate at the Month 6 study visit. |  |  | 
| Control is defined as gastric acid secretory rate below 10 mEq/h or below 5 meq/h for patients with prior gastric acid reducing surgery. |  |  | 
| The following safety variables will be assessed at Month 6 and Month 12: adverse events, clinical laboratory results (ie, chemistry, hematology, urinalysis), physical examinations, and EGDs. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastric acid hypersecretory conditions, Idiopathic Hypersecretion, Excessive Gastric Acid secretion