linjc16/ctgov huggingface dataset:
The Effect of a Reduced Noise Environment on the Response Time of the Anesthesia Provider

Study Overview
=================
Brief Summary
-----------------
This project will investigate whether reduction in ambient light and elimination of noise during induction and emergence from anesthesia influences the response time of the anesthesia provider to auditory and visual alarms when compared to a standard operating room. In addition, the investigators will assess the cumulative level of noise exposure that providers experience during the perioperative period.

Official Title
-----------------
The Effect of a Reduced Noise Environment on the Response Time of the Anesthesia Provider to Auditory and Visual Alarms During Induction and Emergence From General Anesthesia

Conditions
-----------------
Noise Exposure

Intervention / Treatment
-----------------
* Other: Reduced noise
* Other: Normal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anesthesia providers that have agreed to participate. Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noise reduction<br>Reduced operating room personnel, low ambient light and soft background music during induction and emergence from anesthesia. | Other: Reduced noise<br>* All activity will cease when the patient enters the operating room and nonessential personnel will be removed. Ambient lighting will be reduced and communication devices muted.<br>|
| Active Comparator: Control<br>Normal operating room environment. | Other: Normal<br>* No change in the normal operating room environment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction response time | Response time of the anesthesia provider to the auditory/visual alarm during induction of anesthesia | Within 5 mins of patient entering the OR | 
| Emergence response time | Response time of the anesthesia provider to the auditory/visual alarm during emergence from anesthesia | Within 5-15 mins after completion of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Noise exposure | Assess the cumulative level of noise exposure to the anesthesia provider during the entire surgery of a patient | Average of 30 mins - 3 hrs |
Pharmacogenomics of Drug Safety in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
To investigate whether genotypic differences can be identified between MS patients developing 'liver injury' (defined as ALT levels five times the upper normal limit and above) compared to those not developing liver injury after exposure to beta-interferon for MS.

Detailed Description
-----------------
PURPOSE: To investigate whether genotypic differences can be identified between MS patients who develop liver injury compared to those who do not develop injury in response to beta-interferon therapy. OBJECTIVE: To determine whether elevated liver enzyme tests (ALT > 5 times the upper limit of normal) in response to beta-interferon therapy in MS patients is associated with genetic polymorphisms. METHOD OF RECRUITMENT: Patients will be identified through a clinic database and chart reviews. An introductory letter will be mailed to potential participants, inviting them to volunteer. A follow-up phone call will be made to determine interest and consent into study. PROCEDURES: Saliva will be collected for genetic analyses and a questionnaire will be administered

Official Title
-----------------
Canadian Pharmacogenomics Network for Drug Safety: Genetic Factors Associated With Multiple Sclerosis Treatment

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases and controls must have definite MS (Poser or McDonald criteria) relapsing-remitting or secondary-progressive disease course Prescribed a beta-interferon as their immunomodulatory drug for MS Exclusion Criteria: primary-progressive MS an elevated liver test result within 6 months of starting beta-interferon treatment presence of a co-morbidity that is a known risk-factor for liver injury

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 |
| --- | --- |
| Case<br>MS patients experiencing an adverse drug reaction to an MS immunomodulatory therapy | |
| Control<br>MS patients not experiencing an adverse drug reaction to an MS immunomodulatory therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experienced an adverse drug reaction or not? |  | No specified time frame | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genetics, genomics, Multiple Sclerosis, beta-interferons
Adaptive Portable Essential Tremor Monitor

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the utility of a portable motion sensor-based system designed to monitor essential tremor (ET) to better prescribe therapy to minimize symptoms and expand care for ET patients.

Official Title
-----------------
Phase II Study: Adaptive Portable Essential Tremor Monitor

Conditions
-----------------
Essential Tremor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years or older Clinical diagnosis of essential tremor Able to provide informed consent Exclusion Criteria: Significant medical or psychiatric illness Not capable of following the required clinical instructions Serious medical conditions that compromise safety

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 |
| --- | --- | --- |
| Tremor ratings during activities of daily living versus standardized tasks. |  | 10 hours each day the sensor is worn. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
essential tremor, motion sensors, tremor
Early Assessment of Respiratory Function, Inflammation and Bronchial Reshuffle Among Newborns Screened for Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to show that there is a concordance between lung disease at 13 months and the existing 9 weeks in newborn babies with cystic fibrosis asymptomatically. This will identify at the first examination at 8 weeks, newborns who have the most impaired lung function at 13 months. To meet this objective an assessment of their lung function at 9 weeks and 1 month will be performed in newborns diagnosed with cystic fibrosis.

Official Title
-----------------
Early Assessment of Respiratory Function, Inflammation and Bronchial Reshuffle Among Newborns Screened for Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Other: assessment of lung function


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Infant aged 11 weeks Exclusion criteria : Gestational age lower than 35 weeks of gestation, Background invasive mechanical ventilation in positive pressure Documented -Obstructive Sleep Apnea, heart defect, neuromuscular disease

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

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: cystic fibrosis<br>assessment of lung function in newborns screened for cystic fibrosis | Other: assessment of lung function<br>* measurement of lung volumes and flow rates of bronchial<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from respiratory function at 7 months and 11 months | measurement of lung volumes and flow rates of bronchial | 7 months and 11 months |
Bioequivalency Study of Zolpidem Tartrate Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was the bioequivalence of a Roxane Laboratories' Zolpidem Tablets, 10 mg, to Ambien® Tablets, 10 mg (Sanofi-Synthelabo Inc.) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.

Official Title
-----------------
A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of Zolpidem Tartrate Tablets 10 MG Under Fasting Conditions

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: Zolpidem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Zolpidem or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zolpidem|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | Baseline, Two period, Seven day washout |
The Clinical Course of Coronary Artery Disease in Coronary Multidetector Computed Tomographic Angiogram

Study Overview
=================
Brief Summary
-----------------
Study Type: Observational Study Design: Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective

Detailed Description
-----------------
The natural history of individual plaques is unknown and needs to be established. Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality for assessing coronary plaque. Using MDCT, the researchers prospectively investigate the relationship between the presence of coronary plaques and cardiovascular events

Official Title
-----------------
Prognostic Role of Coronary Artery plaquEs in Patients With Suspected Coronary Artery Disease Using Multislice of Computed Tomography (PREDICT)

Conditions
-----------------
Atherosclerosis, Cardiovascular Diseases, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with known or suspected coronary artery disease Exclusion Criteria: Irregular heart beat Known allergy towards the contrast agent Renal dysfunction Impossible breath-hold Acute coronary syndrome patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Major cardiovascular events | Cardiovascular death, non-fatal MI, or any stroke | 1 years after the MDCT-scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all causes of hospitalization | Requiring hospitalization | 1 years after the MDCT-scan |
Protein Ingestion and Muscle Carnitine Uptake

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effects of a protein-carbohydrate beverage on the absorption of an orally ingested bolus of L-carnitine, compared to flavoured water and carbohydrate-only controls, and to determine whether increasing plasma carnitine availability can impact upon insulin-stimulated muscle carnitine uptake.

Official Title
-----------------
The Effects of an Insulinotropic Protein-carbohydrate Beverage on L- Carnitine Absorption and Muscle Carnitine Uptake

Conditions
-----------------
Muscle, Skeletal

Intervention / Treatment
-----------------
* Dietary Supplement: Flavoured water
* Dietary Supplement: Flavoured water + carbohydrate
* Dietary Supplement: Flavoured water + carbohydrate + protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Body mass index of 18-25 kg/cm2 Exclusion Criteria: Unhealthy Smoker Taking any medication that interferes with skeletal muscle metabolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: CON<br>500 ml of flavoured water | Dietary Supplement: Flavoured water<br> <br> |
| Active Comparator: CHO<br>500 ml of flavoured water containing 80 g carbohydrate | Dietary Supplement: Flavoured water + carbohydrate<br> <br> |
| Active Comparator: CHO-PRO<br>500 ml of flavoured water containing 40 g carbohydrate and 40 g whey protein | Dietary Supplement: Flavoured water + carbohydrate + protein<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle carnitine uptake | Change in forearm carnitine uptake (measured using arterialised-venous - venous balance technique) in response to intervention. | 180 minutes |
Prospective Evaluation of Aeromedical EMS Ultrasound in Major Trauma Victims

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the use of ultrasound by aeromedical prehospital providers.

Detailed Description
-----------------
This study will be divided into three parts. The first portion involves the education/inservices of the aeromedical prehospital providers to document the knowledge and skills necessary to perform and interpret eFAST exams using ultrasound pre hospitalization. The second portion involves testing the logistics of utilization of prehospital ultrasound. Data will be collected by the participating aeromedical prehospital providers to rate the durability of the equipment, difficulty in preforming the eFAST exam, interference with other actions and ability of retention of images. The third portion will involve the aeromedical prehospital providers performing the eFAST exam using the ultrasound prehospital and comparing their findings with the gold standard exam, CT scan, while patient is in the emergency department.

Official Title
-----------------
UTHSC-H Proposal for Prospective Evaluation of Aeromedical EMS Ultrasound in Major Trauma Victims.

Conditions
-----------------
Major Trauma Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Code 3 trauma activation Admitted directly from scene Transported via Life Flight (aeromedical ambulance) Exclusion Criteria: transfer from outside hospital

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 |
| --- | --- |
| major trauma victims<br>Code 3 patients (highest acuity) admitted to hospital via air ambulance service | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome for this study is to determine if the aeromedical prehospital providers are able to accurately and rapidly perform and interpret eFAST exams in major trauma victims. |  | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Code III trauma (highest acuity), Life Flight aeromedical ambulance service
Left Atrial Geometry and Outcomes After Atrial Fibrillation Ablation

Study Overview
=================
Brief Summary
-----------------
This is a Multicenter Observational 1-year retrospective cohort study evaluating the predictive value of the Left Atrial Sphericity on the recurrence rate of atrial fibrillation after pulmonary vein ablation procedure. Inclusion of consecutive patients undergoing AF ablation during 2013 in whom a 3D-imaging of the left atrium (Cardiac CT or MRA) was acquired prior to the procedure and when procedural/follow-up data was prospectively collected.

Detailed Description
-----------------
Validation of the predictive value of the Left Atrial Sphericity for AF recurrence of atrial fibrillation after a pulmonary vein ablation procedure in an external, multicenter cohort. In total, 9 centers will include consecutive patients who underwent AF ablation from january to december 2013 in whom a 3D-imaging of the left atrium (Cardiac CT or MRA) was acquired prior to the procedure and when procedural/follow-up data was prospectively collected.

Official Title
-----------------
External Validation of the Left Atrial Sphericity as Predictor of Recurrence After Atrial Fibrillation Ablation: A Multicenter Observational Study.

Conditions
-----------------
Atrial Fibrillation, Recurrence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old First AF ablation procedure Prior 3D-imaging of the left atrium (CT or MRA) Prospective collection procedural and outcome data Obtention of Informed Consent Exclusion Criteria: Previous left atrial ablation or surgical procedure

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 |
| --- | --- | --- |
| Atrial Fibrillation Recurrence (>30 seconds) |  | One Year |
Bilateral Transversus Abdominis Plane Block and Postoperative Pain Intensity After Elective Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
The patients planned to go under elective cesarean delivery under general anesthesia are randomly assigned to have either bilateral transversus abdominis plane (TAP) block or usual standard analgesics after cesarean. Pain score (Verbal Analog Scale VAS) and analgesic requirements are recorded. It's supposed that both are significantly reduced in patients undergoing TAP block.

Official Title
-----------------
Evaluation of the Effect of Bilateral Transversus Abdominis Plane Block on Postoperative Pain Intensity and Analgesia Consumption After Elective Cesarean Delivery

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: TAP blockade


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective cesarean delivery Term pregnancies General anesthesia Pfannenstiel incision Exclusion Criteria: No history of sensitivity to prescribed analgesic (Bupivacaine or related substances) No preeclampsia No history of psychologic disorders

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

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

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: TAP blockade<br>bilateral TAP blockade at the end of cesarean delivery | Procedure: TAP blockade<br>* 15 cc Bupivacaine 0.25% ,injected bilaterally in the TAP blockade arm<br>|
| No Intervention: No TAP<br>These patients would have usual analgesic drugs after cesarean | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity after cesarean section |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic prescribed measurement |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transversus abdominis block, postoperative pain, cesarean