linjc16/ctgov huggingface dataset:
Gastric Ultrasound Prior to Extubation

Study Overview
=================
Brief Summary
-----------------
Serial gastric ultrasound assessments to assess the effect of fasting for 4 hours on gastric volume in mechanically ventilated patients in the ICU fasted for extubation.

Official Title
-----------------
Serial Ultrasound Assessment of Gastric Volume in Mechanically Ventilated Patients Fasted Prior to Extubation: a Prospective Observational Study

Conditions
-----------------
Fasting

Intervention / Treatment
-----------------
* Diagnostic Test: Gastric ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 years of age, mechanically ventilated patients in the ICU, intubated with endotracheal enteral feeding for over 6 hours before fasting Exclusion Criteria: BMI > 40, pregnant, fine bore nasogastric tube, mechanical obstruction to gastric emptying, history of upper GI surgeries

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Gastric ultrasound|Gastric ultrasound upon fasting, after 4 hours, and after nasogastric aspiration, to estimate gastric volume|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in gastric volume before and after 4 hours of fasting | Ultrasound measurement of gastric antrum dimenstions (antero-posterior and cranio-caudal dimensions) before and after 4 hours of fasting | Over 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastric ultrasound, Gastric emptying
Remotely Monitoring Patients With Chronic Conditions in Their Home

Study Overview
=================
Brief Summary
-----------------
Study will collect data from the home using the CoVa Monitoring System. Data will be captured and retrospectively analysis to determine if the data provided can alert clinician about a patient's declining health.

Detailed Description
-----------------
Study will collect data from the home using the CoVa Monitoring System. Data will be captured and retrospectively analysis to determine if the data provided can alert clinician about a patient's declining health. Data from the CoVa Monitoring System will be compared against electronic health records to determine if the data captured will provide insight into a patient's overall health. Additionally, user compliance will be monitored

Official Title
-----------------
Necklace-Shaped Sensor for Non-Invasive Measurement of Vital Signs, Thoracic Impedance, ECG, Skin Temperature and Motion

Conditions
-----------------
CHF

Intervention / Treatment
-----------------
* Device: Discontinuation of using device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic Disease including CHF Currently receiving home health care Recent discharge for a CHF event Exclusion Criteria: Skin reaction to electrodes Inability to take measurements due to low BMI

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 99 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 |
| --- | --- |
| Cohort 3<br>This cohort is living at home with a chronic condition. | Device: Discontinuation of using device<br>* Subject will be instructed to discontinuation of use of device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data correlation | Correlation between data collection and potential heart failure event | 2-6 months |
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Detailed Description
-----------------
To characterize the acute effects of oral Dronabinol (10 mg capsule) in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Official Title
-----------------
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol in Healthy Humans: Sub-Study I

Conditions
-----------------
Cannabis

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Dronabinol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one lifetime exposure to cannabis Good physical and mental health Exclusion Criteria: Cannabis naive individuals Major current or recent stressors Taking estrogen supplements or oral contraceptive pills (for women) Sesame oil allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: THC<br>10 mg Dronabinol will be administered orally. | Drug: Dronabinol<br>* 10 mg capsule of Dronabinol will be administered orally.<br>* Other names: Delta-9-Tetrahydrocannabinol;|
| Placebo Comparator: Placebo<br>Placebo pill (no active cannabinoids). | Drug: Placebo<br>* Placebo pill (no active cannabinoids)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline: Rewarding Effects measured by Visual Analog Scale (VAS) | Subjective measure of THC induced high | changes in high assessed over the following timepoints: baseline, +60, +80, +120, +180, +300 minutes after start of oral Dronabinol administration. | 
| Change from Baseline: Verbal Learning: Measured by Rey Auditory Verbal Learning Test (RAVLT) | Measured as delay recall on the AVLT | baseline and +80 minutes after start of oral Dronabinol administration. |
Clinical Study and Economic Analysis of an Intraoperative Navigation System for Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
This study will assess the clinical and health economic value of an intraoperative navigation system for total hip arthroplasty in one Ontario hospital. The results of this study will be used to generate evidence-based recommendations on the use and funding of the device in public hospitals and inform the development of a provincial healthcare innovation pathway.

Official Title
-----------------
A Single-blinded Randomized Control Study and Economic Analysis of an Intraoperative Navigation System for Total Hip Arthroplasty

Conditions
-----------------
Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Procedure: Intra-Operative Device for THA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving primary THA Elective THA Provision of informed consent Exclusion Criteria: Unable to obtain informed consent Receiving revision THA THA is to treat trauma (i.e. hip fracture and/or dislocation) Patient is undergoing simultaneous bilateral hip replacement Performing surgeon is not participating in the study Hip fracture Hip dislocation Severe osteoporosis Trochanteric osteotomy Suspected or actual infection Existing implanted hardware Severe deformities of the femoral or pelvic bone High Body Mass Index (BMI)*

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: Control<br>The control group will receive primary elective THA as per standard of care surgical protocols for this type of surgery | Procedure: Intra-Operative Device for THA<br>* The intervention group will receive primary elective THA with the use of Intellijoint HIP 3D mini-optical navigation tool.<br>|
| Experimental: Treatment<br>The intervention group will receive primary elective THA with the use of Intellijoint HIP 3D mini-optical navigation tool. | Procedure: Intra-Operative Device for THA<br>* The intervention group will receive primary elective THA with the use of Intellijoint HIP 3D mini-optical navigation tool.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activities of Daily Living | Hip disability and Osteoarthritis Outcome Score (HOOS) Scores are 1-100 and each subscale is scored and then connected with a line on a graph to generate a HOOS profile. 0 indicates extreme problems and 100 indicates no problems. | up to 12 months |
Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
This is a prospective study of pediatric patients with congenital heart disease, in which acetaminophen serum concentrations will be measured following a single intraoperative intravenous dose of acetaminophen. These levels will be used to develop a pharmacokinetic model. Serum concentrations will be compared between two groups of patients: (1) cyanotic patients presenting for the Fontan completion operation and (2) patients with acyanotic congenital heart disease presenting for repair via median sternotomy.

Official Title
-----------------
Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Drug: Acetaminophen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting for Fontan palliation or for surgical repair requiring median sternotomy, will be included in the study. Only patients who receive intravenous acetaminophen in the operating room will have serum levels drawn. Exclusion Criteria: Documentation of an allergy to acetaminophen Severe hepatic disease or other contraindications to acetaminophen use Patient has received acetaminophen within 24 hours of their procedure

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 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 |
| --- | --- |
| Cyanotic CHD<br>Cyanotic congenital heart disease (CHD) patients presenting for Fontan palliation. | Drug: Acetaminophen<br>* IV acetaminophen given as part of standard of care.<br>|
| Acyanotic CHD<br>Acyanotic congenital heart disease (CHD) patients presenting for repair via median sternotomy. | Drug: Acetaminophen<br>* IV acetaminophen given as part of standard of care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Acetaminophen Serum Concentrations | To determine the change in serum concentration of acetaminophen between each timepoint. | 15-20 minutes; 30-40 minutes; 50-70 minutes; 80-100 minutes; 2 Hours, 4 Hours; and 6-Hours Post-IV acetaminophen administration |
Safety Evaluation of Advantage Anti-Caries Varnish

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish.

Detailed Description
-----------------
This is an open-label Phase 1 study. The active ingredients are Povidone Iodine and Sodium Fluoride [Therametrics Technologies, Inc, Noblesville, IN, USA]. The oral soft tissues and teeth of the children will be examined and the test varnish to the teeth. The child will be re-examined at 24-48 hours for the presence of adverse oral soft tissue changes. At the follow-up, a qualified dental provider will ask questions focused on adverse events.

Official Title
-----------------
Phase 1 Safety Evaluation of Advantage Anti-Caries Varnish

Conditions
-----------------
Dental Caries

Intervention / Treatment
-----------------
* Drug: Varnish


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Exclusion Criteria: Weight less than 15 kg or hypersensitivity to iodine

Ages Eligible for Study
-----------------
Minimum Age: 36 Months
Maximum Age: 60 Months

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

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

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: Varnish<br>Dental varnish containing povidone iodine and sodium fluoride | Drug: Varnish<br>* Topical application to the teeth<br>* Other names: Advantage Anti-Caries Varnish;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft Tissue | Proportion of participants with any oral ulcerations OR inflammatory response | within 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Proportion of participants with any emergency medical care OR report of nausea OR not eating OR vomiting OR difficulty swallowing OR swelling around the mouth OR itchiness around the mouth OR hives OR rash OR stomach ache OR diarrhea | within 48 hours |
The Effect of LY333531 on Protein in the Urine in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study are to determine 1) Whether Ly333531 can reduce urinary albumin/creatinine excretion in patients with Type II diabetes and persistent albuminuria 2) Whether LY333531 reduces urinary TGF-B, 3) the safety of LY333531 and any side effects that may be associated with it.

Official Title
-----------------
The Effect of LY333531 on Albuminuria in Patients With Type 2 Diabetes A Pilot Clinical Trial

Conditions
-----------------
Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: LY333531


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus Greater than or equal to 30 years of age Albumin to Creatinine ratio (greater than 200 mg/g and less than 2000 mg/g) 4)Without language barrier. Exclusion Criteria: Serum Creatinine greater than 2.0 mg/dl males or greater than 1.7 mg/dl females B/P greater than 150 systolic and greater than 90 diastolic Hemoglobin Alc greater than 11% Liver Function Tests 2 times upper limit of normal Poor medical or psychiatric risk.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: LY333531|nan|

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
-----------------
Persistent Albuminuria
Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.

Official Title
-----------------
A 12-Week, Randomized, Double-Blind, Multi-Center, Vehicle-Controlled, Parallel Group Study to Assess the Efficacy and Safety of the Diclofenac Sodium Gel 1% for the Relief of Signs and Symptoms in Patients With Osteoarthritis of the Knee.

Conditions
-----------------
Osteoarthritis of the Knee

Intervention / Treatment
-----------------
* Drug: Diclofenac Sodium Gel
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Osteoarthritis of the knee Exclusion Criteria: Other rheumatic disease, such as rheumatoid arthritis Active gastrointestinal ulcer during the last year Known allergy to analgesic drugs Other protocol defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- |
| Experimental: 1<br> | Drug: Diclofenac Sodium Gel<br>* 4 grams per knee, 4 times per day, for 12 weeks<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 4 grams per knee, 4 times per day, for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain in the target knee (WOMAC pain index); |  |  | 
| functional capacity in the target knee (WOMAC function index); and |  |  | 
| global rating of benefit (100 mm Visual Analogue Scale, VAS). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Diclofenac Sodium Gel 1% with regard attainment of: |  |  | 
| Low pain intensity in either knee; and |  |  | 
| Low functional impairment in either knee. |  |  | 
| Safety of Diclofenac Sodium Gel 1% assessed by: |  |  | 
| monitoring adverse events; and |  |  | 
| laboratory evaluations. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee osteoarthritis, degenerative joint disease, knee pain, joint pain, topical NSAID,, diclofenac sodium
Preemptive Analgesia With Intravenous Paracetamol for Post-cesarean Section Pain Control

Study Overview
=================
Brief Summary
-----------------
The investigators designed a prospective randomized study to investigate the efficacy of intravenous (IV) preemptive paracetamol on postoperative pain scores, patient satisfaction, total morfin consumption and the incidence of morfin-related side effects in patients undergoing cesarean section.

Official Title
-----------------
Preemptive Analgesia With Intravenous Paracetamol for Post-cesarean Section Pain Control : A Randomized Controlled Trial

Conditions
-----------------
Cesarean Section; Dehiscence

Intervention / Treatment
-----------------
* Drug: paracetamol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between the ages of 20-40 years, ASA physical status 1-2 who underwent elective cesarean surgery during general anesthesia were included in the study Exclusion Criteria: A history of allergy to any of the study medications (opiod, general anesthetic agents or paracetamol), history of opioid or paracetamol use, hepatic or renal failure, any psychological disorders, complications during cesarean section and unable to use PCIA device were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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 |
| --- | --- |
| Active Comparator: Group Paracetamol (Group P),<br>Drugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group P (n = 30) received 1 g iv paracetamol | Drug: paracetamol<br>* Drugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group P (n = 30) received 1 g iv paracetamol, patients in group S (n = 30) received 100 ml iv %0.9 NaCl<br>|
| Placebo Comparator: Group Saline (Group S)<br>Drugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group S (n = 30) received 100 ml iv %0,9 saline | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores measured by visual analog scale (VAS) |  | Postoperative 24 hours |