linjc16/ctgov huggingface dataset:
DDI HV (ATV - Merck)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to to assess the effect of ATV 300 mg BID on the PK of raltegravir 400 mg BID, to assess the effect of raltegravir 400 mg BID on the PK of ATV 300 mg BID, and to assess the ECG effects of ATV 300 mg BID over 21 days, given with or without raltegravir 400 mg BID.

Official Title
-----------------
Open Label, Multiple Dose, Sequential, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of Atazanavir and Raltegravir Co-Administered Twice Daily in Healthy Subjects

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Raltegravir
* Drug: Atazanavir
* Drug: Atazanavir + Raltegravir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects between the ages of 18 to 45 years old with a body mass index (BMI) of 18 to 32 kg/m² Prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (WOCBP) must have a negative pregnancy test Exclusion Criteria: Any significant acute or chronic medical illness Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations. Use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration Use of any other drugs, including over-the-counter medications and herbal preparations within 1 week prior to study drug administration

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Raltegravir<br>* Tablet, Oral, 400 mg, twice daily for 5 Days<br>|
| Active Comparator: 2<br> | Drug: Atazanavir<br>* Capsule, Oral, 300 mg, twice daily for 7 Days<br>* Other names: Reyataz;|
| Active Comparator: 3<br> | Drug: Atazanavir + Raltegravir<br>* Capsule/Tablet, Oral, 300/400, twice daily for 14 Days<br>* Other names: Reyataz;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessments |  | Screening, Days -1, 1, 5, 6, 8, 10, 12, 13, 15, 19, 22, 26, and Study Discharge | 
| Pharmacokinetic Assessments |  | Days 5, 12, and 26 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antivirals / HIV
Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
Acetaminophen and ibuprofen has been safely used for a long time and reduces postoperative pain and opioid dosages. Investigators are planning to compare the efficacy of 1) acetaminophen only and 2) acetaminophen and ibuprofen combination at postoperative pain after thyroidectomy.

Detailed Description
-----------------
Acetaminophen and ibuprofen has been safely used for a long time and reduces postoperative pain and opioid dosages. Investigators are planning to compare the efficacy of 1) acetaminophen 1g only and 2) the combination of acetaminophen 1g and ibuprofen 300mg at postoperative pain after thyroidectomy. Some recovery valuables such as the postoperative pain and opioid requirements will be assessed

Official Title
-----------------
Efficacy of Acetaminophen-ibuprofen Combination on the Postoperative Pain After Thyroidectomy

Conditions
-----------------
Thyroid Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patients undergoing scheduled thyroidectomy American Society of Anesthesiologists status 1 or 2 Exclusion Criteria: refusal to be enrolled in the study emergency surgery hepatic or renal disease on chronic pain medications psychiatric disorders pregnancy, lactation allergy or contraindication to the study drug

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>acetaminophen 1g iv dripping | Drug: Acetaminophen<br>* acetaminophen 1g iv dripping at end of surgery<br>|
| Experimental: experimental group<br>the combination of acetaminophen 1g and ibuprofen 300mg iv dripping | Drug: Acetaminophen<br>* acetaminophen 1g iv dripping at end of surgery<br>Drug: Ibuprofen<br>* ibuprofen 300mg iv dripping at end of surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | the maximal postoperative pain severity using pain scale(visual analogue scale; 0 cm=no pain; 10 cm=the worst pain) | during 30 minutes after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain killer requirement | the incidence of the patients who require pain killer | during 30 minutes after surgery |
Feasibility of Continuous Noninvasive Finger Arterial Blood Pressure Measurement for Detection and Staging of Aortic Stenosis

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is electronic data collection of arterial pressure waveform signals in patients with Aortic Stenosis. The collected digital pressure waveform data will be used to assess the feasibility of using the arterial pressure signal as a decision support tool for early detection of aortic stenosis conditions. Furthermore we evaluate hemodynamic parameters before and after valve repair and its correlation with outcome.

Official Title
-----------------
Feasibility of Continuous Noninvasive Finger Arterial Blood Pressure Measurement for Detection and Staging of Aortic Stenosis

Conditions
-----------------
Aortic Stenosis, Calcific

Intervention / Treatment
-----------------
* Device: Nexfin measuremtents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: o Patients with severe senile degenerative aortic valve stenosis Clinical team agrees on eligibility including assessment that TAVR is appropriate for the subject Patients undergoing TAVR via the femoral approach Patients who normally require a guiding catheter for central aortic pressure monitoring during the TAVR procedure Patient must be 18 years old or older Patient, or legally authorized representative, has given consent to be in the study Patient height and weight are available prior to study Ability to perform a Nexfin measurement at the left hand side. Exclusion Criteria: o Patients with contraindications for placement of aortic catheter Patients with mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+). Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is noncalcified Patients being treated with an intra-aortic balloon pump Patients less than 40 kg in weight Female patients of childbearing potential with a known pregnancy Patient is currently participating in an investigational drug or another device study that clinically interferes with the study endpoints
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 for TAVR<br>Patients for TAVR | Device: Nexfin measuremtents<br>* There will be only observational recordings, no interevntion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the distinctive morphological characteristics of the aortic pressure waveform | the distinctive morphological characteristics of the aortic pressure waveform | During procedure and 4 hours after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in hemodynamic variables after TAVR and its influence on cardiac recovery. |  | during procedure and up to 6 weeks after intervention |
A Comparison of Injection Pain of Propofol During Endoscopy : LCT Propofol vs MCT/LCT Propofol

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by long chain triglyceride propofol versus medium/long chain combinated triglyceride propofol on endoscopy.

Official Title
-----------------
A Comparison of Injection Pain of Propofol During Endoscopy : LCT Propofol vs MCT/LCT Propofol

Conditions
-----------------
Pain, Complication of Injection

Intervention / Treatment
-----------------
* Drug: Fresofol
* Drug: Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >15 yrs ASA (American Society of Anesthesiologists risk class III-IV)I-II patients undergoing to gastroscopy Exclusion Criteria: significant systemic disease (American Society of Anesthesiologists risk class III-IV) history of allergic reactions to any of the study drugs chronic use of opioid analgesics psychiatric disorder arrythmia pregnancy age <18 yrs

Ages Eligible for Study
-----------------
Minimum Age: 15 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FRESOFOL MCT<br>To compare the incidence and intensity of pain on injection that is caused by propofol (LCT propofol) versus fresofol (MCT/LCT propofol) . | Drug: Fresofol<br> <br> |
| Active Comparator: Propofol<br>The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (LCT propofol) versus fresofol (MCT/LCT propofol). | Drug: Propofol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and Intensity of Pain on Injection That is Caused by Propofol (LCT propofol) Versus the Fresofol (MCT/LCT propofol). |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction With Sedation Including the Recall of Pain. |  | 2 hours and 5-7days after the end of the procedure |
Current Situation and Analysis of ICU Management for Severe Trauma Patients in China

Study Overview
=================
Brief Summary
-----------------
Over the past 10 years, there has not been a consensus on ICU nursing management based on the concept of injury control. Case management for patients with serious trauma continues to be initiated in general services and after discharge.There is no critical care unit case management strategy for the high-risk population following acute intake. Consequently, there is an urgent need to develop and enhance ICU nursing best practice after injury control.

Official Title
-----------------
Current Situation and Analysis of ICU Management in Severe Trauma Patients: A Survey From 12 Provinces in China

Conditions
-----------------
ICU, Trauma Injury, ICU Acquired Weakness

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Registered nurses, doctors, and rehabilitation technicians on the job; Formally hired, and working in ICU for more than 6 months, with ICU patient management experience; Voluntary participation in this survey. Exclusion Criteria: retirees, interns/nurses/rehabilitation technicians, staff on leave, regular training doctors, and departmental nurses; those who are unwilling to participate in this survey.

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 |
| --- | --- |
| ICU management for patients with severe trauma<br>Group to investigate the current status of ICU management for patients with severe trauma | Other: No Intervention<br>* No Intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition of ICU severe trauma patient | The management status of severe trauma patients: including 5 dimensions of risk factor management, related complications management, ICU transition ward preparation plan, discharge preparation plan, and doctor-patient communication | 20 days |
Simvastatin Effect on End Stage Renal Failure Patients Treated by Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
This study will analyse the effect of simvastatin on endothelium dependent venodilation in chronic renal failure patients treated by peritoneal dialysis. The hypothesis is that patients will have a greater endothelium dependent venodilation after four months of simvastatin use.

Detailed Description
-----------------
This study will analyse the effect of simvastatin on endothelium dependent venodilation in chronic renal failure patients treated by peritoneal dialysis. The hypothesis is that patients will have a greater endothelium dependent venodilation after four months of simvastatin use.

Official Title
-----------------
Simvastatin Effect on Endothelium Dependent Venodilation in Chronic Renal Failure Patients Treated by Peritoneal Dialysis

Conditions
-----------------
Renal Failure, End Stage, Peritoneal Dialysis

Intervention / Treatment
-----------------
* Drug: Simvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: end stage renal failure peritoneal dialysis LDL cholesterol > 100mg/dL > 18 years and < 80 years Exclusion Criteria: using statin or nitrate liver disease diabetes mellitus

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial venodilation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation markers (C-reactive protein, IL-6, TNF) |  |  | 
| Lipoproteins |  |  | 
| Oxidative stress |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
end stage renal failure, peritoneal dialysis, simvastatin, endothelium, vasodilation
Coil Embolization of Coronary Artery Fistulas

Study Overview
=================
Brief Summary
-----------------
Background and Purpose: Congenital coronary artery fistula (CAF) is an uncommon anomaly. In some patients they can became symptomatic, associated with significant morbidity and mortality. We report our experience in percutaneous treatment of CAF.

Detailed Description
-----------------
Congenital coronary artery fistula (CAF) can be defined as a direct communication of a coronary artery with a cardiac chamber, great vessel, or other vascular structure, bypassing the myocardial capillary bed. CAF is an uncommon anomaly, occurring as an incidental finding in 0.1% to 0.2% of coronary angiograms. They are not gender specific. Many patients have symptoms like congestive heart failure, infective endocarditis, myocardial ischemia, or rupture of an aneurismal fistula. Surgical closure of coronary artery fistula was initially reported in 1983 with low rates of morbidity and mortality. Percutaneous treatment appeared as an alternative to surgery. Transcatheter closure of CAF was first utilized in 1983. Along this years, with experience and improvements in catheterization equipment and occlusion devices, CAF occlusion have been successfully performed using microcoils. We report our experience in using microcoils to percutaneous treatment of coronary fistulas.

Official Title
-----------------
Coil Embolization of Coronary Artery Fistulas: A Single Centre Experience

Conditions
-----------------
G09330582163324, C14, C14907933, C14907933125, C14280647250

Intervention / Treatment
-----------------
* Device: Coil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary artery fistulas Clinical diagnosis of angina, myocardial infarction, left ventricular insufficiency, ventricular enlargement Exclusion Criteria: Age <18 or > 85 years Cardiogenic shock _ severe ventricular enlargement

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Coil|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
-----------------
coronary fistulas., coils embolization.
Proteomics of Severe Traumatic Brain Injury: A Feasibility Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to: Determine the temporal course of matrix metalloproteinase (MMP) expression in patients wiht severe traumatic brain injury Determine the temporal course of the expression of MMP-related inflammatory mediators of secondary injury in patients with severe traumatic brain injury Describe the association of physiological changes and standard microdialysis analyte measures (lactate, pyruvate, lactate/pyruvate ratio, and glucose) to MMP and neuroinflammatory marker concentrations.

Official Title
-----------------
Proteomics of Severe Traumatic Brain Injury: A Feasibility Study

Conditions
-----------------
Brain Injuries, Traumatic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is 18 years of age or older Patient has GCS less than 9 Patient requires intracranial pressure monitoring Patient life expectancy greater than 72 hours Exclusion Criteria: Patient's TBI is greater than 24 hours old Patient is less than 18 years of age Patient does not require intracranial pressure monitoring Patient has life expectancy less than 72 hours Patient has GCS greater or equal to 9 Patient is currently enrolled in another study

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Craniocerebral trauma, matrix metalloproteinase, microdialysis
Regulation of Tissue Lipolysis by Insulin in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Inadequate suppression of intramuscular and adipose tissue lipolysis, and consequent excessive delivery of fatty acids to ectopic tissues (e.g. muscle, pancreas and liver) could play an important role in the development and exacerbating of insulin resistance. Therefore, the investigators propose to study the regulation of adipose tissue and skeletal muscle lipolysis, as well as further characterize the intracellular lipolytic pathways within these tissues, in obese normoglycaemic versus long-term diagnosed type 2 diabetic subjects.

Official Title
-----------------
Regulation of Lipolysis by Insulin in Skeletal Muscle and Adipose Tissue in Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Other: Hyperinsulinemic euglycemic clamp


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian Normal blood pressure (SBP 100-140 mmHg, DBP 60-90 mmHg) weight stable in last 3 months Exclusion Criteria: Smokers people with intensive fitness training (e.g. athletes > 3 times/week) History of cardiovascular diseases Bleeding disorders Use of medication interfering with the study endpoints/hypotheses (e.g. beta-blockers) Not to be able to understand the study information Subjects on a special diet or vegetarian Blood donation 2 months prior to the study and during the study Participating in an other study

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NGT<br>Normal glycaemic healthy control men, age between 45-65, BMI 25-35 kg/m2 | Other: Hyperinsulinemic euglycemic clamp<br> <br> |
| T2D<br>Type 2 diabetic men, age 45-65 yrs, BMI 25-35, diagnosed >5yrs and Hba1c 7-9% | Other: Hyperinsulinemic euglycemic clamp<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in insulin sensitivity of adipose tissue and skeletal muscle lipolysis | Changes from baseline in glycerol (lactate, pyruvate and glucose) in tissue microdialysate during a 3 step euglycemic hyperinsulinemic clamp (8, 20 and 40mU of insulin), every step for 2h | 8, 20 and 40 mU insulin (2 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline adipose tissue and skeletal muscle gene expression | gene expression of genes related to lipid, glucose metabolism, insulin signalling will be measured in baseline adipose tissue and skeletal muscle biopsies | baseline | 
| Baseline skeletal muscle lipid accumulation | Baseline skeletal muscle lipid accumulation is measured (TAG, DAG, Phospholipid and fatty acids) | Baseline |