linjc16/ctgov huggingface dataset:
Clinical and Economic Impact of an Electronic Medical Record Interfaced Decision Support System Reinforced With Patient Specific Pharmacogenetic Data for Minimizing Severe Drug-Drug Interactions

Study Overview
=================
Brief Summary
-----------------
Leumit Health Services, an health maintenance organization operating in Israel, will incorporate a web-based, decision support system for handling drug-drug interactions and drug information, termed DDI+ reinforced with patient specific pharmacogenetic data. The investigators hypothesize that implementing such a system will reduce health-care expenditures (e.g., hospital admissions, referrals to ERs, Imaging procedures).

Official Title
-----------------
Clinical and Economic Impact of a Web Based, Electronic Medical Record Interfaced Electronic Decision Support System Incorporating Pharmacogenetic Evaluation for Physicians Intended, Mainly for Drug-drug Interaction. A Controlled Study in an Ambulatory Health Maintenance Organization Population

Conditions
-----------------
Healthcare

Intervention / Treatment
-----------------
* Other: DDI+ System and Pharmacogenetic Data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Number of chronic concomitant drugs ≥5 treated with 1 or more drugs with a well established interaction with 1 or more of the following CYP450 enzymes: 2c9, 2c19, 2d6 Exclusion Criteria: Patients diagnosed with HIV/AIDS, and/or viral hepatitis B or C

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DDI+ and Pharmacogenetic data<br>DDI+ System and Pharmacogenetic data | Other: DDI+ System and Pharmacogenetic Data<br> <br> |
| No Intervention: Standard Care<br>Control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Admissions |  | up to 12 month post initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
health care expenditure, drug drug interactions, electronic decision support systems, pharmacogenetics, Potential Reduction
Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the difference between two magnetic resonance imaging (MRI) techniques for visualizing arteries. The study hypothesizes that one method that relies upon imaging flowing blood in the pelvic and leg arteries will not be as accurate or efficient as injecting a safe imaging agent to change the appearance of the blood on the MRI. Both methods will be compared with Digital Subtraction Angiography (DSA).

Official Title
-----------------
A Phase II, Open Label, Randomized, Multicenter Trial Comparing Noncontrast MRA Versus Ferumoxytol Vascular Enhanced MRI (VE-MRI) for the Detection of Clinically Significant Stenosis or Occlusion of the Aortoiliac and Superficial Femoral Arteries in Subjects With Peripheral Arterial Disease Scheduled for Digital Subtraction Angiography (DSA)

Conditions
-----------------
Peripheral Arterial Disease (PAD)

Intervention / Treatment
-----------------
* Drug: ferumoxytol
* Drug: ferumoxytol
* Drug: ferumoxytol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with symptoms of PAD Scheduled for DSA Exclusion Criteria: Critical leg ischemia manifested by ulcers, gangrene or leg amputation Laboratory evidence of iron overload, liver disease, pregnancy History of allergy to or recent exposure to radiocontrast, gadolinium chelates, or intravenous iron therapy Clinical concerns about co-morbidities, subject suitability

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: Diagnostic
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dose 1 versus non-contrast MRA | Drug: ferumoxytol<br>* Dose 1 versus non-contrast MRA<br>|
| Experimental: 2<br>Dose 2 versus non-contrast MRA | Drug: ferumoxytol<br>* Dose 2 versus non-contrast MRA<br>|
| Experimental: 3<br>Dose 3 versus non-contrast MRA | Drug: ferumoxytol<br>* Dose 3 versus non-contrast MRA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess sensitivity and specificity of non-contrast MRA and VE-MRI at three ferumoxytol dosing levels |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess positive and negative predictive values of VE-MRI using ferumoxytol at different dosing levels. |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral arterial disease (PAD); Magnetic Resonance Angiography (MRA); Magnetic Resonance Imaging (MRI), imaging agent or biomarker
Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore the possible cognitive effects of oxybutynin tablets and oxybutynin gel.

Official Title
-----------------
Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: oxybutynin chloride immediate-release
* Drug: oxybutynin chloride topical gel
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females aged 60 and over English as a primary language Given written informed consent by signing and dating an informed consent form prior to study entry Exclusion Criteria: Current diseases in which the use of oxybutynin is contraindicated History of narrow-angle glaucoma or urinary or gastric retention Current use of drugs known to effect memory and cognition Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 79 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>oral oxybutynin | Drug: oxybutynin chloride immediate-release<br>* capsule containing oxybutynin chloride immediate-release 5 mg tablet administered three times daily, and placebo gel administered once daily<br>|
| Experimental: 2<br>oxybutynin topical gel | Drug: oxybutynin chloride topical gel<br>* oxybutynin chloride topical gel applied once daily, and capsule containing placebo tablet administered three times daily<br>|
| Placebo Comparator: 3<br>placebo tablets plus placebo gel | Other: placebo<br>* capsule containing placebo tablet administered three times daily, and placebo gel administered once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of accuracy of delayed recall name-phase association test |  | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects on other cognitive domains measured by various tests |  | one week |
Incidence of Postthoracotomy Pain Following General Anesthesia: A Comparison Between TIVA and Inhalation Anesthesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the incidence of postthoracotomy pain between total intravenous anesthesia (TIVA)and inhalation anesthesia after lung surgery.

Detailed Description
-----------------
Thoracotomy is one of the most painful surgical incisions. It has been shown that 5-80% of patients still suffer from thoracic pain 2-3 months after surgery and the international association for the study of pain (IASP) defines postthoracotomy pain syndrome (PTTS)as pain that recurs or persists at least 2 months after surgical procedure. Previous reports have shown that the incidence of PTTS varies according to preoperative pain, pain intensity, sex, and types of procedure. However, little is known about the effect of the type of anesthesia to postthoracotomy pain.

Official Title
-----------------
Incidence of Postthoracotomy Pain Following General Anesthesia: A Comparison Between TIVA and Inhalation Anesthesia

Conditions
-----------------
Lung Cancer, Neoplasms, Lung

Intervention / Treatment
-----------------
* Drug: propofol, remifentanil, sevoflurane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergo elective thoracotomy of lung surgery Exclusion Criteria: emergency operation age under 18 years patients with unstable hemodynamics

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 |
| --- | --- |
| Group I, Group II<br>Group I: anesthetized with TIVA (Propofol + Remifentanil) Group II: anesthetized with inhalation (sevoflurane) | Drug: propofol, remifentanil, sevoflurane<br>* Propofol: using target controlled infusion (TCI); 1-3ug/ml remifentanil: using TCI by 5-20 ng/ml sevoflurane: 2-3volume% (1-2 MAC)<br>* Other names: ultiva;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pain |  | 3 and 6 months later after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain characters |  | 3 and 6 months later after operation |
Effect of Standardized Exercise on Cardiopulmonary Function in Patients With Permanent Pacemaker Implantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe the changes of cardiopulmonary endurance in patients with pacemaker implantation after long-term exercise, to explore the significance of exercise on patients with pacemaker implantation, and to analyze the difference of the effect of exercise on cardiopulmonary endurance in patients with normal LVEF of different pacing ratios

Official Title
-----------------
Effect of Standardized Exercise on Cardiopulmonary Function in Patients With Permanent Pacemaker Implantation

Conditions
-----------------
Pacemaker DDD, Cardiopulmonary Endurance

Intervention / Treatment
-----------------
* Other: Supervise and guide regular exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-75 years old patients with pacemaker implantation for the first time, 3-6 months after operation stable condition, independent walking ability. Exclusion Criteria: Cognitive impairment; ICD, CRT / Crtd implanted, patients with neurogenic syncope; Atrial tachycardia, atrial fibrillation, NYHA class II or above, difficult to control hypertension; Musculoskeletal disease limiting activity nervous system disease, severe respiratory disease, Patients with acute inflammation, cancer and other diseases uncontrolled.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regular exercise group<br> | Other: Supervise and guide regular exercise<br>* Aerobic exercise, evaluated by cardiopulmonary exercise test, 3-5 times a week<br>|
| No Intervention: non-regurlar exercise group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parameters related to exercise cardiopulmonary assessment | VO2peak | followed up for one year |
The Effects of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease (P08637)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the safety and efficacy of diquafosol tetrasodium ophthalmic solution, 2% vs. placebo, in subjects with dry eye disease.

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Drug: Diquafosol tetrasodium ophthalmic solution, 2%
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have best corrected visual acuity in both eyes of at least +0.7 or better Central corneal staining of 3 on the NEI scale If female, are non-pregnant or non-lactating Have a history of dry eye disease in both eyes Have normal lid anatomy Exclusion Criteria: Unable to withhold the use of contact lenses during the study or 2 weeks prior to the study Have had ocular surface surgery within the past year Are considered legally blind in one eye Have a serious medical condition which could confound study assessments

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* One to two drops in each eye QID for 6 weeks<br>|
| Experimental: Arm 1<br> | Drug: Diquafosol tetrasodium ophthalmic solution, 2%<br>* One to two drops in each eye QID for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects that achieve clearing of fluorescein staining of the central cornea (NEI scale). Subjects must have a score of 0 on the NEI scale at Week 6 to be considered responders. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects that achieve a 2-or-more-unit reduction of fluorescein staining of the central cornea (NEI scale) |  | 6 weeks |
Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)

Study Overview
=================
Brief Summary
-----------------
Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package; i.e. the transthoracic parametric Doppler (TPD) (EchoSense Ltd., Haifa, Israel). Systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may provide important insight into pulmonary blood vessels characteristics by the LDS signals that are related to pulmonary hypertension. The TPD performance in detecting PAH in SSc patients will be assessed in the study.

Official Title
-----------------
Evaluation of Lung Doppler Signals (LDS) in Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc)

Conditions
-----------------
Systemic Sclerosis, Pulmonary Hypertension

Intervention / Treatment
-----------------
* Radiation: Doppler ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able and willing to give signed informed consent prior to enrollment Male or female, ≥ 18 years of age Diagnosis of SSc according to 2013 ACR/EULAR SSc Classification Criteria (van den Hoogen 2013): Score ≥ 9. Patients with RHC data available from measurement within 3 weeks prior to TPD assessment No change in or initiation of PAH specific therapy between the last RHC and TPD Exclusion Criteria: People unable or unwilling to give informed consent. PCWP or LVEDP > 15 mmHg Any PH etiology outside Group 1 (Dana Point, 2008) Pregnant women Patients having severe chest wall deformity

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doppler ultrasound<br> | Radiation: Doppler ultrasound<br>* Recording Doppler ultrasound noninvasively from the right chest wall<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of SSc patients correctly identified with pulmonary hypertension severity in each of the 4 defined groups by RHC. | Analyze Doppler data of 4 SSc groups (according to pulmonary hypertension sevirity) resulting in typical features. The features will be implemented in a pre-determined diagnostic algorithm that will determine the overall statistical analysis success of the method in comparison to RHC data. | 12 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systemic Sclerosis, Pulmonary hypertension, Lung Doppler signals
Double Lumen Tube Intubation

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to compare time, success rates of different double-lumen tubes in intubation in a standardized manikin model.

Official Title
-----------------
Comparison of Techniques for Double-lumen Tube Intubation: Standard Double-lumen Tube or VivaSight Double Lumen Tube by Paramedics. A Randomized Crossover Manikin Trial.

Conditions
-----------------
Endotracheal Intubation, Cardiac Arrest

Intervention / Treatment
-----------------
* Device: standard double-lumen tube
* Device: VivaSight Double Lumen Tube


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: give voluntary consent to participate in the study minimum 1 year of work experience in emergency medicine experienced emergency medicine personnel (physicians, nurses, paramedics) Exclusion Criteria: not meet the above criteria wrist or low back diseases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ETI intubation<br>endotracheal intubation in manikin | Device: standard double-lumen tube<br>* intubation using standard double-lumen tube<br>Device: VivaSight Double Lumen Tube<br>* intubation using VivaSight Double Lumen Tube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of intubation | effectiveness of first, second and third intubation attempts and overall effectiveness of intubation by participants | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | time in seconds required for a successful intubation attempt | 1 day | 
| Cormack-Lehane grading | self-reported percentage the vocal cord visualization using the Cormack-Lehane grading (grade 1-4) | 1 day | 
| Preferred ETI device | participants were asked which method of ETI they would prefer in a real-life. | 1day |