linjc16/ctgov huggingface dataset:
Assessment of Potential Interactions Between GBR 12909 and Cocaine - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and 3 doses of GBR 12909.

Detailed Description
-----------------
This is Phase 1, double-blind, placebo-controlled human laboratory clinical pharmacology study that will assess the potential interactions between IV cocaine and 3 escalating oral doses of GBR 12909. The primary objective is to determine safety of GBR 12909 administration and if there are significant interactions between GBR 12909 treatment concurrent with IV cocaine infusions.

Official Title
-----------------
Study of Interactions Between GBR 12909 and Cocaine

Conditions
-----------------
Cocaine-Related Disorders

Intervention / Treatment
-----------------
* Drug: GBR 12909


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be within 20% ideal body weight and must weigh at least 45 kg. Must understand the study procedures and provide written informed consent. Must meet DSM-4 criteria and are non-treatment seeking at time of study. Exclusion Criteria: Please contact study site for more information

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GBR 12909|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cocaine dependence
The PERFusion Use in Stroke Evaluation Study

Study Overview
=================
Brief Summary
-----------------
This is an open label single center phase II trial, evaluating the utility of 64 slice CT perfusion (CTP) in acute ischemic stroke (AIS) patients. The main aim is to determine which aspects of CTP imaging can aid in expanding the time window for thrombolysis with IV (rt-PA) in AIS patients up to 6 hours after symptom onset.

Official Title
-----------------
Expanding the Time Window for IV Thrombolysis With Rt-PA in Acute Ischemic Stroke Patients Using Computed Tomography Perfusion Imaging: The PERFusion Use in Stroke Evaluation (PERFUSE) Study

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Other: Computed tomography perfusion imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute ischemic stroke ≥ 18 years old presentation up to 6 hours from time of onset of acute stroke symptoms Exclusion Criteria: pregnancy inability to receive CT scan allergy to IV contrast symptoms with full resolution intracerebral hemorrhage severe stroke which is classified as 'malignant' (hypodensity on noncontrast CT greater than 1/3 cerebral hemisphere) premorbid mRS of >3 life expectancy of ≤3 months any condition which, in the opinion of the investigator makes the subject unsuitable for 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute ischemic stroke patients<br>All acute ischemic stroke patients receiving IV rt-PA within 6 hours of symptom onset | Other: Computed tomography perfusion imaging<br>* As per standard of care at CPMC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final infarct volume |  | 24 hour post-thrombolysis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Large vessel occlusion on neuroimaging |  | 24 hours post-thrombolysis | 
| NIHSS |  | 24-hours from tPA adminsitration | 
| Symptomatic intracerebral hemorrhage post-thrombolysis |  | 24 hours post-thrombolysis | 
| Modified Rankin Scale |  | 3-months from tPA administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, tPA, Thrombolysis, rt-PA, Ischemic, CTP, Imaging, CT Perfusion Imaging, Perfusion, CTA, CT Angiography, Acute ischemic stroke, Acute stroke therapy, (AIS)
Heart Monitoring Device After Acute Myocardium Infarction

Study Overview
=================
Brief Summary
-----------------
Verify the effectiveness of a Heart Monitor in preventing events in patients over 18 years after acute myocardial infarction in a clinical unit. Patients with neurological disease or congenital heart disease we excluded from the study.

Detailed Description
-----------------
Heart Monitor can detect early intercurrences. Objective: To verify the effectiveness of a Heart Monitoring system in preventing events in patients after acute myocardial infarction. Methodology: This is a randomized clinical trial to be developed in a clinical unit and will include patients over 18 years , post-acute myocardial infarction who were transferred from the ICU emergency or hemodynamic to clinical unit. Patients with neurological disease or congenital heart disease will be excluded from the study.

Official Title
-----------------
Heart Monitoring Device After Acute Myocardium Infarction

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Device: Heart monitor
* Device: No heart monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over 18 years patients post-acute myocardial infarctium Exclusion Criteria: patients with neurological disease patients with congenital heart disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heart Monitor<br>We used the device (heart monitor) in the patients with myocardial infarction. | Device: Heart monitor<br>* Use of heart monitor device in the patients after acute myocardium infarct.<br>* Other names: Heart monitor device;|
| Active Comparator: No Heart Monitor<br>No heart monitor device in the patients with myocardial infarction (control). | Device: No heart monitor<br>* Standard monitoring by nurses.<br>* Other names: No heart monitor device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rhythm monitoring | Evaluating the effectiveness of a heart monitoring device in the prevention and detection of events in patients after acute myocardial infarction | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Monitoring, Myocardial infarction, Clinical trial
Optical Coherence Tomography (OCT) in Elderly Patients After Elective Orthopaedic Surgery

Study Overview
=================
Brief Summary
-----------------
After obtaining informed consent each patient underwent OCT examination, usually one day before elective orthopaedic surgery (knee replacement). The OCT examination was repeated after the surgery. Both eyes were examined separately. After obtaining data the investigators compared the difference.

Detailed Description
-----------------
Inclusion and exclusion criteria evaluated during the pre-anesthesia visit. After obtaining informed consent, patients were referred to OCT examination in the Ophthalmology clinic. The examination was performed in the 48 hours before the surgery. Between the fourth and the seventh postoperative day, the patients underwent control OCT examination. The results of OCT examinations, baseline clinical data and the data on the course of surgery and postoperative care were recorded for further analysis.

Official Title
-----------------
Optical Coherence Tomography in Elderly Patients After Elective Orthopaedic Surgery

Conditions
-----------------
Change; Retina

Intervention / Treatment
-----------------
* Diagnostic Test: Optical Coherence Tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 Signed informed consent Elective operation Exclusion Criteria: Age under 18 Refusal to sign informed consent Non-elective operation Hospitalization on ICU more than 48 hours after surgery Inability to undergo OCT examination Protocol violation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OCT Arm<br>Each patient underwent OCT examinations. | Diagnostic Test: Optical Coherence Tomography<br>* Every patient underwent OCT examination before and after surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal changes | Patients undergo OCT (Optical Coherence Tomography) examination of both eyes before and after the surgery. | 4.-7. day post surgery |
Three Model Care Pathways for Postnatal Depression

Study Overview
=================
Brief Summary
-----------------
The study evaluates three best-practice care pathways for postnatal depression (PND) by comparing sole General Practitioner (GP) management to GP management in combination with CBT-based counselling from either a Psychologist or a Maternal and Child Health Nurse (MCHN).

Official Title
-----------------
Models of Care: Evaluating a Best Practice Model of Treating Postnatal Depression (PND)

Conditions
-----------------
Postnatal Depression

Intervention / Treatment
-----------------
* Behavioral: CBT-Counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English-speaking women at 3-months postpartum Exclusion Criteria: Psychosis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT-counselling with Nurse<br>CBT-counselling with Maternal Health Nurse, adjunctive to management by general medical practitioner | Behavioral: CBT-Counselling<br>* Intervention entailed six sessions of counselling-CBT delivered either by a trained Nurse, or by a Psychologist. Sessions focussed on: psycho-education about PND, main issues of concern, assessment of symptom severity, problem solving. Behavioural interventions (pleasant activities, anxiety management, relaxation, relationship communication) were used together with cognitive interventions (understanding links between thoughts and feelings, increasing positive thoughts, challenging negative self-talk and unhelpful beliefs).<br>|
| Active Comparator: CBT-Counselling by Psychologist<br>CBT-counselling with Psychologist, adjunctive to management by general medical practitioner | Behavioral: CBT-Counselling<br>* Intervention entailed six sessions of counselling-CBT delivered either by a trained Nurse, or by a Psychologist. Sessions focussed on: psycho-education about PND, main issues of concern, assessment of symptom severity, problem solving. Behavioural interventions (pleasant activities, anxiety management, relaxation, relationship communication) were used together with cognitive interventions (understanding links between thoughts and feelings, increasing positive thoughts, challenging negative self-talk and unhelpful beliefs).<br>|
| No Intervention: Routine management<br>Ongoing management by general medical practitioner | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Depression Score |  | 8 weeks post-randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postnatal Depression, CBT-Counselling, Primary care
SmartScope vs Standard Colposcope for the Evaluation of Cervical Dysplasia

Study Overview
=================
Brief Summary
-----------------
This trial will compare images obtained from a mobile colposcope with those obtained using a standard of care.

Detailed Description
-----------------
This trial will compare images obtained from a mobile colposcope with those obtained using a standard colposcope in women with abnormal pap smears. It is a non-inferiority trial. Blinded images will be evaluated be experts in colpsocopy and compared

Official Title
-----------------
Image Comparison of a Mobile Colposcope (SmartScope) vs. a Standard Colposcope for Directing Cervical Biopsies in Women With Abnormal Pap Smears: A Non-inferiority Trial.

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Device: Mobile OCT M3 scope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: abnormal cervical cancer screening by pap smear of high risk HPV test - Exclusion Criteria: no consent -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active colposcope<br>Mobile OCT M3 scope | Device: Mobile OCT M3 scope<br> <br> |
| No Intervention: Standard of Care<br>Standard of Care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| image non-inferiority | imafge non-inferiority | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
screeening
Magnetic Resonance Imaging of the Coronary Vessel Wall

Study Overview
=================
Brief Summary
-----------------
Despite advances in prevention and treatment, clinical manifestations of atherosclerosis (e.g. myocardial infarction, stroke) remain the largest cause of mortality in the Western world. The occurrence of acute ischemic syndromes, including unstable angina and myocardial infarction, is highly associated with atherosclerotic plaque morphology. Magnetic resonance (MR) imaging is able to noninvasively depict the lumen of coronary arteries without the need for ionizing radiation. In addition, MR imaging is able to generate soft-tissue contrast unlike any other imaging modality. It has been shown in the aorta and carotid artery that MR imaging is able to identify different atherosclerotic plaque components in vivo. Similar MR imaging techniques are becoming available to visualize the coronary arterial wall and preliminary studies have shown the feasibility of MR coronary vessel wall imaging in humans. The overall aim of the current study is to identify in vivo MR coronary vessel wall and plaque features that are associated with acute coronary syndromes. This study is divided into 2 substudies: Detection of atherosclerosis in the coronary vessel wall with contrast-enhanced MR imaging in patients with coronary artery disease and age-matched healthy volunteers. Characterization of coronary vessel wall plaque morphology in patients with stable and unstable angina: validation of MRI with the current standard of reference intravascular ultrasound (IVUS).

Official Title
-----------------
Detection of Vulnerable Plaque With Coronary Vessel Wall Magnetic Resonance Imaging

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with (un)stable angina or non-ST-elevated myocardial infarction patients are scheduled for, or recently had X-ray coronary angiography healthy volunteers, no clinical history of coronary artery disease(control group for substudy 1) patients with non-ischemic heart disease, scheduled for X-ray coronary angiography (control group for substudy 2) informed consent Exclusion Criteria: severe arrhythmia hemodynamic unstable patients contra-indications for MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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
-----------------
coronary atherosclerosis, magnetic resonance imaging, vulnerable plaque
Database of Pelvic Inflammatory Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective study is to collect data on in-patients with pelvic inflammatory disease(PID) at Kangbuk Samsung Hospital.

Detailed Description
-----------------
The aim of this prospective study is to collect data on in-patients with pelvic inflammatory disease(PID) at Kangbuk Samsung Hospital. If patients agree to participate in this clinical trial, patient's data (such as age, body mass index, preoperative findings, laboratory findings, radiologic findings, operative findings, pathologic findings, postoperative findings) will be collected in a research database. The research database will be updated, every 6 month, to include data on patient's disease outcome and follow-up care. Although most data will be collected form the medical record, patient may agin be contacted so that researchers can collection some data if it is not in the medical record.

Official Title
-----------------
Prospective Data Collection of Patients With Pelvic Inflammatory Disease

Conditions
-----------------
Inflammatory Pelvic Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All in-patient with PID who diagnosed at Kangbuk Samsung Hospital Exclusion Criteria: Secondary PID caused by other surgical problem or disease An inability to fill-up the informed consent

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| In-patient with PID<br>In-patient with PID who diagnosed at Kangbuk Samsung Hospital | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PID database | number of participants with pelvic inflammatory disease | 10 years |
Effect of Intraoperative Dexamethasone on Post-op Dry Eye

Study Overview
=================
Brief Summary
-----------------
To compare the signs and symptoms of dry eye after cataract surgery between subjects randomized to receive intraoperative dexamethasone in addition to the use of a standard topical post-op treatment regimen.

Detailed Description
-----------------
Forty patients requiring cataract surgery will be randomized to treatment of post-operative inflammation with a single intraoperative dexamethasone injection plus a standard course of topical ophthalmic corticosteroid drops or the standard treatment alone. Dry eye testing will be administered at baseline, 1 week and 3 weeks following surgery.

Official Title
-----------------
Evaluation of Intraoperative Use of Dexycu on the Signs and Symptoms of Dry Eye

Conditions
-----------------
Dry Eye Syndromes

Intervention / Treatment
-----------------
* Drug: dexamethasone intraocular suspension, 9%
* Drug: Prednisolone Acetate 1% Oph Susp


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing bilateral cataract surgery Exclusion Criteria: central corneal staining with fluorescein and/or a tear film osmolarity of greater than 340 in either eye

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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
Interventional Model Description: Randomized, controlled prospective study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intracameral dexamethasone 9% + postoperative topical prednisolone acetate<br>dexamethasone intraocular suspension, 9% injected intracamerally at the time of cataract surgery + topical ophthalmic prednisolone acetate for 3 weeks post-operatively | Drug: dexamethasone intraocular suspension, 9%<br>* single dose intracameral corticosteroid<br>* Other names: Dexycu;Drug: Prednisolone Acetate 1% Oph Susp<br>* topical ophthalmic steroid drop<br>|
| Active Comparator: postoperative topical prednisolone acetate<br>topical ophthalmic prednisolone acetate for 3 weeks post-operatively | Drug: Prednisolone Acetate 1% Oph Susp<br>* topical ophthalmic steroid drop<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively | Tear Film Osmolarity as measured on Tear Lab system; validated measure of Tear Film Osmolarity Osmolarity was reported in milliosmoles per liter (mOsmol/L) | 3 weeks |