linjc16/ctgov huggingface dataset:
Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject

Study Overview
=================
Brief Summary
-----------------
This clinical trial was evaluated to compare the safety and pharmacokinetics of Besylsartan with Amosartan, which was available commercially after single oral dose in healthy male subjects.

Official Title
-----------------
A Randomized, Open-label, Single Dose, 2-Treatment, 2-Period, 2-Way Crossover Study to Assess Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Besylsartan
* Drug: Amosartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index (BMI) between 18 and 30 Healthy as determined by a responsible physician Exclusion Criteria: History of clinically significant disease Any chronic disease Creatine clearance less than 50ml/min Hypotension (100mmHg/60mmHg) Treatment of barbital type drug within 1 month Administration of herbal medicine within 7 days

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Besylsartan<br>amlodipine besylate 6.944mg+losartan K 100mg | Drug: Besylsartan<br>* Amlodipin besylate 6.944mg+Losartan K 100mg<br>|
| Active Comparator: Amosartan<br>amlodipine besylate 7.841mg+losartan K 100mg | Drug: Amosartan<br>* Amlodipin besylate 7.841mg+Losartan K 100mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in blood concentration of Amlodipine | Detect the change of blood concentration of Amlodipine by LC-MS/MS | 144 hour | 
| Change from baseline in blood concentration of Losartan | Detect the change of blood concentration of Losartan by LC-MS/MS | 10 hour |
Evaluation of Serial Troponin and Cardiac Multimarkers at the Point of Care in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
This is a multi-center study to assess the diagnostic accuracy of the Troponin I assay in the Biosite Triage Cardio3 Panel at the point-of-care (POC) in adults presenting to the emergency department with possible acute myocardial infarction (AMI).

Conditions
-----------------
Acute Myocardial Infarction, Chest Pain, Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older at time of enrollment Presenting to the ED within 6 hours from onset of chest discomfort (pain, pressure, tightness, etc) consistent with a possible diagnosis of AMI or ACS and with an initial ECG non-diagnostic for injury (or injury equivalent resulting in emergent reperfusion therapy). (NOTE: Subjects who have chest discomfort that is episodic or stuttering in nature may be included if the ED presentation is within 6 hours of symptom onset.) Experiencing at least 30 minutes of chest pain or other anginal equivalent symptoms. (Note: Subjects who have symptoms of shorter duration due to pharmacologic intervention may be included.) Exclusion Criteria: Patient (or Legal Representative) unable or unwilling to provide written informed consent. Patient unwilling or unlikely to comply with study procedures, including protocol-specified blood sampling or telephone follow-up at 30 days and 6 months. Vulnerable populations as deemed inappropriate for study by site principal investigator. ST-elevation or other ECG criteria that result that is diagnostic for AMI and results in patient being sent for percutaneous coronary interventions (PCI) or being treated with thrombolytics6. Pulmonary Edema requiring CPAP, BIPAP, or mechanical ventilation Tachyarrhythmias (SVT, V-Tach, rapid atrial fib) End Stage Renal Disease on Hemodialysis Cardiac Arrest prior to arrival Implantable Defibrillator firing prior to arrival Hemodynamically unstable patients Trauma injury to the chest

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 |
| --- | --- | --- |
Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function

Study Overview
=================
Brief Summary
-----------------
The incidence of caesarean section has reached 15-20% in most developed countries. Encouraging vaginal birth after caesareans section (VBAC) has been considered a key component of a strategy to reduce the caesarean section rate. Most medical literature has focused on the efficacy of VBAC in reducing the caesarean section rate and the physical safety of successful VBAC. However, 30%-40% of these women fail to achieve a vaginal delivery. Little is known about how the uncertainty of labour outcome and a failed VBAC impact on the psychosocial function of these women. We propose to study a cohort of women with a prior caesarean section and presenting with a subsequent pregnancy for care. After consent and recruitment, these subjects will be randomly assigned to have a repeat caesarean section or VBAC. The medical outcomes, overall satisfaction of the subjects with the care they received, and the short-term psychosocial function of these subjects will be studied. The result of this study will provide important information that would be useful in assisting women to decide the mode of delivery after a prior caesarean section.

Official Title
-----------------
Vaginal Birth After Caesarean Section - Effect on Maternal Psychosocial Function

Conditions
-----------------
Pregnancy, Cesarean Section, Uterine Rupture

Intervention / Treatment
-----------------
* Procedure: Repeat Caesaen section
* Procedure: vaginal delivery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women who: Have one prior caesarean section No prior vaginal delivery and Agree for either vaginal delivery or elective caesarean section
Sexes Eligible for Study
-----------------
Female

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Repeat Caesaen section|nan|
|Procedure: vaginal delivery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pscyiatric morbidity |  | after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial function |  | 3 and 6 months after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy women with a scarred uterus due to previous caesarean section
WelChol® With Metformin in Treating Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to see how safe and effective and tolerable the use of colesevelam hydrochloride is for type 2 diabetes when added to metformin alone or in combination with other anti-diabetic drugs.

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetics With Inadequate Glycemic Control on Metformin Monotherapy or Metformin Therapy in Combination With Other Oral Anti-Diabetic Agents

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

Intervention / Treatment
-----------------
* Drug: Colesevelam hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 years, inclusive Diagnosed with type 2 diabetes Hemoglobin (HbA1c) between 7.5% to 9.5% Prescribed an ADA accepted diet Receiving stable dose of metformin alone or in combination with other oral anti-diabetic medications for 90 days before Visit 1 Exclusion Criteria: History of type 1 diabetes or ketoacidosis History of chronic (more than 2 months) insulin therapy or the initiation of insulin for chronic treatment History of pancreatitis Uncontrolled hypertension Recent severe cardiovascular disease Allergy or toxic response to colesevelam or any of its components Body mass index (BMI) >45 kg/m2

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Colesevelam hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the additional lowering of HbA1C achieved by addition of colesevelam hydrochloride to current antidiabetic therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the fasting plasma glucose and fructosamine lowering effect; |  |  | 
| To assess the glycemic control response rate; |  |  | 
| To assess the improvement in insulin sensitivity; |  |  | 
| To assess the effect on high sensitivity C-reactive protein; |  |  | 
| To assess the improvement in lipids, and lipoproteins; |  |  | 
| To assess the safety and tolerability of colesevelam hydrochloride when added on to current therapy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus
Nursing Intervention for HIV Regime Adherence Among People With Serious Mental Illness (SMI)

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to investigate how nurses can best help people with serious mental illnesses (SMI) follow their HIV treatment plans.

Detailed Description
-----------------
There is concern that HIV positive SMI persons may be a greater risk for poor treatment adherence, increasing risk for poorer outcomes and development of treatment resistance virus, and also placing others at greater risk. Involvement of advance practice nurses has been previously shown to improve outcomes for persons with HIV/AIDS.

Official Title
-----------------
Nursing Intervention for HIV Regimen Adherence Among Serious Mental Illness (SMI)

Conditions
-----------------
HIV, Mental Illness

Intervention / Treatment
-----------------
* Behavioral: Use of Memory Aids to take medications


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of serious mental illness; HIV positive Exclusion Criteria: None

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 - Experimental<br> | Behavioral: Use of Memory Aids to take medications<br>* Experimental participants will receive an integrated intervention tailored to the communication and comprehension of the individual, and will include memory aid devices, education regarding side effects and other treatment aspects, and active community outreach. For those who fail to adhere using the basic intervention, a treatment cascade that increases in intensity will be implemented. Using 80% adherence as a target, the cascade will include involvement of family and significant others in prompting participants through use of beepers, cellphones, and for those who still fall short of 80% adherence, directly observed therapy.<br>|
| No Intervention: 2 - Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How to best help people with serious mental illness follow HIV treatment regimens |  | baseline, 3, 12 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Mental Illness
Open Label Assessment of Long-Term Safety and Utility

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the long-term analgesic effectiveness, safety, and utility of oxymorphone ER for the relief of moderate to severe pain due to cancer.

Official Title
-----------------
An Open-Label Assessment of the Long-Term Safety and Utility of Numorphan® for the Relief of Moderate to Severe Pain in Patients With Cancer

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Oxymorphone ER


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females aged > 18 years with moderate to severe pain arising from cancer (histologically and/or clinically proven) who require chronic treatment with WHO step 3 analgesics. Women of child-bearing potential must be using an approved method of contraception (hormone contraception, IUD, or double barrier method) and have a negative serum pregnancy test prior to entry into the study. Participated in study EN3202-018; the patient must have been treated with study medication and completed the exit visit to be eligible. Exclusion Criteria: Experienced a serious, adverse experience during study EN3202-018 that was possible or probably related to study medication. Withdrew from study EN3202-018 due to an Adverse experience possibly or probably related to study medication. Known idiosyncratic reaction or hypersensitivity to oxymorphone. Inability to take oral medication for 1 week. Patients with ileosomy, mechanical intestinal obstruction, partial or complete gastric outlet obstruction, parlayticileus, or other conditions that might contraindicate the use of, or impair the absorption of an oral controlled-release dosage form.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label<br> | Drug: Oxymorphone ER<br>* 10mg, 20mg, and 40mg PO<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of AEs and clinical laboratory values |  | 22 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Favorable long-term safety profile for oxymorhpone ER in the treatment of moderate to severe pain in patients with cancer |  | 22 months |
Database Evaluating Outcomes of Using Carbetocin as the Primary Uterotonic Following Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
Carbetocin (Duratocin®) is a long-acting form of oxytocin, with a half-life almost 10 times longer. Studies have demonstrated that carbetocin diminishes the need for secondary uterotonic agents compared to oxytocin for cesarean delivery (CD). Despite certain Canadian guidelines recommending its use for elective CD, several Canadian centers and other countries have not adopted carbetocin. The purpose of this study is to prospectively gather electronic data on all CDs over a one year period, elective and emergent, in a single institution, and to evaluate the efficacy and other clinical outcomes when carbetocin is used as a first line uterotonic for all CDs. A database using Microsoft Dynamics CRM is available on smart phones and tablets. Data regarding additional uterotonic use and impact of carbetocin use during CD on intra and postoperative outcomes are gathered and analyzed. The primary outcome is the use of additional uterotonics in this population compared to that described in the literature for oxytocin as the primary uterotonic.

Official Title
-----------------
Prospective Observational Database Evaluating Outcomes of Using Carbetocin (Duratocin®) as the Primary Uterotonic Following Cesarean Delivery at Maisonneuve-Rosemont Hospital

Conditions
-----------------
Carbetocin, Cesarean Section Complications, Uterotonics, Uterine Atony With Hemorrhage

Intervention / Treatment
-----------------
* Drug: Carbetocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Cesarean deliveries in the operating room. Exclusion Criteria: Vaginal deliveries and double set-up vaginal deliveries conducted in the operating room.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Carbetocin|Carbetocin as the primary uterotonic for all cesarean sections|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of additional uterotonics | The number of participants requiring additional uterotonics after using carbetocin as the initial uterotonic | 24 hours |
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face

Study Overview
=================
Brief Summary
-----------------
To Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face

Official Title
-----------------
A Multicenter, Randomized, Rater-Blinded, No-Treatment Control Design Clinical Study to Evaluate the Effectiveness and Safety of YVOIRE Y-Solution 720 Injected Into the Mid-Face

Conditions
-----------------
Volume Defects in the Mid-face

Intervention / Treatment
-----------------
* Device: YVOIRE Y-Solution 720


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adults 18 to 65 years of age (inclusive) 3 (moderate) or 4 (severe) on MFVDA-SRS sign the written informed consent form Exclusion Criteria: have streptococcal disease or bleeding disorder have an active or infective skin disease, scars, or tumor on mid-face have congenital defect, trauma, abnormalities in adipose tissue related to immune-mediated diseases have undergone facial plastic surgery, tissue grafting, or tissue augmentation with silicone, fat, or other permanent, or semi-permanent procedures/treatment have undergone temporary facial dermal filler within 12 months, porcine-based collagen fillers within 24 months, or neuromodulator injections, mesotherapy, or resurfacing within 6 months have a medical history of hypertrophic cicatrix or keloid have radiation therapy experience on mid-face have a history of anaphylaxis, multiple severe allergies, atopy, or allergy to lidocaine, hyaluronic acid products, or Streptococcal protein

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YVOIRE Y-Solution 720<br>Hyaluronic acid dermal filler | Device: YVOIRE Y-Solution 720<br>* Hyaluronic acid dermal filler<br>|
| No Intervention: Control<br>No Intervention | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asian Faces Mid-Face Volume Deficit Severity Rating Scale (MFVDA-SRS) responder rate | the proportion of subjects with ≥1-grade reduction on the MFVDA-SRS score (The MFVDA-SRS score ranges from 1-4 with higher score indicating increasing severity of mid-face volume deficit.) | 26 weeks from baseline |