TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Significance of Low-Dose Aspirin on Ovarian Responsiveness, Uterine Hemodynamics and Pregnancy Outcome in in Vitro Fertilization and in Intracytoplasmic Sperm Injection: A Randomized, Placebo-Controlled Double-Blind Study
Brief Summary: In this study we hypothesized that low-dose aspirin therapy (100 mg daily) improves ovarian responsiveness, uterine haemodynamics and clinical pregnancy rates in unselected subjects undergoing IVF/ICSI when the treatment is started concomitantly with controlled ovarian hyperstimulation.


Options:
A: The proportion of eligible women that agree to participate in the study (Throughout study completion, less than 40 weeks); Adherence to aspirin if prescribed (36 weeks); The proportion of study subjects in whom it is possible to obtain first trimester trans-abdominal uterine artery Doppler examination (36 weeks); The proportion of study subjects with a completed screening test who are issued the screening result within one week of having the test performed (1 week); Attendance at study visits (36 weeks); Satisfactory collection of all endpoints and variables (36 weeks); Any specific study protocol violations (36 weeks)
B: Prevention of preeclampsia (6 months)
C: Estimated fetal weight (6 weeks)
D: Pregnancy rate (Five weeks after embryo transfer)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Laparoscopic Hysterectomy: a Clinical Randomized Trial Comparing Conventional and Robot-assisted(Da Vinci®)Techniques
Brief Summary: The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.


Options:
A: Duration of Surgery (after surgey)
B: Operative Time (Intra operative)
C: To assess the efficacy and safety of single port-access laparoscopic-assisted vaginal hysterectomy. The pain score and morbidity associated with surgery will be noted. (1 year)
D: Insulin resistance (3 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Laparoscopic Hysterectomy: a Clinical Randomized Trial Comparing Conventional and Robot-assisted(Da Vinci®)Techniques
Brief Summary: The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.


Options:
A: Insulin resistance (3 weeks)
B: postoperative pain measured by a 10 point numeric rating scale (around one week)
C: Duration of Surgery (after surgey)
D: Number of lymph nodes (After aortic lymphadenectomy is completed)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Laparoscopic Hysterectomy: a Clinical Randomized Trial Comparing Conventional and Robot-assisted(Da Vinci®)Techniques
Brief Summary: The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.


Options:
A: Disease free survival (5 years from surgery)
B: Operative Time (1st 24 hours)
C: Duration of Surgery (after surgey)
D: Primary outcome: operative time from incision to closure. (Primary outcome: will be obtained immediately at the end of each procedure.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Strategies for Post Arrest Resuscitation and Care Network
Brief Summary: Background: One of the 2010 Impact Goals of the Emergency Cardiac Care (ECC) Committee of the American Heart Association is to double survival from cardiac arrest. Currently, approximately 60% of adults and 50% of paediatric patients that regain spontaneous circulation following cardiac arrest die before leaving the hospital. A key piece of the "chain of survival" is this fifth link; the care of patients post-arrest. Although there are several modalities recommended for post arrest care, therapeutic hypothermia is the only in-hospital therapy that has been demonstrated in randomized clinical trials to improve patient outcome after cardiac arrest. Despite the strong evidence for its efficacy and the apparent simplicity of this intervention, recent surveys show that hypothermia is delivered inconsistently, incompletely, and with undue delay in hospitals receiving resuscitated patients; only 26% of physicians and 26% of hospitals regularly institute a hypothermia protocol.

Primary Objective: To design and apply a knowledge translation program for the 2005 AHA guideline on hypothermia post cardiac arrest and enable effective implementation of hypothermia in 100% of eligible OHCA patients. The integration of two robust data collection systems, which include both pre-hospital and in-hospital indicators, will give complete process of care and clinical outcome information for all cardiac arrest patients.

Primary Endpoint: the proportion of eligible out of hospital cardiac arrest patients cooled to 32-34°C within 6 hours of ED arrival.

Study Design: This project will be implemented through an established research collaborative of 43 hospitals in southern Ontario currently participating in the Toronto site of the Resuscitation Outcomes Consortium. A stepped wedge study design will be employed, whereby the intervention will be rolled-out sequentially to the participating hospitals over a number of time periods as sites reach pre-defined benchmarks. The multifaceted KT strategy will include 1) local multidisciplinary champions in ED, ICU, and Cardiology 2) A simple protocol for application of hypothermia, tailored to local needs and policy; 3) Identification of perceived and actual barriers to knowledge use; 4) Development of an implementation tool kit and 5) Providing timely feedback on benchmarks for hypothermia and outcomes


Options:
A: Bone mineral density (BMD) testing rates
B: Adherence to guidelines G10 and G17 of the 2003 International Consensus Guidelines on nonvariceal upper GI bleeding. (1 year)
C: colorectal cancer screening (15 months)
D: The proportion of eligible out of hospital cardiac arrest patients cooled to 32-34°C within 6 hours of ED arrival. (Within 6 hours of ED arrival.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tobacco Cessation Via Public Health Dental Clinics (PHD2)
Brief Summary: The study will examine the effectiveness of public health dental practitioners using a brief office based intervention designed to help patients quit smoking or smokeless tobacco use, as compared to usual care.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12.
B: The primary outcome is prolonged abstinence at 7.5 months following intervention. (7.5 months)
C: Number of Participants With a Quit Attempt (6 months)
D: Number of Subjects With Four Week Continuous Quit Rate (CQR) (Week 9 through Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy (ADT) Among Outpatients With Major Depressive Disorder Who Have Responded Inadequately to Prior ADT
Brief Summary: The purpose of this study is to determine whether a reduced dose of aripiprazole is effective in treating patients with major depressive disorder


Options:
A: Change in Total MADRS Scores From Baseline to Week 8 (Baseline, Week 8); Change in the Discontinuation Emergent Signs and Symptoms Check List (DESS) (Baseline, week 9); Change in Safety as Assessed by the Arizona Sexual Experience Scale (ASEX) (Baseline, Weeks 8)
B: Time to Confirmed Response by ≥ 50% Change From Baseline Reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17) (Week 4 through Week 16); Estimated Probability of Not Reaching Confirmed Response at 12 Weeks Based on the Survival Function for the Time to Confirmed Response (Week 4 through Week 16); Time to Confirmed Remission by a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 That is Maintained for Two Consecutive Visits (Week 4 through Week 16); Estimated Probability of Not Reaching Confirmed Remission at 12 Weeks Based on the Survival Function for the Time to Confirmed Remission (Week 4 through Week 16)
C: MADRS (Montgomery-Asberg Depression Rating Scale) Response Rate (12 weeks)
D: Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set) (6 weeks treatment); Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set) (6 weeks of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Transplantation in Myocardial Infarction Evaluation (TIME) Protocol: A Phase II, Randomized, Controlled, Double-Blind Trial Evaluating the Effect of Timing on the Administration of Bone Marrow Mononuclear Cells (BMMNCs) Versus Placebo in Patients With Acute Myocardial Infarction
Brief Summary: Heart attacks are a leading cause of death for both men and women in the United States. A heart attack occurs when blood flow to the heart is restricted, commonly due to a blood clot that has formed in one of the coronary arteries. If the clot becomes large enough, blood flow to the heart can be blocked almost completely and the heart muscle in that area can suffer permanent injury or death. Although a percutaneous coronary intervention (PCI) can be used to open up the blocked artery and restore blood flow to the heart muscle, there may be a significant amount of heart tissue that has been irreversibly damaged. Recent studies have shown that adult stem cells from bone marrow may be able to improve heart function after a heart attack. This study will evaluate the safety and effectiveness of using adult stem cells for improving heart function in people who have had a recent heart attack and a PCI.


Options:
A: myocardial flow (MF) (mL/g/min) evaluated by Positron Emission Tomography(PET) with Nitrogen-13 ammonia (13NH3),; Ejection fraction (%) evaluated by 2D echocardiography;
B: Change in global left ventricular function in quantitative LV angiography after 4 months. (baseline to 4 months)
C: Freedom from occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, revascularization and stroke (12 months)
D: Global Left Ventricular Function (Measured at Baseline and Month 6); Regional Left Ventricular Function (Infarct Zone Wall Motion) (Measured at Baseline and Month 6); Regional Left Ventricular Function (Border Zone Wall Motion) (Measured at Baseline and Month 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Controlled, Double-Blind Pilot Trial Evaluating the Safety and Effect of Administration of Bone Marrow Mononuclear Cells Two to Three Weeks Following Acute Myocardial Infarction
Brief Summary: More than 1 million Americans suffer heart attacks each year. Although current treatments are able to stabilize the condition of the heart, none is able to restore heart function as it was prior to the heart attack. Adult stem cells, which are immature cells that can become many different types of cells, may offer a potential means of reversing or preventing permanent damage caused by a heart attack. Recent studies have shown promise in using adult stem cells from bone marrow to reverse damage to the heart muscle caused by a heart attack, but more research is needed to assess the safety and effectiveness of stem cell use and to discover the best time to administer treatment. This study will evaluate the safety and effectiveness of using adult stem cell infusions 2 to 3 weeks after a heart attack for improving heart function in people who have had a recent heart attack and a common procedure called a percutaneous coronary intervention (PCI).


Options:
A: Global Left Ventricular Function (Measured at Baseline and Month 6); Regional Left Ventricular Function (Infarct Zone Wall Motion) (Measured at Baseline and Month 6); Regional Left Ventricular Function (Border Zone Wall Motion) (Measured at Baseline and Month 6)
B: Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year) (after 3 months and 1 year of treatment)
C: Absolute changes in global LVEF by SPECT (baseline and 6 months)
D: Arrhythmia risk variables; left ventricular function; restenosis assessed by IVUS

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Controlled, Randomized, Parallel, Multicentre Study to Assess Safety and Tolerability of the Oral Direct Thrombin Inhibitor AZD0837, Given as an Extended-release Formulation, in the Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation
Brief Summary: The main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.0 to 3.0) in patients with non-valvular atrial fibrillation (AF) with one or more additional risk factors for stroke.


Options:
A: Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period (First administration until 31-38 days)
B: Bleeding Events (36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)); Creatinine (12 weeks according to protocol.(baseline to week 12 visit)); Alanine Aminotransferase (ALAT) (36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)); Bilirubin (36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit))
C: Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period (6 months)
D: Percentage of Patients With Any Adverse Event (AE) (From first intake of study drug until last intake of study drug plus 6 days (Up to 272 days))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Sine Waveform High Frequency Chest Wall Oscillation Using Different Settings in Cystic Fibrosis
Brief Summary: Our primary hypothesis is that airway clearance therapy with sine waveform HFCWO using higher inflation pressures combined with both low and high oscillator frequencies will result in greater sputum production compared to sine waveform HFCWO with lower inflation pressures and mid-frequency oscillations.


Options:
A: Difference in the number of respiratory exacerbations during the 1 year study period (1 year)
B: Hospital Length of Stay (Admission to Discharge)
C: Lung Clearance Index (90 minutes post treatment)
D: Sputum Wet and Dry Weight (Produced during each airway clearance therapy session on days 1 and 4)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Sine Waveform High Frequency Chest Wall Oscillation Using Different Settings in Cystic Fibrosis
Brief Summary: Our primary hypothesis is that airway clearance therapy with sine waveform HFCWO using higher inflation pressures combined with both low and high oscillator frequencies will result in greater sputum production compared to sine waveform HFCWO with lower inflation pressures and mid-frequency oscillations.


Options:
A: Difference in the number of respiratory exacerbations during the 1 year study period (1 year)
B: Sputum Wet and Dry Weight (Produced during each airway clearance therapy session on days 1 and 4)
C: Average sputum production, as assessed by sputum wet and dry weights, during each treatment session.
D: Lung Clearance Index (90 minutes post treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Sine Waveform High Frequency Chest Wall Oscillation Using Different Settings in Cystic Fibrosis
Brief Summary: Our primary hypothesis is that airway clearance therapy with sine waveform HFCWO using higher inflation pressures combined with both low and high oscillator frequencies will result in greater sputum production compared to sine waveform HFCWO with lower inflation pressures and mid-frequency oscillations.


Options:
A: Sputum Wet and Dry Weight (Produced during each airway clearance therapy session on days 1 and 4)
B: The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test. (8 weeks)
C: 24 hour sputum volume and assessment of cough severity (Leicester Cough Questionnaire) (3 months)
D: 24 hour sputum clearance (24 hours / 12 weeks); Quality of Life SGRQ (12 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Cadaver Donor Renal Transplantation: A Study to Evaluate the Avoidance of Long-Term Nephrotoxic Calcineurin Inhibitor Therapy
Brief Summary: To compare in a randomized prospective study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy vs. our conventional therapy in recipients of first cadaver (CAD) kidneys.


Options:
A: Incidence of CMV disease (1 year)
B: Incidence of Failure on the Composite of Treated Biopsy-proven Acute Rejection (tBPAR) or Estimated Glomerular Filtration Rate (eGFR) < 50 mL/Min/1.73m2. (Month 12 is Primary, Month 24 secondary)
C: Incidence and severity of biopsy-proven acute rejection at 1 year. (1 year)
D: GFR calculated from the serum creatinine with the Cockcroft-Gault formula at 12 months posttransplantation

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Head-to-Head Comparison of Thymoglobulin vs. Campath-1H vs. Our Standard Center Treatment Protocol in Cadaver Donor Renal Transplantation: A Study to Evaluate the Avoidance of Long-Term Nephrotoxic Calcineurin Inhibitor Therapy
Brief Summary: To compare in a randomized prospective study the effectiveness and toxicity of Thymoglobulin vs. Campath-1H used for induction therapy vs. our conventional therapy in recipients of first cadaver (CAD) kidneys.


Options:
A: Composite Endpoint of 5 Components: Fever, Hypoxia, Hypotension, Cardiac Events, and Delayed Graft Function (During first 7 days after kidney transplantation)
B: Incidence and severity of biopsy-proven acute rejection at 1 year. (1 year)
C: Incidence and severity of acute rejection episodes (1 year)
D: Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Trial of Topiramate for Cocaine Addiction
Brief Summary: This is an outpatient clinical trial of topiramate for addressing cocaine dependence and reduction of cocaine associated behaviors in opiate dependent drug users maintained on methadone treatment.

The study aims to answer whether topiramate

1. is safe and acceptable to methadone patients
2. reduces cocaine use
3. helps with collateral problems such as alcohol abuse, tobacco dependence, anxiety, PTSD and/or pain symptoms. The study will also evaluate topiramate effect on neuro-cognitive performance.


Options:
A: Proportion of Cocaine Positive Urine Samples Per Treatment Condition (Urine samples collected 3 times weekly from week 1 through 26)
B: Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed). (These must be the last three weeks (7,8,9) of the trial.)
C: Time to Treatment for Emerging Symptoms of a Mood Relapse (Up to 6 months)
D: Effectiveness of topiramate to reduce cocaine use(assessed by a combination of self-report of use and urine assays for benzoylecgonine, the major metabolite of cocaine). (Throughout the study (Visit 0 to Visit 12, and at 2 weeks, 1, 2, and 3 months following completion of treatment))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tension-free Vaginal Tape Management of Stress Incontinence in Women: Randomized Trial of TVT Secur Versus TVT
Brief Summary: This randomized multi-centre trial will recruit women with stress urinary incontinence who need surgical treatment for their condition. 300 women will be allocated either to receive a TVT Secur or a standard TVT surgical procedure. The main outcome is effectiveness of the procedure, determined using a 1-hour pad test (which tests for urine leakage) 12 months after surgery. The study will be carried out in 4 to 6 centers and will involve urogynaecologists, urologists and general obstetrician-gynaecologists: all clinicians will have received adequate training.


Options:
A: Percentage of Participants With Negative Cough Stress Test (CST) (four years); Patient Global Impression of Improvement (PGI-I) Score (four years)
B: A change in number of cured patients (Up to 1 year)
C: Comparison of the cure rates between the single incision sling Ajust and classical transobturator tapes. (Up to one year)
D: Standardised pad test: "cure" is defined as less than 1g gain in pad weight over the duration of the test (12 months following surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: SWITCH: Rationale, Design, and Implementation of a Community, School, and Family-based Intervention to Modify Behaviors Related to Childhood Obesity
Brief Summary: The purpose of this research is to increase community awareness about the relationship between physical activity, screen time, and nutrition and how these factors influence healthy weight management.

The problem of obesity is at epidemic proportions and has become the most important public health problem confronting the United States today. Of greatest concern is the 300% increase in obesity rates among children and youth over the past twenty years. Childhood obesity is a precursor of adult obesity.


Options:
A: Our outcome measure was reduction of screen time (4 waves of data)
B: Improvement of maximal oxygen uptake
C: Change in the prevalence of overweight and obesity (Baseline, Month 9)
D: Change from baseline in weekly time in moderate-to-vigorous physical activity at 4 months (baseline and after 4-months of intervention); Change from baseline in the daily time using TV/computer/video games at 4 months (baseline and after 4-months of intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: SWITCH: Rationale, Design, and Implementation of a Community, School, and Family-based Intervention to Modify Behaviors Related to Childhood Obesity
Brief Summary: The purpose of this research is to increase community awareness about the relationship between physical activity, screen time, and nutrition and how these factors influence healthy weight management.

The problem of obesity is at epidemic proportions and has become the most important public health problem confronting the United States today. Of greatest concern is the 300% increase in obesity rates among children and youth over the past twenty years. Childhood obesity is a precursor of adult obesity.


Options:
A: Body fat percentage (One year (interim analysis))
B: N/A
C: Insulin area under the curve (oral glucose tolerance test) (10-15 weeks); Body composition (% body fat, visceral fat) (10-15 weeks); Aerobic fitness (10-15 weeks); Cognition (Executive function) (10-15 weeks)
D: Our outcome measure was reduction of screen time (4 waves of data)

Answer: D