TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study To Evaluate Efficacy and Safety of XP12B for the Treatment of Menorrhagia
Brief Summary: The purpose of this study is to determine whether XP12B is effective and safe in the treatment of women with heavy menstrual bleeding associated with menorrhagia.


Options:
A: Randomized trial: Impact of surgery on bleeding, pain,; fatigue, and major problem (symptom) leading the woman to seek treatment for her condition.; Observational study: changes over time in treatment selected, DUB-related symptoms, and quality of life.
B: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) (Baseline MBL over 3 menstrual cycles)
C: Proportion of Participants With no Dysfunctional Uterine Bleeding (DUB) Symptoms (Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7)
D: Mean Reduction From Baseline in Menstrual Blood Loss (MBL) (Baseline MBL over 6 menstrual cycles)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind Placebo-Controlled Study of Methylnaltrexone (MNTX) for the Relief of Constipation Due to Chronic Opioid Therapy in Patients With Advanced Medical Illness
Brief Summary: To test the effectiveness of MNTX in advanced illness subjects.


Options:
A: Rescue-free laxation response (Within 4 hours after at least 2 of the first 4 doses (the first week of treatment).)
B: Efficacy of SC MNTX compared with placebo in inducing laxation (29 days)
C: Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone (4 hours after the dose of subcutaneous methylnaltrexone)
D: Efficacy variable: Bowel Function Index (BFI) score. Amount of laxative medication use recorded at each assessment visit (4 weeks and a 6 month open label); Efficacy variable: Brief Pain Inventory Short-Form (BPI-SF) (Cleeland, 1991). Amount of analgesic rescue medication used (4 weeks and a 6 month open label)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind Placebo-Controlled Study of Methylnaltrexone (MNTX) for the Relief of Constipation Due to Chronic Opioid Therapy in Patients With Advanced Medical Illness
Brief Summary: To test the effectiveness of MNTX in advanced illness subjects.


Options:
A: Efficacy variable: Bowel Function Index (BFI) score. Amount of laxative medication use recorded at each assessment visit (4 weeks and a 6 month open label); Efficacy variable: Brief Pain Inventory Short-Form (BPI-SF) (Cleeland, 1991). Amount of analgesic rescue medication used (4 weeks and a 6 month open label)
B: Efficacy of SC MNTX compared with placebo in inducing laxation (29 days)
C: Change of Pain Intensity From Baseline(visit1) to 4weeks.(visit3) (4weeks)
D: Rate of LIR among the OIC population (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Assessment of the Safety, Efficacy, and Practicality of an Algorithm Including Amantadine, Metformin and Zonisamide for the Prevention of Olanzapine-Associated Weight Gain in Outpatients With Schizophrenia
Brief Summary: The goal of this study is to answer the following questions:

* Whether treatment with amantadine, metformin or zonisamide can prevent or reverse the weight gain that is associated with olanzapine
* Whether taking amantadine, metformin or zonisamide can help patients decrease or eliminate some of the changes in body that occur with weight gain
* How weight gain associated with olanzapine can affect people
* Whether treatment with amantadine, metformin or zonisamide can help eliminate weight gain associated with olanzapine and not interfere with the positive effects of olanzapine on functioning of people with schizophrenia and other diseases


Options:
A: body weight change (24 weeks)
B: Glucose tolerance (Baseline - 16 weeks)
C: The Fagerstrom Test for Nicotine Dependence, expired CO level, and urine cotinine will be used to determine if bupropion SR, when used as an adjunct to antipsychotic medication, is superior to placebo for helping patients with schizophrenia improve their (Expired CO weekly, Fagerstrom baseline and end of study, Urine cotinine baseline, week 2 and week 8); Neuropsychological testing will be used to determine the effects of smoking cessation on patient's attention and memory function. (Beginning and end of study)
D: Change From Baseline to Endpoint in Weight (Baseline to endpoint (22 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Long Term Safety Evaluation of Bronchial Thermoplasty With the Alair® System in Patients With Severe Asthma
Brief Summary: The primary purpose of this study is to gather additional safety data for the subjects treated with the Alair System (hereinafter, "Alair-Treated Subjects") who previously completed the one-year study entitled: "Multicenter Randomized Clinical Trial of Bronchial Thermoplasty with the Alair System for the Treatment of Severe Asthma" (Protocol #0903-27) sponsored by Asthmatx, Inc. Subjects who elect to participate in this safety study will be followed for an additional four (4) year period beyond the PREDECESSOR STUDY'S one-year endpoint (clinicaltrials.gov number NCT00214539).


Options:
A: Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments (2-year, 3-year, 4-year and 5-year follow up post procedure); Respiratory Adverse Events (2-year, 3-year, 4-year and 5-year follow up post procedure)
B: Mild Exacerbation Rate (OFF-LABA) (Change From Baseline) (Baseline, 12 Months)
C: Severe Exacerbations (12 month periods out to 5 Years)
D: Respiratory Adverse Events Per Subject (Baseline, 12 Months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Long Term Safety Evaluation of Bronchial Thermoplasty With the Alair® System in Patients With Severe Asthma
Brief Summary: The primary purpose of this study is to gather additional safety data for the subjects treated with the Alair System (hereinafter, "Alair-Treated Subjects") who previously completed the one-year study entitled: "Multicenter Randomized Clinical Trial of Bronchial Thermoplasty with the Alair System for the Treatment of Severe Asthma" (Protocol #0903-27) sponsored by Asthmatx, Inc. Subjects who elect to participate in this safety study will be followed for an additional four (4) year period beyond the PREDECESSOR STUDY'S one-year endpoint (clinicaltrials.gov number NCT00214539).


Options:
A: Percentage of Subjects With Respiratory Adverse Events (AEs) in Annual Increments (2-year, 3-year, 4-year and 5-year follow up post procedure); Respiratory Adverse Events (2-year, 3-year, 4-year and 5-year follow up post procedure)
B: Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16); Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16)
C: The Number of Participants With a Differential Response to the Three Step-up Therapies Based on Fixed Threshold Criteria for the Following Three Asthma Control Measures: Use of Oral Prednisone for Acute Asthma Exacerbations, Asthma Control Days and FEV1. (Measured during the last 12 weeks of each 16-week treatment period)
D: To evaluate distal airway function using high-resolution CT and lung function test (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Phase 3, Two-Week, Placebo Controlled Study of Methylnaltrexone(MNTX) for the Relief of Constipation Due to Opioid Therapy in Advance Medical Illness.
Brief Summary: To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.


Options:
A: Efficacy of SC MNTX compared with placebo in inducing laxation (29 days)
B: Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone (4 hours after the dose of subcutaneous methylnaltrexone)
C: Rescue-free laxation response (Within 4 hours after at least 2 of the first 4 doses (the first week of treatment).)
D: Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period. (2 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Phase 3, Two-Week, Placebo Controlled Study of Methylnaltrexone(MNTX) for the Relief of Constipation Due to Opioid Therapy in Advance Medical Illness.
Brief Summary: To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.


Options:
A: Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone (4 hours after the dose of subcutaneous methylnaltrexone)
B: Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period. (2 weeks)
C: Rate of LIR among the OIC population (6 months)
D: Assess the efficacy of Targinact® treatment (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin in the First Line Therapy of Advanced NSCLC
Brief Summary: This is a two-arm, parallel, open-label, Phase 2 multicenter study of pemetrexed as first line combination therapy with either cisplatin or carboplatin in the palliative setting of stage IIIb and IV non-small cell lung cancer patients. Approximately 130 patients will be included in about 15 centers in Germany and randomized to one of the above treatment regimens in a 1:1 ratio. Chemotherapy will be administered over a maximum of six cycles with a standard length of 21 days. Primary objective will be the Progression Free Survival Time of patients as assessed in both treatment arms.


Options:
A: Survival (Up to 5 years); Grade 4 or 5 toxicities assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (Up to 5 years)
B: Length of survival
C: Percentage of Participants Surviving Progression-Free at 6 Months (Progression Free Survival [PFS] Rate) (Randomization to Month 6)
D: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging (Up to approximately 21 months); Overall Survival (OS) (Up to approximately 21 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: CONNECT Study - Clinical Evaluation Of Remote NotificatioN to rEduCe Time to Clinical Decision
Brief Summary: The purpose of this study is to determine whether the ability of clinicians to receive and review information from patients implanted with a heart device over the internet (remote care) is comparable to patients who are seen in-office for routine visits to check the status of their device.


Options:
A: Time Per Patient From a Clinical Event to a Clinical Decision in Response to Arrhythmias, Cardiovascular (CV) Disease Progression, and Device Issues (Enrollment to last visit (up to 15 month post-implant))
B: Feasibility (7 months)
C: BP control at primary care visit; Systolic and diastolic BPs as recorded at each primary care provider visit during 24 month enrollment period.
D: HBA1c Glycosylated hemoglobin (one year for every patient)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Dose-range-finding, Parallel-group, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation
Brief Summary: The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.


Options:
A: Patient's Global Assessment of severity of constipation and efficacy of treatment evaluated (for exploratory reasons only). (4 weeks)
B: Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency (Change from Baseline to Week 4)
C: Colonic Transit at 24 Hours (24 hours post-radiolabeled meal)
D: Proportion of subjects with an average of 3 or more SCBM per week (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Interstitial Brachytherapy Alone Versus External Beam Radiation Therapy After Breast Conserving Surgery for Low-risk Invasive Carcinoma and Low-risk Ductal Carcinoma in Situ (DCIS) of the Female Breast
Brief Summary: To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.


Options:
A: Local relapse within the treated breast. (3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108, 120 months)
B: Ipsilateral Breast Tumor Recurrence (5-year)
C: Number of local relapses (5 YEARS)
D: Local control (5-years, 10 ten-years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Interstitial Brachytherapy Alone Versus External Beam Radiation Therapy After Breast Conserving Surgery for Low-risk Invasive Carcinoma and Low-risk Ductal Carcinoma in Situ (DCIS) of the Female Breast
Brief Summary: To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.


Options:
A: Local relapse within the treated breast. (3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108, 120 months)
B: Local control (5-years, 10 ten-years)
C: rate of local recurrence (5 years)
D: Ipsilateral Breast Tumor Recurrence (5-year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Subjects With Acute Coronary Syndromes
Brief Summary: The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the occurrence of death, myocardial infarction (heart attack), repeat myocardial infarctions, stroke, and ischemia (inadequate blood supply to a local area) in patients with recent ACS.


Options:
A: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
B: Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke (Randomization up to 12 months); Participants With Any Major Bleeding Event (First dosing up to 12 months)
C: Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety) (Day 1 to Day 210); The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy) (Day 1 to Day 210)
D: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Subjects With Acute Coronary Syndromes
Brief Summary: The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the occurrence of death, myocardial infarction (heart attack), repeat myocardial infarctions, stroke, and ischemia (inadequate blood supply to a local area) in patients with recent ACS.


Options:
A: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
B: Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety) (Day 1 to Day 210); The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy) (Day 1 to Day 210)
C: Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants (Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years); Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants (From first dose to first occurrence of event (TIMI major bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years)
D: Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke (Randomization up to 15 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Leipzig Immediate Versus Early and Late PercutaneouS Coronary Intervention triAl in NSTEMI - LIPSIA-NSTEMI TRIAL
Brief Summary: In non-ST-elevation the optimal time of percutaneous coronary intervention (PCI) is unclear.

Some studies showed benefit of very early PCI, some others early PCI between 12-48 hours and others even showed a benefit of a selective invasive approach only in case of recurrence of symptoms or a positive stress test.

The optimal timing of intervention is still matter of debate as a result of a randomized clinical trial.


Options:
A: Net Adverse Clinical Event (30-day)
B: The composite of all-cause mortality, myocardial (re)infarction, disabling stroke and re-hospitalization for cardiovascular causes or severe bleeding within 1 yr. (1 year)
C: peak creatine kinase- MB level (5 days)
D: Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out. (96 hours after randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double Dummy, Double Blind, Multinational, Multicenter Trial Comparing the Safety and Efficacy of Sequential (Intravenous/Oral) Moxifloxacin 400 mg OD to Intravenous Piperacillin/Tazobactam 4.0/0.5 g Every 8 Hours Followed by Oral Amoxicillin/Clavulanic Acid Tablets 875/125 mg Every 12 Hours for the Treatment of Subjects With Complicated Skin and Skin Structure Infections
Brief Summary: Patients, who are considered suitable by their physicians to take part in this research, will have a physical examination (including an Electrocardiogram (ECG)), blood and urine samples taken, as well as a sample of the secretions or tissue around their infection site. In addition, the site of the infection will be photographed. The patients will be randomly assigned one of the treatments: intravenous (IV)/per oral (PO) moxifloxacin (drug under evaluation) or IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid (i.e., one of the reference treatments for this kind of infection). The maximum treatment duration will be 21 days, and the minimum will be 7 days. During the hospitalization, the patients will have a physical examination every day. On Day 3-5 during therapy as well as at the end of treatment, the patients will have repeated examinations. These tests and evaluations will be repeated 14 to 28 days after the end of treatment. During this visit, blood and urine samples will be taken only if judged necessary by the physicians.


Options:
A: Clinical Cure/Improvement at discontinuation of IV antibiotic therapy.
B: Skin Abscess Resolution (10-14 days)
C: Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit (up to 6 weeks)
D: Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population (14 - 28 days after last dose of study medication)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Advanced Parenting Education in Pediatrics: The APEP Project
Brief Summary: This study will evaluate the effectiveness of a parent training program in improving parenting skills and reducing behavioral symptoms in young children who are at risk for developing childhood behavior disorders.


Options:
A: Parenting behavior (Measured post-intervention and at 6- and 12-month follow-ups); Child disruptive behaviors (Measured post-intervention and at 6- and 12-month follow-ups)
B: child behavior (1yr, 2 yr, 3 yr, 4 yr, 5 yr); child social skills (1yr, 2 yr, 3 yr, 4 yr, 5 yr); child cognition (1 yr, 3 yr, 5 yr); child language/communication (2 yr, 4 yr, 5 yr); child attachment (2 yr); child peer relationships (5 yr); child academics (4 yr, 5 yr); parent-child interaction (6 months, 5 yr)
C: Change in Child Behavior Problems (baseline, first follow-up (up to 2 years))
D: The Parenting Sense of Competence scale (PSOC) (measured when child is 9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet Intervention to Improve Rural Diabetes Care
Brief Summary: Rural Diabetes Online Care (RDOC) will develop an Internet-based intervention for rural primary care physicians, focusing on improving care for adult patients with diabetes. The intervention, drawing upon the principles of quality improvement and providing tools for system-based changes in practice, is designed for the rural practice, where resources are constrained.


Options:
A: Glucose control (HbA1c levels) (Baseline, 3 months and 6 months)
B: The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups. (6 months to 1 year)
C: A1c (January 2005-present); Blood Pressure (January 2005-present); Lipids (January 2005-present)
D: Glycemic relapse: increase in HbA1c by 1% over baseline and >8%

Answer: C