TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Controlled Study on Short-term Psychotherapy After Acute Myocardial Infarction: The Step-in-AMI Trial (Short TErm Psychotherapy IN Acute Myocardial Infarction)
Brief Summary: Psychosocial factors play an important role in the pathophysiology of acute myocardial infarction (AMI), but it is not known if psychotherapy is beneficial after the contemporary treatment of AMI consisting of medical and interventional therapy.

The investigators have designed a randomized, controlled study to assess the effects of short-term psychotherapy (STP) on the clinical outcomes of patients who have undergone an emergency percutaneous coronary intervention (PCI) post-AMI.


Options:
A: Hamilton Depression Rating Scale (Measured at 16 weeks)
B: Depressive Symptom Reduction (Change from depression at baseline to depression at 6-months); Cost for Healthcare Utilization (Psychiatric Medications, Hospitalizations, Cardiac Procedures, Outpatient Services) (6 months after randomization)
C: Beck Depression Inventory-II (Measured at Baseline and 10 weeks)
D: The cumulative incidence of new cardiological events and the occurrence of new medical pathologies (5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cerebral Autoregulation Monitoring in Adults Undergoing Cardiac Surgery: Comparison of Near Infrared Spectroscopy With Transcranial Doppler
Brief Summary: Blood flow to the brain is normally regulated to ensure a constant supply of blood with oxygen and nutrients. During heart surgery using cardiopulmonary bypass, blood pressure is kept at a level that may or may not be below an individual's lower level of brain blood flow autoregulation. If lower, the brain may be exposed to an inadequate blood flow that could result in brain damage. The purpose of this study is to examine whether monitoring with a non-invasive FDA approved device that measures oxygen saturation of the superficial layers of the brain (near infrared spectroscopy) can, when combined with blood pressure measurements, provide information on the blood pressure level where brain blood flow is not autoregulated. The goal of this research is to develop a method to individualize blood pressure during surgery to a level that is within a patient's brain blood flow autoregulation range as a means for improving outcomes for patient undergoing heart surgery.


Options:
A: Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction (up to 10 days post procedure)
B: Number of Patients With Atrial Arrhythmia (From the end of surgery to postoperative day 5); Number of Patients With Delirium (From the end of surgery to postoperative day 5)
C: Concordance with Doppler measure (at complesion)
D: 90-day mortality (90 day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing
Brief Summary: The study will assess the hypothesis that the combination warfarin \& clopidogrel 75 mg/day is superior to triple therapy (warfarin + clopidogrel 75mg/day + aspirin 80mg/day) with respect to bleeding complications while equally safe with respect to the prevention of thrombotic complications in patients with both indications for warfarin use and dual antiplatelet (clopidogrel 75mg/day + aspirin 80mg/day) treatment.


Options:
A: 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)
B: Composite of death, myocardial infarction, definite stent thrombosis, stroke or major bleeding. (9 months)
C: Time to First Adjudicated ISTH MBE or CRNMBE (up to 30 months)
D: The combined end point of minor, moderate or major bleeding complications during the initial hospitalization & one year follow-up. (TIMI & GUSTO criteria). (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: What is the Optimal antiplatElet & Anticoagulant Therapy in Patients With Oral Anticoagulation and Coronary StenTing
Brief Summary: The study will assess the hypothesis that the combination warfarin \& clopidogrel 75 mg/day is superior to triple therapy (warfarin + clopidogrel 75mg/day + aspirin 80mg/day) with respect to bleeding complications while equally safe with respect to the prevention of thrombotic complications in patients with both indications for warfarin use and dual antiplatelet (clopidogrel 75mg/day + aspirin 80mg/day) treatment.


Options:
A: Number of Participants With Composite of Stroke/MI/Death (From randomization up to 97 days)
B: Adjudicated Recurrent Stroke (From randomisation until full follow up period, approximately 43 months.); First Major Bleed (Adjudicated) (Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.)
C: Recurrence of symptomatic ischemic stroke, with the symptoms lasting for at least 24 hours (every 6 months)
D: The combined end point of minor, moderate or major bleeding complications during the initial hospitalization & one year follow-up. (TIMI & GUSTO criteria). (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia
Brief Summary: The purpose of this study is to investigate and evaluate the efficacy of Eszopiclone in Japanese participants with primary insomnia.


Options:
A: Latency To Persistent Sleep (LPS) (10 days (5 intervals of two consecutive nights)); Sleep Latency (SL) (10 days (5 intervals of two consecutive nights))
B: Mean Subjective Sleep Diary Derived Total Sleep Time (TST) (Postnaprosyn baseline, Week 1, week 2, week 4)
C: mean subjective wake time after sleep onset (WASO) (Week 1)
D: Short PTSD Rating Interview (SPRINT) (8 weeks); Pittsburgh Sleep Quality Index (PSQI) (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-Controlled, Multicentre, Randomised, Parallel Group, Trial to Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (StageIIIB/IV) Non Small Cell Lung Cancer (NSCLC) Chinese Patients Who HaveNot Experienced Disease Progression or Unacceptable Toxicity During Front Line Standard Platinum-Based Chemotherapy
Brief Summary: This is a double blind, multicentre, randomized, placebo-controlled study. The eligible patients will be randomized to receive gefitinib or placebo at 1:1 ratio. This study will recruit 296 male or female, histologically or cytologically diagnosed locally advanced or metastatic NSCLC patients with a World Health Organization (WHO) Performance Status (PS) 0-2. Patients must have completed 4 cycles of platinum based first line doublet chemotherapy without experiencing disease progression or unacceptable toxicity. The chemotherapy shall be given every 3 weeks, which includes cisplatin or carboplatin, combined with any one of the following: gemcitabine, paclitaxel, docetaxel, vinorelbine.


Options:
A: Response Rate (average 6 months)
B: Progression Free Survival (PFS) (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.The primary analysis of PFS will be performed when at least 265 events have occurred, which is expected to occur approximately.)
C: Progression Free Survival (2-7 months)
D: Progression free survival (PFS) (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness
Brief Summary: Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness


Options:
A: Tobacco use abstinence (26 week)
B: Smoking Abstinence (3 months); Smoking Abstinence (6 months); Smoking Abstinence (12 months)
C: Point prevalence of smoking cessation (those who have quitted smoking and have not smoked in the past week prior to the assessment date). (52 weeks after starting the treatment)
D: biologically verified smoking cessation or reduction (8 weeks and delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness
Brief Summary: Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness


Options:
A: Days to Relapse (4 weeks)
B: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
C: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
D: Tobacco use abstinence (26 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness
Brief Summary: Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness


Options:
A: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
B: Tobacco use abstinence (26 week)
C: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. (3 months); Point Prevalence Abstinence at 3 Months. (3 months)
D: Change in smoking status over time (At 12, 26, and 52 weeks following start of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness
Brief Summary: Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness


Options:
A: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
B: Smoking Status (at week 48)
C: Tobacco use abstinence (26 week)
D: Number of Participants With 4-week Continuous Abstinence (Weeks 9 through 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness
Brief Summary: Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness


Options:
A: Tobacco use abstinence (26 week)
B: Continuous Nicotine Abstinence (8 weeks)
C: 4 week continuous quit rate (CQR) at Weeks 9-12 and Weeks 4-7
D: Biochemically Verified Abstinence Verified With Expired Carbon Monoxide (CO) < 8 p.p.m. (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness
Brief Summary: Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness


Options:
A: Smoking Behavior (Nine weeks)
B: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
C: Change in Smoking Behavior (Change in cigarettes per day from Week 2 to Week 5)
D: Tobacco use abstinence (26 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness
Brief Summary: Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness


Options:
A: Self- Reported 7-day Abstinence (6 Months); Carbon Monoxide (CO)-Confirmed 7-day Abstinence (6-Months); Rates of Smoking Cessation Continuous From First Quit Day to 6 Months (6-Months); Self-reported 7-day Abstinence (12 Months); CO-confirmed 7-day Abstinence (12 Months)
B: Cotinine Level (Baseline, 4 weeks, 8 weeks); Change From Baseline in Cognitive Performance (basline and 8 weeks (or end of study iif patient ended participation before the 8-weeks))
C: 7 day point prevalence of cigarette abstinence (End of trial (week 10))
D: Tobacco use abstinence (26 week)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Flexibly-Dosed Combination Pharmacotherapy Versus Standard-Dosed Nicotine Patch Alone for Smokers With Medical Illness
Brief Summary: Randomized clinical trial to evaluate a flexibly-dosed-3-medication combination for up to 6 months in smokers with medical illness


Options:
A: Tobacco use abstinence (26 week)
B: 7-Day Point Prevalence Smoking Abstinence (24 weeks); Continuous Smoking Abstinence (24 weeks)
C: Biochemically verified 7 day point prevalence abstinence from smoking.
D: Participants Abstinent From Cigarettes (Two years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study of SEP-190 (Eszopiclone) in Patients With Insomnia
Brief Summary: The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.


Options:
A: Incidence of Adverse Events (Up to 25 weeks (24 weeks treatment period & 1 week follow-up))
B: Pittsburgh Sleep Quality Index (PSQI) (8 weeks and 5 months); Insomnia Severity Index (8 weeks and 5 months); Actigraphy (8 weeks)
C: Daily Living and Role Functioning (DLRF) Basis-32 Subscale Ratings (9 weeks); Relation to Self/Others (RSO) Basis-32 Subscale Ratings (9 weeks); Quality of Life Ratings, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (9 weeks)
D: TST (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Magnetic Seizure Therapy (MST) in Refractory Major Depression
Brief Summary: The investigators intend to test in a single center, clinical pilot efficacy study the primary hypothesis that Magnetic Seizure Therapy (MST) as add-on therapy to a controlled pharmacotherapy is efficacious in the treatment of refractory major depression assessed with the Hamilton Depression Rating Scale (HAMD).


Options:
A: Recovery Time (same day)
B: Clinical improvement (Hamilton Rating Scale for Depression) (After each treatment and at followups up to 3 months after the treatment course)
C: Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24 (HRSD-24) (7 weeks); Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT) (7 weeks)
D: Score on rating scale that corresponds to diagnosis: i) Hamilton Rating Scale for Depression, 24-item (HRSD-24); or ii) Yale-Brown Obsessive Compulsive Scale (Y-BOCS); or iii) Brief Psychiatric Rating Scale (BPRS) (Change from baseline in HRSD-24 / Y-BOCS / BPRS at date of symptom remission or date of the 24th treatment, whichever comes first, assessed up to 12 weeks); Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS (Change from baseline in HRSD-24 / Y-BOCS / BPRS at 1 month after final treatment); Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS (Change from baseline in HRSD-24 / Y-BOCS / BPRS at 2 months after final treatment); Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS (Change from baseline in HRSD-24 / Y-BOCS / BPRS at 3 months after final treatment); Score on rating scale that corresponds to diagnosis: i) HRSD-24; or ii) Y-BOCS; or iii) BPRS (Change from baseline in HRSD-24 / Y-BOCS / BPRS at 6 months after final treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise Dose and Nonalcoholic Fatty Liver Disease
Brief Summary: The purpose of this research is to provide a better understanding of how exercise (walking) affects non-alcoholic fatty liver disease (NAFLD) in overweight people. NAFLD, which is common in obese people, occurs when the liver has too much fat.


Options:
A: The effect of aerobic exercise on: Intrahepatic fat content (3 years)
B: Change in intrahepatic triglyceride content (6 weeks)
C: Change of intrahepatic triglyceride contents (12 months)
D: Resolution of NAFLD by proton-magnetic resonance spectroscopy (Month 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to demonstrate superiority of percutaneous posterior tibial nerve stimulation (PTNS) therapy compared to sham therapy for the treatment of patients with overall bladder (OAB) symptoms.


Options:
A: The Global Response Assessment (GRA) for Overall Bladder Symptoms to Compare the Proportion of Subjects Reporting "Moderately" or "Markedly Improved" Responses on the GRA After 12 Interventions of Randomized Therapy, in an Intent to Treat Analysis. (13 weeks)
B: Frequency of Voids at 12 Weeks (Baseline to 12 weeks)
C: Proportion of Patients Reporting "Moderately" or "Markedly" Improved on the Global Response Assessment (GRA) at 36 Months as Compared to Baseline (36 months total)
D: Changes in 24-hour micturition frequency (Bladder diaries completed at recruitment and 6 weeks, 12 weeks and 6 months.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Low Molecular Weight Heparin in Advanced Non Small Cell Lung Cancer (NSCLC): a Randomized Open Label Phase III Study Evaluating the Effect of Enoxaparin (Clexane) on Survival and Symptom Control in Patients With Stage IIIB and IV NSCLC Undergoing a Cisplatin Based First Line Chemotherapy: the SYRINGES Trial
Brief Summary: Rationale: a number of recent phase III randomized trials have shown a survival benefit of a treatment with subcutaneous low-molecular weight heparin in patients with advanced solid malignancies. The survival advantages observed in the studies persist for months after the active treatment with LMWHs. Therefore these survival advantages are thought to be due to effects of LMWHs on tumor cell biology.

First line treatment of advanced NSCLC patients with the Cisplatin + Docetaxel combination has been widely studied, and is amongst the most active treatments currently available. The occurrence of grade 3/4 thrombopenia in several phase III trials was in the 0-3% range, making it an ideal chemotherapy regimen to combine with LMWHs in the treatment of advanced NSCLC.


Options:
A: Frequency of Symptomatic Venous Thromboembolism (6 months); Frequency of Major and Clinically Relevant Non-major Bleeding (6 months)
B: Progression Free Survival (during chemotherapy and follow-up)
C: Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding (From first dose to 2 days following last dose of study drug)
D: Number of Participants With Venous Thromboembolic Events (VTE) (16 weeks of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Low Molecular Weight Heparin in Advanced Non Small Cell Lung Cancer (NSCLC): a Randomized Open Label Phase III Study Evaluating the Effect of Enoxaparin (Clexane) on Survival and Symptom Control in Patients With Stage IIIB and IV NSCLC Undergoing a Cisplatin Based First Line Chemotherapy: the SYRINGES Trial
Brief Summary: Rationale: a number of recent phase III randomized trials have shown a survival benefit of a treatment with subcutaneous low-molecular weight heparin in patients with advanced solid malignancies. The survival advantages observed in the studies persist for months after the active treatment with LMWHs. Therefore these survival advantages are thought to be due to effects of LMWHs on tumor cell biology.

First line treatment of advanced NSCLC patients with the Cisplatin + Docetaxel combination has been widely studied, and is amongst the most active treatments currently available. The occurrence of grade 3/4 thrombopenia in several phase III trials was in the 0-3% range, making it an ideal chemotherapy regimen to combine with LMWHs in the treatment of advanced NSCLC.


Options:
A: Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy (Events occurring during the four months of treatment plus 10 days)
B: first episode of objectively documented, symptomatic or asymptomatic VTE (DVT and/or PE) (7 months)
C: Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death (From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first)
D: Progression Free Survival (during chemotherapy and follow-up)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy
Brief Summary: A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of Crohn's disease.


Options:
A: Number of Participants With Clinical Response at Week 6 (Baseline to Week 6)
B: Number of Participants With an American College of Rheumatology (ACR) 20 Response at Week 12 (Week 0 to Week 12)
C: Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.
D: Number of Participants in Population 1 With a Clinical Response at Week 8 (Week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy
Brief Summary: A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of Crohn's disease.


Options:
A: Number of Participants With Clinical Response at Week 6 (Baseline to Week 6)
B: Number of Participants With Clinical Response at Week 6 (Baseline and Week 6)
C: Number of Participants With Clinical Response at Week 6 (Week 6)
D: Number of Participants With Clinical Remission at Week 44 (Week 44)

Answer: A