TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of MK-4305 in Patients With Primary Insomnia - Study B
Brief Summary: This is a multicenter study to test the hypothesis that suvorexant (MK-4305) is superior to placebo in improving insomnia as measured by change from baseline in: subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep.


Options:
A: Change from Baseline in Nighttime Total Sleep Time (Baseline, 14 days follow-up)
B: Change in the Cornell Scale for Depression in Dementia (CSDD) (Week -2, week 0, week 6 and week 13)
C: Pittsburgh Sleep Quality Index (8 weeks)
D: Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Total Sleep Time (sTSTm) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in sTSTm at Month 3 (Baseline and Month 3); Suvorexant HD Versus Placebo: Change From Baseline in Wakefulness After Persistent Sleep Onset (WASO) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in WASO at Month 3 (Baseline and Month 3); Suvorexant HD Versus Placebo: Change From Baseline in Mean Subjective Time to Sleep Onset (sTSOm) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in sTSOm at Month 3 (Baseline and Month 3); Suvorexant HD Versus Placebo: Change From Baseline in Latency to Onset of Persistent Sleep (LPS) at Month 1 (Baseline and Month 1); Suvorexant HD Versus Placebo: Change From Baseline in LPS at Month 3 (Baseline and Month 3); Number of Participants With an Adverse Event (AE) During 3-Month DB TRT Phase (Up to 3 months); Number of Participants Who Discontinued Study Drug Due to an AE Occurring During 3-Month DB TRT Phase (Up to 3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: The PERFECT Registry
Brief Summary: A prospective observational study to evaluate the safety and effectiveness data of catheter-directed therapy (CDT) including percutaneous mechanical thrombectomy (PMT) for treatment of acute pulmonary embolism (PE)


Options:
A: Resolution of hypoxia (Post-procedure and 3 months); Survival from acute PE (Post-procedure and 3 months); Stabilization of hemodynamics (Post-procedure and 3 months)
B: Time left unprotected to venous thromboembolism (two weeks post trauma)
C: Reduction of RV/LV Ratio (24 hours); Major Bleeding and Intracranial Bleeding at 30 Days. (30 days)
D: Exercise Limitation (1 month); Exercise Limitation (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Varenicline for Smokeless Tobacco Use in India
Brief Summary: This study, based in India, is testing the efficacy of varenicline to help smokeless tobacco users with cessation efforts.


Options:
A: Four-week Continuous Abstinence From Cigarette Smoking (Study week 8 thru week 11)
B: Smoking Abstinence - Serum/Urine Measurements (Week 12); Smoking Abstinence - Number of Cigarettes Smoked (Week 12); Smoking Abstinence - Exhaled Carbon Monoxide (Week 12)
C: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))
D: Change in sputum eosinophile-% from >1% to normal or neutrophile-% from >61% to normal, from baseline (week 0) to week 12. (Time frame for primary outcome: 0-12 weeks (total study duration 24 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Varenicline for Smokeless Tobacco Use in India
Brief Summary: This study, based in India, is testing the efficacy of varenicline to help smokeless tobacco users with cessation efforts.


Options:
A: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))
B: Number of Participants With Smoking Abstinence at Month 6 (Month 6)
C: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
D: To Determine the Safety of Varenicline in PLWH Who Smoke (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Varenicline for Smokeless Tobacco Use in India
Brief Summary: This study, based in India, is testing the efficacy of varenicline to help smokeless tobacco users with cessation efforts.


Options:
A: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))
B: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)
C: Smoking Status (at week 48)
D: Number of Subjects With a 4 Week Continuous Quit Rate (CQR) From Smokeless Tobacco (Weeks 9 through 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Varenicline for Smokeless Tobacco Use in India
Brief Summary: This study, based in India, is testing the efficacy of varenicline to help smokeless tobacco users with cessation efforts.


Options:
A: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))
B: effectiveness (2 years)
C: The primary outcome will be the biochemically confirmed (exhaled CO < 10 ppm) self-reported continuous abstinence for weeks 12 to 26. (26 weeks)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Varenicline for Smokeless Tobacco Use in India
Brief Summary: This study, based in India, is testing the efficacy of varenicline to help smokeless tobacco users with cessation efforts.


Options:
A: Change of ExpiredCO Level From Baseline (Weekly for 12 weeks); Level of Nicotine Dependence by Treatment Assignment (Weekly for 12 weeks)
B: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))
C: Seven-day point prevalence and treatment or treatment strategy (At week 6); Main effects of varenicline and nicotine patch + lozenge on smokers who remain on these medications throughout the trial as documented in questionnaires (Up to 12 weeks); Probability of response at week 12 conditional on response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and continuation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and augmentation of treatment (At 12 weeks); Probability of response at week 12 conditional on non-response at week 6 and treatment switching (At 12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after the initial treatment with nicotine patch + lozenge for six weeks (12 weeks); Probability that treatment continuation, switching, or augmentation confers benefit conditional upon failing to quit after initial treatment with varenicline for six weeks (12 weeks)
D: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Varenicline for Smokeless Tobacco Use in India
Brief Summary: This study, based in India, is testing the efficacy of varenicline to help smokeless tobacco users with cessation efforts.


Options:
A: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))
B: Continuous abstinence for the last 4 weeks of varenicline and NRT (Nicotine Replacement Therapy) treatment period
C: The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.
D: to assess the continuous abstinence from tobacco smoking at every visit during the last four weeks of treatment through direct inquiry of patients; exhaled carbon monoxide testing; and plasma cotinine measurements

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Varenicline for Smokeless Tobacco Use in India
Brief Summary: This study, based in India, is testing the efficacy of varenicline to help smokeless tobacco users with cessation efforts.


Options:
A: Hamilton Depression Rating Scale (Ham-D) (Week 8); Memory Saccadic Positional Error, Degrees (Week 8); Predictive Pursuit Gain (Week 8); Maintenance Pursuit Gain (Week 8); Digit Symbol Test (Week 0, Week 2 and Week 8); Conner's Continuous Performance Test (CPT) Detectability Score (Week 0, Week 2 and Week 8); Antisaccade Error Rates (Week 0, Week 2 and Week 8); P50 (Week 0, Week 2 and Week 8)
B: The four-week continuous quit rate over the last four weeks of treatment (Last 4 weeks of therapy)
C: 4-week continuous quit rate (CQR) for Weeks 9-12
D: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Varenicline for Smokeless Tobacco Use in India
Brief Summary: This study, based in India, is testing the efficacy of varenicline to help smokeless tobacco users with cessation efforts.


Options:
A: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
B: 7-day Point Prevalence Smokeless Tobacco Abstinence Biochemically Confirmed With Urine Cotinine at the End of 12 Weeks of Treatment. (At the end of treatment (12 weeks))
C: Smoking Abstinence (3 months); Smoking Abstinence (6 months); Smoking Abstinence (12 months)
D: Cotinine-validated 7-day point prevalence tobacco abstinence at 1 year follow-up; Cotinine-validated 7-day point prevalence tobacco abstinence at 3 month follow-up (end of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment With Acetyl-Choline Esterase Inhibitors in Children With Autism
Brief Summary: We propose a study which will combine multiple modalities in evaluating the treatment response of children with autism spectrum disorders (ASD) to acetyl-choline esterase (AChE) inhibitors and choline supplements. The primary objective of the study is to examine the efficacy of this treatment in improving core autistic symptoms. The Secondary objective of the study is to evaluate the safety and tolerability of the treatment protocol in ASD children. Exploratory objectives include evaluation of the influence of the treatment on linguistic performance, comorbid behaviors, adaptive functioning and executive functions.


Options:
A: hyperactivity, impulsiveness, and distractibility
B: Changes in the Autism Diagnostic Observation Schedule (ADOS) (At baseline and after 12 weeks of treatment); Clinical Global Impression Scale (CGI) (At baseline and every 4 week up to 12 weeks)
C: Mean Post-baseline Aberrant Behavior Checklist Irritability Score, Parent Report, Double-blind Phase (Weeks 1, 2, 3, 4, 6, and 8); Odds of Improvement as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2) (Weeks 1, 2, 3, 4, 6 and 8)
D: Core autistic symptoms (ATEC) (Once every 4 weeks during the first three mounth); Side effects and adverse events questionnaire (Once every 4 weeks during the first phase(12 weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment With Acetyl-Choline Esterase Inhibitors in Children With Autism
Brief Summary: We propose a study which will combine multiple modalities in evaluating the treatment response of children with autism spectrum disorders (ASD) to acetyl-choline esterase (AChE) inhibitors and choline supplements. The primary objective of the study is to examine the efficacy of this treatment in improving core autistic symptoms. The Secondary objective of the study is to evaluate the safety and tolerability of the treatment protocol in ASD children. Exploratory objectives include evaluation of the influence of the treatment on linguistic performance, comorbid behaviors, adaptive functioning and executive functions.


Options:
A: Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Social Domain (16 weeks)
B: Core autistic symptoms (ATEC) (Once every 4 weeks during the first three mounth); Side effects and adverse events questionnaire (Once every 4 weeks during the first phase(12 weeks))
C: Aberrant Behavior Checklist - Social Withdrawal Subscale (Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8)
D: Proportion of Patients Meeting the Criterion for Loss of Therapeutic Response (LTR) by the End of the Study (Based on Observed Cases) (Baseline (Visit 1) to week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment With Acetyl-Choline Esterase Inhibitors in Children With Autism
Brief Summary: We propose a study which will combine multiple modalities in evaluating the treatment response of children with autism spectrum disorders (ASD) to acetyl-choline esterase (AChE) inhibitors and choline supplements. The primary objective of the study is to examine the efficacy of this treatment in improving core autistic symptoms. The Secondary objective of the study is to evaluate the safety and tolerability of the treatment protocol in ASD children. Exploratory objectives include evaluation of the influence of the treatment on linguistic performance, comorbid behaviors, adaptive functioning and executive functions.


Options:
A: Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale (6 Weeks)
B: Core autistic symptoms (ATEC) (Once every 4 weeks during the first three mounth); Side effects and adverse events questionnaire (Once every 4 weeks during the first phase(12 weeks))
C: To evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children 2-6 years measuring the change from baseline in ADOS (Autism Diagnostic Observation Schedule) Composite Total scores compared to placebo at 6 months. (Baseline 1, Week 24)
D: Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function (12 and 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE
Brief Summary: Numerous human cardiac stem cell studies have been published, including relatively small number of patients. Meta-analysis of randomized trials have reported safety and a 3-6% increase in global left ventricular performance after intracoronary stem cell therapy in patients with acute myocardial infarction. Since most of the studies used different type of stem cells, delivery modes, and patient population, the results are heterogenous, therefore the comparison of the results is biased regarding generalizable conclusions about the effect of treatment. The present comparative meta-analysis is based on individual patient data, and gathers and pools the raw data, and analyzes the clinical outcome, safety and efficacy of the cardiac stem cell therapy.


Options:
A: Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol (Baseline and 12 month visit)
B: Troponin samples (1 day after cell injection); Number of patients with adverse events at short term (within 1 week after cell injection); Number of patients with adverse events at mid/long term (up to 12 months after cell injection)
C: Efficacy between groups post-index procedure (39 weeks post-index)
D: Freedom from occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, re-infarction, revascularization and stroke (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE
Brief Summary: Numerous human cardiac stem cell studies have been published, including relatively small number of patients. Meta-analysis of randomized trials have reported safety and a 3-6% increase in global left ventricular performance after intracoronary stem cell therapy in patients with acute myocardial infarction. Since most of the studies used different type of stem cells, delivery modes, and patient population, the results are heterogenous, therefore the comparison of the results is biased regarding generalizable conclusions about the effect of treatment. The present comparative meta-analysis is based on individual patient data, and gathers and pools the raw data, and analyzes the clinical outcome, safety and efficacy of the cardiac stem cell therapy.


Options:
A: Change in Myocardial viability evaluated by thallium scintigraphy (3 months and 1 year) (after 3 months and 1 year of treatment)
B: Global Left Ventricular Ejection Fraction change (6 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: Cardiac function at 3 and 6 months follow-up will be compared to baseline measures obtained the day(s) before CD34+ cell product infusion. (3 & 6 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Study of Lenalidomide Maintenance After Debulking Therapy in Patients With Advanced Cutaneous T-Cell Lymphoma
Brief Summary: RATIONALE: Observation is watching a patient's condition but not giving treatment unless symptoms appear or change. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is not yet known whether observation or lenalidomide is more effective in treating patients who are in complete or partial response after receiving previous gemcitabine hydrochloride or doxorubicin hydrochloride liposome for cutaneous T-cell lymphoma or mycosis fungoides/Sézary syndrome.

PURPOSE: This randomized phase III trial is studying observation to see how well it works compared with lenalidomide in treating patients who are in complete or partial response after receiving previous gemcitabine hydrochloride or doxorubicin hydrochloride liposome for stage IIB, stage III, or stage IV cutaneous T-cell lymphoma or stage IIB, stage III, or stage IV mycosis fungoides/Sézary syndrome.


Options:
A: Progression-free survival
B: overall response rate (every 3 months)
C: Response (complete clinical [CCR] and partial resp. [PR]) rate by Tumor Burden Index for cutaneous disease and appearance or disappearance of lesions for noncutaneous disease every 8 wks during treatment and then every 12 wks until progression
D: Progression Free Survival (From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blinded, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Topically Applied 1.0% WBI-1001 Cream for 12 Weeks, in the Treatment of Mild to Moderate Plaque Psoriasis.
Brief Summary: Psoriasis is a chronic inflammatory skin disorder that is characterized by hyperproliferation of the keratinocytes and inflammation of the epidermal and dermal layers of the skin. This study, in patients with mild to moderate plaque psoriasis, is designed to further determine the efficacy, safety and tolerability of the novel, topically applied, non-steroid, anti-inflammatory WBI-1001 cream over a period of 12 weeks.


Options:
A: Change from baseline (Day 0) in PGA in patients randomized to placebo as compared to patients randomized to 1.0% WBI-1001. (84 days)
B: Difference in percent reduction in Psoriasis Area and Severity Index (PASI) Scores between treatment arms (12 weeks of treatment)
C: Number of Subjects With Treatment Success, Assessed Per the Investigator's Static Global Assessment (8 weeks)
D: - Patients with "Controlled disease" ("Absence of disease" or "Very mild disease") according to investigator's global assessment of disease severity at week 8.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post-Surgical Dental Pain: Study I
Brief Summary: This study will compare the pain relieving effect of a single-dose of a novel ibuprofen formulation to placebo and two formulations of standard ibuprofen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.


Options:
A: 11-point Visual Analog Scale for Pain (1-2 weeks)
B: Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8) (0 to 8 hours); Time to Onset of Meaningful Relief (0 to 8 hours)
C: Number of Participants With Level 3 Postoperative Hemorrhage (Data about post-tonsillectomy bleeding will be obtained after the end of a 14-day postoperative period.)
D: Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h) (0 to 8 hours)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation Treatment for Head & Neck Cancer Patients: Acceptance and Commitment Therapy
Brief Summary: This is Part 1 of a 2-part research study. The goal of this part of the study is to plan and test an investigational type of counseling called Acceptance and Commitment Therapy, for use in patients who have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal cancer, or genitourinary cancer.

This part of the study is also designed to train the study counselors how to perform Acceptance and Commitment Therapy.

In this part of the study, participants will either receive Acceptance and Commitment Therapy or the standard type of counseling, called Motivational and Behavioral Counseling.

This is Part 2 of a 2-part research study. In both parts of the study, participants receive either an investigational type of counseling (Acceptance and Commitment Therapy) or a standard type of counseling (Motivational and Behavioral Counseling). Part 1 was also designed to train the study counselors how to perform Acceptance and Commitment Therapy.

The goal of Part 2 is to compare Acceptance and Commitment Therapy against Motivational and Behavioral Counseling. Researchers want to learn which type of counseling may be more effective in helping patients to stop smoking. These types of counseling will be tested in patients who have or had head and neck cancer, lung cancer, breast cancer, gastrointestinal cancer, or genitourinary cancer.


Options:
A: Connor-Davidson's Resilience Scale (CDRISC; Connor and Davidson, 2003) (Up to 3 months)
B: Self-reported quit rate for the past 7 days (6-month follow-up)
C: Smoking Abstinence Rate (Baseline up to 6 weeks)
D: Change from baseline in ED staff burn out using the Maslach Burnout Inventory (MBI) (Week 8 and 20)

Answer: C