TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Efficacy of Methadone Versus Morphine for Treatment of Neonatal Abstinence Syndrome (NAS).
Brief Summary: Hypothesis is that the effectiveness of opiate treatment with morphine will result in shorter duration of opiate medication treatment and fewer infants treated with a second drug.


Options:
A: Finnegan Neonatal Abstinence Scoring System (14 days); Duration of Treatment (120 days)
B: Days of Treatment With Opioid Medication (From date of randomization until the date of last opioid dose or date of death from any cause, whichever came first, assessed up to 12 months)
C: Child's Head Circumference Measurement (Measured at Birth) (birth); Child's Length of Hospital Stay (delivery until hospital discharge (min=2 days, max=79 days)); Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) (From birth until hospital discharge (min=4 days, max=10, depending on site)); Child's Peak Daily Total NAS Score (minimum twice daily from birth until NAS no longer measured (min=10 days)); Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS (Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days))
D: Length of treatment for neonatal abstinence syndrome (duration of the treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comprehensive Information Imparted to Patients With Epilepsy and Comorbidity and Decreased Prevalence of Adverse Treatment Effects. The EDU-COM Study.
Brief Summary: Epilepsy requires long-term drug treatment and is frequently associated with other clinical conditions. Combinations of antiepileptic drugs and other compounds are fairly common and increase with age. Adverse drug reactions and drug interactions are expected and may affect compliance, particularly in patients not receiving adequate information. Primary objective of the study is to verify if a comprehensive and standardized educational plan is followed by a significant reduction of the number of adult patients with epilepsy and comorbidity presenting clinically relevant adverse treatment effects. Secondary objectives include effects on number of adverse treatment events, health-related quality of life (HRQOL), direct medical costs, and patient's compliance. The study is a randomized, controlled, open-label, pragmatic trial. Included are consecutive adult outpatients with 1+ concurrent clinical conditions on chronic treatment and at least one clinically relevant treatment-related adverse event and/or clinically relevant drug interaction. Eligible patients will be randomized to receive a comprehensive and standardized educational plan (experimental arm) or to usual care, ie management of adverse event/drug interaction as done in clinical practice (control arm). The experimental plan consists in discussing with patient and caregiver the cause and nature of adverse event/drug interaction, the tolerability profile of each drug, the clinical manifestations associated with current drug interaction(s), contraindications of potentially interfering over-the-counter drugs, indications and benefits of suggested treatment changes, and withdrawal of potentially interfering, contraindicated or ineffective drugs. All patients will be seen at one, three and six months after admission.

Expected results: The number of patients free from clinically relevant adverse treatment events and/or drug interactions in each treatment arm at end of study is expected to be higher in patients assigned to comprehensive and standardized educational plan compared to usual care (primary outcome). Patients on the experimental plan are also expected to be more commonly free from relevant adverse events and/or drug interactions at each intermediate visit, to present a lower number of adverse treatment events, to imply lower costs for medical contacts, hospital admissions, and drugs, to present better HRQOL scores, and to present less weekly treatment omissions.


Options:
A: All-cause mortality (within 5 years of enrollment)
B: The primary outcome is defined by the number of patients free from clinically relevant adverse treatment events and/or drug interactions in each treatment arm at end of study. (6 months)
C: Quick Inventory of Depressive Symptoms (Measured at Month 7)
D: Work limitations (One year); Work engagement (One year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Open Label, Non-randomized Study of Second or Third Line Treatment With the Combination of Sorafenib and Everolimus in Patients Affected by Relapsed and Non-resectable High-grade Osteosarcoma
Brief Summary: This is a trial for patients affected by metastatic or relapsed osteosarcoma which progressed after first or further line treatments. In this trial, all patients will be treated until progression or unacceptable toxicity with sorafenib and everolimus. The treatment with sorafenib and everolimus aimed to obtain a 50% rate of patients free from further progression of the disease after 6 months from study entry.


Options:
A: Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Week 12 (Part B) (Week 12)
B: To determine the objective response (Weeks 24)
C: Overall Survival (OS) (approximately 3 years 8 months (From Study start date [27 May 2011] up to final analysis data cut-off [05 January 2015])
D: Progression Free Survival rate at 6 months (6 months from registration into the study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Investigation of the Clinical Effectiveness of Adolescent Weight-management Delivered Via a Portable Device
Brief Summary: Though face-to-face treatment of childhood obesity can be effective, it is time consuming and costly. This study will test whether treatment can be delivered via an Android app and whether such treatment reduces obesity.


Options:
A: Mediterranean diet compliance (1 year)
B: Changes from baseline BMI (At baseline (0 years) and followed for 2 years); Changes from baseline Fatty mass (At baseline (0 years) and followed for 2 years); Changes from baseline Free-fatty mass (At baseline (0 years) and followed for 2 years); Changes from baseline Muscular Mass (At baseline (0 years) and followed for 2 years); Changes from baseline Corporal Water (At baseline (0 years) and followed for 2 years); Adherence to dietary pattern will be also measured through personal interview (At baseline (0 years) and followed for 2 years); Adherence to physical activity patterns will be also measured through IPAQ (International Physical Activity Questionnaire) (At baseline (0 years) and followed for 2 years); Changes from baseline in the number of steps per day (At baseline (0 years) and followed for 2 years)
C: BMI Z score (12 months)
D: Weight Loss (Omron Weight Balance) (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Investigation of the Clinical Effectiveness of Adolescent Weight-management Delivered Via a Portable Device
Brief Summary: Though face-to-face treatment of childhood obesity can be effective, it is time consuming and costly. This study will test whether treatment can be delivered via an Android app and whether such treatment reduces obesity.


Options:
A: To evaluate the effect, at 12 months, of the 3 intensities of the PACEi-DP intervention on Body Mass Index (BMI) among male & female adolescents. (baseline, 6 mo, 12 mo)
B: Body mass index (BMI) (Change through 2 years)
C: Frequency of binge eating; weight
D: BMI Z score (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Concomitant Use of Nevirapine and Rifampicin in Antiretroviral Naive Patients Co-infected With HIV and Tuberculosis in India.
Brief Summary: The purpose of the study is to evaluate the efficacy and safety of Nevarapine and Rifampicin vs Efavirenz and Rifampicin in antiretroviral naive patients co-infected with HIV and TB and to investigate whether Rifampicin co-administration in clinical practice leads to a clinically relevant decrease of Nevirapine plasma concentrations in Indian patients co-infected with HIV and Tuberculosis and to characterize drug-associated toxicities (especially hepatic).


Options:
A: Virological suppression at 48 weeks. (5 years)
B: To compare proportion of patients who achieved undetectable plasma HIV-1RNA< 50 copies/mL at 48 weeks after initiation of antiretroviral treatment between the 2 groups (48 weeks)
C: Suppression of Viral load to < 400 copies/ml or a two log reduction in viral load from the baseline value at the end of 6 months and a viral load <400 copies/ml at 24 months of antiretroviral therapy (Dec 2008)
D: Viral load measure (Virological failure will be defined after 2 consecutive measures as : More than 1 log10 increase in plasma HIV-1 RNA concentration for patients with detectable viral load (> 50 copies/mL) at the previous dosage.) (3, 6 and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: SAFARI-Return to Work: Promoting Health and Productivity in Workers With Common Mental Disorders
Brief Summary: Evidence-based clinical treatments for common mental disorders, such as CBT and/or pharmacotherapy, have resulted in significant and sustained improvement in clinical symptoms. However, the individual-focused treatments rarely have sickness absence as a target of intervention or evaluate work-related outcomes, such as return to work. A recent review of the evidence for managing stress at work showed that individual interventions give effects on mental health measures but did not impact absenteeism at work. The purpose of this study is to examine the efficacy and cost-effectiveness of two different rehabilitation models, one based on psychotherapy and the other on workplace-interventions, when these are offered as standalone interventions and in combination for patients with adjustment, anxiety and depressive disorders.


Options:
A: Return to work (at 6, 12, 24 and 60 months)
B: Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) (26 weeks)
C: Daily Depression (Change in daily depression assessed daily for seven days during week 2 and week 16 of the study.); Depression I (Change in depression over 4-month period.); Depression II (Change in depression over 4-month period.); Daily Social Connection (Change in daily social connection assessed daily for seven days during week 2 and week 16 of the study.); Daily Belonging (Change in loneliness over 4-month period.); Loneliness (Change in loneliness over 4-month period.)
D: Physician burnout (September 2010 - June 2012)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: SAFARI-Return to Work: Promoting Health and Productivity in Workers With Common Mental Disorders
Brief Summary: Evidence-based clinical treatments for common mental disorders, such as CBT and/or pharmacotherapy, have resulted in significant and sustained improvement in clinical symptoms. However, the individual-focused treatments rarely have sickness absence as a target of intervention or evaluate work-related outcomes, such as return to work. A recent review of the evidence for managing stress at work showed that individual interventions give effects on mental health measures but did not impact absenteeism at work. The purpose of this study is to examine the efficacy and cost-effectiveness of two different rehabilitation models, one based on psychotherapy and the other on workplace-interventions, when these are offered as standalone interventions and in combination for patients with adjustment, anxiety and depressive disorders.


Options:
A: Change From Baseline in HAM-D17 Total Score at Week 8 or Final On-therapy (FOT) Evaluation (Baseline and Week 8 or FOT)
B: Change in Depressive symptoms (3, 6 and 12 months.)
C: Hamilton Depression Rating Scale (HAMD-17) (Baseline, 4, 8, 24, 36, 52 week)
D: Return to work (at 6, 12, 24 and 60 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy to Effectiveness Transition of an Educational Program to Increase Colorectal Cancer Screening
Brief Summary: * Hypothesis 1. When compared to passive dissemination, active dissemination will result in greater participant enrollment.
* Hypothesis 2. The intervention will be offered with equal fidelity in churches, clinics and community sites.
* Hypothesis 3. Knowledge of CRC screening and perceived risk of CRC will be positively correlated.


Options:
A: Targeted risk and protective factors, substance use, delinquency, violence (Baseline through thirteen-year follow-up (age 23)); CTC coalition functioning, prevention system transformation, evidence-based program (EBP) implementation (Baseline through eight-year follow-up (age 18))
B: Reach (RE-AIM Framework) (up to 12 months); Effectiveness (RE-AIM Framework) (up to 24 months)
C: Blood Pressure (6 months post enrollment into trial); LDL Cholesterol (6 months post enrollment into trial); Use of Anti-thrombotic Medication (6 months post enrollment into trial)
D: Weight loss. (1 year); HgbA1c (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers
Brief Summary: Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study.


Options:
A: Proportion of Daily Cigarettes Smoked in the 4 Hours After Receiving Methadone Dose (7 weeks)
B: The primary outcome measure for alcohol use will be the number of drinks/week at the end of the treatment phase, relative to baseline and during-treatment data. (8 weeks)
C: Primary efficacy and Safety endpoint: (within 12 month from enrollment)
D: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers
Brief Summary: Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study.


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 Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)
C: Days of abstinence following the programmed lapse (7 days)
D: Number of Participants Not Smoking in the Previous 7 Days, Confirmed by Expired Carbon Monoxide Reading < 10 Parts Per Million at Week 52 (7-day point prevalence)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers
Brief Summary: Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study.


Options:
A: Smoking abstinence at 6 months after inclusion (yes/no) (6 months after inclusion)
B: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)
C: 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))
D: 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)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers
Brief Summary: Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study.


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 Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)
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: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers
Brief Summary: Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study.


Options:
A: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)
B: Smoking Abstinence (3 months); Smoking Abstinence (6 months); Smoking Abstinence (12 months)
C: Tobacco use abstinence (26 week)
D: 6 Month Self-reported Abstinence From Smoking (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers
Brief Summary: Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study.


Options:
A: tobacco abstinence (6 months)
B: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)
C: Smoking Behavior (Nine weeks)
D: The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers
Brief Summary: Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study.


Options:
A: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (weeks 8-11 after quit date)
B: Short term continuous abstinence (weeks 9 to 12)
C: Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking (Week 15 - 24)
D: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers
Brief Summary: Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study.


Options:
A: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)
B: 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)
C: 4-week continuous quit rate (CQR) for Weeks 9-12
D: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers
Brief Summary: Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study.


Options:
A: Number of Participants Completing Continuous Four-week Abstinence From Smoking Between the 8-week and 11-week Post Quit Day Visits (Period between 8-week and 11-week visits post target Quit Day)
B: N/A
C: continuous abstinence (CAR) from weeks 9 to 12 of treatment (3 months)
D: Biochemically-confirmed 7-Day Point-Prevalence Abstinence at 26 Weeks (Assessed 26 weeks after the target quit day.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Multi-center Study to Assess Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Emergency Presentation at the Hospital Because of Worsening Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone Versus Eplerenone
Brief Summary: To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.


Options:
A: Pulse wave velocity (24 weeks); Pulse Wave velocity (12 weeks); Pulse wave velocity (baseline)
B: Change of serum potassium (4 weeks)
C: Percentage of Participants With a Relative Decrease in NT-proBNP of More Than 30% From Baseline to Day 90 (Baseline and Day 90)
D: Urinary albumin excretion (18 months)

Answer: C