TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Bup/Nx - Facilitated Rehab for Opioid Dependent Adolescents
Brief Summary: The purpose of this study is to compare two 3-month treatments for adolescents/young adults who are addicted to heroin: buprenorphine/naloxone combined with psychosocial therapy and treatment as usual, a 7-14 day detoxification with buprenorphine and three weeks of psychosocial therapy.


Options:
A: The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 (12 weeks); The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment (12 weeks in Phase 2 period (i.e., 24 weeks into the study))
B: opiate use
C: Opiate abstinence
D: unmet need (past 6 months); abstinent from alcohol and opioid use, past 30 days (past 30 days); negative consequences related to substance use (past 3 months); Functioning (past 4 weeks); Engagement (30 days of initiation); initiation (Within 14 days of index visit); heavy alcohol use (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Bup/Nx - Facilitated Rehab for Opioid Dependent Adolescents
Brief Summary: The purpose of this study is to compare two 3-month treatments for adolescents/young adults who are addicted to heroin: buprenorphine/naloxone combined with psychosocial therapy and treatment as usual, a 7-14 day detoxification with buprenorphine and three weeks of psychosocial therapy.


Options:
A: Retention to substance abuse treatment (12 months)
B: Opiate abstinence
C: The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 (12 weeks); The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition, Phase 2 End of Treatment (12 weeks in Phase 2 period (i.e., 24 weeks into the study))
D: Number of Participants Retained in Treatment (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Bup/Nx - Facilitated Rehab for Opioid Dependent Adolescents
Brief Summary: The purpose of this study is to compare two 3-month treatments for adolescents/young adults who are addicted to heroin: buprenorphine/naloxone combined with psychosocial therapy and treatment as usual, a 7-14 day detoxification with buprenorphine and three weeks of psychosocial therapy.


Options:
A: percentage of subjects abstinent from all opioids through the final day of detoxification (up to 12-week trial)
B: Opiate abstinence
C: CDF of the percent of urine samples negative for opioids in Probuphine and Placebo groups from weeks 1-24 (1-24 weeks); CDF of the percent of urine samples negative for opioids from weeks 1-24 with imputation based on illicit drug use self-report data for Probuphine and placebo groups (1-24 weeks)
D: Opiate abstinence

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Bup/Nx - Facilitated Rehab for Opioid Dependent Adolescents
Brief Summary: The purpose of this study is to compare two 3-month treatments for adolescents/young adults who are addicted to heroin: buprenorphine/naloxone combined with psychosocial therapy and treatment as usual, a 7-14 day detoxification with buprenorphine and three weeks of psychosocial therapy.


Options:
A: Opiate abstinence
B: Opiate abstinence
C: OOWS Score (Change from baseline in OOWS score at 180 minutes (15 minutes post naloxone administration))
D: Withdrawal intensity (6 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Bup/Nx - Facilitated Rehab for Opioid Dependent Adolescents
Brief Summary: The purpose of this study is to compare two 3-month treatments for adolescents/young adults who are addicted to heroin: buprenorphine/naloxone combined with psychosocial therapy and treatment as usual, a 7-14 day detoxification with buprenorphine and three weeks of psychosocial therapy.


Options:
A: Opiate abstinence
B: Hepatitis C seroconversion
C: 1. decrease in the number and proportion of times participants practiced vaginal or anal sex without a condom.; 2. decrease in the overall number of persons participants shared syringes or injection equipment with.; 3. decrease in the number and proportion of injections done with a syringe previously used by another person.; 4. decrease in the number and proportion of times participant used another person's equipment to prepare or divide drugs before injecting.
D: prevalence of non-users of street opioid after one year of treatment will be compared between arms. (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Motivational Enhancement Therapy (MET) to Improve Treatment Utilization in Pregnant Substance Users
Brief Summary: The purpose of this study is to compare Motivational Enhancement Therapy (MET) with standard drug abuse treatment among pregnant women.


Options:
A: Treatment Utilization; Substance Abuse
B: Number of Times Used Alcohol (Past 3 months)
C: The Number of Alcohol Drinks Per Week (as Measured by the Time Line Follow Back Procedure) at the 6 Month Follow-up. (6-months); Percent Days Abstinent From Alcohol at 6 Months (6-months)
D: Reduction in past 30 day drug misuse (12 months post-randomization); Reduction in behaviors associated with drug misuse (12 months post-randomization); Reduction negative physical health, psychosocial health, and socioeconomic consequences (12 months post-randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Women's Treatment for Trauma and Substance Use Disorders
Brief Summary: The purpose of this study is to compare the effectiveness of adding Seeking Safety to standard substance abuse treatment to adding a control condition: Women's Health Education to standard substance abuse treatment.


Options:
A: Linkage to Alcohol Behavioral Therapy Counseling (i.e., "Aftercare") (1 month)
B: Proportion Days Abstinent (PDA) (Every 3 months out to 2 years)
C: Drug abstinence
D: Change in number of alcohol use days from baseline to 6 months (Baseline, 1, 3, and 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Women's Treatment for Trauma and Substance Use Disorders
Brief Summary: The purpose of this study is to compare the effectiveness of adding Seeking Safety to standard substance abuse treatment to adding a control condition: Women's Health Education to standard substance abuse treatment.


Options:
A: Evidence of change in incidence and frequency of intimate partner physical assault and psychological aggression assessed by questionnaires and clinical interviews. (Change determined by assessments pre and post treatment, 6 months, 12 months, and 18 months following treatment)
B: Severity of Violence Against Women (6 months); Women's Experience with Battering (6 months); Safety Behavior Checklist (6 months); Decisional Conflict Scale (6 months)
C: Reducing children's exposure to Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Patterns of Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.); Reducing Intimate Partner Violence (Baseline (entry into the study), birth of the infant, and 3, 6, 12 and 24 months after the infant's birth.)
D: Drug abstinence

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Women's Treatment for Trauma and Substance Use Disorders
Brief Summary: The purpose of this study is to compare the effectiveness of adding Seeking Safety to standard substance abuse treatment to adding a control condition: Women's Health Education to standard substance abuse treatment.


Options:
A: Severity of Alcohol Use (ASI Alcohol Composite Scores) (Administered at baseline and 3 months, 6 months and 12 months post baseline.); ASI Drug Composite Score (1 year)
B: Decrease from baseline in PTSD symptom severity (Clinician Administered PTSD Scale (CAPS) score (30 day)) at 3-months and at 6-months (Baseline, 3-month, & 6-month follow-ups); Decrease from baseline in positive toxicology screens (urine drug screen and breathalyzer) at 3-months and at 6-months (Baseline, 3-month, & 6-month follow-ups); Decrease from baseline in drug and alcohol symptom severity (Addiction Severity Index (ASI)-Self Administered (30 day)) at 3-months and at 6-months (Baseline, 3-month, & 6-month follow-ups); Decrease from baseline in frequency of substance use (Timeline Follow-Back (TLFB) Interview (90 day)) at 3-months and at 6-months (Baseline, 3-month, & 6-month follow-ups)
C: Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV) (Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)); Drinking Timeline Follow-back Interview (TFBI) (Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up))
D: Drug abstinence

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Women's Treatment for Trauma and Substance Use Disorders
Brief Summary: The purpose of this study is to compare the effectiveness of adding Seeking Safety to standard substance abuse treatment to adding a control condition: Women's Health Education to standard substance abuse treatment.


Options:
A: Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013) (Baseline, changes from baseline at 1 week post-treatment, 3 months post-treatment, and 6 months post-treatment)
B: Change in telomerase activity (pre-intervention (baseline) and post-intervention (5.5 months later))
C: Composite Abuse Scale (CAS)-CAS Victimization Total Score (Assessed at baseline, and again three months later); Safety Behavior Checklist (SBC) (Assessed at baseline, and again three months later); Effectiveness in Obtaining Resources Scale (EOR) (Assessed at baseline, and again three months later)
D: Drug abstinence

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis
Brief Summary: The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.


Options:
A: Primary objectives of this study are to determine if natalizumab is effective in reducing the rate of clinical relapse at 1 year and in slowing the progression of disability at 2 years as measured by EDSS. (1 year and 2 years)
B: Change in each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC) (Throughout study); Glatiramer acetate-specific cytokine secretion of IL-13 cytokine secretion and IFN-gamma secretion by glatiramer acetate-reactive T-cell lines (At Months 3, 6, and 12)
C: Percentage of Participants With Sustained Accumulation of Disability (SAD) (Up to 2 years); Annualized Relapse Rate (Up to 2 years)
D: Time to First Relapse (Baseline up to 96 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis
Brief Summary: The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.


Options:
A: Flu-like-syndrome (309 days); Injection-site Reactions (309 days); Liver Enzyme Elevations (309 days); Hematological Abnormalities (309 days)
B: ARR - PDEs (Baseline to Month 36)
C: Hazard ratio for relapses (During the first and during the second 52 weeks)
D: Time to First Relapse (Baseline up to 96 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis
Brief Summary: The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.


Options:
A: Annualized Relapse Rate (ARR) at 1 Year (1 Year)
B: Time to First Relapse (Baseline up to 96 weeks)
C: Probability of Participants With Sustained Accumulation of Disability (SAD) (Up to 3 years); Annualized Relapse Rate (Up to 3 years)
D: Core Treatment Period: Overview of Failures (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled); Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis
Brief Summary: The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.


Options:
A: Time to First Relapse (Baseline up to 96 weeks)
B: Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005) (Various time points from randomization up to 24 months); Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005) (Various time points from randomization up to 36 months)
C: Core Treatment Period: Time to Conversion to Clinically Deﬁnite Multiple Sclerosis (CDMS) (Up to a maximum of 108 weeks depending on time of enrollment)
D: Annualized Relapse Rate (ARR) (Year 3, 4, 5, 6 from the Baseline (Month 0 of CAMMS323 and Month 0 of CAMMS324 for "Alemtuzumab Treatment CAMMS323 Extension" group and "Alemtuzumab Treatment CAMMS324 Extension" group, respectively)); Annualized Relapse Rate (ARR) Before and After Receiving Alemtuzumab (Baseline (Year 0 of initial studies) up to Year 4); Annualized Relapse Rate (ARR) Before and After Alemtuzumab Retreatment (Year 1 prior to retreatment, Year 1, 2, 3 after retreatment); Number of Participants With Sustained Accumulation of Disability (SAD) (Baseline (Year 0) up to Year 6); Number of Participants With Sustained Accumulation of Disability (SAD) Before and After Alemtuzumab Treatment: 2 Year Comparison (Baseline (Year 0 of initial studies) up to Year 4)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis
Brief Summary: The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.


Options:
A: Time to First Relapse (Baseline up to 96 weeks)
B: Change in each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC) (Throughout study); Glatiramer acetate-specific cytokine secretion of IL-13 cytokine secretion and IFN-gamma secretion by glatiramer acetate-reactive T-cell lines (At Months 3, 6, and 12)
C: The primary objectives of this study are to determine whether natalizumab, when compared with placebo, is effective in reducing the rate of clinical relapses at 1 year and, in slowing the progression of disability at 2 years. (1 year and 2 years)
D: Hazard ratio for relapses (During the first and during the second 52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase III Study of the Effects of Selenium on Adenomatous Polyp Recurrence
Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Selenium may be effective in preventing the recurrence of adenomatous colorectal polyps.

PURPOSE: This randomized phase III trial is studying selenium to see how well it works in preventing the recurrence of polyps in patients with adenomatous colorectal polyps.


Options:
A: N/A
B: Number of Recurrent Adenomas at Surveillance Colonoscopy (3 to 5 years after baseline colonoscopy); Median Selenium Blood Levels at One Year. (One year)
C: Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Antiplatelet Comparison Only) (time since randomization; follow-up period is 1.5 to 4.4 years); Number of Patients With First Recurrent Stroke of Any Type, Fatal or Nonfatal (Telmisartan vs. Placebo Only) (time since randomization; follow-up period is 1.5 to 4.4 years)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone
Brief Summary: RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases.

PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.


Options:
A: uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13 (13 weeks)
B: Numbers of SRE or Death Occurred Cumulatively (36 months)
C: Time to First Skeletal Related Event (Up to 10 years)
D: Overall survival (1:Not applicable)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone
Brief Summary: RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases.

PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.


Options:
A: N/A
B: Time to First Skeletal Related Event (Up to 10 years)
C: Time to the First On-Study SRE (Non-inferiority) (Up to 40.5 months)
D: Numbers of SRE or Death Occurred Cumulatively (36 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Study of Cetuximab (Erbitux™, C225) and Best Supportive Care Versus Best Supportive Care in Patients With Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR)-Positive Colorectal Carcinoma
Brief Summary: RATIONALE: Monoclonal antibodies, such as cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Best supportive care is the use of drugs and other treatments to improve the quality of life of patients. Combining cetuximab with best supportive care may slow the growth of the tumor and help patients live longer and more comfortably. It is not yet known whether cetuximab combined with best supportive care is more effective than best supportive care alone in treating metastatic epidermal growth factor receptor-positive colorectal cancer.

PURPOSE: This randomized phase III trial is studying cetuximab and best supportive care to see how well they work compared to best supportive care alone in treating patients with metastatic epidermal growth factor receptor-positive colorectal cancer.


Options:
A: Progression-free Survival Time (From randomization to the data cut-off date of 30 June 2005. The median follow-up time was 20.0 weeks in the panitumumab plus BSC group and 18.2 weeks in the BSC alone group.)
B: Overall survival
C: Progression-free Survival (PFS) (From randomization up to 65 months.)
D: Overall Survival (From randomization until the data cut-off date of 5 February 2013. Maximum time on study was 155 weeks.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Study of Cetuximab (Erbitux™, C225) and Best Supportive Care Versus Best Supportive Care in Patients With Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR)-Positive Colorectal Carcinoma
Brief Summary: RATIONALE: Monoclonal antibodies, such as cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Best supportive care is the use of drugs and other treatments to improve the quality of life of patients. Combining cetuximab with best supportive care may slow the growth of the tumor and help patients live longer and more comfortably. It is not yet known whether cetuximab combined with best supportive care is more effective than best supportive care alone in treating metastatic epidermal growth factor receptor-positive colorectal cancer.

PURPOSE: This randomized phase III trial is studying cetuximab and best supportive care to see how well they work compared to best supportive care alone in treating patients with metastatic epidermal growth factor receptor-positive colorectal cancer.


Options:
A: Progression-free Survival (PFS) as Assessed by the Investigator (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)); Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months))
B: Overall survival
C: Median Progression Free Survival (PFS) in Months (Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).)
D: Progression free survival (12 months)

Answer: B