TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Smoking Cessation With Varenicline (Champix) and Integrated Voice Response Technology (IVR)
Brief Summary: The goal of this study is to provide you with an effective treatment for reducing the physical and emotional stress that can occur during the early phase of being without cigarettes. It is our hope that this treatment will help you to stay smoke-free. You will receive counseling and a supply of Champix, a medication to help suppress the symptoms of nicotine withdrawal.

Purpose: To assess the effect of extended Integrated Voice Response (IVR) on smoking cessation after varenicline (Champix) and IVR treatment Hypothesis: There will be significant increase in participants who do not smoke at 1 year if extended IVR is used after 12 weeks of varenicline (Champix) and IVR treatment.


Options:
A: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)
B: Smoking Abstinence (12 months)
C: Days of abstinence following the programmed lapse (7 days)
D: Self-reported continuous abstinence of smoking and exhaled carbon monoxide levels less than 10 ppm as measured and recorded by the research nurse at weeks 12 and 52. (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Parallel Arm, Open-label Trial Comparing Degarelix With Goserelin Plus Anti-androgen Flare Protection (Bicalutamide), in Terms of Prostate Size Reduction in Prostate Cancer Patients of Intermediate-to-high Risk, Who Require Neoadjuvant Hormone Therapy Prior to Radiotherapy (Curative Intent)
Brief Summary: The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.


Options:
A: Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment (Up to 24 months after end of induction period)
B: Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 (After treatment of 12 weeks compared to Baseline)
C: Intratumoral androgen levels (Week 12)
D: Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) (After treatment of 12 weeks compared to Baseline); Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) (After treatment of 12 weeks compared to Baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pivotal Phase II, Multicenter, Single-arm, Two-cohort Trial Evaluating the Efficacy and Safety of GDC-0449 in Patients With Advanced Basal Cell Carcinoma
Brief Summary: This was a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma. All patients received vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.


Options:
A: Absence of local recurrence at 3 years after start of treatment
B: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)
C: Number of New Surgically Eligible Basal-cell Carcinomas (3 months of receiving study drug)
D: Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (for Metastatic Basal Cell Carcinoma (mBCC)) Per Primary Efficacy Analysis Set (pEAS) (6 months); Objective Response Rate (ORR) Based on Central Review According to mRECIST (for Locally Advanced Basal Cell Carcinoma (laBCC)) and RECIST 1.1 (Metastatic Basal Cell Carcinoma (mBCC)) Per Full Analysis Set (FAS) (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pivotal Phase II, Multicenter, Single-arm, Two-cohort Trial Evaluating the Efficacy and Safety of GDC-0449 in Patients With Advanced Basal Cell Carcinoma
Brief Summary: This was a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma. All patients received vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.


Options:
A: Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body. (one year)
B: Peer review of subject images using the Total Inflammatory Lesion Count at the end of active recruitment (6 months)
C: All-cause mortality (Until December 2015)
D: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pivotal Phase II, Multicenter, Single-arm, Two-cohort Trial Evaluating the Efficacy and Safety of GDC-0449 in Patients With Advanced Basal Cell Carcinoma
Brief Summary: This was a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma. All patients received vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.


Options:
A: Absence of local recurrence at 3 years after start of treatment
B: Sensitivity and Specificity (Within 120 days of Data Lock)
C: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)
D: All-cause mortality (Until December 2015)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pivotal Phase II, Multicenter, Single-arm, Two-cohort Trial Evaluating the Efficacy and Safety of GDC-0449 in Patients With Advanced Basal Cell Carcinoma
Brief Summary: This was a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma. All patients received vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.


Options:
A: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)
B: All-cause mortality (Until December 2015)
C: Absence of local recurrence at 3 years after start of treatment
D: Sensitivity and Specificity (Within 120 days of Data Lock)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pivotal Phase II, Multicenter, Single-arm, Two-cohort Trial Evaluating the Efficacy and Safety of GDC-0449 in Patients With Advanced Basal Cell Carcinoma
Brief Summary: This was a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma. All patients received vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.


Options:
A: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)
B: All-cause mortality (Until December 2015)
C: Absence of local recurrence at 3 years after start of treatment
D: Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body. (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pivotal Phase II, Multicenter, Single-arm, Two-cohort Trial Evaluating the Efficacy and Safety of GDC-0449 in Patients With Advanced Basal Cell Carcinoma
Brief Summary: This was a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma. All patients received vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.


Options:
A: All-cause mortality (Until December 2015)
B: Comparison between one stop shop using reflectance confocal microscopy in the surgical treatment of BCC and current standard of care using punch biopsy, by assessing incomplete surgical excision on the final pathology report. (Within the first week after surgical excision of suspected BCC lesion)
C: Absence of local recurrence at 3 years after start of treatment
D: Objective Response (OR) Determined by the Independent Review Facility (From study initiation (enrollment of first patient) through 9 months following the first treatment of the last enrolled patient (clinical cutoff date of 26 November 2010), up to 90 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Controlled Study of Mechanical Left Ventricular Unloading With Counterpulsation to Reduce Infarct Size Pre-PCI for Acute Myocardial Infarction - CRISP AMI
Brief Summary: Subjects with anterior acute STEMI who receive an IABC before primary PCI will have decreased MI size.


Options:
A: Left ventricular ejection fraction (LVEF) on day 30 (30 days)
B: Responder Analysis - Peak Oxygen Uptake (Peak VO2) (Baseline to 6 months); Responder Analysis - Six (6) Minute Walk (6MW) Distance (Baseline to 6 months); Responder Analysis - Minnesota Living With Heart Failure (MLWHF) Quality of Life Overall Score (baseline to 6 months); Number of Participant Deaths (12 months)
C: To determine whether IABC before mechanical reperfusion decreases myocardial infarct (MI) size. (3-5 days)
D: 30-day mortality and/or severe renal failure requiring renal replacement therapy (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Repetitive Transcranial Magnetic Stimulation in Amyotrophic Lateral Sclerosis
Brief Summary: The investigators' preliminary studies demonstrated that repetitive transcranial magnetic stimulation (rTMS) of the brain may determine a slight slowing in the rate of disease progression in ALS patients (Di Lazzaro et al 2004, 2006). The aim of this study is to investigate whether rTMS of the motor cortex performed over a long period of time (12 months) in a group of patients with ALS, can have a more pronounced beneficial effect. The investigators will compare the disease progression in two groups of patients: the first group of patients will be treated with real rTMS (one week daily treatment every month) and the second group of patients will be treated with sham (placebo) rTMS.


Options:
A: to evaluate the long-term safety and tolerability of thalidomide; to compare the total number of adverse events (AE), abnormal laboratory tests, and number of patients who completed the study between groups
B: Rate of decline of ALSFRS-R score (one year)
C: Survival
D: Amyotrophic Lateral Sclerosis Functional Rating Scale - Revised Questionnaire (ALSFRS-R) (9 months: Baseline to study termination (January 2009 - October 2009))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza
Brief Summary: With this study the investigators will try to assess the tolerability and measurability of the efficacy of non pharmaceutical measures to prevent seasonal influenza in individual households. Households with an identified index case of influenza will be randomised into one of three intervention arms: 1. group, where the household will receive general information about transmission of influenza virus and means to prevent it (Controls); 2. group, which will receive surgical masks and be asked to wear them whenever they are in close contact with the index case or other persons of the household that became ill during the observation period; 3. group, which will be given and asked to wear surgical masks as well as to execute intensified hand hygiene.

In addition to assessing the secondary attack rate as our primary outcome measure, the investigators will also try to evaluate compliance to those interventions by questionnaires.


Options:
A: the incidence rates of influenza infection (Until 3 months gargling)
B: Number of laboratory confirmed cases of Influenza (8 weeks, including the 6 weeks of intervention and two weeks post-intervention)
C: Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes (every month)
D: Secondary infection with influenza of the household members who are healthy at the start of the study

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza
Brief Summary: With this study the investigators will try to assess the tolerability and measurability of the efficacy of non pharmaceutical measures to prevent seasonal influenza in individual households. Households with an identified index case of influenza will be randomised into one of three intervention arms: 1. group, where the household will receive general information about transmission of influenza virus and means to prevent it (Controls); 2. group, which will receive surgical masks and be asked to wear them whenever they are in close contact with the index case or other persons of the household that became ill during the observation period; 3. group, which will be given and asked to wear surgical masks as well as to execute intensified hand hygiene.

In addition to assessing the secondary attack rate as our primary outcome measure, the investigators will also try to evaluate compliance to those interventions by questionnaires.


Options:
A: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)
B: Secondary infection with influenza of the household members who are healthy at the start of the study
C: Number of laboratory confirmed cases of Influenza (8 weeks, including the 6 weeks of intervention and two weeks post-intervention)
D: Number of individuals vaccinated with two dose of oral cholera vaccine. (Six months from initiation of vaccination); Decrease number of cholera cases in intervention arm compared to non-intervention arm. (Two years after completion of vaccination)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza
Brief Summary: With this study the investigators will try to assess the tolerability and measurability of the efficacy of non pharmaceutical measures to prevent seasonal influenza in individual households. Households with an identified index case of influenza will be randomised into one of three intervention arms: 1. group, where the household will receive general information about transmission of influenza virus and means to prevent it (Controls); 2. group, which will receive surgical masks and be asked to wear them whenever they are in close contact with the index case or other persons of the household that became ill during the observation period; 3. group, which will be given and asked to wear surgical masks as well as to execute intensified hand hygiene.

In addition to assessing the secondary attack rate as our primary outcome measure, the investigators will also try to evaluate compliance to those interventions by questionnaires.


Options:
A: The number of individuals with self-reported URTI in each of the intervention and control groups (Over the course of 8 weeks spanning September and October)
B: COVID-19 incidence (21 days of follow-up, RT-PCR test at day 21)
C: Secondary infection with influenza of the household members who are healthy at the start of the study
D: To test the efficacy of a handwashing promotion intervention for prevention of intrahousehold transmission of influenza virus in a rural setting in Bangladesh (17 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tolerability and Measurability of the Efficacy of Non Pharmaceutical Measures to Prevent Seasonal Influenza
Brief Summary: With this study the investigators will try to assess the tolerability and measurability of the efficacy of non pharmaceutical measures to prevent seasonal influenza in individual households. Households with an identified index case of influenza will be randomised into one of three intervention arms: 1. group, where the household will receive general information about transmission of influenza virus and means to prevent it (Controls); 2. group, which will receive surgical masks and be asked to wear them whenever they are in close contact with the index case or other persons of the household that became ill during the observation period; 3. group, which will be given and asked to wear surgical masks as well as to execute intensified hand hygiene.

In addition to assessing the secondary attack rate as our primary outcome measure, the investigators will also try to evaluate compliance to those interventions by questionnaires.


Options:
A: Secondary infection with influenza of the household members who are healthy at the start of the study
B: Duration of diarrhea (within the first 72 hours during hospitalization)
C: COVID-19 RNA test positivity (At the end of Cycle 1 (cycle length is 14 days)); Hospital admission for COVID-19 (7 days after the end of Cycle 1 (cycle length is 14 days))
D: Number of individuals vaccinated with two dose of oral cholera vaccine. (Six months from initiation of vaccination); Decrease number of cholera cases in intervention arm compared to non-intervention arm. (Two years after completion of vaccination)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of Exercise in Men With Prostate Cancer Receiving Androgen Depletion Therapy
Brief Summary: The purpose of this pilot study is to compare a walking exercise program (Exercise Group) to standard medical care (Control Group) in prostate cancer survivors receiving androgen depletion therapy (ADT). The central hypothesis of the proposed research is that the walking exercise program will have a positive impact on the bone health, health-related quality of life, and physical function of men with prostate cancer receiving ADT.


Options:
A: Changes in estrone, estradiol and adiposity levels (Up to 12 months)
B: Six Minute Walk Distance 6MWD (Change from baseline in 6MWD at 12 weeks)
C: Baseline to post intervention (12 weeks) and follow-up (32 weeks) change in Body Composition. (Change from baseline to post intervention (12 weeks) and follow-up (32 weeks))
D: bone health (baseline, 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of Exercise in Men With Prostate Cancer Receiving Androgen Depletion Therapy
Brief Summary: The purpose of this pilot study is to compare a walking exercise program (Exercise Group) to standard medical care (Control Group) in prostate cancer survivors receiving androgen depletion therapy (ADT). The central hypothesis of the proposed research is that the walking exercise program will have a positive impact on the bone health, health-related quality of life, and physical function of men with prostate cancer receiving ADT.


Options:
A: N/A
B: Fatigue measured by Fatigue Assessment Questionnaire (FAQ) (change between baseline and week 13 (end of intervention))
C: bone health (baseline, 12 months)
D: Fatigue as measured by the Brief Fatigue Inventory (prior to beginning of treatment and after treatment ends. Up to an average of 44 weeks.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder: Predictors of Change
Brief Summary: This study will compare the effectiveness of two treatments, dialectical behavior therapy versus fluoxetine with clinical management, for reducing the risk of self-injury and suicidal behavior in people with borderline personality disorder.


Options:
A: Suicidal thoughts or attempts (Measured at Year 2)
B: Measures of impulsivity, aggression, affective impulsivity, immediate and delayed memory, and cognitive processing at baseline, 6 months and 9 months
C: Deliberate Self-harm Inventory (DSHI; Gratz, 2001) and Lifetime Suicide Attempt Self-Injury interview (LSASI; formerly Lifetime Parasuicide Count, Linehan MM, Comtois KA, unpublished manuscript, 1996) (baseline; 10 weeks; 20 weeks; 3 month follow up)
D: Suicide Events (Measured after 6 months of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Suicidal Behavior and Self-Mutilation in Borderline Personality Disorder: Predictors of Change
Brief Summary: This study will compare the effectiveness of two treatments, dialectical behavior therapy versus fluoxetine with clinical management, for reducing the risk of self-injury and suicidal behavior in people with borderline personality disorder.


Options:
A: Suicide Events (Measured after 6 months of treatment)
B: Change in scores on Beck Scale for Suicidal Ideation (Baseline, post-therapy, 6 months and 12 months after therapy)
C: Acceptability of Lethal Means Decision Aid (Baseline); Decision Making Quality in Emergency Department (ED) (Baseline); Home Firearm Storage (Baseline and 1 week follow up); Decision Making Quality - Follow up (1 week follow up); Suicidal Ideation and Behavior at One Month (1 month post baseline); Suicidal Ideation and Behavior at Three Months (3 months post baseline); Vital Statistics (Suicide death) (3 months post baseline)
D: Suicide repetition (or death by suicide) (12 months)

Answer: A