TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial
Brief Summary: The overall aim of this trial, which is called STAMPEDE, is to assess novel approaches for the treatment of men with prostate cancer who are starting long-term ADT for the first time, termed hormone-naïve prostate cancer. This trial aims to see if we can improve the way in which prostate cancer is currently managed, either by adding new treatments to the standard approach or by modifying the type of hormone therapy aiming to improve quality-of-life by reducing the side effects of treatment. Each new treatment approach is compared against a control arm receiving the current standard treatments. We aim to identify treatment strategies that enable men to live longer, or as long but with an improved quality-of-life, as well as offering value for money for the health service.

Since opening to accrual in Oct-2005, the trial has tested many ways of treating prostate cancer and some results are now already known. More than 10,000 men will join the trial with answers becoming available throughout the trial. New patients joining the trial from Protocol version 17.0 onwards (activated in December 2018) may be eligible to join one of two treatment comparisons, metformin (treatment group K; the "metformin comparison") and transdermal oestradiol (treatment group L; the "transdermal oestradiol comparison"). A computer program will be used to allocate which treatment each participant receives, using a chance process.

Summary of the research arms in STAMPEDE trial platform Summary of research treatment groups currently open to recruitment (June 2017)

1. Metformin (Arm K): This anti-diabetic medication is proposed to have both anti-cancer effects and may help prevent the adverse metabolic effects of long-term ADT. STAMPEDE will investigate whether adding metformin to the current standard-of-care for non-diabetic men can improve all-cause survival.
2. Transdermal oestradiol (Arm L): This is an alternative form of hormone treatment which has been shown to suppress testosterone as effectively as standard ADT and avoid some of the side-effects. It may also help to avoid the adverse metabolic effects and fatigue and therefore improve overall quality of life compared with standard forms of ADT. STAMPEDE will investigate whether transdermal oestradiol can treat the cancer as well as current standard forms of ADT.
3. Control group (Arm A): Patients allocated to this group receive the current standard-of-care ADT +/- RT +/- docetaxel.


Options:
A: Overall Survival Time (3 years)
B: Overall Survival (Up to 60 months)
C: Overall Survival (From randomization (Day 1) up to end of study (Month 60)); Radiographic Progression-free Survival (rPFS) (From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18))
D: Overall survival (1:Not applicable)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: STAMPEDE: Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial
Brief Summary: The overall aim of this trial, which is called STAMPEDE, is to assess novel approaches for the treatment of men with prostate cancer who are starting long-term ADT for the first time, termed hormone-naïve prostate cancer. This trial aims to see if we can improve the way in which prostate cancer is currently managed, either by adding new treatments to the standard approach or by modifying the type of hormone therapy aiming to improve quality-of-life by reducing the side effects of treatment. Each new treatment approach is compared against a control arm receiving the current standard treatments. We aim to identify treatment strategies that enable men to live longer, or as long but with an improved quality-of-life, as well as offering value for money for the health service.

Since opening to accrual in Oct-2005, the trial has tested many ways of treating prostate cancer and some results are now already known. More than 10,000 men will join the trial with answers becoming available throughout the trial. New patients joining the trial from Protocol version 17.0 onwards (activated in December 2018) may be eligible to join one of two treatment comparisons, metformin (treatment group K; the "metformin comparison") and transdermal oestradiol (treatment group L; the "transdermal oestradiol comparison"). A computer program will be used to allocate which treatment each participant receives, using a chance process.

Summary of the research arms in STAMPEDE trial platform Summary of research treatment groups currently open to recruitment (June 2017)

1. Metformin (Arm K): This anti-diabetic medication is proposed to have both anti-cancer effects and may help prevent the adverse metabolic effects of long-term ADT. STAMPEDE will investigate whether adding metformin to the current standard-of-care for non-diabetic men can improve all-cause survival.
2. Transdermal oestradiol (Arm L): This is an alternative form of hormone treatment which has been shown to suppress testosterone as effectively as standard ADT and avoid some of the side-effects. It may also help to avoid the adverse metabolic effects and fatigue and therefore improve overall quality of life compared with standard forms of ADT. STAMPEDE will investigate whether transdermal oestradiol can treat the cancer as well as current standard forms of ADT.
3. Control group (Arm A): Patients allocated to this group receive the current standard-of-care ADT +/- RT +/- docetaxel.


Options:
A: Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24 (24 months)
B: uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13 (13 weeks)
C: Overall survival (1:Not applicable)
D: To compare the effects of Atrasentan monotherapy with combination therapy using Atrasentan and Zometa on bone specific alkaline phosphatase.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk: A Randomized, Controlled Trial
Brief Summary: The present study is a new approach of examining tailored cognitive-behavioral interventions for fibromyalgia patients at risk. For this purpose, fibromyalgia patients are screened with respect to cognitive-behavioral risk factors and these patients are offered tailored cognitive-behavioral treatment options. It is expected that this approach will result in increased magnitude and maintenance of effects.


Options:
A: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year
B: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
C: Oswestry Disability Index; Cost-effectiveness (full economic analysis)
D: Pain intensity (Measured at Week 4 and Month 6); Pain-related disability (Measured at Week 4 and Month 6)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk: A Randomized, Controlled Trial
Brief Summary: The present study is a new approach of examining tailored cognitive-behavioral interventions for fibromyalgia patients at risk. For this purpose, fibromyalgia patients are screened with respect to cognitive-behavioral risk factors and these patients are offered tailored cognitive-behavioral treatment options. It is expected that this approach will result in increased magnitude and maintenance of effects.


Options:
A: Fibromyalgia Impact Questionnaire (Baseline, 16 wks and 10 months)
B: Ambulatory Pain (Higher Values Indicate Greater Pain) (Baseline and after 12-weeks); Ambulatory Fatigue, Higher Values Indicate Greater Fatigue (Baseline and after 12-weeks)
C: Decrease of pain and use of specific medicine for fibromyalgia (16 weeks)
D: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk: A Randomized, Controlled Trial
Brief Summary: The present study is a new approach of examining tailored cognitive-behavioral interventions for fibromyalgia patients at risk. For this purpose, fibromyalgia patients are screened with respect to cognitive-behavioral risk factors and these patients are offered tailored cognitive-behavioral treatment options. It is expected that this approach will result in increased magnitude and maintenance of effects.


Options:
A: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
B: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score (wks 12)
C: Ambulatory Pain (Higher Values Indicate Greater Pain) (Baseline and after 12-weeks); Ambulatory Fatigue, Higher Values Indicate Greater Fatigue (Baseline and after 12-weeks)
D: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk: A Randomized, Controlled Trial
Brief Summary: The present study is a new approach of examining tailored cognitive-behavioral interventions for fibromyalgia patients at risk. For this purpose, fibromyalgia patients are screened with respect to cognitive-behavioral risk factors and these patients are offered tailored cognitive-behavioral treatment options. It is expected that this approach will result in increased magnitude and maintenance of effects.


Options:
A: Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity (12 weeks after baseline (or last observation carried forward))
B: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
C: Change in Pain intensity (Change from baseline pain intensity at 12 months); Change in Depression (Change from baseline depression at 12 months); Change in Catastrophizing (Change from baseline catastrophizing at 12 months); Change in Acceptance (Change from baseline acceptance at 12 months); Change in Disability (Change from baseline disability at 12 months)
D: Change in time spent awake during the night. (Change from baseline to the two study follow-ups (immediately and 3-months following treatment)); Change in mood. (Change from baseline to the two follow-up periods (immediately and 3-months following treatment))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk: A Randomized, Controlled Trial
Brief Summary: The present study is a new approach of examining tailored cognitive-behavioral interventions for fibromyalgia patients at risk. For this purpose, fibromyalgia patients are screened with respect to cognitive-behavioral risk factors and these patients are offered tailored cognitive-behavioral treatment options. It is expected that this approach will result in increased magnitude and maintenance of effects.


Options:
A: Ambulatory Pain (Higher Values Indicate Greater Pain) (Baseline and after 12-weeks); Ambulatory Fatigue, Higher Values Indicate Greater Fatigue (Baseline and after 12-weeks)
B: Measure the effects of exercise-based MI intervention improving exercise adherence. (This is a five year study, each subject will participate in a 9-month study sequence)
C: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
D: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk: A Randomized, Controlled Trial
Brief Summary: The present study is a new approach of examining tailored cognitive-behavioral interventions for fibromyalgia patients at risk. For this purpose, fibromyalgia patients are screened with respect to cognitive-behavioral risk factors and these patients are offered tailored cognitive-behavioral treatment options. It is expected that this approach will result in increased magnitude and maintenance of effects.


Options:
A: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
B: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
C: Fibromyalgia Impact Questionnaire (Baseline, 16 wks and 10 months)
D: Visual Analog Scale for Pain (baseline, after 16 weeks and after 32 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk: A Randomized, Controlled Trial
Brief Summary: The present study is a new approach of examining tailored cognitive-behavioral interventions for fibromyalgia patients at risk. For this purpose, fibromyalgia patients are screened with respect to cognitive-behavioral risk factors and these patients are offered tailored cognitive-behavioral treatment options. It is expected that this approach will result in increased magnitude and maintenance of effects.


Options:
A: Muscle function (2010-2013)
B: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
C: Six-minute Walk Test (15 weeks); Change of Pain Level From Baseline. (15 weeks)
D: pain (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk: A Randomized, Controlled Trial
Brief Summary: The present study is a new approach of examining tailored cognitive-behavioral interventions for fibromyalgia patients at risk. For this purpose, fibromyalgia patients are screened with respect to cognitive-behavioral risk factors and these patients are offered tailored cognitive-behavioral treatment options. It is expected that this approach will result in increased magnitude and maintenance of effects.


Options:
A: Measure the effects of exercise-based MI intervention improving exercise adherence. (This is a five year study, each subject will participate in a 9-month study sequence)
B: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
C: Change in average pain according to the Brief Pain Inventory (6 months)
D: Aim 1: Test the feasibility and subject acceptability of a potentially objective tool (NFR) for measuring pain severity. (Baseline, Week 9, and Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Prospective Study to Assess the Impact of Physician's Reinforcement on the Subject's Compliance and Persistence on Treatment Using Feedback on Bone Markers in Previously Undiagnosed Postmenopausal Osteoporotic Women Treated With Risedronate.
Brief Summary: The primary objective of this study is to assess the impact of physician's reinforcement using bone marker data on the subject's compliance (at least 50% drug taken) and persistence on treatment after one year in postmenopausal osteoporotic women.


Options:
A: To assess the impact of physician's reinforcement using bone marker data on the treatment adherence of women with PMO. (collected at week 10 and 22)
B: Proportion of Participants With New Vertebral Fractures (Baseline through 24 Months)
C: Urinary markers of bone resorption; measured at the end of each treatment phase (Every 50 days)
D: Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population (52 weeks / Endpoint)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Glycine Treatment of Prodromal Symptoms
Brief Summary: This is an open label trial of the NMDA agonist glycine used alone for symptoms that appear to be prodromal for schizophrenia in adolescents and young adults.


Options:
A: Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) (6 months (for Phases 1 and 2) after completion of intervention); Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) (12 months (for Phases 1 and 2) after completion of intervention); Perceived burden of care (Chinese version of the 25-item Family Burden Interview Schedule) (24 months (for Phase 2 only) after completion of intervention); Coping style (42-item Revised Ways of Coping Checklist) (6 months (for Phases 1 and 2) after completion of intervention); Coping style (42-item Revised Ways of Coping Checklist) (12 months (for Phases 1 and 2) after completion of intervention); Coping style (42-item Revised Ways of Coping Checklist) (24 months (for Phase 2 only) after completion of intervention)
B: Mean Heinrichs-Carpenter Quality of Life Scale Scores Over Time (Baseline, Month 6, month 12, month 18 and month 24)
C: Scale Of Prodromal Symptoms total score (8 weeks)
D: Transition to psychotic disorder (12 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Outcome With an Intervention From the Cape Cod Model of Psychotherapy for Subjects in a Behavioral Crisis and With the Diagnosis of Borderline Personality Disorder (BPD) or Post-Traumatic Stress Disorder (PTSD)
Brief Summary: Dr. Laddis will test a hypothesis about the nature and the management of behavioral crises in patients with borderline personality disorder (BPD) or post-traumatic stress disorder (PTSD). The term "behavioral crisis" is used strictly for periods of uncontrollable urges to repeat mental or outward activity, e.g., flashbacks, cutting, binging on food, drugs or sex, with no intervals to rethink one's priorities or to consider others' direction.

The clinical hypothesis states, in two steps, that:

1. the perception of a life crisis precedes and then underlies every behavioral crisis;
2. the behavioral crisis resolves promptly and all symptoms end if the clinicians engage the patient about his management of the life crisis that underlies the symptoms.


Options:
A: Brief Psychiatric Rating Scale (BPRS) scores; Scores on Client Observation and Client Interview, tools designed for this study
B: Change From Baseline in Scores on the Patient Health Questionnaire (PHQ-9) Scale at Week 6 (Baseline, Week 1, Week 2, Week 3, Week 4, Week 5)
C: Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008) (one year); Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010) (one year); Coping Styles and Strategies Scale (COPE) (Crespo 1997) (one year)
D: Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) (baseline, weekly until week 8); Montgomery-Åsberg Depression Rating Scale (MADRS) (baseline to 8 weeks); Borderline Evaluation of Severity Over Time (BEST) (Baseline to 8 weeks); Overt Aggression Scale - Modified (OAS-M) (Change from Baseline Overt Aggression Scale - Modified to 8 weeks); Global Assessment of Functioning Scale (GAF) (Change in Global Assessment of Functioning from Baseline to 8 weeks); Barratt Impulsiveness Scale (BIS) (Change in Impulsiveness from Baseline to 8 weeks); Symptom Checklist -90-Revised (SCL-90-R) (Change in psychological problems and symptoms from Baseline to 8 weeks); Young Mania Rating Scale (YMS) (Change in manic symptoms from Baseline to 8 weeks); Sheehan Disability Scale (SDS) (Change in functional impairment from Baseline to 8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Lipid-Altering Efficacy, Safety and Tolerability of MK0524A in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia
Brief Summary: A 28-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia to study the effects of MK0524A on lipids and tolerability. There will be 9 scheduled clinic visits, and 3 treatment groups. A patient can be randomly assigned to 1 of the 3 treatment groups.


Options:
A: Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12 (Baseline and 12 Weeks)
B: Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo (Baseline and 12 Weeks)
C: N/A
D: Reductions of LDL-C concentrations at 24 weeks and better tolerability (at 24 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, "Factorial" Design Study to Evaluate the Lipid-Altering Efficacy and Safety of Coadministered MK0524B Tablets in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia
Brief Summary: This is a 12-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia, studying the effects of coadministered MK0524B on lipids. There will be 6 scheduled clinic visits, and 7 treatment arms.


Options:
A: Major Vascular Event (During scheduled treatment period (median duration 3.9 years))
B: Coadministered MK0524B will be more efficacious in reducing LDL-C concentrations compared to MK0524A.
C: change in percent atheroma volume at 12 months intravascular ultrasonography (12 months)
D: Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization (Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individual 65 and Over With Chronic Mechanical Neck Pain
Brief Summary: The purpose of this randomized clinical trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic neck pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.


Options:
A: Patient-rated pain (0-10 scale, 11 box) (short term = 12 weeks; long term = 52 weeks)
B: Neck Pain (Up to 10 months)
C: Manual Examination of the Cervical Spine; Pressure algometry; Thermal stimulation; Perceived effect; HIT-6
D: Patient-rated pain (0-11 box scale) (short term = 12 weeks; long term = 52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individual 65 and Over With Chronic Mechanical Neck Pain
Brief Summary: The purpose of this randomized clinical trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic neck pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.


Options:
A: Reduction in number of days per month with headache and shoulders pain after 6 months.Proportion of subjects with more than 4 days with headache and shoulder pain at the baseline that will have reduction in pain frequency of more than 50%, after 6 months (6 months)
B: N/A
C: Neck Pain (Up to 10 months)
D: Patient-rated pain (0-10 scale, 11 box) (short term = 12 weeks; long term = 52 weeks)

Answer: D