TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Subacute and Chronic, Non-specific Back and Neck Pain: Cognitive-behavioral Rehabilitation Compared With Traditional Primary Care Concerning Sick-listing and Health-care Visits. A Randomized Controlled Trial, 18-month Follow-up
Brief Summary: BACKGROUND

Non-specific back and neck pain (BNP) dominates sick-listing. A program of cognitive-behavioral rehabilitation for subacute and chronic BNP was compared, with 18-month follow-up, with traditional primary care concerning sick-listing and health-care visits.

METHODS

After stratification to age (44 (years) and younger/45 and older) and subacute/chronic BNP (= full-time sick-listed 43-84/85-730 days respectively), 125 primary-care patients were randomized to a rehabilitation center or continued health-center care. Outcome measures were Return-to-work (=the proportion who regained work ability for at least 30 consecutive days), the proportion with Work ability at different time points, Total sick-listing (expressed in whole days) and the total number of Visits (to physicians, physiotherapists etc.) 1-18 months and corresponding six-month periods. For the analyses were used t-test, z-test, generalized estimating equations and a mixed, linear model.


Options:
A: Multiple standardized measures of key domains of the chronic pain experience (12 weeks)
B: Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. (18 months.)
C: Brief Pain Inventory-Intensity (BPI-Intensity) (Post-treatment (10-weeks) and follow-up (6 months))
D: Insomnia Severity Index (ISI) (Baseline); Insomnia Severity Index (ISI) (Post treatment- 2 months post baseline assessment); Insomnia Severity Index (ISI) (9 months post baseline assessment); Insomnia Severity Index (ISI) (18 months post baseline assessment); Global Pain Severity-Graded Chronic Pain Scale (Baseline); Global Pain Severity-Graded Chronic Pain Scale (Post treatment-2 mos. post baseline); Global Pain Severity-Graded Chronic Pain Scale (9 months post baseline assessment); Global Pain Severity- Graded Chronic Pain Scale (18 months post baseline assessment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Subacute and Chronic, Non-specific Back and Neck Pain: Cognitive-behavioral Rehabilitation Compared With Traditional Primary Care Concerning Sick-listing and Health-care Visits. A Randomized Controlled Trial, 18-month Follow-up
Brief Summary: BACKGROUND

Non-specific back and neck pain (BNP) dominates sick-listing. A program of cognitive-behavioral rehabilitation for subacute and chronic BNP was compared, with 18-month follow-up, with traditional primary care concerning sick-listing and health-care visits.

METHODS

After stratification to age (44 (years) and younger/45 and older) and subacute/chronic BNP (= full-time sick-listed 43-84/85-730 days respectively), 125 primary-care patients were randomized to a rehabilitation center or continued health-center care. Outcome measures were Return-to-work (=the proportion who regained work ability for at least 30 consecutive days), the proportion with Work ability at different time points, Total sick-listing (expressed in whole days) and the total number of Visits (to physicians, physiotherapists etc.) 1-18 months and corresponding six-month periods. For the analyses were used t-test, z-test, generalized estimating equations and a mixed, linear model.


Options:
A: Neck Disability Index (4 weeks, 6 months)
B: Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. (18 months.)
C: Global Perceived Effect (GPE), Neck disability index (NDI-DV ) (0-3-7-13-26-52 weeks)
D: Patient-rated neck and back disability (9 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Subacute and Chronic, Non-specific Back and Neck Pain: Cognitive-behavioral Rehabilitation Compared With Traditional Primary Care Concerning Sick-listing and Health-care Visits. A Randomized Controlled Trial, 18-month Follow-up
Brief Summary: BACKGROUND

Non-specific back and neck pain (BNP) dominates sick-listing. A program of cognitive-behavioral rehabilitation for subacute and chronic BNP was compared, with 18-month follow-up, with traditional primary care concerning sick-listing and health-care visits.

METHODS

After stratification to age (44 (years) and younger/45 and older) and subacute/chronic BNP (= full-time sick-listed 43-84/85-730 days respectively), 125 primary-care patients were randomized to a rehabilitation center or continued health-center care. Outcome measures were Return-to-work (=the proportion who regained work ability for at least 30 consecutive days), the proportion with Work ability at different time points, Total sick-listing (expressed in whole days) and the total number of Visits (to physicians, physiotherapists etc.) 1-18 months and corresponding six-month periods. For the analyses were used t-test, z-test, generalized estimating equations and a mixed, linear model.


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: Pain of the neck and shoulders (At week 0 (baseline) and week 20 (follow-up)); Pain in the arm/hand (At week 0 (baseline) and week 20 (follow-up))
C: Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. (18 months.)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Subacute and Chronic, Non-specific Back and Neck Pain: Cognitive-behavioral Rehabilitation Compared With Traditional Primary Care Concerning Sick-listing and Health-care Visits. A Randomized Controlled Trial, 18-month Follow-up
Brief Summary: BACKGROUND

Non-specific back and neck pain (BNP) dominates sick-listing. A program of cognitive-behavioral rehabilitation for subacute and chronic BNP was compared, with 18-month follow-up, with traditional primary care concerning sick-listing and health-care visits.

METHODS

After stratification to age (44 (years) and younger/45 and older) and subacute/chronic BNP (= full-time sick-listed 43-84/85-730 days respectively), 125 primary-care patients were randomized to a rehabilitation center or continued health-center care. Outcome measures were Return-to-work (=the proportion who regained work ability for at least 30 consecutive days), the proportion with Work ability at different time points, Total sick-listing (expressed in whole days) and the total number of Visits (to physicians, physiotherapists etc.) 1-18 months and corresponding six-month periods. For the analyses were used t-test, z-test, generalized estimating equations and a mixed, linear model.


Options:
A: Adjusted Change in Pain-related Function (Roland Disability Score) (12 months)
B: Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. (18 months.)
C: Pain VAS
D: Days with pain (Change from baseline to follow-up after 16 weeks); Physical functioning (Change from baseline to follow-up after 16 weeks); Role physical (Change from baseline to follow-up after 16 weeks); Bodily pain (Change from baseline to follow-up after 16 weeks); General health (Change from baseline to follow-up after 16 weeks); Vitality (Change from baseline to follow-up after 16 weeks); Social functioning (Change from baseline to follow-up after 16 weeks); Role emotional (Change from baseline to follow-up after 16 weeks); Mental health (Change from baseline to follow-up after 16 weeks); Disability (Change from baseline to follow-up after 16 weeks); Stress (Change from baseline to follow-up after 16 weeks); Well-being (Change from baseline to follow-up after 16 weeks); Use of prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of non-prescription analgesics (Change from baseline to follow-up after 16 weeks); Use of conventional care (Change from baseline to follow-up after 16 weeks); Use of complementary care (Change from baseline to follow-up after 16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Magnetic Seizure Therapy (MST) for the Treatment of Severe Mood Disorder
Brief Summary: This study will compare the clinical efficacy and side effects of Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in patients currently experiencing a major depressive episode in the context of either unipolar or bipolar depression. The investigators will conduct a number of clinical and neuropsychological tests to assess clinical and cognitive response to treatment. The investigators hypothesize that:

1. MST and ECT will have similar antidepressant efficacy.
2. MST will have less post-treatment amnesia than ECT as reflected in primary measures of anterograde and retrograde amnesia following the acute treatment phase.
3. At follow up, MST will show a lesser degree of persisting deficit in measures of retrograde amnesia than ECT.


Options:
A: Hamilton Rating Scale for Depression, 24-item (HRSD-24) (Change from baseline in HRSD-24 score at date of symptom remission or date of the 15th treatment, whichever comes first, assessed up to 6 months.)
B: Clinical improvement (Hamilton Rating Scale for Depression) (After each treatment and at follow-ups up to 6 months after the treatment course)
C: Hamilton Rating Scale for Depression, 24-Item (HRSD-24) (baseline (pre-treatment) and post-treatment)
D: Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24 (HRSD-24) (7 weeks); Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT) (7 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis
Brief Summary: The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).


Options:
A: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 (Week 52)
B: Number of Participants With Clinical Response (Week 6)
C: Clinical Response at Week 8 Based on Mayo Score (Eight week treatment period)
D: Clinical and Endoscopic Remission. (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
Brief Summary: RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy.

PURPOSE: This randomized phase III trial is studying duloxetine to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.


Options:
A: Patient's Global Impressions of Improvement (PGI-I) at Week 12 (12 weeks)
B: Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item (Day 1 of Week 1 to Day 1 of Week 6)
C: Change in Ventricular Lactate Levels in the Brain (Baseline and 2 months)
D: Change from baseline in the endpoint mean pain score (14 weeks); Fibromyalgia Impact Questionnaire (14 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
Brief Summary: RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy.

PURPOSE: This randomized phase III trial is studying duloxetine to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.


Options:
A: Efficacy of each ABT-894 dose (1 mg, 2 mg, or 4 mg BID) versus placebo in the treatment of pain due to DNP (Change from baseline to final 24-hour average pain score)
B: Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-week Treatment Period (Day 1 through 8 weeks); Change From Baseline in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 8 (Baseline, 8 weeks)
C: Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine (baseline, 12 weeks)
D: Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item (Day 1 of Week 1 to Day 1 of Week 6)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Double Blind Trial of Oral Duloxetine for Treatment of Pain Associated With Chemotherapy-Induced Peripheral Neuropathy
Brief Summary: RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy.

PURPOSE: This randomized phase III trial is studying duloxetine to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.


Options:
A: Average Joint Pain According to BPI-SF (Weeks 2, 6, 12, and 24; Week 12 reported)
B: assess efficacy of duloxetine (QD) vs placebo on pain in patients, w/ or w/o MDD during a 6-month therapy phase; evaluate change in pain measured by Brief Pain Inventory score; evaluate endpoint of patient-reported improvement on the Patient's Global Impression of Improvement scale
C: Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item (Day 1 of Week 1 to Day 1 of Week 6)
D: Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale (baseline to 6 months); Change in Hand Grip Strength (baseline to 6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Double Blind Trial to Evaluate the Efficacy and Safety of Dronedarone (400mg BID) Versus Amiodarone (600mg Daily for 28 Days, Then 200mg Daily Thereafter) for at Least 6 Months for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation (AF)
Brief Summary: The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.


Options:
A: Time to Recurrence of AF lasting longer than 15 seconds (1 year)
B: First Hospitalization for Cardiovascular Reason or Death From Any Cause (minimum follow-up duration: 1 year ; maximum: 2.5 years)
C: The primary endpoint is the time from randomization to first documented AF/AFL recurrence indicated by 12-lead ECG or trans-telephonic ECG monitoring tracings showing AF/AFL.
D: Treatment Failure (minimum study duration is 6 months (+10 days); maximum is 15 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Randomised, Double-blind, Cross-over Design Study to Evaluate Efficacy on Exercise Tolerance of Symbicort ®(Budesonide/Formoterol) 320/9μg One Inhalation Twice Daily Compared With Placebo and Oxis® 9μg One Inhalation Twice Daily in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD).
Brief Summary: The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.


Options:
A: Eosinophils in induced sputum (as % of Total Cell Count), change from the start of the exacerbation to the end of 14 days treatment
B: Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose (Single measurement taken1 hour post-dose at the end of each 1-week treatment period)
C: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
D: Change in serum C-reactive protein levels over 3 months between treatment groups.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Randomised, Double-blind, Cross-over Design Study to Evaluate Efficacy on Exercise Tolerance of Symbicort ®(Budesonide/Formoterol) 320/9μg One Inhalation Twice Daily Compared With Placebo and Oxis® 9μg One Inhalation Twice Daily in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD).
Brief Summary: The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.


Options:
A: All cause mortality at 3 years
B: Exercise Endurance Time (EET) at 75% of Peak Work Capacity With Cycle Ergometry 1 Hour Post-dose (Single measurement taken1 hour post-dose at the end of each 1-week treatment period)
C: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
D: Pre-dose and 1-hour post-dose FEV1 over the 12 months treatment period

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Double-blind, Parallel-group, Placebo Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures.
Brief Summary: This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.


Options:
A: Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period (From Baseline to 12-week Treatment Period)
B: Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period (During the 7-week Treatment Period)
C: Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration (12 week Treatment Period); 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration (Baseline to 12 week Treatment Period)
D: Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period (Week 2 to the end of the Treatment Period (Week 16)); Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period (Baseline (Week 0) to the end of the Treatment Period (Week 16))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Double-blind, Parallel-group, Placebo Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures.
Brief Summary: This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.


Options:
A: Percentage of Subjects With at Least One Adverse Event During the 16-week Treatment Period (Week 2 to the end of the Treatment Period (Week 16)); Partial Onset Seizure (Type I) Frequency Per Week Over the 16-week Treatment Period (Baseline (Week 0) to the end of the Treatment Period (Week 16))
B: Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period (Baseline to 12-week Treatment Period)
C: Percent Reduction Over Placebo for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration (12 week Treatment Period); 50% Responder Rate for Partial Onset Seizure (Type I) Frequency Over the Treatment Period Standardized to a 28-day Duration (Baseline to 12 week Treatment Period)
D: Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period (From Baseline to 12-week Treatment Period)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Double-blind, Parallel-group, Placebo Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures.
Brief Summary: This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.


Options:
A: Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period (From Baseline to 12-week Treatment Period)
B: Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period (During the 7-week Treatment Period)
C: Log Transformed (Loge) 28-day Seizure Rate for All Partial Onset Seizures During the Double-blind Treatment Phase (Week 0 to Week 14)
D: Partial onset seizure frequency (Type I) per week over the 7-week maintenance period (7-week maintenance period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Placebo-controlled Trial of the Safety and Effectiveness of Vitamin D Supplement to Improve Tubular Reabsorption of Phosphate and Decrease Bone Turnover in Adolescents and Young Adults With HIV Infection Being Treated With Antiretroviral Therapy Containing Tenofovir Compared to Those Being Treated With Antiretroviral Therapy Not Containing Tenofovir
Brief Summary: The purpose of this study is to test the effects of Vitamin D on renal phosphate and bone loss, which are common in HIV infected adolescents and young adults being treated with tenofovir.


Options:
A: Triglycerides (Measured at 24 weeks); Non-HDL-C (Measured at 24 weeks); HDL-C (Measured at 24 weeks); Total Cholesterol (Measured at 24 weeks); Total Cholesterol : HDL-C Ratio (Measured at 24 weeks)
B: serum-vitamin D metabolites (week 0); serum-vitamin D metabolites (week 2); serum-vitamin D metabolites (week 4); serum-vitamin D metabolites (week 8); serum-vitamin D metabolites (week 12); serum-vitamin D metabolites (week 16)
C: Mortality
D: To compare the change in renal tubular reabsorption of phosphate and markers of bone turnover. (Baseline, Week 4, Week 12); To measure the safety of 50,000 IU dose of vitamin D3 (Baseline, Week 4, and Week 8)

Answer: D