TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: TeleCare Management of Pain and Depression in Cancer
Brief Summary: RATIONALE: Telemedicine may help in the treatment of depression and/or pain caused by cancer. It is not yet known whether telemedicine is more effective than standard care in treating depression and/or pain caused by cancer.

PURPOSE: This phase III randomized clinical trial is studying telemedicine to see how well it works compared to standard care in treating patients with depression and/or pain caused by cancer.


Options:
A: To test for differences in rates of screening between the early intervention and delayed groups, the chi-square test will be used for each outcome. (End of project, 12/2011)
B: Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB) (12-months)
C: Bone mineral density screening rates
D: Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: TeleCare Management of Pain and Depression in Cancer
Brief Summary: RATIONALE: Telemedicine may help in the treatment of depression and/or pain caused by cancer. It is not yet known whether telemedicine is more effective than standard care in treating depression and/or pain caused by cancer.

PURPOSE: This phase III randomized clinical trial is studying telemedicine to see how well it works compared to standard care in treating patients with depression and/or pain caused by cancer.


Options:
A: Episodes of low back pain (2 years); Duration of low back pain (2 years); Severity of low back pain (2 years)
B: Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months
C: The Roland Morris Disability Questionnaire (RDQ) Score (12 months)
D: Change in catastrophizing cognitions (T1: At the start of in-house rehabilitation T2: At the end of in-house rehabilitation - begin situational feedback intervention T3: End of situational feedback intervention T4: 6 month after T1 T5: 12 months after T1)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: TeleCare Management of Pain and Depression in Cancer
Brief Summary: RATIONALE: Telemedicine may help in the treatment of depression and/or pain caused by cancer. It is not yet known whether telemedicine is more effective than standard care in treating depression and/or pain caused by cancer.

PURPOSE: This phase III randomized clinical trial is studying telemedicine to see how well it works compared to standard care in treating patients with depression and/or pain caused by cancer.


Options:
A: Reduction in symptoms of major depression (Measured at Months 12, 18, and 24)
B: Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months
C: Adjusted Change in Pain-related Function (Roland Disability Score) (12 months)
D: Recovery from Common Mental Disorder (defined by ICD10) (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: TeleCare Management of Pain and Depression in Cancer
Brief Summary: RATIONALE: Telemedicine may help in the treatment of depression and/or pain caused by cancer. It is not yet known whether telemedicine is more effective than standard care in treating depression and/or pain caused by cancer.

PURPOSE: This phase III randomized clinical trial is studying telemedicine to see how well it works compared to standard care in treating patients with depression and/or pain caused by cancer.


Options:
A: Symptom cluster (4 weeks); Fatigue (4 weeks); Pain (4 weeks); Sleep disturbance (4 weeks)
B: average and worst pain as reported daily by patients on a scale from 0 (no pain) to 10 (worst imaginable pain) (measured daily for 10 weeks and in week 14 and 22)
C: Change in Patient Health Questionnaire-8 (baseline, 2 and 6 weeks post-intervention); Change in Generalized Anxiety Disorder 7-item scale (baseline, 2 and 6 weeks post-intervention)
D: Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury
Brief Summary: The purpose of this study is to determine the effect of early administration of recombinant human erythropoietin on long-term neurological outcome after severe traumatic brain injury.


Options:
A: Number of Units of Packed Red Blood Cell Transfused (duration of the protocol, an average of 15 days); Percentage of Transfused Patients in Each Group (duration of the protocol, an average of 15 days)
B: Glasgow Outcome Scale (at 6 months after injury)
C: 90-day mortality (after 90 days from study enrollment)
D: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury
Brief Summary: The purpose of this study is to determine the effect of early administration of recombinant human erythropoietin on long-term neurological outcome after severe traumatic brain injury.


Options:
A: Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline. (Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.)
B: 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality (2 weeks, 4 weeks, 12 weeks, 90 days)
C: Glasgow Outcome Scale (at 6 months after injury)
D: We will test the hypothesis that the transfusion of red cells of lesser storage age, (5 days or less) will produce less changes of pulmonary function and immune activation than will transfusion of red cells of conventional storage age (median 21 days). (At the end of the transfusion as compared to the beginning of the transfusion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury
Brief Summary: The purpose of this study is to determine the effect of early administration of recombinant human erythropoietin on long-term neurological outcome after severe traumatic brain injury.


Options:
A: Quality of Life (QOL)/Function based on the FACT-BMT scale (3 years)
B: Hemoglobin Concentration (In-hospital up to 30 days post randomization); Red Blood Cell Transfusion (In-hospital up to 30 days post randomization)
C: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)
D: Glasgow Outcome Scale (at 6 months after injury)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury
Brief Summary: The purpose of this study is to determine the effect of early administration of recombinant human erythropoietin on long-term neurological outcome after severe traumatic brain injury.


Options:
A: In-stent Neointimal volume; In-stent Late lumen loss; Semi-Quantitative evaluation of infarcted size of myocardium
B: Left ventricular ejection fraction measured by magnetic resonance imaging (4-6 months)
C: Glasgow Outcome Scale (at 6 months after injury)
D: incidence of acute kidney injury (change of renal function including SCr, cystatin C, creatinine clearance from 24 h before operation to postoperative day (POD) 5)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury
Brief Summary: The purpose of this study is to determine the effect of early administration of recombinant human erythropoietin on long-term neurological outcome after severe traumatic brain injury.


Options:
A: The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS. (Through post-operative day 7, hospital discharge, or death, whichever occurs first)
B: Glasgow Outcome Scale (at 6 months after injury)
C: Timed Up and Go-test (TUG)in seconds. (30 days)
D: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Back-to Back Trial of Narrow Band Imaging (NBI) With Magnification Versus Standard Colonoscopy for Colonic Neoplasia Surveillance in Hereditary Non-Polyposis Colorectal Cancer (HNPCC) Patients
Brief Summary: The purpose of this study is to determine whether a new colonoscopic viewing technique called narrow band imaging (NBI)can help doctors detect more patients with at least one pre-cancerous area than conventional colonoscopy using white light alone in patients with genetically inherited high risk for bowel cancer (HNPCC).


Options:
A: Neoplasm Miss Rate (same day)
B: adenoma detection rate (number of polyps/number of patients examined) (6 months)
C: The prevalence of adenomas in the three arms of the study. (2 years)
D: Number of patients with at least one adenoma; after white light endoscopy compared with the number of patients; with at least one adenoma after white light NBI in the right colon.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 13-Week, Randomized, Multi-Center, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150-600 Mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Central Post-Stroke Pain (CPSP)
Brief Summary: Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (CPSP)


Options:
A: Baseline Mean Pain Score (Baseline); Change From Baseline in Mean Pain Score at Endpoint (Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint))
B: Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS) (Up to Week 12)
C: Total pain intensity as measured by numeric rating scale 0-10 points. (Median of ratings from last week of each treatment period)
D: Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) (End of Period (includes both Visits 6 and 11)); DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period) (End of Period (includes both Visits 6 and 11))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Large Scale Safety Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine, in Comparison to Tritanrix-Hep B/Hib™ and OPV Administered at 2, 4, and 6 Months of Age in Latin American Infants
Brief Summary: To demonstrate that DTaP-IPV-HB-PRP\~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject.

To evaluate the overall safety in terms of:

Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial.

Immunogenicity:

To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP\~T vaccine.


Options:
A: Phase A - Inoculum Dose Determination (Up to volunteer visit Day 14)
B: Diagnosis of IgE-mediated food allergy (birth-15 years)
C: Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. (Day 0 up to Day 7 post-injection)
D: kinetics of Pertussis toxin (PT) IgG titers in infants (from birth until 19 months of age); kinetics of Filamentous haemagglutinin (FHA) IgG titers in infants (from birth until 19 months of age); kinetics of Pertactin (Prn) IgG titers in infants (from birth until 19 months of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: MAST - Magnesium for Sickle Cell Acute Crisis in Children
Brief Summary: The purpose of this study is to determine if intravenous magnesium sulfate treatment is effective in reducing the length of stay and pain in children with sickle cell disease suffering an acute vaso-occlusive episode.


Options:
A: N/A
B: Hospital Length of Stay (Hours) (From the time of the start of first study med infusion until hospital discharge or 12 hours after the last IV opioid, whichever occurs first, up to 10 days post enrollment)
C: Length of stay in the hospital (Time frame determined by outcome)
D: Dose Limiting Toxicities as a Measure of Whether Infusional Lexiscan is Safe in Individuals With SCD. (30 to 54 hours plus 30-day follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: MAST - Magnesium for Sickle Cell Acute Crisis in Children
Brief Summary: The purpose of this study is to determine if intravenous magnesium sulfate treatment is effective in reducing the length of stay and pain in children with sickle cell disease suffering an acute vaso-occlusive episode.


Options:
A: Dose Limiting Toxicities as a Measure of Whether Infusional Lexiscan is Safe in Individuals With SCD. (30 to 54 hours plus 30-day follow-up)
B: Distribution of the Density of Hemoglobin SC Red Cells (measured 2 months after initiation of treatment)
C: N/A
D: Length of stay in the hospital (Time frame determined by outcome)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 Weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients
Brief Summary: This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Options:
A: Change in Weight From Baseline (Baseline and 52 weeks); Percent of Subjects Who Lost More Than 5% of Body Weight From Baseline (52 weeks)
B: body weight, body mass index, waist circumference, fasting glucose, fasting insulin, insulin resistance index
C: Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase) (Baseline, Endpoint (Week 6))
D: Time from randomization to recurrence of a mood event

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
Brief Summary: The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.


Options:
A: Weekly Average Pain Score from the Daily Pain Diary.
B: Change in Ventricular Lactate Levels in the Brain (Baseline and 2 months)
C: Change From Baseline in the Brief Pain Inventory (BPI) 24-hour Average Pain Score (Baseline, Week 13)
D: Composite Syndrome Responder Status (At the end of the three-month stable dose treatment phase); Composite Pain Responder Status (At the end of three-month stable dose treatment phase)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
Brief Summary: The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.


Options:
A: Composite responder analysis based on pain and patient global status, with or without physical function.
B: Change in Weekly Average Pain Intensity (Baseline and Week 21clinic visits)
C: Composite Syndrome Responder Status (At the end of the three-month stable dose treatment phase); Composite Pain Responder Status (At the end of three-month stable dose treatment phase)
D: Patient's Global Impressions of Improvement (PGI-I) at Week 12 (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
Brief Summary: The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.


Options:
A: To demonstrate the efficacy of treatment with milnacipran as compared to placebo in the treatment of the fibromyalgia syndrome in outpatients after a 12-week period of fixed dose exposure through a primary composite criterion (12 weeks)
B: Change From Baseline in Mean Pain Score at Endpoint (Up to Week 14) (Baseline, Week 14); Patient Global Impression of Change (PGIC) (Week 14)
C: Composite Syndrome Responder Status (At the end of the three-month stable dose treatment phase); Composite Pain Responder Status (At the end of three-month stable dose treatment phase)
D: Visual Analogue Scale for Pain (Baseline, Week 1, 2,4, and 6 weeks); Changes in The Fatigue Severity Scale (FSS) (Baseline, Week 1, 2,4, and 6 weeks); Composite Brief Assessment of Cognition (BAC) Score (Baseline, Week 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
Brief Summary: The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.


Options:
A: Composite Syndrome Responder Status (At the end of the three-month stable dose treatment phase); Composite Pain Responder Status (At the end of three-month stable dose treatment phase)
B: To evaluate the efficacy of pregabalin for pain relief by comparing the mean pain score between treatment groups and placebo.
C: Composite responder analysis based on pain and patient global status, with or without physical function.
D: Endpoint mean pain score derived from the subject's daily pain diary (Endpoint); Patient Global Assessment (Patient Global Impression of Change) at Termination Visit (Weeks 5 and 13); Change from baseline in functioning (score created from the Short Form-36 [SF-36] Social and Physical Functioning, Fibromyalgia Impact Questionnaire [FIQ]-Total Score, and Sheehan Disability Scale [SDS] Total Score) at Termination Visit (Baseline and Weeks 5, 9, and 13)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Xolair in Subjects With Moderate to Severe Persistent Asthma Who Are Inadequately Controlled With High-Dose Inhaled Corticosteroids and Long-Acting Beta-Agonists
Brief Summary: This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose inhaled corticosteroids (ICS)+ long-acting beta-agonists (LABA) with or without additional controller therapy.


Options:
A: The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12. (12 weeks)
B: Rate of Asthma Exacerbations Over the 48 Week Treatment Period (48 weeks)
C: Number of Participants With 50% Reduction in Peripheral Blood Eosinophilia (3 months)
D: Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils (Baseline and 16 weeks); Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells (Baseline and 16 weeks)

Answer: B