TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Oritavancin Versus IV Vancomycin for the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infection (SOLO I)
Brief Summary: The purpose of this Phase 3 trial was to evaluate the efficacy, safety, and tolerability of oritavancin in acute bacterial skin and skin structure infections (ABSSSIs), including those caused by methicillin-resistant staphylococcus aureus (MRSA), and to evaluate the potential economic benefit of oritavancin administered as a single 1200-milligram (mg) intravenous (IV) dose.


Options:
A: Number of patients with infection resolution reaching clinical stability, as a measure of effectiveness (Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).); Number of patients reaching clinical stability, as a measure of effectiveness (Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).); Number of patients death, as a measure of clinical failure (Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).); Number of patients with infection recurrence, as a measure of clinical failure (Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).); Number of patients requiring change in antibiotic, as a measure of clinical failure (Retrospective. Outcome measures will be determined in patients hospitalized between 2010-12-01 and 2011-01-31, from the date of hospitalization, up to the date of hospital discharge (2011-02-28 at the latest).)
B: Incidence of bacterial "acute attacks", assessed monthly.; Reported or observed severity of these acute attacks.; Duration of acute attacks.
C: Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention (1 month follow-up)
D: Cessation Of Spread Or Reduction In Size Of Baseline Lesion, Absence Of Fever, And No Rescue Antibiotic Medication At Early Clinical Evaluation (ECE) (48 To 72 Hours) (48-72 hours after the initiation of study therapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Equivalency Trial of Strength Compared to Aerobic Exercise on Pain Severity in Adults With Fibromyalgia
Brief Summary: Randomized equivalency trial of the effects of strength training compared to aerobic exercise on pain severity in adults with fibromyalgia.


Options:
A: Pain severity (Week 3)
B: Visual Analog Scale for Pain (baseline, after 16 weeks and after 32 weeks)
C: The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment. (7 days)
D: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score (wks 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Equivalency Trial of Strength Compared to Aerobic Exercise on Pain Severity in Adults With Fibromyalgia
Brief Summary: Randomized equivalency trial of the effects of strength training compared to aerobic exercise on pain severity in adults with fibromyalgia.


Options:
A: pain; disability; fatigue; psychological distress at post treatment and 6 month follow-up
B: 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
C: Overall impact of fibromyalgia (Participants will be followed over 24 weeks)
D: Pain severity (Week 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Equivalency Trial of Strength Compared to Aerobic Exercise on Pain Severity in Adults With Fibromyalgia
Brief Summary: Randomized equivalency trial of the effects of strength training compared to aerobic exercise on pain severity in adults with fibromyalgia.


Options:
A: The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment. (7 days)
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: Pain severity (Week 3)
D: Visual Analog Scale for Pain (baseline, after 16 weeks and after 32 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Equivalency Trial of Strength Compared to Aerobic Exercise on Pain Severity in Adults With Fibromyalgia
Brief Summary: Randomized equivalency trial of the effects of strength training compared to aerobic exercise on pain severity in adults with fibromyalgia.


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: Fibromyalgia Impact Questionnaire (Baseline, 16 wks and 10 months)
C: Overall impact of fibromyalgia (Participants will be followed over 24 weeks)
D: Pain severity (Week 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Equivalency Trial of Strength Compared to Aerobic Exercise on Pain Severity in Adults With Fibromyalgia
Brief Summary: Randomized equivalency trial of the effects of strength training compared to aerobic exercise on pain severity in adults with fibromyalgia.


Options:
A: Decrease of pain and use of specific medicine for fibromyalgia (16 weeks)
B: pain (4 weeks)
C: Fibromyalgia Impact Questionnaire (Baseline, 16 wks and 10 months)
D: Pain severity (Week 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: PACE CALL: A Tailored Weight Management Program for Childhood ALL Survivors
Brief Summary: UC San Diego researchers conducted a study to develop and evaluate an internet and text message based weight loss study for childhood acute lymphoblastic leukemia (ALL) survivors. We hypothesized that those study participants randomized to the intervention will demonstrate greater reduction in BMI-z score as compared to the control group.


Options:
A: Fatigue (immediately before and after the intervention)
B: BMI (Baseline, 4 months)
C: Hematological and Immunological Recovery (This assessments will be performed at baseline, 7, 14, 28, 56, 84 and 180 days after stem cell transplantation (SCT))
D: feasibility of isometric exercise in vertebral bony metastases (12 weeks post completion of radiotherapy)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: TAHLC - Texting to Promote Adolescent Health Liaisons and Chronic Disease Management
Brief Summary: UCSD researchers are conducting a study aimed to develop and evaluate a chronic disease self management web and text message based program on health-related self-efficacy and frequency of adolescent-conducted healthcare interactions. We hypothesize that users of the program will demonstrate greater gains between baseline and 8 month measures of health related self-efficacy and adolescent-conducted healthcare interactions as compared to the usual care comparison group.


Options:
A: Health related self-efficacy (8 months)
B: Lung function (FEV1, FVC, FEF25-75)
C: Change in lung functions determined at 0,3,6,12,18,24 months; Change in exercise capacity determined at 0,3,6,12,18,24; months; Change in physical activity determined at 0,3,6,12,18,24 months; Change in quality of life determined at 0,3,6,12,18,24 months
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: TAHLC - Texting to Promote Adolescent Health Liaisons and Chronic Disease Management
Brief Summary: UCSD researchers are conducting a study aimed to develop and evaluate a chronic disease self management web and text message based program on health-related self-efficacy and frequency of adolescent-conducted healthcare interactions. We hypothesize that users of the program will demonstrate greater gains between baseline and 8 month measures of health related self-efficacy and adolescent-conducted healthcare interactions as compared to the usual care comparison group.


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Knowledge, realistic expectations and decisional conflict 3 weeks after using the decision aid.
C: The primary outcome measure was total medical costs (capped at $200,000 per individual per year) and pharmacy costs.
D: Health related self-efficacy (8 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: TAHLC - Texting to Promote Adolescent Health Liaisons and Chronic Disease Management
Brief Summary: UCSD researchers are conducting a study aimed to develop and evaluate a chronic disease self management web and text message based program on health-related self-efficacy and frequency of adolescent-conducted healthcare interactions. We hypothesize that users of the program will demonstrate greater gains between baseline and 8 month measures of health related self-efficacy and adolescent-conducted healthcare interactions as compared to the usual care comparison group.


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Change in FEV1 (12 months)
C: Health related self-efficacy (8 months)
D: Number of inpatient hospital days in the home monitoring group compared to the routine clinical care group (up to 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: TAHLC - Texting to Promote Adolescent Health Liaisons and Chronic Disease Management
Brief Summary: UCSD researchers are conducting a study aimed to develop and evaluate a chronic disease self management web and text message based program on health-related self-efficacy and frequency of adolescent-conducted healthcare interactions. We hypothesize that users of the program will demonstrate greater gains between baseline and 8 month measures of health related self-efficacy and adolescent-conducted healthcare interactions as compared to the usual care comparison group.


Options:
A: use of Internet site (2 months)
B: Transition Readiness Assessment Questionnaire (TRAQ) Score (Baseline, 1 month and 6 months)
C: N/A
D: Health related self-efficacy (8 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Glucose 25% and Facilitated Tucking for Reducing Procedural Stress During Neonatologist-performed Cardiac Echocardiography in Infants in the NICU
Brief Summary: The purpose of this study is to compare the effect of a 25% glucose solution given via a soother with or without facilitated tucking with a similarly administered water placebo (control condition) on infant stress responses during and immediately after a neonatologist performed ECHO (np-ECHO).


Options:
A: Change in Behavioral Indicators of Infant Pain (BIIP) Score (study day 1)
B: Heart rate (Change from Baseline Heart rate at 3 minutes before, during, and at the first and 10th minute after heel lance procedure); Respiratory rate (Change from Baseline Respiratory rate at 3 minutes before, during, and at the first and 10th minute after heel lance procedure); Oxygen Saturation (Change from Baseline Oxygen Saturation at 3 minutes before, during, and at the first and 10th minute after heel lance procedure); Respond of Pain (Change from Baseline Pain at 3 minutes before, during, and at the first and 10th minute after heel lance procedure)
C: The primary outcome: Feasibility and acceptability of study procedure (after the study completion (4 months after the baseline survey))
D: Pain-specific event related potential (Isolated within the one-minute window post-procedure.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness for Symptom Reduction: A Transplant Candidate Study in Program Grant Studies of Organ Transplantation in Animals and Man 2P01 DK013083
Brief Summary: The purpose of this study is to determine whether telephone-adapted Mindfulness Based Stress Reduction (tMBSR) - a program of mindfulness meditation and gentle Hatha yoga delivered mostly by phone, is an effective program to reduce symptoms (anxiety, depression, sleep) and improve quality of life for people waiting for a kidney transplant. Participants will be randomly assigned to tMBSR or to a support group emphasizing communication skills and selecting resources. Both 8-week programs include an initial in-person meeting, 6 weekly teleconference calls, and conclude with an in-person meeting. Participants will complete questionnaires at 3 timepoints over 6 months, and if they receive a transplant, will complete additional questionnaires. Participants will complete sleep diaries and wear Actiwatches (similar to a wristwatch) for one week before programs start, and when programs end, to measure sleep. Participants will provide saliva samples, over 3 days before programs start, and again when programs end, to measure salivary cortisol, an indicator of stress. tMBSR participants will record daily home meditation practice.


Options:
A: Percent change in left ventricular volume index (LVVI) at Week 96.
B: Insomnia Severity Index (ISI) Short-term (Week 7); Insomnia Severity Index (ISI) Long-term (Week 25)
C: State-Trait Anxiety Inventory (Baseline, 8 weeks, 26 weeks)
D: Changes in Fatigue Symptom Inventory (FSI) (Baseline and week 4); Changes in Fatigue Symptom Inventory (FSI) (Baseline and week 8); Changes in Fatigue Symptom Inventory (FSI) (Baseline and week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness for Symptom Reduction: A Transplant Candidate Study in Program Grant Studies of Organ Transplantation in Animals and Man 2P01 DK013083
Brief Summary: The purpose of this study is to determine whether telephone-adapted Mindfulness Based Stress Reduction (tMBSR) - a program of mindfulness meditation and gentle Hatha yoga delivered mostly by phone, is an effective program to reduce symptoms (anxiety, depression, sleep) and improve quality of life for people waiting for a kidney transplant. Participants will be randomly assigned to tMBSR or to a support group emphasizing communication skills and selecting resources. Both 8-week programs include an initial in-person meeting, 6 weekly teleconference calls, and conclude with an in-person meeting. Participants will complete questionnaires at 3 timepoints over 6 months, and if they receive a transplant, will complete additional questionnaires. Participants will complete sleep diaries and wear Actiwatches (similar to a wristwatch) for one week before programs start, and when programs end, to measure sleep. Participants will provide saliva samples, over 3 days before programs start, and again when programs end, to measure salivary cortisol, an indicator of stress. tMBSR participants will record daily home meditation practice.


Options:
A: Bedtime (Mean Bedtimes over 21 days for each period)
B: State-Trait Anxiety Inventory (Baseline, 8 weeks, 26 weeks)
C: The primary end-point for this study is the difference in the change in quality of life between the two groups from randomisation to the 12 month follow-up as measured by the EQ-5D instrument. (12 months from randomisation)
D: clinical response rate (at 8 weeks from baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness for Symptom Reduction: A Transplant Candidate Study in Program Grant Studies of Organ Transplantation in Animals and Man 2P01 DK013083
Brief Summary: The purpose of this study is to determine whether telephone-adapted Mindfulness Based Stress Reduction (tMBSR) - a program of mindfulness meditation and gentle Hatha yoga delivered mostly by phone, is an effective program to reduce symptoms (anxiety, depression, sleep) and improve quality of life for people waiting for a kidney transplant. Participants will be randomly assigned to tMBSR or to a support group emphasizing communication skills and selecting resources. Both 8-week programs include an initial in-person meeting, 6 weekly teleconference calls, and conclude with an in-person meeting. Participants will complete questionnaires at 3 timepoints over 6 months, and if they receive a transplant, will complete additional questionnaires. Participants will complete sleep diaries and wear Actiwatches (similar to a wristwatch) for one week before programs start, and when programs end, to measure sleep. Participants will provide saliva samples, over 3 days before programs start, and again when programs end, to measure salivary cortisol, an indicator of stress. tMBSR participants will record daily home meditation practice.


Options:
A: Systolic Blood Pressure (SBP) (one year)
B: Number of patients that start home-based dialysis. (1 year)
C: State-Trait Anxiety Inventory (Baseline, 8 weeks, 26 weeks)
D: Change in blood pressure measurement at baseline and at one year follow-up (Baseline and one year follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of Adductor-Canal-Block (ACB) in Patients After Knee Arthroscopy
Brief Summary: The Purpose of this study is to determine whether Adductor-Canal-Block (ACB) is superior to placebo when it comes to analgetic efficacy after Knee-Arthroscopy.


Options:
A: Difference in VAS between ACB and placebo during active 45 degrees knee flexion (45 minutes)
B: Pain-Score (VAS) - patient standing (2 hours postoperative)
C: Pain during 45 degrees active flexion of the knee (1 hour postoperative)
D: Timed Up and Go test (2-3 days post srugery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobilizing Evidence Into Action to Improve Outcomes of Vulnerable Seniors
Brief Summary: This is a parallel Randomized Controlled Trial comparing two different delivery modes of post hip fracture management-a specialized Fracture Follow-up Clinic versus Usual Care alone. The Fracture Follow-up Clinic will focus on bone health and fall risk factors. The investigators will evaluate the effect of the clinic and exercise program on mobility and falls. The investigators primary hypothesis is that within the first year following a hip fracture, older adults who are assessed in the B4 Clinic and prescribed an exercise program will have significantly improved Short Physical Performance Battery (SPPB) scores compared with participants who receive usual care alone.


Options:
A: Short Physical Performance Battery (12 months post-fracture)
B: Mobility (1, 4 and 12 months after surgery)
C: We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) (4 and 12 months)
D: Self-care ability (1, 3, 6, 12 months after hospital discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 4, Randomized, 52-Week Study To Evaluate Two Assessment Tools To Predict Treatment Success At 52 Weeks Based On A Treatment Decision At Week 12 In Subjects With Moderate To Severe Rheumatoid Arthritis Receiving Cimzia
Brief Summary: Phase 4 study to evaluate a routine patient completed assessment (RAPID3) compared to a physician completed assessment (CDAI) to predict treatment success with subjects with moderate to severe rheumatoid arthritis


Options:
A: Response at Week 12 as Assessed by Randomized Tool [Clinical Disease Activity Index (CDAI) or Routine Assessment of Patient Index Data 3 (RAPID3)] (Baseline (Week 0) to Week 12); Responders at Week 12 (as Assessed by Randomized Tool Clinical Disease Activity Index [CDAI] or Routine Assessment of Patient Index Data [RAPID3]) Achieving Low Disease Activity (Disease Activity Score 28 [Erythrocyte Sedimentation Rate]≤3.2) at Week 52 (Baseline (Week 0) to Week 52)
B: Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 2-fold Titer Increase in ≥ 3 of 6 Pneumococcal Antigens (6B, 9V, 14, 18C, 19F, and 23F) at Week 6. (Baseline, End of single blind period (Week 6)); Percentage of Subjects Without Baseline Protective Titers Achieving a ≥ 4-fold Titer Increase in ≥ 2 of 3 Influenza Antigens (2009/2010 Composition) at Week 6. (Baseline, End of single blind period (Week 6))
C: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
D: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 (Baseline, Week 34)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: EXerCise Introduction To Enhance Performance in Dialysis: the EXCITE Study
Brief Summary: To evaluate if a model of intervention based on a low-grade physical program prescribed in the dialysis centre and performed at home can modify the functional capacity and quality of life, reduce the risk of cardiovascular and all-causes mortality, non-fatal cardiovascular events and vascular access failure in dialysis patients.


Options:
A: Change in non-invasive measures of arterial stiffness using applanation tonometry. (4 months and 8 months after study initiation)
B: Change from baseline in walking speed on the 10-meter walking test at week 6 and change from baseline in walking speed on 10-meter walking test at week 12 (Baseline, Week 6, and Week 12)
C: Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT) (3 months)
D: Assessment of Quality of Life (QoL) modification by the KIDNEY DISEASE QUALITY OF LIFE (KDQOL)questionary (6 months); Assessment of functional capacity by Six-Minute Walking test and Sit-to-Stand-to-sit test (6 months)

Answer: D