TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Biomechanical Therapy for Osteoarthritis of the Knee: a Randomized Controlled Trial(BIOTOK)
Brief Summary: Painful knee osteoarthritis is common and treatments, short of knee replacement, are limited. The investigators plan to test the efficacy of a novel promising device for treatment of knee osteoarthritis affecting the inner part of the knee, the most common location. There are no disease modifying treatments available and therefore there is an emphasis on conservative management techniques to benefit individuals. Many of these treatments (insoles, braces, physiotherapy etc) have been shown to have relative success in individuals but a new novel device is demonstrating better effectiveness in this patient group. APOS (All Phases of Step) therapy consists of a shoe oriented system of care that works by shifting the load across parts of the knee and retraining the lower extremity muscles. Preliminary data suggest impressive favourable reductions in knee pain and a commensurate decrease in knee loading during walking. However, APOS treatment has never been evaluated in a randomised controlled trial even though it is widely used. The investigators propose to conduct a randomised blinded controlled trial of APOS treatment among persons with painful knee osteoarthritis affecting the inside (medial or lateral) of their knees. The investigators will focus on pain outcomes and quality of life. APOS has committed to provide the shoe system and a matched sham device, that they have developed, and will also provide the technicians trained to calibrate the pertupods (balls under the sole of the foot) on the shoe without charge. The research will be undertaken in a University setting for the gait evaluations.


Options:
A: Pain: Numerical pain scale (Baseline, 6 weeks, 3 months, 1 year)
B: Change in Pain on the VIsual Analog Scale (VAS) (6 weeks); Change in WOMAC Pain Scale (6 weeks)
C: WOMAC pain subscale (End of treatment (at 24 weeks))
D: Patient Global Impression of Change for Knee Pain (Assessed after the 8-16 week intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Acupuncture vs. Placebo Acupuncture and vs. Standard Therapy for Pain Control After Elective Caesarean Section - a Randomized Controlled Trial
Brief Summary: The study entitled "Acupuncture vs. placebo acupuncture and vs. standard therapy for pain control after elective caesarian section - a randomized controlled trial" aims to investigate whether acupuncture with indwelling fixed needles reduces pain and analgesic requirement as compared to placebo and standard therapy in patients after after elective caesarian section (CS) in the period from January 2015 to May 2016.

For that purpose 180 adult patients scheduled to elective elective CS in spinal anesthesia will be recruited according to eligibility criteria. 120 patients will be randomized either to verum or placebo acupuncture, 60 patients will be included in non-randomized "standard therapy" arm. The outcome measures are: postoperative analgesic requirement, pain intensity, incidence of side effects and physiological parameters.


Options:
A: Pain intensity as measured by Numeric Rating Scale 1-10 (4:00 P.M. on the 1st postoperative day)
B: Medication Use (Data collected daily for 7 Days)
C: Daily average postoperative pain scores (An average of pain scores at 8:00 am and 4:00 pm, up to 7 days postoperation); Postoperative functional recovery (In the morning of postoperative day 3)
D: Pain, assessed by patients using a pain scale (72 hours or hospital stay)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Prebiotic (Fructooligosaccharide) on Uremic Toxins and Cardiovascular Markers of Chronic Kidney Disease Patients
Brief Summary: This 12-week double-blind randomized controlled clinical trial aims to investigate the effect of a prebiotic (fructooligosaccharide - FOS) on serum and urinary levels of uremic toxins (p-cresyl sulfate and indoxyl sulfate) of non-dialysis dependent CKD patients, and the impact of such intervention on cardiovascular markers, intestinal permeability, endotoxemia and inflammatory response.


Options:
A: Uremic toxicity evaluated by serum and urinary levels of p-cresyl sulfate and indoxyl sulfate (12 weeks)
B: Change in hs CRP (baseline and after 16 weeks); Change in TNF alpha (Baseline and at week 16); Change in IL6 (Baseline and at week 16); Change in IL10 (Baseline and at week 16); Change in MCP1 (Baseline and at week 16)
C: Change from Baseline Triglyceride/HDL cholesterol ratio at 3 months, 6 months and 3 months after the trial (baseline,3 months, 6 months and 3 months after the trial)
D: Change from baseline of the microbial gut populations (5 months); Change from baseline of the microbial inflammatory uremic toxins (5 months); Change from baseline of the markers of cardiovascular diseases (5 months); Change from baseline of the markers of intestinal barrier permeability (5 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Translation of COPE for Publicly-Funded Home Care Clients and Their Families
Brief Summary: This community-based translational trial tests the value of a proven non-pharmacologic intervention for older adults living with dementia and informal caregivers when this intervention is incorporated into a publicly-funded home and community based service program. Half the participants will receive customary publicly-funded services alone, and half will receive customary services plus the proven non-pharmacologic intervention.


Options:
A: Admittance to nursing home care (24 months)
B: The Neuropsychiatric Inventory (NPI). Measures the Frequency and Severity of Behavioral Symptoms in Dementia. (Baseline, 4 month (short-term follow-up), 8 month (long-term))
C: Functional dependence (Change in functional dependence score between baseline (pre-randomization) and 4 months post-randomization)
D: Behavioral occurrence; Care recipient depressive mood; Caregiver upset

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Translation of COPE for Publicly-Funded Home Care Clients and Their Families
Brief Summary: This community-based translational trial tests the value of a proven non-pharmacologic intervention for older adults living with dementia and informal caregivers when this intervention is incorporated into a publicly-funded home and community based service program. Half the participants will receive customary publicly-funded services alone, and half will receive customary services plus the proven non-pharmacologic intervention.


Options:
A: Frequency by severity of Agitated and Aggressive Behavior in person with dementia (3 months)
B: Functional dependence (Change in functional dependence score between baseline (pre-randomization) and 4 months post-randomization)
C: Change in cognitive function assessed on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) (Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months))
D: ADL/IADL (Baseline, t2, t3); Caregiver upset (Baseline, t2, t3); Caregiver confidence (when needed); Behaviors (Baseline, t2, t3)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Binocular iPad Sub-Study; Suppression in Amblyopia
Brief Summary: 1. To determine whether a binocular iPad game app is effective in improving visual acuity and reducing interocular suppression in amblyopic children
2. To compare the amount of visual acuity improvement achieved with the binocular game app to the amount achieved with patching (standard treatment for amblyopia)


Options:
A: Visual acuity in the amblyopic eye (6 months)
B: The primary outcome measure was logMAR visual acuity, measured 6-weekly for 18 weeks in refractive adaptation phase. In occlusion phase measured 2-weekly until no further gains
C: Visual Acuity of the Amblyopic Eye HOTV (for children <7 y) or ETDRS for children 7+y (2 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 4 weeks (for deprivation amblyopia))
D: Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort (Baseline and 4 weeks); Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort) (4 weeks); Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort (Baseline and 8 weeks); Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort) (8 weeks); Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort (baseline and 4 weeks); Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort) (4 weeks); Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort (Baseline and 8 weeks); Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort) (8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Binocular iPad Sub-Study; Suppression in Amblyopia
Brief Summary: 1. To determine whether a binocular iPad game app is effective in improving visual acuity and reducing interocular suppression in amblyopic children
2. To compare the amount of visual acuity improvement achieved with the binocular game app to the amount achieved with patching (standard treatment for amblyopia)


Options:
A: Distribution of Visual Acuity in the Amblyopic Eye at 24 Weeks (24 weeks); Mean (SD) of Amblyopic Eye Visual Acuity at 24 Weeks (24 weeks); Distribution of Change in Amblyopic Eye Visual Acuity Scores From Baseline to 24 Weeks (Baseline to 24 weeks); Mean Change in Amblyopic Eye Visual Acuity From Baseline to 24 Weeks (Baseline to 24 weeks)
B: maximal improvement in visual acuity
C: Visual Acuity of the Amblyopic Eye HOTV (for children <7 y) or ETDRS for children 7+y (2 weeks (for strabismic, anisometropic, and combined mechanism amblyopia); 4 weeks (for deprivation amblyopia))
D: Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to <13 Years) (Baseline and 16 weeks); Mean Amblyopic Eye Visual Acuity (Younger Cohort) (16 Weeks from baseline); Mean Change in Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years) (Baseline and 16 weeks); Mean Amblyopic-eye Visual Acuity in the Older Cohort (13 to <17 Years) (16 weeks); Distribution of Change in Amblyopic-eye Visual Acuity (Baseline and 16 weeks); Distribution of Amblyopic-eye Visual Acuity (At 16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Modifying Risk in Ventral Hernia Patients
Brief Summary: A pre-operative physical conditioning and weight loss intervention (prehabilitation) compared to standard counseling prior to ventral hernia repair for obese patients (BMI 30-40 kg/m2) at a safety-net hospital results in a higher proportion of patients being hernia- and complication-free 2 years after surgical consultation.


Options:
A: Proportion of patients who are hernia- and complication-free (2 years after enrollment)
B: 6 minute walk test (6MWT) (up to 8 weeks after surgery)
C: Post operative complications (30 days after surgery)
D: Six Minute Walk Test (6MWT) (up to 8 weeks after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Modifying Risk in Ventral Hernia Patients
Brief Summary: A pre-operative physical conditioning and weight loss intervention (prehabilitation) compared to standard counseling prior to ventral hernia repair for obese patients (BMI 30-40 kg/m2) at a safety-net hospital results in a higher proportion of patients being hernia- and complication-free 2 years after surgical consultation.


Options:
A: Proportion of patients who are hernia- and complication-free (2 years after enrollment)
B: 6 Minute Walk Test (baseline, 3 weeks, 4 weeks, 8 weeks, 24 weeks)
C: 6-minute-walking-distance (6MWD) (4 weeks postoperatively)
D: six minute walk test (baseline, preop, 4 weeks, 8weeks postop)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: PAWS CLUB: Peer Education About Weight Steadiness
Brief Summary: The proposed integrated project will evaluate the effects of an evidence-based extension education program, Family Fitness Program (FFP) grounded in Stages of Change Learning Theory and guided by Social Cognitive Theory (SCT), with and without a peer-education mode of delivery on balancing calories to manage body weight (BW), reducing certain foods and food components, increasing selected foods and nutrients, building healthy eating patterns \[i.e., fundamental principles of the Dietary Guidelines for Americans (DGAs), 2010\] and SCT variables. Briefly, the 12-week program will target early adolescent children, ages 11-14 years, test a peer-education approach to behavioral change and will be delivered as an after-school program in local middle schools in support of childhood obesity prevention. Data will be collected at baseline (preintervention), after the 12-week program (post-intervention) and 6 months after completion of the program (maintenance).


Options:
A: Physical activity opportunities delivered (minutes/week); School environment scores; Height (cm); Weight (kg); Body mass index (kg/m^2); Physical fitness (Fitnessgram (C)); Children's leisure time physical activity (PAQ-C); Children's dietary intake; Physical activity interventions planned
B: Fitness (Day 0, Day 120)
C: Change in minutes spent in moderate to vigorous physical activity in after school programs from baseline to end of intervention (7 months) and 1 year after end of intervention. (Baseline, end of intervention (7 months), 1 year after intervention)
D: Change in Demographic data (Evaluation at three time points: 0 months, 2 months and 8 months); Goal setting tool (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in 24-hour dietary intake recall (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in 3-day dietary intake record (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in 24-hour physical activity recall (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in 3-day physical activity record (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in Anthropometric measurements (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in Social Cognitive Theory (SCT) variables (Evaluation at three time points: 0 months, 2 months and 8 months); Changes in blood pressure (BP) measurements (Evaluation at three time points: 0 months, 2 months and 8 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Pulsed Electromagnetic Field Therapy on Pain After Cesarean Delivery
Brief Summary: A double-blinded randomized control study using a pulsed electromagnetic field therapy to establish whether this device decreases patient pain and decreases narcotic use in women who have undergone cesarean delivery.


Options:
A: assessing the effects of PENS therapy in Postoperative period of Lower Segment Caesarean Section pain using VAS score. (2 hours of device activation)
B: Lowest Pain Level Postoperative (24 hours postoperative); Average Pain Level Postoperative (24 hours postoperative); Worst Pain Level Postoperative (24 hours postoperative)
C: Pain, assessed by patients using a pain scale (72 hours or hospital stay)
D: Number of Subjects Who Achieved 50% Sustained Pain Reduction (12 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation and Quality of Life in Residential Units for People With Longer Term Mental Health Problems
Brief Summary: The study design is that of a cluster randomised controlled trial

The aims of the study were: 1) to assess the quality of care of the residential units for people with long-term mental disorders; 2) to design a training intervention for the staff of the units in the intervention group; 3) to assess the effectiveness of the intervention 4 and 8 months after it ended.

The main outcome variable was level of activity of the users. Secondary outcome variables were the QuIRC dimensions.

The selection of the sample was by residential units for people with long-term mental disorders.

The inclusion criteria were all the middle and high-support residential units in Portugal. Units that had only one type of service users (e.g., mental retardation, dementia) were excluded.

The quality of care of the units was assessed with the QuIRC filled on line by the managers of the units and validated with Service Users Interview Schedule, a face-to-face interview with the users (users that could not give informed consent or collaborate in the interview were excluded).


Options:
A: Rate of First or Only Clinical Episode of Plasmodium Falciparum (P. Falciparum) Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD) (From Month 2.5 to Month 14); Rate of First or Only Clinical Episode of P. Falciparum Malaria Infection (CPFMI), or Clinical Malaria Episode of Primary Case Definition (CPFMI-PCD) (From Month 2.5 to Month 14)
B: Child BMI (3 years)
C: Percentage of time spent in any activity during a week by patients (Four months)
D: Practice-level colon cancer screening rate (12-months post baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Brief Summary: This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).


Options:
A: Overall survival (OS) (approximately 48 months); Progression-free Survival (PFS) as determined by blinded independent central review (BICR) (approximately 40 months)
B: Overall Survival (OS) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Percentage of Participants Experiencing Adverse Events (AEs) (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)); Percentage of Participants Discontinuing Study Drug Due to AEs (Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months))
C: Progression Free Survival (PFS), as Determined by the Investigator in Arm B Versus Arm C in the Teff-high WT Population and ITT-WT Population (Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months)); Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population (Baseline until death until data cut-off on 22 January 2018 (up to approximately 34 months)); Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population (Baseline until death (up approximately 53 months))
D: Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.); Overall Survival (From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Minimal Homebased Psychoeducative Intervention Versus Usual Care for the Management of Anxiety and Dyspnea in Patients With Severe Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this trial is to determine whether a minimal homebased psychoeducative intervention is effective in management of anxiety and dyspnea in patients with severe chronic obstructive pulmonary disease.


Options:
A: Change in HADS-A score from baseline to three months follow-up (Three months)
B: Dyspnea; Exercise adherence and performance; Pulmonary exacerbations
C: Daily physical activity in steps counts a day (Experimental group: assessment during first 3 months, 2 week assessment at 6 months, 9 months and 15 months. Control group: 2 weeks assessment at baseline, 3 months, 9 months and 15 months)
D: COPD Assessment Test (CAT) (1 Year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Minimal Homebased Psychoeducative Intervention Versus Usual Care for the Management of Anxiety and Dyspnea in Patients With Severe Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this trial is to determine whether a minimal homebased psychoeducative intervention is effective in management of anxiety and dyspnea in patients with severe chronic obstructive pulmonary disease.


Options:
A: -Thromboembolic recurrences; -Bleeding Complications; -Deaths
B: Change in HADS-A score from baseline to three months follow-up (Three months)
C: Anxiety and depression (HADS) (At 1 month, 3 months and 12 months, change from baseline)
D: Walking distance at 6 months post surgery, measured using the Six-Minute Walk Test (6MWT) (Pre surgery; 10 weeks, six months and twelve months after surgery.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Minimal Homebased Psychoeducative Intervention Versus Usual Care for the Management of Anxiety and Dyspnea in Patients With Severe Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this trial is to determine whether a minimal homebased psychoeducative intervention is effective in management of anxiety and dyspnea in patients with severe chronic obstructive pulmonary disease.


Options:
A: Overall functioning (18 months); Incremental cost-effectiveness ratio (ICER) (18 months)
B: Hospital readmission (30 days)
C: N/A
D: Change in HADS-A score from baseline to three months follow-up (Three months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of a Minimal Homebased Psychoeducative Intervention Versus Usual Care for the Management of Anxiety and Dyspnea in Patients With Severe Chronic Obstructive Pulmonary Disease
Brief Summary: The purpose of this trial is to determine whether a minimal homebased psychoeducative intervention is effective in management of anxiety and dyspnea in patients with severe chronic obstructive pulmonary disease.


Options:
A: Change in HADS-A score from baseline to three months follow-up (Three months)
B: Weight change
C: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
D: Hospital readmission (30 days)

Answer: A