TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Home-based Exercise Program on Functional Capacity and Quality of Life in Heart Failure Patients
Brief Summary: Heart failure (HF) is a multisystemic disease leading to exercise intolerance and fatigue. Supervised physical training improves functional capacity, quality of life and reduces hospital admissions in HF patients. In this way, home physical training may be a good alternative to patients who, for any reason, cannot perform supervised training. Objective: To asses the effects of a home-based training program on functional capacity, sedentary lifestyle and quality of life of patients with chronic HF compared to supervised training.


Options:
A: Effectiveness measured by exercise testing and control of cardiovascular risk factors (During 12 months)
B: Quality of life (At inclusion (baseline), change from baseline at 3, 6 and 12 months)
C: Changes in peak oxygen uptake (ml/kg/min) (Baseline and after 12 weeks of exercise programs)
D: VO2peak (baseline, after 12 weeks and after 1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Hemodialysis-based Interventions to Preserve Cognitive Function
Brief Summary: This is a randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (HD). The investigators will test three interventions cognitive training (CT), exercise training (ET), and combined cognitive and exercise training (CT+ET) relative to standard of care (SC).


Options:
A: Change in Executive Function as Assessed by the Trail Making Test Assessment (TMT) (3 months)
B: Physical Activity (Baseline and 12 weeks)
C: Effects of aerobic training during hemodialysis on exercise tolerance and VO2 kinetics in end stage renal disease patients (3 months)
D: IRLS severity scale (24 and 48 wks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Neoadjuvant Phase II Study of TLR9 Agonist CMP-001 in Combination With Nivolumab in Stage IIIB/C/D Melanoma Patients With Clinically Apparent Lymph Node Disease
Brief Summary: The purpose this research study is to determine if the combination of nivolumab and CMP-001 improves the likelihood of eradicating (destroying) disease in the lymph node (pathologic response rate).


Options:
A: Recurrence Free Survival (RFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population (Date of randomization to first date of recurrence or death or last available disease assessment with RFS data up to 5 years. Median follow-up was 2.7 years.); Number of Participants With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population (Date of randomization to first date of recurrence or death or last available disease assessment with RFS data upto 5 years. Median follow-up was 2.7 years.); Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population (At years 1, 2, and 3)
B: Major Pathologic Response Rate (MPR) (Every 6 weeks from start of study treatment, up to 52 weeks)
C: Progression-free Survival (Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months))
D: Progression Free Survival (PFS) (From randomization until disease progression or death, whichever occurred first (assessed up to February 2015, approximately 20 months)); Overall Survival (OS) (From randomization to date of death (Assessed up to September 2016, approximately 39 months)); Rate of Overall Survival (6, 12, and 24 months); Rate of Progression-Free Survival (6, 12, and 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Neoadjuvant Phase II Study of TLR9 Agonist CMP-001 in Combination With Nivolumab in Stage IIIB/C/D Melanoma Patients With Clinically Apparent Lymph Node Disease
Brief Summary: The purpose this research study is to determine if the combination of nivolumab and CMP-001 improves the likelihood of eradicating (destroying) disease in the lymph node (pathologic response rate).


Options:
A: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1) (Up to 28 days in Cycle 1); Number of Participants Who Experienced an Adverse Event (AE) (Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)); Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)); ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015))
B: Overall Survival (From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).); Progression-free Survival (From randomization (initiated January 2010) to December 30 2010.)
C: Progression-free Survival (Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months))
D: Major Pathologic Response Rate (MPR) (Every 6 weeks from start of study treatment, up to 52 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Program Evaluation of an In-school Daily Physical Activity Initiative for Children and Youth
Brief Summary: The school system is one setting in which children's physical activity levels may be increased through daily physical activity (DPA) policies and initiatives. Adherence to DPA policies is typically poor and results are limited in regard to the associated benefits for participating children. Therefore, the purpose of this study was to evaluate a range of psychosocial outcomes following a community-led, in-school DPA initiative for 9-14 year old children and youth. This program evaluation examined the impact of a DPA program consisting of 20 minutes of teacher-led DPA for 20 consecutive weeks. Student outcomes were measured using a questionnaire administered at three time points: baseline, mid-intervention, and post-intervention. A teacher questionnaire regarding program adherence and student behaviour was completed at post-intervention.


Options:
A: Reduction in prevalence of obesity (Changes from baseline in prevalence of obesity at 3 academic years)
B: Our outcome measure was reduction of screen time (4 waves of data)
C: Change in self-esteem from baseline to 20-weeks (Change from baseline to 20-weeks); Change in grit from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Global Happiness from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Commitment to School from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Sense of Belonging at School from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Physical Activity from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Self-efficacy from baseline to 20-weeks (Change from baseline to 20-weeks)
D: Percent Body Fat (Baseline and One year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Program Evaluation of an In-school Daily Physical Activity Initiative for Children and Youth
Brief Summary: The school system is one setting in which children's physical activity levels may be increased through daily physical activity (DPA) policies and initiatives. Adherence to DPA policies is typically poor and results are limited in regard to the associated benefits for participating children. Therefore, the purpose of this study was to evaluate a range of psychosocial outcomes following a community-led, in-school DPA initiative for 9-14 year old children and youth. This program evaluation examined the impact of a DPA program consisting of 20 minutes of teacher-led DPA for 20 consecutive weeks. Student outcomes were measured using a questionnaire administered at three time points: baseline, mid-intervention, and post-intervention. A teacher questionnaire regarding program adherence and student behaviour was completed at post-intervention.


Options:
A: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)
B: Change in body mass index (BMI) (Baseline, Month 3)
C: Changes in the composite ICH score of adolescents from baseline to year 2 and 4 (2 and 4 years)
D: Change in self-esteem from baseline to 20-weeks (Change from baseline to 20-weeks); Change in grit from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Global Happiness from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Commitment to School from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Sense of Belonging at School from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Physical Activity from baseline to 20-weeks (Change from baseline to 20-weeks); Change in Self-efficacy from baseline to 20-weeks (Change from baseline to 20-weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Low Energy Shock Wave for the Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) - a Randomized, Double-blind, Placebo-controlled, Prospective Study
Brief Summary: To investigate the efficacy and safety of LESW on participants with IC/BPS


Options:
A: O'Leary-Santa Interstitial Cystitis Symptom Index and Problem Index (OSPI) Score (Baseline/12 Weeks)
B: Change from Baseline in Average Mean Daily Pain (MDP) Score at Week 12 (Baseline and Week 12)
C: Change of the O'Leary-Sant symptom score (OSS, including ICSI and ICPI) (Baseline and 1 month)
D: Symptom Interpretation Questionnaire (SIQ) (Change from baseline symptom attribution at 6-weeks); Brief Pain Inventory (BPI) (Change from baseline pain at 6-weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE)
Brief Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).


Options:
A: Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA) Score From Baseline at Month 24 (Baseline to Month 24)
B: Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations (From Baseline through Week 56)
C: fluorescein angiography leakage area (from baseline to week 48.)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)
Brief Summary: This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).


Options:
A: fluorescein angiography leakage area (from baseline to week 48.)
B: Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12 (Baseline (Day 0), Week 12)
C: Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations (From Baseline through Week 56)
D: Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations (From Baseline through Week 56)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Kinesio Taping on Muscle Force, Pain, Edema, Physical Function and Global Perception of Change of Women With Knee Osteoarthritis: Randomized and Blind Clinical Trial
Brief Summary: Osteoarthritis (OA) of the knee is a disease characterized mainly by the wear and tear of the articular structures, which affects 6% to 13% of men and 7% to 19% of women, and their prevalence may be increased proportionally with increasing age. Signs and symptoms include pain, joint stiffness and loss of function. In this perspective, kinesio taping (KT) appears as an alternative therapeutic resource for the treatment of this type of patient. However, the current evidence on this technique is limited and conflicting, making its effects on the symptomatology of the disease still uncertain. Thus, the present study will evaluate the effects of KT application on muscle strength, pain, physical function, edema and quality of life of elderly women with knee OA. It will be a randomized, blind clinical trial in which 45 volunteers will be allocated to three groups: G1 (placebo group), G2 (control group) and G3 (intervention group). The G1 will be submitted to the placebo (no tension) application of KT on rectos femoris muscle and knee; the G2 will receive a protocol of a health education activity session lasting 60 minutes and finally the G3 will be submitted to the simultaneous application (with tension) of two KT techniques on rectos femoris muscle and knee. All groups will be evaluated before, immediately after and 72 hours after the application. To measure the variables, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Numerical Pain Rating Scale (NPRS), 6-minute walk test (6MWT), isometric dynamometer, perimetry and global rating of change. Statistical analysis will be done using SPSS® software (Statistical Package Social Science) version 20.0. The Kolmogorov-Smirnov and Levene tests will be applied to evaluate the normality and homogeneity of the data, respectively. Intra and intergroup comparisons will be evaluated using analysis of variance ANOVA of mixed model. In the presence of a significant F, the Benferroni pot-hoc test will be used to identify where the difference occurred. For all statistical analyzes, a significance level of 5% (p \<0.05) and 95% confidence interval (95% CI) will be adopted.


Options:
A: The Change in Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index (3 weeks)
B: Change in knee pain intensity from baseline at 4 weeks (4 weeks)
C: Pain (Baseline and 12-month follow-up)
D: Numerical Pain Rating Scale (NPRS) (Time 0 - baseline); Numerical Pain Rating Scale (NPRS) (Time 1 - after 10min of the baseline); Numerical Pain Rating Scale (NPRS) (Time 2 - after 72 hours of baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of BMS-986165 in Subjects With Moderate-to-Severe Plaque Psoriasis
Brief Summary: The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.


Options:
A: Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 (Week 12)
B: Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 (0-12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (0 - 12 Weeks)
C: The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1) (Week 16); The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75) (Baseline and Week 16)
D: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-center, Randomized, Controlled Clinical Study of the Effects of Modified and Traditional BII+Braun Digestive Tract Reconstruction Methods on Quality of Life After Radical Gastrectomy for Distal Gastric Cancer
Brief Summary: The jejunum of the input segment is properly ligated with double line 7 at 3-5cm from the anastomotic site, and the jejunum of the output segment is extended to 30cm


Options:
A: Effects of quality of life (The quality of life questionnaire was conducted at six months after surgery.)
B: the incidence of Roux stasis syndrome (3 month after surgery)
C: The time of reconstruction during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction (within 2 hours after surgery); change of potential of hydrogen ( pH) in remnant stomach (1-6 days after surgery); the amount of blood loss during operations of Uncut Roux-en-Y Reconstruction and Billroth II Reconstruction (within 2 hours after surgery)
D: the postoperative quality of life (QOL) (3 years after operation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter Randomized Trial of Personalized Acupuncture, Fixed Acupuncture, Letrozole and Placebo on Live Birth for Infertility in Women With Polycystic Ovary Syndrome
Brief Summary: This study is a randomized assessor-blind controlled trial. A total of 1,100 women with PCOS will be recruited from 28 hospitals and randomly allocated into four groups: personalized acupuncture, fixed acupuncture, letrozole or placebo letrozole. Patients will receive treatment for 16 weeks and the primary outcome is live birth.


Options:
A: Live birth rate (Up to 14 months)
B: Pregnancy rate (14 moths)
C: ongoing pregnancy (3 months)
D: Live Birth (as few as 5 months, up to 16 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Haloperidol to Decrease the Burden of Delirium in Adult Critically Ill Patients (EuRIDICE): a Prospective Randomised Multi-center Double-blind Placebo-controlled Clinical Trial
Brief Summary: The EuRIDICE trial will study whether haloperidol as a first line treatment for ICU delirium reduces delirium duration (and severity). Adverse outcomes typically associated with delirium will also be studied and include long term cognition, functional outcome and quality of life. Further, patient and family experiences and cost-effectiveness will be assessed. Finally, safety concerns associated with the use of haloperidol in this vulnerable population will be studied.


Options:
A: delirium- and coma-free days (within the first 14 days after randomisation)
B: Individual Physical Function and Mental Health domains from SF-36 (for participants who complete the phone surveys); 6-minute walk distance and memory evaluation (for participants who attend the study visits) (Measured at Months 6 and 12)
C: Ventilator-free hours (7 days following randomisation)
D: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Canine Assisted Therapy to Reduce Emergency Care Provider Stress
Brief Summary: The main study hypothesis is that emergency healthcare workers on shift who interact for 5 min with a therapy dog and handler will have lower perceived and manifested stress response compared with use of a time out that includes voluntary use of a coloring mandalas. The work will also address two exploratory hypotheses: The first is that salivary cortisol will correlate significantly with perceived stress and will increase from beginning to end of shift, and that exposure to a therapy dog will blunt this increase. The second exploratory hypothesis states that participants who interact with a therapy dog will display more empathic behaviors.


Options:
A: Level of psychological stress measured by psychometric questionnaires (PSM, PSS, COPE, PSQI, SWLS, STAI) (five weeks); quality of life questionnaire (5 weeks); psychophysiological measures (heart rate and heart rate variability indexes) (5 weeks)
B: Rate of participant recruitment (1 year); Rate of retention (1 year); Completeness of data entry (1 year); Cost of interventions (1 year); Unexpected costs (1 year)
C: Change in Connor-Davidson Resilience Scale (CD-RISC) scores (Administered prior to the intervention, and then at 12 and 24 weeks post-intervention); Change in Perceived Stress Scale (PSS) scores (Administered prior to the intervention, and then at 12 and 24 weeks post-intervention); Change in Generalized Anxiety Disorder-7 (GAD-7) scale scores (Administered prior to the intervention, and then at 12 and 24 weeks post-intervention); Change in Subjective Happiness Scale (SHS) scores (Administered prior to the intervention, and then at 12 and 24 weeks post-intervention)
D: Cortisol change (4 hours)

Answer: D