TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized ActiveStep Comparative Effectiveness Trial
Brief Summary: The investigators are conducting a multi-center randomized prospective trial comparing a standard physical therapy gait and balance program with a gait and balance program that includes the ActiveStep™ treadmill.

Subjects will be randomized to either have the ActiveStep™ as part of their therapy or to have their therapy without it. Data will be gathered from session notes, medical records and short interviews with the subjects at baseline and every 3 months over the telephone for the duration of the study.


Options:
A: Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise (9 to 26 weeks)
B: Change From Baseline in Mean Total Daily OFF Time Using Parkinson's Disease Patient Diary (Baseline and Weeks 4, 8, 12, and 16)
C: Unified Parkinson's Disease Rating Scale (UPDRS) Part III (30 minutes post-dose at week 12)
D: Number of Subjects Reporting Any Fall (3 months); Number of Subjects Reporting a Fall-related Injury (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized ActiveStep Comparative Effectiveness Trial
Brief Summary: The investigators are conducting a multi-center randomized prospective trial comparing a standard physical therapy gait and balance program with a gait and balance program that includes the ActiveStep™ treadmill.

Subjects will be randomized to either have the ActiveStep™ as part of their therapy or to have their therapy without it. Data will be gathered from session notes, medical records and short interviews with the subjects at baseline and every 3 months over the telephone for the duration of the study.


Options:
A: Falls rate (6 months post intervention)
B: Reduction of frailty (12 months); Frailty score (continuous variable) (12 months); Measures of frailty components (BMI, fast gait speed test, knee extension, exhaustion score and time spent on physical activities per day). (12 months)
C: The number of fallers who have fallen at least once during the 9-month study period (9 months)
D: Number of Subjects Reporting Any Fall (3 months); Number of Subjects Reporting a Fall-related Injury (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: BRIM 3: A Randomized, Open-Label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma With V600E BRAF Mutation Receiving Vemurafenib (RO5185426) or Dacarbazine
Brief Summary: This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.


Options:
A: 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.)
B: 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)
C: Progression-free Survival (PFS) as Assessed by the Investigator (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)); Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase (Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months))
D: Recurrence-free Survival (RFS) (Up to ~32.7 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: BRIM 3: A Randomized, Open-Label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma With V600E BRAF Mutation Receiving Vemurafenib (RO5185426) or Dacarbazine
Brief Summary: This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.


Options:
A: Overall Survival (OS) (Date of randomization to 37 months through 5-year follow-up and up to approximately 76 months)
B: Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants (From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months))
C: Recurrence-free Survival (RFS) (up to 36 months)
D: 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.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: BRIM 3: A Randomized, Open-Label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma With V600E BRAF Mutation Receiving Vemurafenib (RO5185426) or Dacarbazine
Brief Summary: This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.


Options:
A: Comparison between one stop shop using reflectance confocal microscopy in the surgical treatment of BCC and current standard of care using punch biopsy, by assessing incomplete surgical excision on the final pathology report. (Within the first week after surgical excision of suspected BCC lesion)
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: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))
D: Frequency of BRAF Mutations Among Nevi (up to 30 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: BRIM 3: A Randomized, Open-Label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma With V600E BRAF Mutation Receiving Vemurafenib (RO5185426) or Dacarbazine
Brief Summary: This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.


Options:
A: Progression-free Survival (Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months))
B: Best Overall Response (BOR) Assessed by an Independent Review Committee Using Response Evaluation Criteria In Solid Tumors (RECIST 1.1) (From first treatment through September 27, 2010)
C: 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.)
D: Major Pathologic Response (MPR) (54 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: BRIM 3: A Randomized, Open-Label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma With V600E BRAF Mutation Receiving Vemurafenib (RO5185426) or Dacarbazine
Brief Summary: This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.


Options:
A: Overall survival (Evaluated at regular intervals: every 3 months for 2 years, every 6 months up to 5 years and yearly up to 10 years following randomization. Actual median follow-up is 72.4 months)
B: distant-metastasis free-survival (DMFS) (from randomization)
C: To determine whether wide excision of the primary with intraoperative lymphatic mapping (LM) followed by selective lymphadenectomy will effectively prolong overall survival compared to wide excision of the primary melanoma alone. (10 years)
D: 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.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Docosahexaenoic Acid (DHA) on Fetal Cardiac Outcomes
Brief Summary: DHA, a type of fatty acid, is important in early development, both in terms of reproductive physiology of gestation and in postnatal behavioral and cognitive function. In adults, DHA has been shown to lower triglycerides and is important to cardiovascular health and autonomic control, lowering heart rate and blood pressure and increasing heart variability. Little is known about how fatty acids impact cardiac control in infants, children or the fetus. Our hypothesis is that maternal DHA supplementation (600 mg/day) will lower fetal HR and increase fetal HRV.


Options:
A: Insulin sensitivity (Measured at approximately Month 3)
B: N/A
C: Heart Rate (24, 32 and 36 weeks gestational age)
D: Change of Visual Development of newborn (Change from Baseline at 12 months of life)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: TDCS-enhanced Stroke Recovery and Cortical Reorganization
Brief Summary: The purpose is to determine whether application of a non-invasive battery powered device called transcranial direct current stimulation (tDCS) can improve recovery of hand weakness after stroke beyond what is achievable with rehabilitative treatment alone.


Options:
A: Motor Assessment Scale (18 months after inclusion)
B: Upper Extremity Fugl-Meyer (2 weeks); Upper Extremity Fugl-Meyer (3 months); Upper Extremity Fugl-Meyer (1 year after stroke)
C: Korean-Montreal Cognitive Assessment (K-MoCA) (Change of K-MoCa after intensive cognitive rehabilitation for 4 weeks)
D: Jebsen Taylor Hand Function Test (2 weeks); Cortical Excitability (1 hour); Cortical Oscillations - EEG (15 minutes)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: TDCS-enhanced Stroke Recovery and Cortical Reorganization
Brief Summary: The purpose is to determine whether application of a non-invasive battery powered device called transcranial direct current stimulation (tDCS) can improve recovery of hand weakness after stroke beyond what is achievable with rehabilitative treatment alone.


Options:
A: Change in Upper Limb function (Baseline and posttest (an average of 2 weeks from baseline))
B: Upper Extremity Fugl-Meyer (2 weeks); Upper Extremity Fugl-Meyer (3 months); Upper Extremity Fugl-Meyer (1 year after stroke)
C: maximum voluntary isometric strength of knee extensors (2 hours)
D: Trunk Impairment Scale (reporting a change on trunk performance at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Rivermead Motor Assessment Battery (RMAB) (reporting a change on motricity of gross function, arm, leg and trunk at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months); Tinetti Test (reporting a change on balance and gait tasks at baseline, after 1 month and after two months) (baseline, after 1 month, After 2 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-week Treatment, Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel-group Study to Assess the Effect of Omalizumab on the Expression of FcεRI Receptors of Blood Basophils and Dendritic Cells in Patients With Severe Persistent Non-atopic Asthma, Uncontrolled Despite Optimal Therapy
Brief Summary: This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.


Options:
A: Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment (Day 1 to Week 52)
B: Mean Change From Baseline (BL) in St. George's Respiratory Questionnaire (SGRQ) Score at Week 24 (Baseline and Week 24)
C: 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)
D: Change From Baseline in Prebronchodilator Clinic-Measured, Percent-Predicted Forced Expiratory Volume in 1 Second (Baseline and Week 24); Number of Severe Asthma Exacerbations Per Patient From Baseline Through 6 Months (Baseline to Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-week Treatment, Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel-group Study to Assess the Effect of Omalizumab on the Expression of FcεRI Receptors of Blood Basophils and Dendritic Cells in Patients With Severe Persistent Non-atopic Asthma, Uncontrolled Despite Optimal Therapy
Brief Summary: This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.


Options:
A: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL (Immediately following the first administration of study drug through Study Week 48.)
B: Number of Clinically Significant Exacerbations of Asthma Per Year (From randomization (Week 0) to Week 52 or early withdrawal (EW))
C: Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants (Week 1 up to Week 52)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 16-week Treatment, Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel-group Study to Assess the Effect of Omalizumab on the Expression of FcεRI Receptors of Blood Basophils and Dendritic Cells in Patients With Severe Persistent Non-atopic Asthma, Uncontrolled Despite Optimal Therapy
Brief Summary: This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.


Options:
A: 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)
B: Safety and tolerability in healthy volunteers.Assessed using clinical safety assessments and blood and urine analysis (Throughout the study); Safety and tolerability in mild asthmatics.Assessed using clinical safety assessments and blood and urine analysis. (Throughout the study)
C: Incidence of Adverse Events (Days 0 - 150); Incidence of Serious Adverse Events (Days 0 - 150)
D: Change in forced expiratory volume in 1 second (FEV1) (From baseline to Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Specified Work Site Physical Activity Intervention on Musculoskeletal Disorders Among Employees With Physical Heavy Work
Brief Summary: The purpose of this study is to evaluate the effect of specified worksite physical-activity interventions on musculoskeletal disorders in an industry with physical heavy workload.


Options:
A: muscle strength (3 months); Aerobic capacity (3 months)
B: Change in employer practices in health benefits, policies and programs (15 month follow-up survey)
C: Change in Body Mass Index (BMI) (Baseline to 24 months)
D: Aerobic fitness (before and after the 10 week intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis.


Options:
A: complete cure of the target nail (outcome measured after 1 year)
B: Variation of the percentage of healthy surface after 30, 60, 120, and 180 days between both treatments, and versus baseline. Evaluation is done by digital analysis of photographs of the great, infected toenail (After 30, 60, 120 and 180 days of treatment)
C: Percentage of patients who achieve clinical cure (52 weeks)
D: Percentage of patients who achieve clinical cure (52 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis.


Options:
A: Variation of the percentage of healthy surface after 30, 60, 120, and 180 days between both treatments, and versus baseline. Evaluation is done by digital analysis of photographs of the great, infected toenail (After 30, 60, 120 and 180 days of treatment)
B: complete cure of the target nail (outcome measured after 1 year)
C: Percentage of patients who achieve clinical cure (52 weeks)
D: Percentage of patients who achieve clinical cure (52 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Randomized, Controlled, Multicenter, Phase I/II Trial Investigating 2 EMD 525797 Doses in Combination With Cetuximab and Irinotecan Versus Cetuximab and Irinotecan Alone, as Second-line Treatment for Subjects With K-ras Wild Type Metastatic Colorectal Cancer (mCRC)
Brief Summary: The purpose of this study is to assess the safety and clinical activity of the experimental drug EMD 525797 (study drug), a monoclonal antibody targeting alfa integrins, in combination with irinotecan and cetuximab in K-ras wildtype metastatic colorectal cancer patients.


Options:
A: Overall survival (Assessed until 1.5 years after the last patient enrolment)
B: To estimate the treatment effect as measured by progression free survival (PFS) in subjects treated with AMG 386 + FOLFIRI relative to subjects treated with FOLFIRI + placebo. (The time frame will be event driven and will occur when 100 subjects have experienced a PFS event (radiographic disease progression or death).)
C: Overall survival (study duration)
D: Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity) (Time from the first dose of study drug up to 2 weeks); Randomized Part: Progression Free Survival (PFS) (Time from randomization until progressive disease or death; assessed up to 18 months (i.e data cut-off date: 09 Oct 2013))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Is Antibiotic Therapy Mandatory for Treatment of Uncomplicated Acute Colonic Diverticulitis: a Randomized Clinical Trial
Brief Summary: The purpose of this study is to evaluate if antibiotic therapy is necessary for treatment of uncomplicated colonic diverticulitis.

The hypothesis is that Patients with acute uncomplicated colonic diverticulitis will recover the condition without antibiotic therapy and the lack of antibiotic therapy will not lead to complications.

The patients will be randomized to conservative treatment with and without antibiotic therapy.


Options:
A: Global Symptom Score (GSS) at Week 12, Primary Efficacy Population (12 Weeks)
B: Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon (one year)
C: diverticulitis relapse (24 months)
D: discharge without complications +/- antibiotic therapy (Within 30 days after discharge)

Answer: D