TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIb, Randomized, Placebo-Controlled, Dose-Finding Clinical Trial to Study the Safety and Efficacy of MK-8237 Using an Environmental Exposure Chamber in Subjects With House Dust Induced Allergic Rhinitis/Rhinoconjunctivitis
Brief Summary: The purpose of this study is to evaluate the dose-related effectiveness, the safety and the tolerability of MK-8237, compared to placebo, in the treatment of house dust mite (HDM)-induced allergic rhinitis/rhinoconjunctivitis in adults. The primary hypothesis is that administration of MK-8237, compared to placebo, results in dose-related improvement in the average total nasal symptom score (TNSS) determined during environmental exposure chamber (EEC) challenge.


Options:
A: Use of inhaled corticosteroid (ICS).
B: change in symptom score active versus placebo
C: Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24 (Week 24)
D: Number of Participants With Allergic Sensitization at Month 36 Status Post Treatment Completion (Three years (36 months) after Treatment Completion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIb, Randomized, Placebo-Controlled, Dose-Finding Clinical Trial to Study the Safety and Efficacy of MK-8237 Using an Environmental Exposure Chamber in Subjects With House Dust Induced Allergic Rhinitis/Rhinoconjunctivitis
Brief Summary: The purpose of this study is to evaluate the dose-related effectiveness, the safety and the tolerability of MK-8237, compared to placebo, in the treatment of house dust mite (HDM)-induced allergic rhinitis/rhinoconjunctivitis in adults. The primary hypothesis is that administration of MK-8237, compared to placebo, results in dose-related improvement in the average total nasal symptom score (TNSS) determined during environmental exposure chamber (EEC) challenge.


Options:
A: Average Adjusted Symptom Score (Year 2 of treatment)
B: Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment (Last 8 weeks of treatment (Weeks 44 to 52)); Number of Participants Who Experience At Least One Adverse Event (AE) (Up to 54 weeks); Number of Participants Who Discontinue Study Drug Due to an AE (Up to 52 weeks)
C: Average Total Nasal Symptom Score (TNSS) During Environmental Exposure Chamber (EEC) Challenge Session at Week 24 (Week 24)
D: Total Combined Score (TCS) During the Peak Ragweed Season (RS) (The 15-day period during the ragweed season with the highest moving pollen average)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: MITO-11: A Randomized Multicentre Phase II Trial With Pazopanib and Weekly Paclitaxel vs Weekly Paclitaxel in Platinum Resistant or Refractory Ovarian Cancer
Brief Summary: The purpose of this study is to evaluate the safety and activity of adding pazopanib to weekly chemotherapy with paclitaxel for patients with ovarian cancer that is resistant or refractory to treatment with platinum based therapy.


Options:
A: Peritoneal adhesion ORR (pORR) (3weeks after the last treatment)
B: progression free survival (6 months from randomization)
C: Progression free survival (From date of first treatment until date of verified progression or death. 12 months of follow-up)
D: PFS Rate at 36 Weeks (After 9 Months) (36 weeks (after 9 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: MITO-11: A Randomized Multicentre Phase II Trial With Pazopanib and Weekly Paclitaxel vs Weekly Paclitaxel in Platinum Resistant or Refractory Ovarian Cancer
Brief Summary: The purpose of this study is to evaluate the safety and activity of adding pazopanib to weekly chemotherapy with paclitaxel for patients with ovarian cancer that is resistant or refractory to treatment with platinum based therapy.


Options:
A: Progression-Free Survival (The timeframe is from enrollment onto the study up to 3 years following enrollment.)
B: progression free survival (6 months from randomization)
C: Overall survival (After follow-up is complete (year 3-4 of the trial))
D: Progression-Free Survival (8 Months on average)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: MITO-11: A Randomized Multicentre Phase II Trial With Pazopanib and Weekly Paclitaxel vs Weekly Paclitaxel in Platinum Resistant or Refractory Ovarian Cancer
Brief Summary: The purpose of this study is to evaluate the safety and activity of adding pazopanib to weekly chemotherapy with paclitaxel for patients with ovarian cancer that is resistant or refractory to treatment with platinum based therapy.


Options:
A: N/A
B: progression free survival (6 months from randomization)
C: Progression-Free Survival (PFS) Comparison (2 Years)
D: Progression-free Survival (PFS), Based on Radiological or Pathologic Assessment (From randomization of the first patient until 32.5 months later, assessed every 8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke to Increase Upper Limb Motor Recovery, a Randomised, Controlled, Double-blind Study
Brief Summary: Rehabilitation after stroke improves motor functions by promoting plastic changes however, after completing standard rehabilitation, 50-60% of patients still exhibit some degree of motor impairment and require at least partial assistance in activities of day living. Therefore, the exploration of other approaches to promote recovery is compulsory. Non invasive brain stimulation and motor rehabilitation are thought to share similar mechanisms in inducing neuroplastic changes in the human cortex and an emerging field of research is focusing on the possibility of coupling both therapies in order to achieve an additive effect and improve outcome.

We hypothesize that coupling bihemispheric transcranial direct current stimulation (tDCS) with simultaneous physical/occupational therapy in the subacute phase of ischemic stroke patients may improve upper limb motor recovery in humans.

This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial. Thirty-six ischemic stroke patients in the subacute phase will be recruited in three centers of neurorehabilitation in Switzerland. After stratification based on the Fugl-Meyer Assessment Upper Extremity according to the severity of the deficit, the patient will be randomized to receive besides standardized physical/occupational treatment according to the Impairment-Oriented Training, tDCS of themotor cortex (1.5 mA, 30 minutes) (group 1: 12 patients) or sham stimulation (without current) (group 2: 12 patients). After three weeks of treatment group 1 and 2 will cross-over and will be treated for other three weeks. Group 3 (12 patients) will receive routine physical/occupational treatment and sham tDCS for six weeks. Assessment will be performed before starting tDCS, at week 3, 6 and at 6 months. Outcome measures are the Fugl-Meyer Assessment Upper Extremity, the extended Barthel Index, the Ashworth scale, the Test of Upper Limb Apraxia (only baseline, week 6, month6), the grip strength evaluated by the Jamar Hydraulic Hand dynamometer. At baseline at week 6 and at month 6 depression will be assessed by the Hamilton depression Rating Scale.


Options:
A: Change in the Reintegration to Normal Living Index (RNL) from baseline (baseline, 12 weeks, 24 weeks)
B: Change in Extended Barthel Index (EBI) between admission and discharge (Data were collected before randomisation (T0), after 15 days (T1) and at discharge / 30 days (T2))
C: Fugl-Meyer Assessment Upper Extremity (6 weeks)
D: Change in Fugl-Meyer assessment of paretic upper limb motor function (baseline, after sessions, 30 and 90 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke to Increase Upper Limb Motor Recovery, a Randomised, Controlled, Double-blind Study
Brief Summary: Rehabilitation after stroke improves motor functions by promoting plastic changes however, after completing standard rehabilitation, 50-60% of patients still exhibit some degree of motor impairment and require at least partial assistance in activities of day living. Therefore, the exploration of other approaches to promote recovery is compulsory. Non invasive brain stimulation and motor rehabilitation are thought to share similar mechanisms in inducing neuroplastic changes in the human cortex and an emerging field of research is focusing on the possibility of coupling both therapies in order to achieve an additive effect and improve outcome.

We hypothesize that coupling bihemispheric transcranial direct current stimulation (tDCS) with simultaneous physical/occupational therapy in the subacute phase of ischemic stroke patients may improve upper limb motor recovery in humans.

This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial. Thirty-six ischemic stroke patients in the subacute phase will be recruited in three centers of neurorehabilitation in Switzerland. After stratification based on the Fugl-Meyer Assessment Upper Extremity according to the severity of the deficit, the patient will be randomized to receive besides standardized physical/occupational treatment according to the Impairment-Oriented Training, tDCS of themotor cortex (1.5 mA, 30 minutes) (group 1: 12 patients) or sham stimulation (without current) (group 2: 12 patients). After three weeks of treatment group 1 and 2 will cross-over and will be treated for other three weeks. Group 3 (12 patients) will receive routine physical/occupational treatment and sham tDCS for six weeks. Assessment will be performed before starting tDCS, at week 3, 6 and at 6 months. Outcome measures are the Fugl-Meyer Assessment Upper Extremity, the extended Barthel Index, the Ashworth scale, the Test of Upper Limb Apraxia (only baseline, week 6, month6), the grip strength evaluated by the Jamar Hydraulic Hand dynamometer. At baseline at week 6 and at month 6 depression will be assessed by the Hamilton depression Rating Scale.


Options:
A: maximum voluntary isometric strength of knee extensors (2 hours)
B: JTT (crossover design, four different sessions with four different interventions)
C: Behavioural Inattention Test (BIT) (Assessed at the recruitment interview (week 0) and at the exit interview (8 weeks after the intervention)); Neglect Test Battery (Assessed at 2 separate pre-intervention baseline sessions at least 1 week apart. Re-assessed following the intervention at intervals of 1, 2, 4 and 8 weeks.)
D: Fugl-Meyer Assessment Upper Extremity (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Physical Activity in Pediatric Cancer Patients With Solid Tumor Trial
Brief Summary: The aim of this randomized controlled trial on Physical Activity and Pediatric Cancer (PAPEC) is to assess the impact of an exercise program intervention in pediatric cancer patients undergoing chemotherapy for solid tumors. The investigators hypothesized the intervention will have a beneficial effect on the study outcomes.


Options:
A: feasibility of isometric exercise in vertebral bony metastases (12 weeks post completion of radiotherapy)
B: Muscle strength (kg) measured in 5-repetition maximum (5RM) leg and bench press and lateral row exercise tests (up to 3 years)
C: Accelerometer, average counts of dynamic acceleration (physical activity) (1 week at baseline and at 12 months)
D: Hematological and Immunological Recovery (This assessments will be performed at baseline, 7, 14, 28, 56, 84 and 180 days after stem cell transplantation (SCT))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Phone Technology for Prevention of Mother-to-Child Transmission of HIV: Acceptability, Effectiveness, and Cost
Brief Summary: Although gains have been made in achieving the health-related Millennium Development Goals (MDG), much is still needed in countries affected by high levels of HIV/AIDS. Prevention of mother-to-child transmission (PMTCT) is a cornerstone strategy in reducing infant mortality from HIV. The study will employ a cluster randomized control trial (cRCT) with 26 health facilities randomized to two arms (intervention or control) to determine the effect of mobile phone technology on completion of key PMTCT milestones from antenatal to six weeks postpartum. The study will examine the acceptability, effectiveness, and cost of implementing a PMTCT-focused mHealth strategy among HIV-infected pregnant women, health workers, and male partners.


Options:
A: Difference in Number and proportion of adults responding to standard appointment versus intense follow up. (2 weeks)
B: Immunization Rate (12 months)
C: Adherence to ART and HIV RNA suppression (6,12 months)
D: The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum. (~ 6 months); Initiation of Infant prophylaxis, Facility delivery and receipt of results of 6 weeks early infant diagnosis by DNA PCR (~ 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Phone Technology for Prevention of Mother-to-Child Transmission of HIV: Acceptability, Effectiveness, and Cost
Brief Summary: Although gains have been made in achieving the health-related Millennium Development Goals (MDG), much is still needed in countries affected by high levels of HIV/AIDS. Prevention of mother-to-child transmission (PMTCT) is a cornerstone strategy in reducing infant mortality from HIV. The study will employ a cluster randomized control trial (cRCT) with 26 health facilities randomized to two arms (intervention or control) to determine the effect of mobile phone technology on completion of key PMTCT milestones from antenatal to six weeks postpartum. The study will examine the acceptability, effectiveness, and cost of implementing a PMTCT-focused mHealth strategy among HIV-infected pregnant women, health workers, and male partners.


Options:
A: Immunization Rate (12 months)
B: HIV-1 Viral Load (log10 Transformed) (Past 90 days); Self-reported Medication Adherence (Past 30 days)
C: On-time Completion of the Human Papillomavirus Vaccine Series (32 weeks after receipt of initial vaccine)
D: The proportion of women who successfully complete key PMTCT transition points from antenatal to six weeks postpartum. (~ 6 months); Initiation of Infant prophylaxis, Facility delivery and receipt of results of 6 weeks early infant diagnosis by DNA PCR (~ 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Novel Dietary Supplement on Visual Function in Patients With Diabetes With and Without Early Diabetic Retinopathy
Brief Summary: This study will evaluate the effects of a novel multi-component dietary supplement on the visual function and retinal structure of patients with diabetes with both no diabetic retinopathy and mild to moderate diabetic retinopathy. This is a placebo-controlled trial and neither subjects nor examiners will know if any given subject is taking active supplement or placebo.

The hypothesis is that the supplement will improve visual function and retinal structure in subjects on active supplement


Options:
A: Differences detected on the time evolution of BP both in two arms of intervention (5 weeks)
B: Summed ADHD score of the ADHD-Rating Scale as rated by teachers (10 weeks)
C: Change in Endothelial Function Between the Visit at Start of Supplementation Phase and the Visit on the Final Day of the 4 Week Supplementation Phase (Delta "lnRHI") (Intervention period of 4 weeks)
D: Changes in visual function (At baseline and again at six months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet-Based Sun Protection Program for Kidney Transplantation Recipients
Brief Summary: This study is being done to evaluate the effectiveness of a Sun Protection Strategies internet-based program for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at increased risk of developing a sunburn as well a skin cancer, the program will help people learn how to practice effective sun protection for their condition.


Options:
A: Use of sun protection (6 weeks)
B: self-reported status of the series of HBV vaccinations by follow-up calls in seven months after mailing the results verified by the medical records (Seven months after mailing the results)
C: Colorectal cancer screening completion (6 months)
D: Body weight (4 months); Physical activity (4 months); Caloric intake (4 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet-Based Sun Protection Program for Kidney Transplantation Recipients
Brief Summary: This study is being done to evaluate the effectiveness of a Sun Protection Strategies internet-based program for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at increased risk of developing a sunburn as well a skin cancer, the program will help people learn how to practice effective sun protection for their condition.


Options:
A: Consent to psychological screen rate using self-report measures of depression (PHQ-9) and anxiety (GAD-7) (Baseline recruitment/screening)
B: Taking Adherence (12 months); Timing Adherence (12 months)
C: Use of sun protection (6 weeks)
D: medication adherence (5 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet-Based Sun Protection Program for Kidney Transplantation Recipients
Brief Summary: This study is being done to evaluate the effectiveness of a Sun Protection Strategies internet-based program for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at increased risk of developing a sunburn as well a skin cancer, the program will help people learn how to practice effective sun protection for their condition.


Options:
A: Physical activity CHAMPS (Baseline, 3 and 6 months); Glycemic control - HbA1c (Baseline, 3 and 6 months); Dietary adherence (Baseline, 3 and 6 months)
B: Change in Medication Knowledge Score from baseline to 3 months (Baseline and 3 months)
C: Use of sun protection (6 weeks)
D: Deceased Donor Kidney Transplant (DDKT) and Living Donor Kidney Transplant (DDKT) Knowledge (9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate to Severe Plaque Psoriasis With a Long-Term Extension Period
Brief Summary: This study will assess the safety and efficacy of ixekizumab (LY2439821), compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.


Options:
A: Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 (Week 12, as compared to Week 0 (baseline))
B: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)
C: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)
D: Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT (112 and 140 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate to Severe Plaque Psoriasis With a Long-Term Extension Period
Brief Summary: This study will assess the safety and efficacy of ixekizumab (LY2439821), compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.


Options:
A: Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Baseline and 12 weeks)
B: Percentage of Participants With a Static Physician Global Assessment (sPGA) of (0,1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA]) (Week 12); Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) ≥75% (PASI75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI]) (Week 12)
C: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)
D: Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 (Week 16); Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response at Week 16 (Week 16)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate to Severe Plaque Psoriasis With a Long-Term Extension Period
Brief Summary: This study will assess the safety and efficacy of ixekizumab (LY2439821), compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.


Options:
A: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)
B: Proportion of subjects with clinical response relative to Baseline PASI score (Week 12, Week 40 and Week 60)
C: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Week 12); Percentage of PASI Improvement From Baseline to 12 Week Endpoint (Baseline to Week 12)
D: Number of Participants Who Achieved Pain Assessment Severity Index (PASI) 90 at Week 52. (Baseline, Week 52)

Answer: A