TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double Blinded, Multi-Center Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Sorafenib in Combination With AMG 386 or Placebo In Subjects With Metastatic Clear Cell Carcinoma of the Kidney
Brief Summary: This is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in progression free survival (PFS) and evaluate the safety and tolerability of AMG 386 in combination with sorafenib in the treatment of subjects with advanced clear cell carcinoma of the kidney.


Options:
A: Objective Response Rate (ORR) - Percentage of Participants With Objective Response (Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.)
B: Progression Free Survival (2 3/4 years)
C: Percentage Change From Baseline in Tumour Size at 12 Weeks (Baseline to Week 12)
D: Progressive Free Survival (PFS) in Patients Who Receive RAD001 Plus Best Supportive Care(BSC) Versus Patients Who Receive Matching Placebo Plus BSC (Time from randomization to dates of disease progression, death from any cause or last tumor assessment reported between date of first patient randomized until 28Feb2008 cut of date.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Aspirin in Gestation and Reproduction: A Multi-center, Controlled, Double-blind Randomized Trial.
Brief Summary: The primary objective of the study is to help elucidate the effects of low-dose aspirin in combination with folic acid on the incidence of live births and spontaneous abortions among a group of women who become pregnant compared to a control group.


Options:
A: Prevention of preeclampsia (6 months)
B: Live Birth (after delivery)
C: Preeclampsia - Change in blood pressure (Hypertension) (From 20 weeks gestation to delivery); Preeclampsia - Change in Proteinuria (From 20 weeks gestation to birth); Birth weight (weight will be measured on the day of birth and plotted on standard WHO UK RCPCH growth charts (per gender).); Preterm birth (Gestational age at birth will be verified with respect to the Estimated Date of Delivery calculated at the first study visit.); Perinatal mortality (Stillbirth or neonatal death after 24 completed weeks of gestation and within 28 days of birth.)
D: Incidence of Preterm Birth (At delivery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Aspirin in Gestation and Reproduction: A Multi-center, Controlled, Double-blind Randomized Trial.
Brief Summary: The primary objective of the study is to help elucidate the effects of low-dose aspirin in combination with folic acid on the incidence of live births and spontaneous abortions among a group of women who become pregnant compared to a control group.


Options:
A: Live Birth (after delivery)
B: ongoing intact pregnancy at 24 weeks of gestation (at 24 weeks of gestation)
C: Pregnancy continuation beyond twelve weeks gestation (ONE YEAR)
D: Number of Successful Pregnancies Defined as an Ongoing Pregnancy Over 20 Weeks Gestation, Per Number of Index Pregnancies (20 weeks gestation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Aspirin in Gestation and Reproduction: A Multi-center, Controlled, Double-blind Randomized Trial.
Brief Summary: The primary objective of the study is to help elucidate the effects of low-dose aspirin in combination with folic acid on the incidence of live births and spontaneous abortions among a group of women who become pregnant compared to a control group.


Options:
A: Feasibility of Recruitment and Trial Operations. (4 months)
B: To investigate whether treatment with LMW heparin plus ASA results in an increased rate of livebirths compared to treatment with ASA alone. (Duration of pregnancy)
C: Successful pregnancy outcome
D: Live Birth (after delivery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Aspirin in Gestation and Reproduction: A Multi-center, Controlled, Double-blind Randomized Trial.
Brief Summary: The primary objective of the study is to help elucidate the effects of low-dose aspirin in combination with folic acid on the incidence of live births and spontaneous abortions among a group of women who become pregnant compared to a control group.


Options:
A: pregnancy loss (during first 20 weeks of gregnancy)
B: Live Birth (after delivery)
C: Study Feasibility: Mean Recruitment Rate Per Center Per Month (24 months)
D: Successful pregnancy outcome

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Aspirin in Gestation and Reproduction: A Multi-center, Controlled, Double-blind Randomized Trial.
Brief Summary: The primary objective of the study is to help elucidate the effects of low-dose aspirin in combination with folic acid on the incidence of live births and spontaneous abortions among a group of women who become pregnant compared to a control group.


Options:
A: Study Feasibility: Mean Recruitment Rate Per Center Per Month (24 months)
B: Successful pregnancy outcome
C: Live Birth (after delivery)
D: Pregnancy outcome: livebirths (>37 weeks of gestation), premature livebirths (> 24, but <37 weeks of gestation) (gestational weeks >37 and gestational weeks > 24, but <37)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Continuous Glucose Monitoring With and Without Real Time Access to Glucose Values and Glucose Alerts on Course of Glucose and Satisfaction With CGMS in Type 1 Diabetic Patients
Brief Summary: The objective of this cross over study is to access if continuous glucose monitoring (CGMS) with a real time feed back and hypoglycemic as well as hyperglycemic glucose alerts vs. only retrospective analysis of glucose values is able to improve course of glucose with special regard to time spent in hypoglycemic glucose ranges in type 1 diabetic patients with impaired hypoglycemia awareness or a history of severe hypoglycemia. The second objective is to access satisfaction with CGMS during both conditions


Options:
A: Difference in HbA1C From Baseline and 6 Months (Baseline and 6 months)
B: Clinical effectiveness: percentage of time spent in euglycaemia (3-6 days)
C: Daily time spent in the hypoglycemic glucose range during continuous glucose measurement with and without real time access to glucose values and glucose alarms (during the 48 hours of using blind vs. unblind continuous glucose monitoring)
D: Change in A1c From Baseline to 52 Weeks (Baseline and 52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Fortified Products on Improving Long Term Cognitive Performance in School Children in India
Brief Summary: Nutritional deficiencies are a major problem in school children in India and have a variety of adverse effects on their cognitive development and growth, and increase susceptibility to infections. There is strong evidence for beneficial effects of iodine, iron and protein-energy on cognitive development in children, while evidence for vitamin B6, vitamin B12, folate, zinc and, omega-3 fatty acids and in particular docosahexanoic acid (DHA) is limited and inconclusive. A randomised, double-blind, placebo-controlled 2x2 factorial design will be conducted to assess the effect of a micronutrient with or without omega-3 fatty acids on cognitive development and performance and other selected outcome variables such as growth, morbidity and immune response in children of 7-9 years of age in India.


Options:
A: Cognitive development and performance (1 year)
B: Anthropometry (6 months); Micronutrient status (6 months); Cognition (6 months); absentism (6 months); morbidity (6 months)
C: Diarrhea; Pneumonia; Febrile illness; Growth; Development; Activity
D: Mean birth weight (9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children
Brief Summary: Hypothesis: (1) Aripiprazole treatment will be superior to placebo in reducing aggression and irritability in autistic individuals as shown by reductions in the Aberrant Behavior Checklist-irritability subscale.

(2) Aripiprazole treatment will be superior to placebo in the acute treatment of global autism severity.

The purpose of this study is to examine the possible benefit of the medication Aripiprazole in autistic individuals.


Options:
A: Clinical Global Improvement (Week 12)
B: Home Situations Questionnaire (Week 24); Vineland Daily Living Skills Scale (Week 24)
C: Extent of Absorption of Memantine (Part One) (Baseline to 144 hours. Measurements were taken 0 (predose), 4, 8, 24, 30, 48, 96 and 144 hours post-dose); Change in Total Raw Score of Social Responsiveness Scale (From Baseline to Week 12)
D: Clinical Global Impression Improvement (CGI-AD) (Administered weekly, initial and week 8 reported)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children
Brief Summary: Hypothesis: (1) Aripiprazole treatment will be superior to placebo in reducing aggression and irritability in autistic individuals as shown by reductions in the Aberrant Behavior Checklist-irritability subscale.

(2) Aripiprazole treatment will be superior to placebo in the acute treatment of global autism severity.

The purpose of this study is to examine the possible benefit of the medication Aripiprazole in autistic individuals.


Options:
A: Clinical Global Impression-Improvement Scale (CGI-I) (Baseline to 12 weeks)
B: Percentage of Patients Relapsing by Week 16 (From end of Phase 1 (Date of randomization) to Week 16 of Phase 2 and end of treatment)
C: Change in Aberrant Behavior Checklist Irritability (ABC-I) Subscale (Baseline and 6 weeks)
D: Clinical Global Impression Improvement (CGI-AD) (Administered weekly, initial and week 8 reported)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall
Brief Summary: The purpose of this pilot study is to compare Adderall ® and Adderall XR ® in terms of their effectiveness and side effects for the treatment of ADHD in adults.


Options:
A: Percent of Treatment Failures at up to 6 Weeks (Up to 6 weeks)
B: Clinician-administered ADHD-rating scale (ADHD-RS) performed using adult DSM-IV prompts (weekly over a period of 4 weeks)
C: Medication Event Monitoring System (MEMS®) Dosage Adherence (The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)); Medication Event Monitoring System (MEMS®) Regimen Adherence (The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks)); Medication Event Monitoring System (MEMS®) Time Adherence (The MEMS information was noted at clinic visit 3, 4, 5, 7, 8, and 9 (over 8 weeks))
D: Change From Baseline in Subject-reported Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at up to 10 Weeks (Baseline and up to 10 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies
Brief Summary: This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.


Options:
A: remission without corticosteroids and without surgical resection (month 6 and 12 after inclusion)
B: Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response (Baseline to the end of the retreatment period (up to 7 years, 6 months))
C: ASAS 40 at week 12
D: Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20). (Week 12); Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score (Week 104)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies
Brief Summary: This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.


Options:
A: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)
B: Percentage of Patients Developing a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the First Course of Rituximab Treatment (From first treatment with rituximab (Day 1) through Week 24)
C: Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20) (Week 48)
D: Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response (Baseline to the end of the retreatment period (up to 7 years, 6 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized Trial of Transcervical Foley Catheter With or Without Oxytocin for Preinduction Cervical Ripening
Brief Summary: The transcervical Foley catheter (TFC) is a proven and effective mode of cervical ripening. It is common practice to use TFC with simultaneous low-dose oxytocin under the assumption that the combination results in a more successful labor induction. Scientific validation of this practice is lacking. We seek to determine if the addition of oxytocin to TFC improves induction success.


Options:
A: induction time to delivery (Time from induction to delivery, average 12-28 hours)
B: Delivery rate (proportion) (Within 24 hours)
C: Delivery Rate (Within 24 hours)
D: Time from the start of labor induction to delivery

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized Trial of Transcervical Foley Catheter With or Without Oxytocin for Preinduction Cervical Ripening
Brief Summary: The transcervical Foley catheter (TFC) is a proven and effective mode of cervical ripening. It is common practice to use TFC with simultaneous low-dose oxytocin under the assumption that the combination results in a more successful labor induction. Scientific validation of this practice is lacking. We seek to determine if the addition of oxytocin to TFC improves induction success.


Options:
A: Caesarean section rate for non-reassuring fetal status. (Up to 2 days after cervical ripening)
B: Time to Delivery (an average of 20 hours, up to 40 hours)
C: Delivery rate (proportion) (Within 24 hours)
D: To evaluate and compare the efficacy of the Atad Ripening Device (ARD), of the double balloon instillation device (AID) with concomitant continuous extra-amniotic NS instillation - 50 Ml/hour and of the folly catheter combined with continuous extra-a (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies
Brief Summary: This study will assess the safety and efficacy of rituximab combined with MTX in participants with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 participants. Eligible participants may receive re-treatment with rituximab under a separate protocol WA17531.


Options:
A: Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 16 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 16); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 8 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 8); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 4 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 4); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 2 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 2); Change in Synovitis Measured by Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Image Scoring System (RAMRIS) Score at Week 1 Compared to Baseline for Certolizumab Pegol Arm (From Baseline to Week 1)
B: Number of Participants With American College of Rheumatology 20 Response at Week 24 (Week 24)
C: Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24 (Baseline to Week 24)
D: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies
Brief Summary: This study will assess the safety and efficacy of rituximab combined with MTX in participants with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 participants. Eligible participants may receive re-treatment with rituximab under a separate protocol WA17531.


Options:
A: Number of Participants With American College of Rheumatology 20 Response at Week 24 (Week 24)
B: American College of Rheumatology 20% (ACR20) Response at Week 12 (Baseline, Week 12)
C: Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR) (Day 1 of Period 1, Day 43 of Period 1)
D: Percentage of ACR20 (American College of Rheumatology 20% Improvement) Responders at Week 34 in Patients Randomized at Week 18 (Baseline, Week 34)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies
Brief Summary: This study will assess the safety and efficacy of rituximab combined with MTX in participants with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 participants. Eligible participants may receive re-treatment with rituximab under a separate protocol WA17531.


Options:
A: Proportion of Participants With at Least One Serious Infection Through Week 24 (Through Week 24); Number of Participants With Any Infections or Any Grade 3/4 Infections Through Week 24 (Through Week 24); Maximum Duration of Infections Through Week 24 (Week 24); Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Through Week 24 (Through Week 24); Number of Participants With Clinically Significant Immunological and Laboratory Assessment Findings (Through Week 24)
B: Number of Participants With American College of Rheumatology 20 Response at Week 24 (Week 24)
C: Percentage of Patients Developing a Serious Adverse Event (SAE) Within 24 Weeks After Receiving the First Course of Rituximab Treatment (From first treatment with rituximab (Day 1) through Week 24)
D: Change From Baseline in Modified Total Sharp Score (mTSS) From Screening at Week 52 (Baseline and week 52)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Alpha Therapies
Brief Summary: This study will assess the safety and efficacy of rituximab combined with MTX in participants with active rheumatoid arthritis (RA) who have had an inadequate response to anti-Tumor Necrosis (TNF) alpha therapy. The anticipated time in the study is up to 2 years and the target sample size is 500 participants. Eligible participants may receive re-treatment with rituximab under a separate protocol WA17531.


Options:
A: Adjusted Geometric (Geo) Mean-Fold Change at End of Period 1 From Baseline in Measured Glomerular Filtration Rate (mGFR) (Day 1 of Period 1, Day 43 of Period 1)
B: Number of Participants With American College of Rheumatology 20 Response at Week 24 (Week 24)
C: Percentage of patients with ACR 20 response (Week 24); AEs, laboratory parameters, vital signs, ECGs. (Throughout study)
D: Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4 (Week 78)

Answer: B