TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Titration Study to Evaluate the Efficacy and Safety of CONCERTA (Methylphenidate HCl) Extended-release Tablets in Adults With Attention Deficit Hyperactivity Disorder at Doses of 36 mg, 54 mg, 72 mg, 90 mg, or 108 mg Per Day.
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of methylphenidate HCl extended-release tablets at five dose levels compared to placebo in adults with Attention Deficit Hyperactivity Disorder (ADHD)


Options:
A: Number of days of use of cannabis (12 weeks)
B: Symptom reduction using ADHD-Clinical Global Impression and ADHD Symptom Checklist Severity scale administered at each visit. (34 weeks)
C: The change from Baseline in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score as assessed by the Investigator at the Final Visit/2 Week Efficacy Assessment Visit
D: Prolonged Abstinence (Weeks 7-10)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Continuous Versus Cyclic Use of an Oral Contraceptive Pills in Adolescents
Brief Summary: The primary purpose of this study is to compare the compliance rates of adolescents who take oral contraceptives (OCPs) continuously to those who take OCPs cyclically.


Options:
A: The primary objective is to compare the compliance rates of adolescents who take OCPs continuously to those who take OCPs cyclically. (1 year)
B: serum 25-hydroxy vitamin D concentrations (baseline, 3, 6 months); serum concentrations of inflammatory markers (Interleukin-6, TNF-alpha, c reactive protein) (baseline and 6 mos); Hemoglobin A1C, serum glucose and insulin concentrations (baseline, 3 and 6 months)
C: BMI Z score (12 months)
D: BMI SDS or Z-score (12 months primary/ 18 months secondary outcome)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Intranasal Midazolam Versus Rectal Diazepam for the Home Treatment of Seizure Activity in Pediatric Patients With Epilepsy
Brief Summary: The investigators will conduct a randomized controlled trial comparing the use of nasal midazolam, using a Mucosal Atomization Devise, to rectal diazepam for the treatment of acute seizure activity in children under the age of 18 years with epilepsy in the community setting. The primary hypothesis is that nasal midazolam will be more effective and have shorter seizure time compared to rectal diazepam in the community. The secondary hypotheses are that patients treated with nasal midazolam will have fewer respiratory complications, emergency department visits, and admissions.


Options:
A: Number of participants with resolution of refractory convulsive status epilepticus (participant wil be followed for 24 hours after discontinuation of study drug)
B: whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration
C: Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given (Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes).)
D: Length of Seizure After Study Medication Administration (24 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Zoledronate Versus Ibandronate Comparative Evaluation: A Randomized Phase III, Open-Label, Multicenter, Parallel Group Clinical Trial to Evaluate and Compare the Efficacy, Safety Profile and Tolerability of Oral Ibandronate Versus Intravenous Zoledronate in the Treatment of Breast Cancer Patients With Bone Metastases
Brief Summary: RATIONALE: Ibandronate and zoledronate may help relieve some of the symptoms caused by bone metastases. It is not yet know whether ibandronate is more effective than zoledronate in treating bone metastases from breast cancer.

PURPOSE: This randomized phase III trial is studying ibandronate to see how well it works compared with zoledronate in treating patients with newly diagnosed bone metastases from breast cancer.


Options:
A: Time to the First On-Study Skeletal-Related Event (Non-Inferiority) (up to 33 months)
B: Frequency and timing of skeletal-related events (SREs) (96 weeks)
C: Increase in apoptotic index between diagnostic core biopsy and repeat core biopsy taken on day 5 (Repeat biopsy on day 5 (+/- day 21))
D: Evaluate the impact of Zometa (zoledronic acid) on the clearance of bone marrow micrometastases (Prior to therapy initiation, after completion of neoadjuvant chemotherapy, and 12-15 months from registration); Evaluate the protective effect of Zometa (zoledronic acid) on chemotherapy-induced loss of bone mineral density (Prior to therapy initiation and 12-15 months from registration)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
Brief Summary: This randomized phase III trial studies sunitinib malate to see how well it works compared to sorafenib tosylate or placebo in treating patients with kidney cancer that has been removed by surgery. Sunitinib malate and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate or sorafenib tosylate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib malate is more effective than sorafenib tosylate or placebo in treating kidney cancer.


Options:
A: Overall Survival (From date of subject randomization to date of death; assessed up to 42 months or until 290 deaths have been accrued on study)
B: Disease-free Survival (DFS) (Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry)
C: Number of Subjects With Overall Confirmed Objective Response (OR) (From start of treatment through Day 1 of Weeks 5, 9, and every 8 weeks thereafter)
D: Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants (From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)); Overall Survival (OS) in PD-L1 Positive Participants (From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Randomized, Open-Label Study of Cetuximab and Bevacizumab Alone or in Combination With Fixed-Dose Rate Gemcitabine as First-Line Therapy of Patients With Metastatic Adenocarcinoma of the Pancreas
Brief Summary: Eligible patients with metastatic pancreatic cancer will be treated with dual agent monoclonal antibody consisting of cetuximab and bevacizumab alone or in combination with gemcitabine


Options:
A: Overall survival (A subject's survival time will be defined as the time from randomization to the date of his or her death. If the subject has not died, survival will be censored on last date the subject was known to be alive.)
B: Progression free survival (4 years)
C: Progression-Free Survival (From the time of randomization until progression of disease or death (up to 30 months))
D: Progression-free Survival (PFS) (Time from randomization to disease progression or death from any cause (Range: 0 -10 months))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Age of Red Blood Cells in Premature Infants Study (ARIPI)
Brief Summary: To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.


Options:
A: The Effects of Storage-related RBC Changes on Acetylcholine-stimulated (NO-mediated) Forearm Blood Flow. (5 years)
B: Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery. (30 days post surgery.); Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events (30 days post surgery); Effect of RBC Age on Occurrence of Neurologic Events (30 days post surgery.); Effect of RBC Age on Occurrence of Pulmonary Events. (30 days post surgery.); Effect of RBC Age on Occurrence of Renal Failure (30 days post surgery.); Effect of RBC Age on Occurrence of Infection Events (30 days post surgery.); Effect of RBC Age on Occurrence of Atrial Fibrillation (30 days post surgery.); Effect of RBC Age on Occurrence of Asystole (30 days post surgery.); Effect of RBC Age on Occurrence of Gastrointestinal Events (30 days post surgery.); Effect of RBC Age on Occurrence of Any Reoperation (30 days post surgery.); Effect of RBC Age on Occurrence of Vascular Events (30 days post surgery.)
C: Measure of Non-transferrin-bound Iron (four hours after transfusion)
D: 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality (2 weeks, 4 weeks, 12 weeks, 90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Age of Red Blood Cells in Premature Infants Study (ARIPI)
Brief Summary: To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.


Options:
A: Glasgow Outcome Scale (at 6 months after injury)
B: Patient Health Questionnaire (PHQ-9); Change in Depression Scores Taken at 4-, 8-, and 12-month Follow Ups as Compared to Baseline. (Baseline, 4-month (immediate post treatment), and 8- and 12-month follow up.)
C: 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality (2 weeks, 4 weeks, 12 weeks, 90 days)
D: Mortality at Day 90 (90 Day)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Age of Red Blood Cells in Premature Infants Study (ARIPI)
Brief Summary: To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.


Options:
A: 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality (2 weeks, 4 weeks, 12 weeks, 90 days)
B: Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury) (neonatal phase); Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay) (follow-up phase 18 months corrected age)
C: 12 Hour Plasma Interleukin (IL)-6 to IL-10 Ratio (12 hours post-cardiopulmonary bypass)
D: Serum lactate levels (measured 1 hour after surgery); Developmental outcome (measured by Bayley Scales of Infant Development at age 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Extracorporal Shock Wave Therapy for Induction of Therapeutic Neovascularization and Homing of Bone Marrow Progenitor Cells in Patients With Chronic Ischemic Heart Disease
Brief Summary: Extracorporal shock wave therapy is performed prior to cell therapy for induction of therapeutic neovascularization and improvement of homing of bone marrow progenitor cells in patients with chronic ischemic heart disease following anterior myocardial infarction.

Shock waves can induce growth factor expression in the ischemic myocardium and might augment homing of autologous bone marrow mononuclear cells which are injected intracoronary 24 h following shock wave therapy


Options:
A: Improvement in global ejection fraction on LV angiography (4 months)
B: Intervention Related Adverse Events (90 days)
C: Change in global left ventricular ejection fraction (12 months)
D: Does a bone marrow transplantation therapy increase the ejection fraction of the heart measured with MRI, when compared with placebo treatment? (1 year after the transplantation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Brief Summary: The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone


Options:
A: Steady State Beta Cell Compensation (24 months)
B: Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 52 weeks)
C: Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy (Baseline, Week 24); Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy (Baseline, Week 24)
D: Novel cardiovascular risk factors modification (2 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR as Initial Therapy Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control
Brief Summary: The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone


Options:
A: Change From Baseline in Hemoglobin A1c (A1C) at Week 24, Saxagliptin Plus Metformin Versus Saxagliptin Monotherapy (Baseline, Week 24); Change From Baseline in A1C at Week 24, Saxagliptin Plus Metformin Versus Metformin Monotherapy (Baseline, Week 24)
B: Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia (Baseline to last participant visit (up to 72 weeks))
C: Change in Haemoglobin A1c (HbA1c) From Baseline to Week 52 (Baseline, week 52. Values recorded after rescue treatment or collected more than 8 days after the last dose date were excluded from the analysis)
D: Change in Glycosylated Haemoglobin A1c (HbA1c) (week 0, week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.
Brief Summary: The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion.


Options:
A: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell (between the begining of surgery (day 1) and the eighth post-operative day (day 8))
B: Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). (Death, discharge or four weeks post randomisation whichever occurs first.)
C: Postoperative Bloodloss (Day 1 after surgery)
D: Blood transfusion rate (Hospital stay (3-7 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.
Brief Summary: The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion.


Options:
A: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell (between the begining of surgery (day 1) and the eighth post-operative day (day 8))
B: 24 hours postoperative drainage blood loss; incidence of allogeneic blood transfusion
C: Number of allogenic blood units transfused (Measured through the 8th postoperative day)
D: Death in hospital within four weeks of injury (causes of death will be described to assess whether deaths were due to haemorrhage or vascular occlusion). (Death, discharge or four weeks post randomisation whichever occurs first.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.
Brief Summary: The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion.


Options:
A: The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion (30 days after surgery)
B: Postoperative Functional mobility; Restricting factors for functional mobility
C: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell (between the begining of surgery (day 1) and the eighth post-operative day (day 8))
D: Primary outcomes are related to feasibility and include recruitment rate, protocol adherence & difference in mean Hb concentration and RBC exposure between the 2 groups. (60 days following randomisation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.
Brief Summary: The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion.


Options:
A: Enrollment rate (Time Frame: 6 months); Non-adherence (30 days)
B: The primary purpose of this study is to compare clinical outcomes after cardiac surgery in patients submitted to different strategies of red blood cell transfusion (30 days after surgery)
C: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell (between the begining of surgery (day 1) and the eighth post-operative day (day 8))
D: FACT-G, FACT-An, Numeric Rating Scale on symptoms of anaemia, Performance status (Before each cylces of chemotherapy in up to six months, and before transfusion, and daily in seven days after transfusion)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Parallel-arm, Two-stage Study of the Efficacy and Safety of AVE0005 (VEGF Trap) Administered Intravenously Every 2 Weeks in Patients With Platinum-resistant and topotecan-and/or Liposomal Doxorubicin-resistant Advanced Ovarian Cancer
Brief Summary: This study evaluated outcomes in participants with advanced ovarian epithelial adenocarcinoma receiving aflibercept.

The primary objective was to compare the objective response rate of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) 4.0 mg/kg and 2.0 mg/kg, administered intravenously (IV) every 2 weeks with historical control in participants with advanced ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma resistant to platinum and topotecan and/or liposomal doxorubicin.

The secondary objectives was to further assess efficacy, safety, pharmacokinetics, potential biological and pharmacogenomic markers of study drug activity, and health-related quality of life.

This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation. If an endpoint was evaluated by the IRC, the IRC reviewed data is reported for this study.


Options:
A: Time to Repeat Paracentesis (TRP) (From Day 1 up to 6 months from randomization)
B: To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin (Once 244 planned pts. received at least 2 cycles of study treatment(s))
C: Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)); Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months))
D: Progression Free Survival (PFS) (From the date of randomization to the date of first documentation of PD, or date of death, whichever occurs first up to approximately 5 years 5 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Parallel-arm, Two-stage Study of the Efficacy and Safety of AVE0005 (VEGF Trap) Administered Intravenously Every 2 Weeks in Patients With Platinum-resistant and topotecan-and/or Liposomal Doxorubicin-resistant Advanced Ovarian Cancer
Brief Summary: This study evaluated outcomes in participants with advanced ovarian epithelial adenocarcinoma receiving aflibercept.

The primary objective was to compare the objective response rate of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) 4.0 mg/kg and 2.0 mg/kg, administered intravenously (IV) every 2 weeks with historical control in participants with advanced ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma resistant to platinum and topotecan and/or liposomal doxorubicin.

The secondary objectives was to further assess efficacy, safety, pharmacokinetics, potential biological and pharmacogenomic markers of study drug activity, and health-related quality of life.

This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation. If an endpoint was evaluated by the IRC, the IRC reviewed data is reported for this study.


Options:
A: Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (after 6 weeks (2 cycles))
B: Complete response rate (average 24 months)
C: Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by an Independent Review Committee (IRC) - Simon's Cohort (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months)); Number of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Based on the Analysis by the IRC - Efficacy Evaluable Population (From enrollment to efficacy cut-off date, 18 January 2008 (approximately 20 months))
D: Radiographic imaging and clinical evaluation will be used for tumor assessment (every 6 weeks)

Answer: C