TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Parallel Group Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Mepolizumab (SB240563)(0.55mg/kg, 2.5mg/kg or 10mg/kg) in Pediatric Subjects With Eosinophilic Esophagitis, Aged 2 to 17 Years (Study MEE103219)
Brief Summary: This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.


Options:
A: Change in Eosinophil Numbers Per High Power Field Proximally and Distally Between Baseline and Post-treatment and Between Both Groups (16 weeks)
B: Peak Esophageal Eosinophil Count (2 months)
C: Percentage of Subjects With ≤6 Peak Eosinophils/High-power Field (HPF) (Week 12)
D: Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) (From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24)); Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. (From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24)); Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. (From first dose of study treatment (Day 1) up to Long-term Follow-up Phase (Week 34)); Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline (Screening, Weeks 4, 8 and 12); Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points (Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24); Change From Baseline in Heart Rate at the Indicated Time Points (Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24); Change From Baseline in Temperature at the Indicated Time Points (Screening, Day 1, Weeks 4, 8, 12, 16, 20 and 24); Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit. (Day 1, Weeks 4, 8, 12, 24, and 34); Number of Participants Achieving a Reduction in Peak Esophageal Eosinophil Count to < 5 Cells Per High Power Field (HPF) at Week 12 (Week 12); Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab (Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34); Plasma Clearance (CL) of Mepolizumab (Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mycoplasma Genitalium Antibiotic Susceptibility and Treatment: A Randomized Double-blind Trial of the Efficacy of Azithromycin and Doxycycline for Clinical and Microbiological Cure of M. Genitalium in Men With Nongonococcal Urethritis
Brief Summary: The purpose of this study is to find out which of 2 different antibiotics, doxycycline or azithromycin, works best against germs that may cause nongonococcal urethritis.

Study participants will include approximately 1200 men, 16 years of age or older, attending a sexually transmitted diseases clinic in Seattle, Washington with clinical signs of urethral inflammation (\>=5PMNs/HPF on a Gram-stained slide prepared from urethral exudates and/or a visible urethral discharge upon examination).

Urine specimens will be collected and tested for Mycoplasma genitalium and Ureaplasmas. Each participant will receive a blinded packet of study medication. Participants will answer an enrollment questionnaire and will also receive a log to complete between visits to record information about treatment adherence, side effects, symptoms, and sexual activity. All subjects will be asked to return for evaluation 3 weeks after the initial clinic visit. Subjects who test positive for M. genitalium and/or Ureaplasmas at the initial clinic visit will also be asked to return for a third study visit, 6 weeks following the initial clinic visit. During follow-up visits, participants will answer a follow-up questionnaire and will be re-evaluated for signs of urethritis. Those who were initially positive for M. genitalium and/or Ureaplasmas will be re-tested for these organisms.

Study participants with signs and/or symptoms of urethritis or who test positive for M. genitalium or Ureaplasmas at the follow-up study visit will receive another blinded treatment packet containing the alternate medication. Those who require additional treatment at the 6-week visit will be asked to return for a fourth follow-up study visit at 9-10 weeks. Study participants who did not test positive for M. genitalium or Ureaplasmas at the initial clinic visit, but who continue to demonstrate signs and/or symptoms of infection at their single follow-up study visit will treated according to clinic standard of care (after the study clinician unblinds their randomly-assigned treatment regimen).


Options:
A: mITT Analysis of Eradication of M. Genitalium at First Follow-up Study Visit (approximately 3 weeks after initial study visit (allowable window is 2-5 weeks after initial study visit)); mITT Analysis of Eradication of U. Urealyticum at First Follow-up Visit (3 weeks (allowable window 2-5))
B: chlamydia and gonorrhea tests completed; chlamydia and gonorrhea infections detected
C: Number of Female Subjects With Overall Vaccine Effectiveness Against Genital Infection With Human Papilloma Virus (HPV)-16/18 Types in Cervarix/Engerix-B B Group Versus Engerix-B Group and in Cervarix/Engerix-B A Group Versus Engerix-B Group (At the time of Visit 5 (i.e. at 18.5 years of age))
D: Long term infertility complications (2008)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Dose Ranging Study to Assess the Safety, Efficacy, and Pharmacokinetics of an Oral Thrombopoietin Receptor Agonist (Eltrombopag) Administered to Subjects Receiving Adriamycin and Ifosfamide (AI) Regimen
Brief Summary: The study will evaluate the safety and tolerability, optimal biologic dose, and pharmacokinetics of eltrombopag for patients with advanced sarcoma who have a low platelet count and are receiving ADRIAMYCIN and ifosfamide (AI) chemotherapy.


Options:
A: Safety and tolerability endpoints will consist of the evaluation of adverse events (AE), and changes from baseline in vital signs and clinical laboratory parameters (Approximately 42 weeks)
B: Part A: Number of Participants With Adverse Events (Treatment period (4 weeks) plus treatment extension (1 year)); Part B: Number of Participants With Adverse Events (Treatment period (8 weeks) plus treatment extension (1 year))
C: Change in baseline platelet count from the first day of the second cycle of chemotherapy to the lowest count observed (nadir) during the cycle(21 days) (throughout entire study)
D: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE): Pre-therapy, On-therapy + 30 Days and Post-therapy in Phase I (From Cycle 1, Day 1 (C1D1) until at least 30 days post-investigational product discontinuation (longer for AEs considered related to study participation)); Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Hematology Parameters, at Anytime Post-Baseline in Phase I (After Baseline (C1D1), on-treatment and 30 day follow-up); Number of Participants With Indicated Maximum Toxicity Grades for the Indicated Clinical Chemistry Laboratory Parameters, at Anytime Post-Baseline in Phase I (After Baseline (C1D1), on-treatment and 30 day follow-up); Number of Participants With a Change From Baseline in Creatinine of >=26.5 Micromoles/Liter (UMOL/L) in Phase I (After Baseline (C1D1), on-treatment and 30 day follow-up); Number of the Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Scores at the Indicated Time Points in Phase I (Screening, C1D1, C2D1, C2D8, C2D15, C3D1, C4D1, C4D22, C5D1, C5D8, C6D1, C6D15); Number of Participants With Electrocardiogram (ECG) Findings at Anytime Post-Baseline in Phase I (C2D4, C2D8, C5D8, C6D15); Mean Day 1 Scheduled Pre-chemotherapy Platelet Count Evaluated Across Cycles 1 to 6 in Phase II (Day 1 (averaged across cycles 1 to 6))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blinded Multi-centre Trial Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest at the Emergency Department. (Preadmission Intravenous Vasopressin, Adrenaline Outcome Trial: PIVOT vII)
Brief Summary: The effectiveness of medications in cardiac arrest has been greatly debated and questioned. Historically intravenous adrenaline has been the drug of choice since 1906. There have been few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical trials have not been able to show any benefit with intravenous adrenaline (compared to placebo or no treatment) in the field.

Thus the purpose of this study is to compare vasopressin and adrenaline in the treatment of cardiac arrest to answer the question whether there is an improvement in survival between vasopressin and adrenaline.


Options:
A: Survival to Hospital Discharge. (at 30 days post arrest)
B: 1) Return of Spontaneous Circulation for > 15 min and 2) Survival to discharge either to home or to a rehabilitation facility. (60 days (actual))
C: Hospital Discharge (From time of first contact until hospital discharge, up to 90 days.)
D: Survival at hospital admission

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Satavaptan Cirrhotic Ascites Treatment Study: a Double-blind, Randomised, Parallel-group Comparison of Treatment With Satavaptan at 5 to 10 mg Daily Versus Placebo on Top of Conventional Treatment in Patients With Ascites Due to Cirrhosis of the Liver
Brief Summary: Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver.

Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).


Options:
A: Dyspnea Improvement Measured by Likert Scale at 8 and 24 Hours (8 and 24 hours)
B: Number and time of recurrences of therapeutic paracenteses (up to 12 weeks)
C: Composite endpoint of ascites worsening (at week 12)
D: change in body weight, change in serum sodium (within 14 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Prevention of Obesity Through Infancy Interventions
Brief Summary: Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even among very young children. Because the current evidence base regarding potentially effective early intervention components to prevent obesity is so incomplete, it is logical to initiate obesity prevention intervention research during infancy, focusing on the two major components of the infant lifestyle, sleeping and feeding.


Options:
A: Exclusive Breastfeeding on the Day Preceding the Interview as Assessed by Cross Sectional Survey (Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017)
B: Percent of infants sleeping 5 consecutive hours at night at 2 months of age (2.5 years)
C: Cardiovascular risk (5 years); Breastfeeding habits (1 years)
D: Infant Feeding Questionnaire (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Prevention of Obesity Through Infancy Interventions
Brief Summary: Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even among very young children. Because the current evidence base regarding potentially effective early intervention components to prevent obesity is so incomplete, it is logical to initiate obesity prevention intervention research during infancy, focusing on the two major components of the infant lifestyle, sleeping and feeding.


Options:
A: Percent of infants sleeping 5 consecutive hours at night at 2 months of age (2.5 years)
B: Weight-for-Length Percentile (Weight and length were measured at both pre-treatment (when infant was 3 months of age) and post-treatment (when infant was 9 months of age).); Appetite Regulation (The BEBQ was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).); Fruit and Vegetable Variety (The Block Food Frequency Questionnaire was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).)
C: Effectiveness of a nutrition advice programme in exclusive breastfeeding. (1 year); Effectiveness of a nutrition advice programme in dietary intake (1 year); Effectiveness of a nutrition advice programme in dietary intake (4 years); Effectiveness of a nutrition advice programme in dietary intake (8 years); Effectiveness of a nutrition advice programme in dietary intake (12 years)
D: Frequency of exclusive and total breastfeeding (First year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Prevention of Obesity Through Infancy Interventions
Brief Summary: Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even among very young children. Because the current evidence base regarding potentially effective early intervention components to prevent obesity is so incomplete, it is logical to initiate obesity prevention intervention research during infancy, focusing on the two major components of the infant lifestyle, sleeping and feeding.


Options:
A: Parent and child health behaviors (Baseline, 6 months); TV Viewing Time (Baseline, 6 months)
B: Increase MVPA (6 months)
C: % Body Fat (Boys) (Baseline and 3 years); BMI Z-score (Boys) (Baseline and three years); % Body Fat (Girls) (Baseline and 3 years); BMI Z-score (Girls) (Baseline and three years)
D: Percent of infants sleeping 5 consecutive hours at night at 2 months of age (2.5 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Prevention of Obesity Through Infancy Interventions
Brief Summary: Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even among very young children. Because the current evidence base regarding potentially effective early intervention components to prevent obesity is so incomplete, it is logical to initiate obesity prevention intervention research during infancy, focusing on the two major components of the infant lifestyle, sleeping and feeding.


Options:
A: Exclusive breastfeeding (EBF) among children 0-6 months of age (4 years after baseline); Child anthropometry (height, weight) among children 24-48 months of age (4 years after baseline); Complementary feeding among children 6-23.9 months of age (4 years after baseline); Anemia among children 6-23.9 months (4 years after baseline)
B: Percent of infants sleeping 5 consecutive hours at night at 2 months of age (2.5 years)
C: Breastfeeding Initiation (Three days postpartum); Positive parenting behavior (Parent Child Observation Guide) (4 months postpartum)
D: Early Child Development (24 months of child age); Child Growth (24 months of child age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Primary Prevention of Obesity Through Infancy Interventions
Brief Summary: Childhood obesity has reached epidemic proportions and its prevalence continues to rise, even among very young children. Because the current evidence base regarding potentially effective early intervention components to prevent obesity is so incomplete, it is logical to initiate obesity prevention intervention research during infancy, focusing on the two major components of the infant lifestyle, sleeping and feeding.


Options:
A: Early initiation of breastfeeding (Within 1 hour of birth); Exclusive breastfeeding rate (up to 6 months after birth)
B: Percent of infants sleeping 5 consecutive hours at night at 2 months of age (2.5 years)
C: Newborn survival (to 28 days) (July 2010 to June 2013)
D: Breastfeeding duration and intensity (Assessed at 1,3, and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy
Brief Summary: The purpose of this trial is to determine whether a mucosa-to-mucosa technique of pancreaticojejunostomy will improve the pancreatic fistula rate.


Options:
A: pancreatic fistula (From date of operation until the date of dischage or date of death from any cause, whichever came first,, assessed up to 200 days)
B: postoperative pancreatic fistula(POPF) rate (30 days)
C: The primary endpoint will be the pancreatic fistula rate. (1 year)
D: The frequency of pancreatic fistula including ISGPF grade B and C (Ninety days after operation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventional Management of Stroke Trial (IMS III): A Phase III Clinical Trial Examining Whether a Combined Intravenous (IV) and Intra-Arterial (IA) Approach to Recanalization is Superior to Standard IV Rt-PA (Activase®) Alone
Brief Summary: The purpose of this study is to compare two different treatment approaches to recanalization started within 3 hours of symptom onset-combined intravenous (IV) and endovascular therapy and standard intravenous (IV) rt-PA alone.


Options:
A: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. (at 90 days post randomization); Death Due to Any Cause (within 90 days post randomization); Symptomatic Intracranial Hemorrhage (within the first 30 hours post IV rt-PA)
B: 90-day Global Disability Assessed Via the Blinded Evaluation of Modified Rankin Score (mRS). (90 days)
C: The Modified Rankin Scale Score (at 90 days post-stroke)
D: modified Rankin Scale (mRS) (at 90 days from randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventional Management of Stroke Trial (IMS III): A Phase III Clinical Trial Examining Whether a Combined Intravenous (IV) and Intra-Arterial (IA) Approach to Recanalization is Superior to Standard IV Rt-PA (Activase®) Alone
Brief Summary: The purpose of this study is to compare two different treatment approaches to recanalization started within 3 hours of symptom onset-combined intravenous (IV) and endovascular therapy and standard intravenous (IV) rt-PA alone.


Options:
A: Between-group comparison of the distribution of the modified Rankin Scale scores (shift analysis) (90 days after enrollment)
B: Good Functional Outcome as Defined by a Modified Rankin Score of 0-2 (90 days); Incidence of All Serious Adverse Events (90 days)
C: To assess whether IA thrombolysis, as compared to IV rt-PA, increases survival free of disability (modified Rankin score of zero or 1) at 3 months. (3 months)
D: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. (at 90 days post randomization); Death Due to Any Cause (within 90 days post randomization); Symptomatic Intracranial Hemorrhage (within the first 30 hours post IV rt-PA)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventional Management of Stroke Trial (IMS III): A Phase III Clinical Trial Examining Whether a Combined Intravenous (IV) and Intra-Arterial (IA) Approach to Recanalization is Superior to Standard IV Rt-PA (Activase®) Alone
Brief Summary: The purpose of this study is to compare two different treatment approaches to recanalization started within 3 hours of symptom onset-combined intravenous (IV) and endovascular therapy and standard intravenous (IV) rt-PA alone.


Options:
A: Number of Participants With a Score of 5 or 6 on the Modified Rankin Scale (mRS) (90 days)
B: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. (at 90 days post randomization); Death Due to Any Cause (within 90 days post randomization); Symptomatic Intracranial Hemorrhage (within the first 30 hours post IV rt-PA)
C: Shift in the mRS score, defined by a proportional odds model. (90 days)
D: composite of functional independence at 3 months and absence of medical complication occurring by day 7 after endovascular therapy for anterior circulation AIS (Day 90)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventional Management of Stroke Trial (IMS III): A Phase III Clinical Trial Examining Whether a Combined Intravenous (IV) and Intra-Arterial (IA) Approach to Recanalization is Superior to Standard IV Rt-PA (Activase®) Alone
Brief Summary: The purpose of this study is to compare two different treatment approaches to recanalization started within 3 hours of symptom onset-combined intravenous (IV) and endovascular therapy and standard intravenous (IV) rt-PA alone.


Options:
A: modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90 (at day 90)
B: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. (at 90 days post randomization); Death Due to Any Cause (within 90 days post randomization); Symptomatic Intracranial Hemorrhage (within the first 30 hours post IV rt-PA)
C: To assess whether local intra-arterial (LIA) recombinant tissue plasminogen activator rt-PA, as compared to intravenous (IV) rt-PA, increases survival free of disability (modified Rankin score of 0 or 1) . (3 months)
D: Arterial Recanalization of the Occluded Target Vessel Measured by Thrombolysis in Cerebral Infarction (TICI) Score Equal or Superior to 2b Following the Use of the Study Device. (Immediately post procedure); Incidence of Device-related and Procedure-related Serious Adverse Events (SAEs). (90 Days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Interventional Management of Stroke Trial (IMS III): A Phase III Clinical Trial Examining Whether a Combined Intravenous (IV) and Intra-Arterial (IA) Approach to Recanalization is Superior to Standard IV Rt-PA (Activase®) Alone
Brief Summary: The purpose of this study is to compare two different treatment approaches to recanalization started within 3 hours of symptom onset-combined intravenous (IV) and endovascular therapy and standard intravenous (IV) rt-PA alone.


Options:
A: Feasibility of enrolling 12 subjects with major vessel occlusion within 1 year and random 1:1 assignment to treatment with IV (N=6) and IA (N=6) IA Activase using the following criteria: Time to clinical and radiological assessments (3 years); Time to IA Activase treatment (3 years); Preliminary safety assessment: 24 hour symptomatic ICH (3 years); Resources utilized and risk-benefit of IA Activase treatment. (3 years)
B: To assess whether IA thrombolysis, as compared to IV rt-PA, increases survival free of disability (modified Rankin score of zero or 1) at 3 months. (3 months)
C: Functional Handicap (Modified Rankin Score) (3 months)
D: Modified Rankin Scale (mRS) Score Dichotomized to 0-2 Versus Greater Than 2. (at 90 days post randomization); Death Due to Any Cause (within 90 days post randomization); Symptomatic Intracranial Hemorrhage (within the first 30 hours post IV rt-PA)

Answer: D