TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Program of TCM on Early Rehabilitation and Secondary Prevention of Ischemic Stroke
Brief Summary: Complex project of Traditional Chinese Medicine (TCM) with Western Medicine (WM) project under stroke unit mode contrast,assuming that the efficiency of TCM on early rehabilitation and secondary prevention of ischemic stroke is same or better than that of WM.


Options:
A: Difference in the percentage of patients who Door-to-Needle Time≤60min (Up to 24 hours)
B: NIHSS Stroke Scale, relapse rate (360 days)
C: Six minute walk test (walking ability) (1-3 months); Functional Independence Measure (1-3 months); Functional Ambulation Category (1-3 months)
D: Mortality (30 days after hospital admission)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Program of TCM on Early Rehabilitation and Secondary Prevention of Ischemic Stroke
Brief Summary: Complex project of Traditional Chinese Medicine (TCM) with Western Medicine (WM) project under stroke unit mode contrast,assuming that the efficiency of TCM on early rehabilitation and secondary prevention of ischemic stroke is same or better than that of WM.


Options:
A: Number of patients hospitalized due to COPD worsening (180 days)
B: NIHSS Stroke Scale, relapse rate (360 days)
C: Proportion of patients adherent to medication at 1 month after discharge as assessed by the Morisky Medication Adherence Scale - 8 items (1 month)
D: Hospital readmission rate (all cause) (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment With Lenalidomide (Revlimid®)) Alone and in Combination With Epoetin Alfa (Procrit®)) in Subjects With Low- or Intermediate-1 Risk MDS and Symptomatic Anemia
Brief Summary: This randomized phase III trial studies lenalidomide to see how well it works with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia. Lenalidomide may stop the growth of myelodysplastic syndrome by blocking blood flow to the cells. Colony stimulating factors, such as epoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood. It is not yet known whether lenalidomide is more effective with or without epoetin alfa in treating patients with myelodysplastic syndrome and anemia.


Options:
A: Hb response rate (up to week 15)
B: Red blood cell (RBC) transfusion rate (6 months)
C: Incidence of adverse events (throughout study)
D: Proportion of Patients With Major Erythroid Response (MER) (Assessed after completion of 16 weeks of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Study of the Treatment of Urodynamic Stress Incontinence: the Tension Free Vaginal Tape (TVT) Versus the Miniarc Sling.
Brief Summary: The aim of this study is to assess whether the Miniarc suburethral sling is equivalent to the TVT in the treatment of women with urodynamic stress incontinence (USI). If equivalence is proven, the advantages to women with USI will be potentially significant since the Miniarc may be carried out as an office based procedure, negating the need for an anaesthetic and hospital admission. The investigators null hypothesis is that there is no difference in subjective or objective outcome between the TVT and the Miniarc in the treatment of USI.

Eligible women will be initially assessed with a full history and examination, King's Health Questionnaire and twin channel subtraction cystometry. They will be randomised (using a series of numbered opaque envelopes) to undergo either the TVT or Miniarc. Follow up will be at 6 weeks, with a subjective outcome measure and at 6 months with a repeat subjective assessment and repeat twin channel cystometry.


Options:
A: A change in number of cured patients (Up to 1 year)
B: • Feasibility of the single incision sub-urethral tape to be done under local anaesthesia (1 year)
C: The absence of stress incontinence at 6 weeks ascertained by direct questioning and from the Kings Quality of life questionnaire and the absence at 6 months by the same criteria and by urodynamics. (6 weeks and 6 months)
D: Subjective Cure of Urinary Incontinence at 12 Months After Surgery (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Medication Adherence Enhancement in Heart Transplant Recipients: a Randomized Clinical Trial
Brief Summary: Medication-related non-adherence increases the risk of rejections and associated graft loss after solid organ transplantation. A randomized controlled intervention will use adherence enhancing strategies out of a larger sample of 300 heart transplant recipients. Non-Adherence will be assessed by patients' self-report and based on immunosuppression level. All non-adherent patients will be randomly designed to either intervention or control group. Multi-module interventions include patient education, electronic medication event monitoring, and a combined behavior and symptom management. Longitudinal follow-up is envisioned after initial intervention.


Options:
A: Difference in adherence to immunosuppressant medications between intervention and control (self-report) (3 months and 12 months after enrolment); Difference in adherence to immunosuppressant medications between intervention and control (immunosuppressant blood levels) (3 months and 12 months after enrolment)
B: Occurrence of adverse events (composite endpoint) (at month 60)
C: electronic monitor of medication taking (4 months)
D: 12-week immunosuppression medication adherence (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh
Brief Summary: The primary aim is to establish the non-inferiority of several simplified, home-based antibiotic regimens compared to the standard course of parenteral antibiotics for the empiric treatment of suspected sepsis in Bangladeshi young infants whose parents refuse hospitalization. Three alternative regimens will be compared with a standard (reference) regimen of injectable procaine-benzyl penicillin and gentamicin once daily each for seven days. Alternative regimens are (1) injectable gentamicin once daily and oral amoxicillin twice daily for seven days; (2) injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days; and (3) injectable gentamicin once daily and oral amoxicillin twice daily for two days followed by oral amoxicillin twice daily for five days.

Hypothesis

The proportion who fails treatment will be 10 percent in the reference group and the alternative treatment groups. An alternative therapy will be considered non-inferior to the standard therapy if the failure rate in the alternative therapy exceeds the failure rate in the injectable therapy by less than 5 absolute percentage points.

Secondary Objectives:

* To identify baseline clinical predictors of treatment failure in severe infections in young infants.
* To determine the proportion of relapse (young infants who were considered cured by day 7 but developed any of the signs of suspected severe infection by day 14).


Options:
A: Proportion of women who exclusively breastfeed to 6 months (The outcome will be measured when the infant is 6-7 months old.)
B: N/A
C: delayed bathing of baby (24 months)
D: Treatment failure (Seven days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh
Brief Summary: The primary aim is to establish the non-inferiority of several simplified, home-based antibiotic regimens compared to the standard course of parenteral antibiotics for the empiric treatment of suspected sepsis in Bangladeshi young infants whose parents refuse hospitalization. Three alternative regimens will be compared with a standard (reference) regimen of injectable procaine-benzyl penicillin and gentamicin once daily each for seven days. Alternative regimens are (1) injectable gentamicin once daily and oral amoxicillin twice daily for seven days; (2) injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days; and (3) injectable gentamicin once daily and oral amoxicillin twice daily for two days followed by oral amoxicillin twice daily for five days.

Hypothesis

The proportion who fails treatment will be 10 percent in the reference group and the alternative treatment groups. An alternative therapy will be considered non-inferior to the standard therapy if the failure rate in the alternative therapy exceeds the failure rate in the injectable therapy by less than 5 absolute percentage points.

Secondary Objectives:

* To identify baseline clinical predictors of treatment failure in severe infections in young infants.
* To determine the proportion of relapse (young infants who were considered cured by day 7 but developed any of the signs of suspected severe infection by day 14).


Options:
A: Treatment failure (Seven days)
B: Number of Children Who Received Early and Appropriate Treatment for Pneumonia. (one year); Number of Children With Fever Who Received Coartem (Artemether-lumefantrine) (one year)
C: Neonatal mortality rate
D: All cause Neonatal Mortality (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Multi-Center Controlled Clinical Trial Of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive Atypical Hemolytic Uremic Syndrome (AHUS)
Brief Summary: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adolescent patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS).


Options:
A: TMA complication-free survival (5 Years)
B: Percentage of Patients With TMA Event-free Status (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks); Percentage of Patients With Complete TMA Response (Through 26 weeks)
C: The effect of OMS721 as measured by platelet count change from baseline (26 weeks)
D: Percentage of Patients With TMA Event-free Status (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks); Percentage of Patients With Complete TMA Response (Through 26 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Multi-Center Controlled Clinical Trial Of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive Atypical Hemolytic Uremic Syndrome (AHUS)
Brief Summary: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adolescent patients with plasma therapy-sensitive Atypical Hemolytic-Uremic Syndrome (aHUS).


Options:
A: Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period (6 months)
B: Guillain Barré Syndrome (GBS) disability score (1 year); MRC sum score (1 year)
C: Percentage of Patients With TMA Event-free Status (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks); Percentage of Patients With Complete TMA Response (Through 26 weeks)
D: Platelet Count Change From Baseline to 26 Weeks (From Baseline to 26 weeks); Percentage of Patients With Platelet Count Normalization (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant Atypical Hemolytic Uremic Syndrome (aHUS)
Brief Summary: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).


Options:
A: Platelet Count Change From Baseline to 26 Weeks (From Baseline to 26 weeks); Percentage of Patients With Platelet Count Normalization (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks)
B: Percentage of Patients With TMA Event-free Status (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks); Percentage of Patients With Complete TMA Response (Through 26 weeks)
C: Proportion of Patients With Complete TMA Response (Through 26 weeks)
D: Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA (Day 1 to 37 days after end of treatment, approximately up to 31 weeks.); Number of Participants With HSCT-TMA Who Respond to OMS721 (Day 1 to up to 2 years following the first dose of OMS721)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant Atypical Hemolytic Uremic Syndrome (aHUS)
Brief Summary: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adult patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).


Options:
A: Platelet Count Change From Baseline to 26 Weeks (From Baseline to 26 weeks); Percentage of Patients With Platelet Count Normalization (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks)
B: Guillain Barré Syndrome (GBS) disability score (1 year); MRC sum score (1 year)
C: Determine the incidence of AE/SAEs after treatment with eculizumab and IVIg compared to placebo controls (6 months); Improvement of one or more grade in functional outcome (on the 6 point GBS disability scale) at 4 weeks (4 weeks)
D: Comparison of the Responder Rates Between Two Treatment Groups in the Efficacy Period (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of an E-learning Program About Child Maltreatment for Nurses on an A&E Department: a Randomised Controlled Trial
Brief Summary: The purpose of this study is to determine whether the e-learning program about the recognition of child maltreatment is effective in nurses on the A\&E department compared to a control group.


Options:
A: Questionnaire on Knowledge and Attitude of child abuse (2 questionnaires each for 15 minutes before and after the learning module)
B: Change in knowledge regarding reporting suspected child abuse. (48 months)
C: Percentage of "High Quality" reports of suspected child abuse submitted to the State of Maine by childcare providers (48 months)
D: Clinical behaviour on the A&E department, self-efficacy of the nurse in the detection of child abuse and assessment of the individual performance on screening child abuse. (2-3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness of an E-learning Program About Child Maltreatment for Nurses on an A&E Department: a Randomised Controlled Trial
Brief Summary: The purpose of this study is to determine whether the e-learning program about the recognition of child maltreatment is effective in nurses on the A\&E department compared to a control group.


Options:
A: Clinical behaviour on the A&E department, self-efficacy of the nurse in the detection of child abuse and assessment of the individual performance on screening child abuse. (2-3 months)
B: Model of Integrated Capacity Building Program (monthly over 3 years); Competence of individual clinicians (3 observations at pre/post IMID and final); Practice of individual clinicians (Baseline and Endline (9 months)); Clinical performance indicators (Monthly beginning 5 months before OSS)
C: Knowledge; Learning efficiency
D: Improvement of drug prescribing (Participants will be followed for the duration of hospital stay, an expected average of 12 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Atomoxetine, Placebo and Parent Management Training in Autism
Brief Summary: The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where the atomoxetine will have a dose titration over a 6 week period. All children will be seen weekly during this titration period, with additional visits at Week 8 and Week 10. Families assigned to the PMT arm will have an additional weekly meeting with a clinician for a total of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with their children. Subjects who are clinical responders (ADHD Responders and Compliance Responders) from the 10 week study period will be followed every 4 weeks in a 24-week extension study. Subjects who are clinical nonresponders will continue in PMT if they received PMT during the double-blind phase, and they will receive an open trial of atomoxetine if they were on placebo during the double-blind phase. All subjects (responders and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for 24 weeks after the completion of the double-blind phase.


Options:
A: Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents (week 10); Percentage of Participants Who Were Autism Spectrum Disorder Respondents (week 10)
B: Number of Participants With Improvement on the Clinical Global Impression-Improvement (CGI-I) Scale (6 Weeks)
C: N/A
D: Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity (Least Mean Squares Double-blind phase: change from baseline to week 24); Change in Aberrant Behavior Checklist-Modified Social Withdrawal Subscale ABC-mSW, a Measure of Social Reciprocity (Least mean squares for Open Label: Change between weeks 24-48)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Atomoxetine, Placebo and Parent Management Training in Autism
Brief Summary: The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where the atomoxetine will have a dose titration over a 6 week period. All children will be seen weekly during this titration period, with additional visits at Week 8 and Week 10. Families assigned to the PMT arm will have an additional weekly meeting with a clinician for a total of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with their children. Subjects who are clinical responders (ADHD Responders and Compliance Responders) from the 10 week study period will be followed every 4 weeks in a 24-week extension study. Subjects who are clinical nonresponders will continue in PMT if they received PMT during the double-blind phase, and they will receive an open trial of atomoxetine if they were on placebo during the double-blind phase. All subjects (responders and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for 24 weeks after the completion of the double-blind phase.


Options:
A: Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents (week 10); Percentage of Participants Who Were Autism Spectrum Disorder Respondents (week 10)
B: Core autistic symptoms (ATEC) (Once every 4 weeks during the first three mounth); Side effects and adverse events questionnaire (Once every 4 weeks during the first phase(12 weeks))
C: Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6 (Baseline to 6 Weeks)
D: Aberrant Behavior Checklist - Social Withdrawal Subscale (Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Atomoxetine, Placebo and Parent Management Training in Autism
Brief Summary: The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where the atomoxetine will have a dose titration over a 6 week period. All children will be seen weekly during this titration period, with additional visits at Week 8 and Week 10. Families assigned to the PMT arm will have an additional weekly meeting with a clinician for a total of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with their children. Subjects who are clinical responders (ADHD Responders and Compliance Responders) from the 10 week study period will be followed every 4 weeks in a 24-week extension study. Subjects who are clinical nonresponders will continue in PMT if they received PMT during the double-blind phase, and they will receive an open trial of atomoxetine if they were on placebo during the double-blind phase. All subjects (responders and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for 24 weeks after the completion of the double-blind phase.


Options:
A: 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)
B: Aberrant Behavior Checklist- 2nd Edition (ABC-2): Irritability subscale raw score (Baseline to Week 12)
C: Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents (week 10); Percentage of Participants Who Were Autism Spectrum Disorder Respondents (week 10)
D: Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment. (Baseline; Week 4)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Multi-Center Controlled Clinical Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant Atypical Hemolytic Uremic Syndrome (aHUS)
Brief Summary: The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adolescent patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).


Options:
A: Platelet Count Change From Baseline to 26 Weeks (From Baseline to 26 weeks); Percentage of Patients With Platelet Count Normalization (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks)
B: Proportion Of Participants With Normalization Of Lactate Dehydrogenase (LDH) Levels (Day 29 through Day 183); Percentage Of Participants Who Achieved Transfusion Avoidance (TA) (Baseline through Day 183)
C: Platelet Count Change From Baseline to 26 Weeks (From Baseline to 26 weeks); Percentage of Patients With Platelet Count Normalization (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks)
D: Percentage of Patients With TMA Event-free Status (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks); Percentage of Patients With Complete TMA Response (Through 26 weeks)

Answer: C