TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Restoring Insulin Secretion Pediatric Medication Study
Brief Summary: The RISE Pediatric Medication Study is a 2-arm, 4-center, clinical trial of children with prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose lowering will lead to recovery of beta-cell function that will be sustained after withdrawal of treatment. Pediatric participants (ages 10-19) will be randomized to one of the following treatment regimens: (1) metformin alone or (2) early intensive treatment with basal insulin glargine followed by metformin.

The primary clinical question RISE will address is: Are improvements in ß-cell function following 12 months of active treatment maintained for 3 months following the withdrawal of therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell function, insulin sensitivity and glucose tolerance and the response to an intervention.


Options:
A: Change from baseline in HbA1c at 24 weeks
B: Glycosylated Hemoglobin (HbA1c) Change From Baseline (Baseline, 52 weeks)
C: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); M/I (3-months after a medication washout)
D: Safety during 104 weeks of treatment; Change from baseline in HbA1c at 104 weeks

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Restoring Insulin Secretion Pediatric Medication Study
Brief Summary: The RISE Pediatric Medication Study is a 2-arm, 4-center, clinical trial of children with prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose lowering will lead to recovery of beta-cell function that will be sustained after withdrawal of treatment. Pediatric participants (ages 10-19) will be randomized to one of the following treatment regimens: (1) metformin alone or (2) early intensive treatment with basal insulin glargine followed by metformin.

The primary clinical question RISE will address is: Are improvements in ß-cell function following 12 months of active treatment maintained for 3 months following the withdrawal of therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell function, insulin sensitivity and glucose tolerance and the response to an intervention.


Options:
A: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); Insulin Sensitivity, M/I (3-months after a medication washout)
B: Triglyceride concentration in serum (Before and up to 8-hours post-injection)
C: Change From Baseline in Apnoea-hypopnoea Index (AHI) (Week 0, Week 32)
D: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); M/I (3-months after a medication washout)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Continuous Renal Replacement Therapy With Anticoagulation-free Regimen in Bleeding-risk Patients Using oXiris Membrane - CARROM Study
Brief Summary: The investigators hypothesize that the use of heparin-grafted membrane versus conventional membrane in critically-ill patients with bleeding-risk undergoing continuous renal replacement therapy, will effectively prolong the circuit lifespan, without worsening of the systemic APTT or underlying bleeding risk.


Options:
A: Circuit lifespan during continuous renal replacement therapy (up till termination as defined above) with each dialyzer (oXiris or M150) (usually 10 - 30 hours from commencement of circuit)
B: We will study the feasibility of recruiting ther target population, administering the study therapies according to pre-defined protocols and following patients for clinical endpoints. (60 days)
C: Measurement of the endotoxin activity 72 hours after treatment initiation (72 hours)
D: Time of insertion without complication

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label Study to Assess the Safety and Tolerability of a Single Intrathecal Dose of ISIS 396443 in Patients With Spinal Muscular Atrophy Who Previously Participated in ISIS 396443-CS1
Brief Summary: The primary objective of this study is to examine the safety and tolerability of nusinersen (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA) who previously participated in ISIS 396443-CS1 (NCT02865109). The secondary objective was to examine the plasma pharmacokinetics of a single dose of ISIS 396443 administered intrathecally to participants with SMA who previously participated in ISIS 396443-CS1.


Options:
A: Number of Participants That Experienced One Grade III or Higher Unanticipated, Treatment-related Toxicity That Presents With Clinical Symptoms and Requires Medical Treatment (2 years)
B: Percentage of Motor Milestones Responders (assessed at the later of the Day 183, Day 302, or Day 394 study visits); Time to Death or Permanent Ventilation (Day 91, Day 182, Day 273, Day 364, Day 394)
C: To assess safety and tolerability of VPA in SMA patients greater than 2 years of age
D: Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (Up to 24 Weeks); Number of participants with clinically significant neurological examination abnormalities (Up tp 24 Weeks); Number of participants with clinically significant vital sign abnormalities (Up to 24 Weeks); Number of participants with clinically significant physical examination abnormalities (Up to 24 Weeks); Number of participants with clinically significant weight abnormalities (Up to 24 Weeks); Number of participants with clinically significant laboratory parameters (Up to 24 Weeks); Number of participants with clinically significant electrocardiograms (ECGs) abnormalities (Up to 24 Weeks); Number of participants who use concomitant medications (Up to 24 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of the Pharmacokinetics of Primaquine in Lactating Women and Breastfed Infants for the Radical Treatment of Uncomplicated Maternal P. Vivax
Brief Summary: The weight of malaria falls most heavily on young children and pregnant women but studies of the safety of antimalarials in pregnancy and lactation are few. The only recommended medication used for radical treatment of P.vivax is primaquine. The 2010 WHO malaria guidelines recommend its use in all patients with P.vivax infection in areas of low transmission, in the absence of contraindications. Primaquine is contraindicated in pregnancy. The postpartum period presents a key opportunity to definitively treat women who suffer multiple malaria relapses during pregnancy. The 2010 WHO malaria treatment guidelines allow for primaquine use during lactation but there are no studies to date quantifying primaquine excretion in breast milk and the dose that breastfed infants would be exposed to is unknown. The investigators propose to study the pharmacokinetics of primaquine in maternal and infant plasma and in breast milk during a 14 day radical treatment of P.vivax.

Some inferences about the expected behavior of primaquine in lactation can be drawn from its known pharmacologic properties. Primaquine pharmacokinetics have been well characterized in healthy subjects and malaria patients after single and multiple oral dosing. Peak concentrations are reached within 2-3 hours after dosing and the plasma elimination half-life is \~7 hours. It is extensively distributed in the tissue and largely metabolized to inert carboxyprimaquine, the major plasma metabolite, which undergoes further biotransformation to unknown metabolites that are probably more toxic than the parent compound. The identification of other metabolites in humans has been difficult to pursue because the expected aminophenol metabolites are unstable.

No pharmacokinetic studies have been done to measure primaquine excretion in breast milk. A few studies have been done of other antimalarials during lactation and have shown low levels of drug in breast milk during treatment.


Options:
A: Primary Efficacy Variable: Proportion with relapse(s) of P. vivax in 12 months of follow-up. (2004-March 2007)
B: Pharmacokinetic Parameters of Primaquine and Carboxyprimaquine in breast milk. Area Under Curve (AUC) (13 Days. Time Frame: predose, 0,1,2,3,4,6,8,12,24,72 hours; Day 7, Day 13 post-dose)
C: The first recurrence of Plasmodium vivax malaria (Day 28)
D: Adequate Clinical Response (ACR) of Tafenoquine: 28 Day Cure Rate (28 Days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Care Management Technology to Facilitate Depression Care in Safety Net Diabetes Clinics
Brief Summary: The specific aims of the proposed study are to:

1. Develop the innovative depression care management technology, including the speech recognition technology for automated monitoring and patient prompts over time, automatic integration of the responses into the patient registry, and evidence-based decision-support algorithms for care actions;
2. Conduct the quasi-experiment in eight Los Angeles County Department of Health Services (LAC-DHS) clinics to test the interventions;
3. Use mixed-method evaluation to assess the extent of the implementation of the interventions, the acceptance to the providers and to the patients, and the impact on adoption of depression screening and treatment management over time, utilization, and cost of healthcare services, and patient health outcomes; and
4. Conduct a cost-effectiveness analysis of the three study arms. Successful completion of the study will demonstrate which Comparative Effectiveness Research (CER) adoption strategies are successful and why, their comparative cost-effectiveness, as well as which strategies are successful under which circumstances to inform system-wide implementation of same.

Hypotheses of the Proposed Study

The following are the main hypotheses of the study:

1. There will be statistically significant difference in the adoption of depression care screening and management over time among the three study groups.

   1.1. The adoption rate will be Technology-supported care (TC) \> Supported Care (SC) \> Usual Care (UC).
2. There will be statistically significant difference in the depression symptom reduction, and better functional status, and quality of life among the three study groups.

   2.1. The difference between the TC and the SC will not be statistically significant, but both will be greater than the UC group.
3. There will be statistically significant difference in the diabetes care process and outcomes among the three study groups.

   3.1. The difference between the TC and the SC will not be statistically significant, but both will be greater than the UC group.
4. There will also be statistically significant differences in healthcare utilization among the three study groups, with least utilization in the TC group where the greatest level of technology is applied.
5. Of the three groups compared, the TC group will be the most cost-effective approach for accelerating adoption of the CER depression care results.


Options:
A: Validated 7-day point prevalence tobacco abstinence (6 months after discharge)
B: Change from baseline in depression outcome at 6-months (6-months from enrollment)
C: Bone mineral density screening rates
D: Weight (Measured at Month 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: MI-SPRINT (Myocardial Infarction - Stress PRevention INTervention): A Randomized Controlled Minimal Early Behavioral Intervention Trial to Reduce the Development of Posttraumatic Stress Caused by Acute Myocardial Infarction
Brief Summary: Posttraumatic Stress Disorder (PTSD) is a mental disorder that may occur after someone experiences a traumatic event. Between 10-20% of patients may develop PTSD in response to the traumatic experience of myocardial infarction (MI). PTSD is associated with impaired quality of life, social functioning, and high economic burden to the society. Posttraumatic stress attributable to MI has also been shown to be predictive of poor cardiovascular prognosis, whereby this link might relate to several atherothrombotic processes. Therefore the prevention of PTSD after MI is of high relevance. Guidelines have been published for early interventions to prevent the development of posttraumatic stress after different types of trauma but not in terms of acute MI as a traumatic event.

The overarching aim of the planned trial is to test whether a minimal behavioral intervention performed shortly after acute MI in patients at a high risk to develop PTSD and in the setting of a coronary care unit reduces the development of posttraumatic stress.

The primary hypothesis is that posttraumatic stress levels at the 3-month follow-up will be at least 20% lower in the intervention group than in the control group, and that this effect will last up to 12 months after the intervention. The secondary hypothesis is that the intervention group will show better psychosocial functioning, and a more favourable cardiometabolic biomarker profile than the control group 3 and 12 month after the intervention.


Options:
A: Perceived control measure by Control Attitude Scale (3 months)
B: Clinician-rated posttraumatic stress level (3 months)
C: Changes from baseline to 18 months in depressive symptoms (HADS-D) (18 months)
D: Generic Mental Health-Related Quality of Life (Measured 8 months post-CABG)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer
Brief Summary: Trial for the optimization of risk assessment and therapy success prediction in patients with early breast cancer by the use of biomarkers in advance to therapy decision-making to personalize therapies.


Options:
A: Invasive Disease Free Survival (IDFS) (From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months))
B: pathological complete response (pCR= ypT0/is ypN0) (18 weeks (time window + 3 weeks)); Only for those patients randomized for the supportive anemia treatment: frequency of patients reaching hemoglobin (Hb) levels ≥ 11g/dl 6 weeks after treatment start of a first episode of anemia grade ≥2 (18 weeks (time window + 3 weeks))
C: Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11 (8 years)
D: Determine whether adding experimental agents to standard neoadjuvant medications increases the probability of pathologic complete response (pCR) over standard neoadjuvant chemotherapy for each biomarker signature established at trial entry. (Post surgery based on upto 36-week treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma
Brief Summary: This randomized phase III trial studies armodafinil to see how well it works in reducing cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve fatigue in patients with high grade glioma.


Options:
A: Percent Change in Delayed Recall at 4 Months as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) (Baseline and 4 months from start of treatment)
B: The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 8 Weeks. (At 8 weeks)
C: Progression-free-survival (6 months)
D: Time to Neurocognitive Failure (From randomization to last follow-up. Maximum follow-up was 15.6 months.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients
Brief Summary: A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. \& Celebrex Cap. for Comparative Evaluation of Safety \& Efficacy in Rheumatoid Arthritis Patients


Options:
A: Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) (6 month treatment duration)
B: Changes in '100 mm pain VAS' value from baseline (-14, 0, 14, 28, 42 day)
C: The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC). (Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months)
D: ulcer rebleeding over period of 13 months

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on the Clinical Course Of Pulmonary Embolism
Brief Summary: The course of both pulmonary embolism (PE) and one of its more relevant late complications, i.e. chronic thromboembolic pulmonary hypertension (CTEPH) is still substantially unknown.

Recent evidence has shown that the incidence of CTEPH is higher than previously believed, but this has not been confirmed by other studies. A clear link between PE and CTEPH has been questioned by some experts. A great number of patients affected by PE persistently have residual chronic thromboembolic material the meaning of which is a matter of debate. The evidence sustaining a link between chronic residual PE and subsequent PE recurrences or CTEPH is insufficient.

Thus, a nationwide, multicentre, prospective cohort study was designed with the following aims:

1. to ascertain the incidence of symptomatic CTEPH after a first episode of acute PE;
2. to ascertain the incidence of venous thromboembolic (VTE) recurrences after a first episode of acute PE;
3. to evaluate whether a relation exists between chronic residual PE and CTEPH
4. to evaluate whether a relation exists between chronic residual PE and VTE recurrences;
5. to evaluate whether a relation exists between persistent right ventricular dysfunction and CTEPH;
6. to evaluate whether a relation exists between persistent right ventricular dysfunction and PE recurrences.

For each enrolling centre, consecutive outpatients or inpatients with an objectively diagnosed first acute PE episode are considered eligible.


Options:
A: Clinically relevant reduction of RVD (24 hours from Tenecteplase or Placebo injection)
B: Incidence of chronic thromboembolic pulmonary hypertension (within 3 years)
C: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)
D: Clinical composite endpoint of all-cause mortality or haemodynamic collapse within 7 days (Day 7); Haemodynamic collapse is defined as: need for cardiopulmonary resuscitation; or systolic blood pressure < 90 mm Hg for at least 15 min or drop of syst (Day 7)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Fluticasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD. (FLAME).
Brief Summary: This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.


Options:
A: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
B: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
C: Rate of COPD Exacerbations (52 weeks)
D: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h)) (baseline (BL), 12 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Fluticasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD. (FLAME).
Brief Summary: This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.


Options:
A: Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC (Week 12 (Visit 4)); Trough FEV1 at Week 12 for Group: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Week 12 (Visit 4)); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Short-acting Bronchodilators (SABA and/or SAMA as Monotherapy or in Free or FDC) (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Glycopyrronium vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. LABA and ICS in Free or FDC (Day 1 (baseline) and week 12); Change From Baseline on Transition Dyspnea Index (TDI) for Groups: Indacaterol Maleate and Glycopyrronium Bromide FDC vs. Long-acting Bronchodilators (LABA or LAMA Monotherapy) (Day 1 (baseline) and week 12)
B: Change From Baseline in Trough Pre-dose FEV1 in Both Arms (Baseline, week 12)
C: Rate of COPD Exacerbations (52 weeks)
D: Moderate and severe COPD exacerbation rate over 52 weeks of treatment (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Fluticasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD. (FLAME).
Brief Summary: This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.


Options:
A: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
B: Peak Forced Expiratory Volume in One Second (FEV1) at Week 24 (At Week 24)
C: Trough Forced Expiratory Volume in One Second (FEV1) Following 26 Weeks of Treatment to Demonstrate the Non-inferiority of QVA149 110/50 μg o.d. to Fluticasone/Salmeterol 500/50 μg b.i.d (26 weeks)
D: Rate of COPD Exacerbations (52 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Fluticasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD. (FLAME).
Brief Summary: This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.


Options:
A: Rate of COPD Exacerbations (52 weeks)
B: Trough Forced Expiratory Volume in 1 Second (FEV1). (12 weeks)
C: Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI (Up to Week 52)
D: Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84) (Baseline to Day 84 (Early Withdrawal))

Answer: A