TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety Evaluation of 12-h and 2-h Urokinase Regimes in the Treatment of Pulmonary Thromboembolism: A Multi-Center, Randomized Controlled Trial in China
Brief Summary: Comparative trials of urokinase (UK) for 12 hours（UK-12h）or 24 hours (UK-24h) have produced similar results in acute pulmonary thromboembolism (PTE) thrombolysis. It is unclear whether the infusion time can be reduced further. The aim of this study was to investigate the efficacy and safety of weight adjusted dosage of UK-2h (20 000 IU/Kg) regime with the Uk-12h regime in selected patients with PTE in Chinese population.


Options:
A: The improvement of the right hart function on echocardiograms (within the 1st 14 days); Perfusion defect score of lung V/Q scans (within the 1st 14 days); Quantitative computed tomographic pulmonary angiography (CTPA) score on 2d, 14d after treatment. (within the 1st 14 days)
B: The improvement of the right ventricular function , perfusion defect score on lung V/Q scans or quantitative computed tomographic pulmonary angiography (CTPA) score. (14d)
C: 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)
D: Cumulative Incidence of Post-Thrombotic Syndrome (Villalta Scale) (Between 6 and 24 months after randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Parent Mentors to Improve Asthma Care for Urban Minority Children
Brief Summary: Asthma disproportionately affects minorities, but few studies have evaluated interventions to improve asthma outcomes in minority children.The purpose of the study is to determine whether Parent Mentors (PMs) are more effective than traditional asthma care in reducing minority children's asthma morbidity, costs, and use of services, while increasing families' quality of life and parental self-efficacy.


Options:
A: Neonatal mortality rate
B: N/A
C: To evaluate in a community based controlled effectiveness trial whether addition of zinc as a therapeutic modality for diarrhea delivered through existing channels, including at village level to the current case management package for under-five children (20 months (Jan 2005 to Sep 2006)); - Reduction in visits to health care providers for treatment of illness (20 months (Jan 2005 to Sep 2006)); - Reduction in drug use; antibiotics and other drugs during diarrheal illnesses (20 months (Jan 2005 to Sep 2006)); - Increase in ORS use during diarrhea in the intervention communities. (20 months (Jan 2005 to Sep 2006))
D: Incidence of diarrhea (weekly)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Parent Mentors to Improve Asthma Care for Urban Minority Children
Brief Summary: Asthma disproportionately affects minorities, but few studies have evaluated interventions to improve asthma outcomes in minority children.The purpose of the study is to determine whether Parent Mentors (PMs) are more effective than traditional asthma care in reducing minority children's asthma morbidity, costs, and use of services, while increasing families' quality of life and parental self-efficacy.


Options:
A: Mental Component Summary of the General Health Questionaires Short Form 12 (SF-12) (3 months)
B: N/A
C: Parental Self-Efficacy (baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge)
D: Caregiver Burden Inventory (one year); Proportion of days spent at home by the AD patient in the past year (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Parent Mentors to Improve Asthma Care for Urban Minority Children
Brief Summary: Asthma disproportionately affects minorities, but few studies have evaluated interventions to improve asthma outcomes in minority children.The purpose of the study is to determine whether Parent Mentors (PMs) are more effective than traditional asthma care in reducing minority children's asthma morbidity, costs, and use of services, while increasing families' quality of life and parental self-efficacy.


Options:
A: medication adherence (1 year)
B: Number of Participants With Unscheduled Use of Healthcare (1 year)
C: medication adherence, parental involvement , perceived parent-adolescent conflict, associated health outcome
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Using Parent Mentors to Improve Asthma Care for Urban Minority Children
Brief Summary: Asthma disproportionately affects minorities, but few studies have evaluated interventions to improve asthma outcomes in minority children.The purpose of the study is to determine whether Parent Mentors (PMs) are more effective than traditional asthma care in reducing minority children's asthma morbidity, costs, and use of services, while increasing families' quality of life and parental self-efficacy.


Options:
A: Reduce the cost of asthma health care. (18 Months)
B: Symptom-free days; Quality of Life Questionnaire (AQLQ, PAQLQ); Rate of asthma-related hospitalizations over 18 months of enrollment; Rate of asthma-related emergency room (ER) visits over 18 months of enrollment
C: N/A
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Bridge or Continue Coumadin for Device Surgery Randomized Controlled Trial (BRUISE CONTROL)
Brief Summary: Many cardiac patients requiring device (defibrillator or pacemaker) related surgery are on chronic oral anticoagulation therapy (usually coumadin). The risk of blood clot formation related to stopping oral anti-coagulant therapy is currently managed by using bridging heparin therapy in patients with moderate to high risk of blood clot formation. There is a substantial risk of bleeding in the pocket where the device is situated (pocket hematoma)related to bridging therapy. The purpose of this study is to compare the current standard of care of bridging with heparin to an experimental strategy of continuing coumadin therapy in higher risk patients undergoing device surgery, with the hypothesis being that the continued oral anti-coagulation group will have a lower pocket hematoma rate as compared to the bridging with heparin group.


Options:
A: Number of Patients With Clinically-Significant Bleeding (Randomization to 1 month post catheter ablation); Number of Patients With Thrombotic Events (Randomization to 1 month post catheter ablation)
B: therapeutic ACT retention rate during procedure (2 years)
C: Clinically significant hematoma (defined as hematoma requiring reoperation and/or transfusion and/or unplanned or prolonged hospitalization and/or interruption of LMWH or IV heparin or oral anti-coagulant. (Device implant until first routine post-op visit)
D: Composite of recurrence of cerebral infarction, systemic embolism, all-cause death, hospitalization for heart failure. (Up to 6 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement
Brief Summary: The purpose of this study is to determine whether early intervention with neuromuscular electrical stimulation (NMES) for muscle strengthening immediately after total knee arthroplasty (TKA) is more effective than voluntary exercise alone in countering changes in quadriceps muscle activation, force production, and function in older adults.


Options:
A: Change From Baseline in Quadriceps Central Activation Ratio at 12 Weeks (Baseline and 12 weeks post-intervention); Change From Baseline in Quadriceps Strength at 12 Weeks (Baseline and 12 weeks following the intervention)
B: mRNA level of IGF-1Ea
C: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)
D: Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively (Baseline through 3.5 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Randomized Diabetes Intervention Among Inner-city African American and Latino Adults
Brief Summary: The objectives of the proposed study are to determine whether culturally diverse community residents with diabetes are willing to participate in our community health worker intervention using randomized controlled trial (RCT) methods and to explore and document effective processes and protocols for RCT methods in these communities. The investigators will examine retention rates, identify reasons for attrition through interviews and focus groups, and determine strategies for improving recruitment, retention, and intervention methods. As a secondary objective, the investigators will explore the potential impacts of the intervention for improving healthy lifestyles, diabetes self-management, and selected health outcomes of participants.


Options:
A: Glycosylated Hemoglobin (HbA1c): (baseline and at the end of 12 months post index date)
B: Hemoglobin A1c (6 months)
C: Adherence to hypertension guidelines (Measured for two 6 month periods: the first is prior to the participant's enrollment in the study and the second is while the participant is enrolled in the study)
D: Change in the outcome (SBP, Hb A1c, or LDL) from baseline to the 12 month evaluation. (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Randomized Diabetes Intervention Among Inner-city African American and Latino Adults
Brief Summary: The objectives of the proposed study are to determine whether culturally diverse community residents with diabetes are willing to participate in our community health worker intervention using randomized controlled trial (RCT) methods and to explore and document effective processes and protocols for RCT methods in these communities. The investigators will examine retention rates, identify reasons for attrition through interviews and focus groups, and determine strategies for improving recruitment, retention, and intervention methods. As a secondary objective, the investigators will explore the potential impacts of the intervention for improving healthy lifestyles, diabetes self-management, and selected health outcomes of participants.


Options:
A: Diet. Starting the Conversation is a 9 items measure of eating patterns (including 2 items from the NCI Fruit and Vegetable Screener). NCI Percent Energy from Fat Screen (PFAT) contains 17 items concerning frequency of intake for 15 food groups. (Baseline, 16 weeks, and 12 months); Physical Activity. The CHAMPS (28 items) will be used to measure physical activity. (Baseline, 16 weeks, and 12 months); Medication Adherence. Medication taking will be assessed by the Hill-Bone Medication Adherence scale. Questions will also cover smoking and alcohol use. (Baseline, 16 weeks, and 12 months); Distress. Patient distress will be assessed across several measures including: the 20-item CES-D, the 17-item DDS, the PHQ8, and screening items from the SCID to rule out psychosis. (Baseline, 16 weeks, and 12 months)
B: Self-Care Behaviors; Glycemic control (HbA1c); fitness
C: Hemoglobin A1c (6 months)
D: Hemoglobin A1c (6 and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety in Type 2 Diabetic Patients With Severe Chronic Renal Impairment, 5 mg BI 1356 vs. Placebo, DB, Parallel Group, Randomized, Insulin Background Inclusive
Brief Summary: to determine safety, efficacy and tolerability of BI 1356 versus placebo


Options:
A: Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population) (Up to 5 years); Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population) (Up to 5 years)
B: HbA1c Change From Baseline at Week 12 (Baseline and Week 12)
C: Change from baseline in postprandial glucose (baseline to 7 days)
D: Hemoglobin A1c (A1C) Changes From Baseline at Week 24 (Baseline, Week 24); A1C Changes From Baseline at Week 24 - Open Label Cohort (Baseline, Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Cholesterol Lowering on the Progression of Aortic Stenosis in Patients With Mild to Moderate Aortic Stenosis (ASTRONOMER)Aortic Stenosis Progression Observation Measuring Effects of Rosuvastatin and The Sub-Study Protocol.
Brief Summary: The purpose of this study is to assess the effects of rosuvastatin compared to usual care in patients diagnosed with aortic valvular stenosis. Patients must have a diagnosis of mild to moderate aortic stenosis (AS) and no clinical indication for the use of cholesterol lowering agents. A multi-centre, randomized, double-blind, placebo-controlled study, with a two year recruitment period, and a treatment duration of a minimum of 3 years from the time of the last patient randomized to a maximum of 5 years.


Options:
A: The primary objective of the study is to compare the efficacy of rosuvastatin 10 mg with atorvastatin 10 mg by assessment of the percentage of subjects who reach EAS LDL-C target goals after 12 weeks of therapy
B: Mean Percent Change in Triglycerides From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit)); Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit)); Mean Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Final Visit (Baseline to 12 Weeks (Final Visit))
C: The changes in transvalvular aortic velocities and the changes in aortic valve area. (Between baseline and close-out measurments.)
D: Reduction of LDL-C following 12 weeks of treatment

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Vyvanse on the Driving Performance of Young Adults With ADHD: A Randomized, Double-Blind, Placebo-Controlled Study
Brief Summary: The primary objective of the study is to assess the benefice of Vyvanse on the factors that cause impairments in driving behavior in individuals with ADHD using a driving simulation aimed at examining the factors that cause impairments in driving behavior in individuals with ADHD such as driving speed, collision risk, and visual attention of 60 young drivers (ages 18-24) with ADHD. We hypothesize: 1.) young adults with ADHD treated with Vyvanse will show lower velocity (speed) scores and spend less time driving over the posted speed limit in the driving simulation when compared to subjects taking a placebo; 2.) young adults with ADHD treated with Vyvanse will show a lesser likelihood to collide with a suddenly appearing peripheral object, less difficulty maintaining the vehicle within their lane, and a lesser likelihood of driving through stop signs and solid red traffic lights without slowing down when compared to subjects taking a placebo; and 3.) young adults with ADHD treated with Vyvanse will exhibit more focused visual attention on details in the visual field when compared to subjects taking a placebo while driving. In addition, young adults with ADHD treated with Vyvanse will exhibit less visual tunneling and shorter off-road glances when compared to subjects taking a placebo.


Options:
A: Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS) (12 weeks)
B: Change score from baseline of the ADHD-RS (4 weeks)
C: N/A
D: Participants Experiencing Collisions During "Surprise Events" in Driving Simulator (6 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy
Brief Summary: The purpose of this uncontrolled, multi-center, open-label trial was to investigate the feasibility of using degarelix as intermittent androgen deprivation (IAD) therapy in the treatment of prostate cancer.


Options:
A: Median and Between Participant Variability of Time to Prostate-specific Antigen (PSA) >4 ng/mL During the First Cycle of Intermittent Androgen Deprivation (IAD) After 7 Monthly Injections of Degarelix Induction Treatment (Up to 24 months after end of induction period)
B: Intratumoral androgen levels (Week 12)
C: Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12 (After treatment of 12 weeks compared to Baseline)
D: Cumulative castration rate of treatment in terms of serum testosterone level (Up to one year of the treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability and Antiviral Activity of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591) in Genotype 1 Chronic Hepatitis C Patients. INFORM 1
Brief Summary: This 7 cohort study will evaluate the efficacy and safety of combination treatment with an HCV nucleoside polymerase inhibitor(RO5024048)and an HCV protease inhibitor(RO5190591/ITMN-191/danoprevir) in patients with chronic hepatitis C, genotype 1.Cohorts A,B,C,D and G will be treatment-naive patients, cohort E will be treatment-experienced excluding null responders, and cohort F will be null responders. Cohorts A and B will evaluate doses of 500mg po bid RO5024048 and 100mg po q8h RO5190591, alone or in combination, for up to 7 or 14 days. Cohort C will evaluate combination treatment with either 1000mg po bid RO5024048 and 100mg q8h RO5190591 or 500mg po bid RO5024048 and 200mg q8h RO5190591 for 14 days. Cohort D will evaluate 1000mg po bid RO5024048 and 200mg q8h RO5190591 for 14 days.Cohort E will evaluate 1000mg RO5024048/600mg RO5190591 po twice daily for 14 days, and Cohorts F and G will evaluate 1000mg RO5024048/900mg RO5190591 po twice daily for 14 days. Cohorts will be tested sequentially or in parallel, if supported by appropriate safety and pharmacokinetic data.Following the last dose of study medication patients have the option of continuing treatment with Standard of care therapies. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Options:
A: Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12 (A Weeks 4 and 12)
B: HCV RNA (At each clinic visit, throughout study); Adverse events, laboratory parameters, vital signs (At each clinic visit, throughout study)
C: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (12 weeks after the last actual dose of study drug)
D: Percentage of Participants Achieving RVR (Week 4); Number of Participants Experiencing an Adverse Event (AE) (Up to Day 42); Number of Participants Discontinuing From Study Therapy Due to AEs (Day 1 to Day 28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo-controlled, Dose-ranging Study to Evaluate the Safety, Tolerability and Antiviral Activity of Combination Treatment With an HCV Polymerase Inhibitor (RO5024048) and an HCV Protease Inhibitor (RO5190591) in Genotype 1 Chronic Hepatitis C Patients. INFORM 1
Brief Summary: This 7 cohort study will evaluate the efficacy and safety of combination treatment with an HCV nucleoside polymerase inhibitor(RO5024048)and an HCV protease inhibitor(RO5190591/ITMN-191/danoprevir) in patients with chronic hepatitis C, genotype 1.Cohorts A,B,C,D and G will be treatment-naive patients, cohort E will be treatment-experienced excluding null responders, and cohort F will be null responders. Cohorts A and B will evaluate doses of 500mg po bid RO5024048 and 100mg po q8h RO5190591, alone or in combination, for up to 7 or 14 days. Cohort C will evaluate combination treatment with either 1000mg po bid RO5024048 and 100mg q8h RO5190591 or 500mg po bid RO5024048 and 200mg q8h RO5190591 for 14 days. Cohort D will evaluate 1000mg po bid RO5024048 and 200mg q8h RO5190591 for 14 days.Cohort E will evaluate 1000mg RO5024048/600mg RO5190591 po twice daily for 14 days, and Cohorts F and G will evaluate 1000mg RO5024048/900mg RO5190591 po twice daily for 14 days. Cohorts will be tested sequentially or in parallel, if supported by appropriate safety and pharmacokinetic data.Following the last dose of study medication patients have the option of continuing treatment with Standard of care therapies. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Options:
A: Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) (Post-treatment Week 24); Percentage of Participants Who Experienced Adverse Events (Baseline (Day 1) to post-treatment Day 30)
B: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (12 weeks after the last actual dose of active study drug)
C: HCV RNA (At each clinic visit, throughout study); Adverse events, laboratory parameters, vital signs (At each clinic visit, throughout study)
D: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) (Week 36 or Week 60)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Oily Fish in Pregnancy on Markers and Manifestations of Allergic Diseases in Infants at Risk of Atopy
Brief Summary: The number of infants and children with allergic disease (dermatitis, allergies, asthma) has increased over the last several decades. This may be related to changes in diet. It is now thought that children become sensitised to allergens very early in life maybe even before they are born. Some studies show that a high omega-3 fat intake by mothers decreases risk of sensitisation in their babies. There is a biological mechanism to explain this. Omega-3 fats are found in oily fish like salmon. In the UK pregnant women are recommended to eat oily fish twice per week. However, consumption of oily fish is known to be low in pregnant women in the UK. This study sets out to identify the effects of increasing salmon intake in pregnant women. The hypothesis being investigated is that : increased consumption of oily fish during pregnancy by women at risk of having offspring who will develop atopy will increase their omega-3 fat and antioxidant status and that of their developing baby and will ameliorate the development of atopic markers and manifestations in the infants.


Options:
A: total score of the Hamilton Rating Scale for Depression (HAMD) (Twelve weeks)
B: Delivery before than 37 weeks gestation (Up to 37 weeks gestation)
C: Omega-3 fatty acid status in maternal and umbilical cord plasma (Weeks 20, 34 and 38 of pregnancy and at birth (in cord))
D: Infant neurodevelopment as measured by his/her Development quotient scores (DQS) at 12 months of age (12 months (± 4 weeks))

Answer: C