TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Primary Care for Chronic Lung Diseases in Less Developed Countries: Pragmatic Trial of the Practical Approach to Care Kit in Brazil (PACK Brazil)
Brief Summary: This study will evaluate a complex intervention based on a patient management tool (PMT), combined with educational outreach to primary care doctors, nurses and other health workers, in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality of respiratory care and respiratory health outcomes, and comorbid conditions, in adults with asthma and chronic obstructive pulmonary disease (COPD). The effectiveness of the intervention will be assessed by randomly allocating 48 primary care clinics to receive the intervention or not, and comparing patient and clinic level endpoints that reflect the health and quality of care provided over the following year. About 1250 patients known to have been diagnosed with asthma and 700 with COPD in participating clinics and will be included in the study. The primary endpoints for patients with asthma and COPD, respectively, will be composite scores indicating appropriate prescribing and diagnostic testing. The third primary endpoint, among all adult clinic users, will be rates of new diagnoses of asthma and COPD in each clinic. Secondary endpoints will include the individual components of the composite scores, health measures (hospital admissions and deaths), and indicators of appropriate management of comorbid conditions such as cardiovascular risk factors. Eligible patients will be identified and outcomes measured using electronic medical records.


Options:
A: Percentage of prescriptions of penicillin for respiratory tract infections (Two years); Percentage of prescriptions of TMP/SMX for lower urinary tract infections in adults (Two years)
B: Asthma composite score (During first year of follow-up); COPD composite score (During first year of follow-up); Asthma-or-COPD diagnosis rate (During first year of follow-up)
C: Cardiovascular risk and diabetes testing (During the first year of the trial); Systolic blood pressure (During the first year of the trial)
D: Disease-specific health related quality of life assessed with the Chronic Respiratory Questionnaire (CRQ-SR) (At baseline, after one year follow-up, and after two years follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Primary Care for Chronic Lung Diseases in Less Developed Countries: Pragmatic Trial of the Practical Approach to Care Kit in Brazil (PACK Brazil)
Brief Summary: This study will evaluate a complex intervention based on a patient management tool (PMT), combined with educational outreach to primary care doctors, nurses and other health workers, in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality of respiratory care and respiratory health outcomes, and comorbid conditions, in adults with asthma and chronic obstructive pulmonary disease (COPD). The effectiveness of the intervention will be assessed by randomly allocating 48 primary care clinics to receive the intervention or not, and comparing patient and clinic level endpoints that reflect the health and quality of care provided over the following year. About 1250 patients known to have been diagnosed with asthma and 700 with COPD in participating clinics and will be included in the study. The primary endpoints for patients with asthma and COPD, respectively, will be composite scores indicating appropriate prescribing and diagnostic testing. The third primary endpoint, among all adult clinic users, will be rates of new diagnoses of asthma and COPD in each clinic. Secondary endpoints will include the individual components of the composite scores, health measures (hospital admissions and deaths), and indicators of appropriate management of comorbid conditions such as cardiovascular risk factors. Eligible patients will be identified and outcomes measured using electronic medical records.


Options:
A: change from baseline in Modified Medical Research Council dyspnea score (12 weeks); change from baseline in COPD Assessment Test(CAT) score (12 weeks); change from baseline in real distance walked for 6 minutes (12 weeks)
B: Asthma composite score (During first year of follow-up); COPD composite score (During first year of follow-up); Asthma-or-COPD diagnosis rate (During first year of follow-up)
C: The two primary outcomes are disease-specific quality of life assessed with the St. George's Respiratory Questionnaire (SGRQ) and the total number of exacerbations
D: The number of ED presentations (1 year after randomization.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: REACH Lifestyle Program for Older Adults
Brief Summary: The purpose of this study is to test feasibility for the delivery and perceptions of a lifestyle model for middle-aged and older adults by involving participants in its development. The goal of the program is to reduce sedentary behaviour, increase physical activity, and increase strength and balance. An optional walking program will be run in parallel to emphasize the importance of moving more. Participants will be asked to fill out questionnaires on course delivery, content and effect throughout the program and 2-3 recorded interviews throughout the study. We will collect measurements of physical performance before and after the program.


Options:
A: Study uptake rates (as % of those approached who are randomised, recruitment rates (N/mth) (Assessed post-study-endpoint (up to month 18)); Intervention adherence to goals (Assessed post-study-endpoint (up to month 18)); Percentage of participants whose surgery is scheduled up to 2 weeks prior to the end of the intervention (Assessed post-study-endpoint (up to month 18)); Percentage of participants whose surgery is scheduled up to three weeks after the end of the intervention (Assessed post-study-endpoint (up to month 18)); Percentage of participants whose surgery is cancelled or delayed for too long (Assessed post-study-endpoint (up to month 18)); Retention rates (% of participants randomised who provide data at follow-up) (Assessed post-study-endpoint (up to month 18)); Acceptability of intervention for participants (Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)); Practicality of intervention for participants (Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)); Participant satisfaction with the study (Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)); Patient perception of the safety of the study as assessed by questionnaire (Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18))
B: REACH Session Feedback (6 weeks)
C: Change in objective total, light and moderate-to-vigorous physical activity (PA) (Pretest, posttest (6 weeks) and follow-up (6 months)); Change in objective sedentary behaviour (Pretest, posttest (6 weeks) and follow-up (6 months)); Change in self-reported total, light and moderate-to-vigorous physical activity (PA) (Pretest, posttest (6 weeks) and follow-up (6 months)); Change in self-reported sedentary behaviour (Pretest, posttest (6 weeks) and follow-up (6 months))
D: Number of myPAtHS exercise sessions. (12 weeks & 24 weeks); Time spent doing the myPAtHS exercise programme. (12 weeks & 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of the Effects of Mirabegron on Symptoms in Patients With Interstitial Cystitis
Brief Summary: Bladder pain syndrome/interstitial cystitis (BPS/IC) is a difficult disease to both diagnose and treat. It is defined as an unpleasant sensation (pain, pressure, or discomfort) perceived to be related to the urinary bladder and associated with lower urinary tract symptoms for at least 6 weeks duration, in the absence of infection or other identifiable causes. Pain is the universal symptom, but many also experience symptoms of overactive bladder, possibly directly related to the mechanism of pain. Treating pain may influence the symptom of urgency, if the urge arises from a need to alleviate pain. In some patients whose pain improves with treatment, troubling overactive bladder symptoms still remain. Beta-3 adrenergic agonists have been found to decrease signaling of C-fibers in animal models. So, the investigators hypothesize that mirabegron, which is FDA-approved for treatment of overactive bladder, would also improve symptoms in patients with BPS/IC. As a selective beta-3 agonist, mirabegron acts on the beta-3 receptors found in the bladder which mediate relaxation of the detrusor muscle. It has been shown to significantly decrease the number or micturition episodes, urgency episodes, and increased mean volume of urine voided per micturition. It also has a favorable tolerability profile.


Options:
A: Number consenting to join study out of eligible patients approached (6 months); Number of times therapists adhered to prescribed therapeutic protocol (12 weeks)
B: Number of Participants With Interstitial Cystitis Symptom Improvement (12 weeks)
C: Net change of Patient Perception of Visual Analogue Scale (VAS) (Baseline and 8 weeks)
D: Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire (Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Carbohydrate-restricted Diet to Reverse Fatty Liver in Adolescents With Obesity
Brief Summary: The purpose of this study is to determine the effects of a low carbohydrate diet vs a low fat diet on improvement in aminotransferases, hepatic fat infiltration, markers of inflammation, insulin resistance, and body composition in obese adolescents with non-alcoholic fatty liver disease (NAFLD).


Options:
A: Body composition (six months)
B: Change of intrahepatic triglyceride contents (12 months)
C: Change in hepatic lipid assessed via magnetic resonance imaging (MRI and magnetic resonance spectroscopy (MRS). (8 weeks after baseline)
D: percent liver fat as determined by nMR spectroscopy (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Pharmacist-delivered Multifaceted Intervention to Enhance Medication Adherence Among Post-acute Coronary Syndrome Patients in Vietnam: A Randomised Controlled Trial
Brief Summary: Adherence to treatment in post-acute coronary syndrome patients has been found to be poor in several studies. Pharmacists play a significant role in enhancing medication adherence and reducing rates of mortality and re-admission to hospital by performing medication reconciliation and tailoring, and patient education. The purpose of this study is to determine the effect of pharmacist-delivered multifaceted intervention on medication adherence and clinical outcomes of post-acute coronary syndrome patients. The study will be designed as a randomised controlled trial with blinded outcome assessors. The population includes patients who survive during hospitalisation with discharge diagnosis of acute coronary syndrome. Pharmacist-delivered multifaceted intervention consists of two counselling sessions within 1 week before and after hospital discharge including medication reconciliation and tailoring, and support with pill organiser and drug information leaflet. Primary outcome measure is the proportion of patients adherent to medication at 1 month after discharge. Secondary outcome measures are the proportions of patients (1) adherent to medication at 3 months after discharge, (2) readmitted to hospital and (3) dying within 3 months after discharge. The investigators also measure (4) the change in quality of life and (5) beliefs about medicines from baseline at 3 months.


Options:
A: Proportion of patients adherent to medication at 1 month after discharge as assessed by the Morisky Medication Adherence Scale - 8 items (1 month)
B: 30-day hospital readmissions (30-days); Emergency Department use (30-days post-discharge)
C: Hospital readmission rate (all cause) (90 days)
D: ADEs (Measured 30 and 90 days after hospital discharge); Medication appropriateness (Measured 30 and 90 days after hospital discharge by the Hanlon et al. Medication Appropriateness Index); Complications related to medications, including the number of hospital readmissions, unscheduled visits to emergency departments or urgent care facilities, and physician visits related to a medication problem or ADE (Measured 30 and 90 days after hospital discharge); Cost-effectiveness of the minimal or enhanced treatment compared to usual care (Measured 30 and 90 days after hospital discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Infant Sleep Hygiene Counseling: A Randomized Controlled Trial
Brief Summary: This study will evaluate the efficacy of an intervention to improve quality and duration of self-regulated nighttime sleep (the amount of time the child maintains a combination of uninterrupted sleep, quiet wakefulness, and re-initiation of sleep without parental intervention).


Options:
A: Nighttime self-regulated sleep duration at 6, 12 and 24 months of age (Up to 24 months)
B: Change child body mass index z-score. (Baseline, end of program, 6 month follow up)
C: Overweight and obesity according to IOTF references (0-1-2 years)
D: Preventing childhood obesity (Offspring age until six years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase II Trial to Assess the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous Recombination Deficiency (HRD Patients With Deleterious BRCA1/2 Tumor or Germline Mutation and/or HRD Score High)
Brief Summary: This is a multicenter, prospective, randomized, open-label phase II study evaluating the efficacy and safety of PO→EC as neoadjuvant treatment of operable and locally advanced breast cancer in patients with HR deficiency. Patients will be randomized to receive

* paclitaxel 80 mg/m² iv weekly in combination with olaparib tablets 100 mg (4X25mg) twice daily for 12 weeks (65 patients) or
* paclitaxel 80 mg/m² iv weekly in combination with carboplatin AUC 2 iv weekly for 12 weeks (37 patients) both followed by 4 cycles of epirubicin 90 mg/m² and cyclophosphamide 600 mg/m² (EC) either every 3 or every 2 weeks followed by surgery.

The control arm was chosen to allow direct comparison with one of the currently considered standard of care regimen.


Options:
A: Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is). (At the time of definitive surgical removal, up to 28 weeks); Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is). (At the time of definitive surgical removal, up to 28 weeks)
B: response by pCR =ypT0/is ypN0 (24 weeks)
C: Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11 (3 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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Multi-pronged Intervention to Address Prevention of Violence in Zambia
Brief Summary: This study evaluates the effectiveness of a multi-pronged intervention in reducing and preventing violence against women and children compared to a treatment as usual control group among families living in Lusaka, Zambia.


Options:
A: Alcohol use (12 months); HIV viral load (12 months)
B: Change in violence against women as measured by Severity of Violence Against Women Scale (SVAWS) (Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline)
C: Baby's health status (6 days after birth; 6 months after birth; 12 months after birth)
D: Post-intervention ASSIST screening score. (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating a Novel Cognitive-Behavioral Online Depression Intervention for Persons With Epilepsy (Desiconnect): Randomized Controlled Trial
Brief Summary: The trial aims to evaluate the effectiveness of a novel internet intervention (Desiconnect), which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to Persons with Epilepsy (PwE) and comorbid depression. Therefore, 200 PwE and a current depressive disorder (major depressive disorder or dysthymic disorder) will be recruited and randomized to two groups: (1) a control group, in which they may engage with any epilepsy treatment (Care-as-Usual, CAU) and receive access to Desiconnect after a delay of three months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately receives six-month access to Desiconnect and may also use CAU. The primary outcome measure is the depression scale of the Patient Health Questionnaire (PHQ-9), collected at three months post-baseline.


Options:
A: Mean SCL-20 depression scores (6 & 12 months post-baseline); Depression treatment response, defined as greater than 50% decrease in SCL-20 score from baseline (6 & 12 months post-baseline); Complete depression remission defined as SCL-20 score less than 0.5. (6 & 12 months post-baseline)
B: The primary outcome is defined by the number of patients free from clinically relevant adverse treatment events and/or drug interactions in each treatment arm at end of study. (6 months)
C: Severity of depressive symptoms, measured by Patient Health Questionnaire - 9 items (PHQ-9) (Change from baseline to 3 months (also assessed at 6 and 9 months post-baseline))
D: Severity of depressive symptoms (7 Days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week, Phase III, Open-label, Multi-center Study to Evaluate Efficacy and Safety of GSK1278863 in Japanese Non-dialysis and Peritoneal Dialysis Subjects With Anemia Associated With Chronic Kidney Disease
Brief Summary: This is a Phase III, open-label, active-controlled, parallel-group, multi-center study to compare the efficacy and safety of GSK1278863 administered for 52 weeks versus epoetin beta pegol in approximately 286 Japanese ND and 50 PD subjects with renal anemia. The study will consist of three cohorts. Cohort 1 and Cohort 3 will consist of ND subjects (Erythropoiesis-Stimulating Agent \[ESA\] users and ESA non-users) randomized to receive GSK1278863 or epoetin beta pegol in a ratio of 1:1. PD subjects will be enrolled into Cohort 2 and will receive GSK1278863. This study consists of a 4-week screening phase, a 52-week treatment phase (including primary efficacy evaluation period \[Weeks 40 to 52\]), and a 4-week follow-up phase following the treatment phase. The primary objective of this study is to demonstrate non-inferiority of GSK1278863 to epoetin beta pegol based on mean hemoglobin (Hgb) during the primary efficacy evaluation period in ND subjects. ESA non-users from Cohort 1 will be excluded from the primary efficacy analysis. Study results will be used as pivotal study data for an NDA submitted for GSK1278863 for the treatment of renal anemia in Japan.


Options:
A: Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Normoresponder Participants Treated for 6 Weeks Only (Week 7); Number of Participants With Week 7 Hb ≥ Baseline Hb - 0.5 g/dL, Among Hyporesponsive Participants Treated for at Least 6 Weeks (Week 7); Number of Participants With a Mean Hb Above 11 g/dL When the Mean Hb Values at Weeks 17, 18, 19, and 20 Were Averaged, Among Participants Treated for 19 Weeks (Weeks 17, 18, 19, and 20)
B: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to 176 weeks)
C: Rate of rise in hemoglobin (g/dL/week) (Baseline and at Week-6)
D: Mean Hemoglobin (Hgb) During the Primary Efficacy Evaluation Period (Weeks 40 to 52) in ND Participants (Weeks 40 to 52)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis
Brief Summary: To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis


Options:
A: ARR - PDEs (Baseline to Month 36)
B: Annualized Relapse Rate (ARR) (Baseline up to 2.5 years)
C: Part 1: Percentage of Participants With Confirmed Progression of Disability in One or More of the Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), or 9-Hole Peg Test (9HPT) (Up to 96 weeks (2 years)); Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (218 weeks)
D: Total Number of Confirmed Relapses During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression (Day 1 to 12 months); Annualized Rate of Confirmed Relapses Comparing Early Starters to Delayed Starters Estimated by Negative Binomial Regression (Day 1 up to 6.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis
Brief Summary: To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis


Options:
A: Annualized Relapse Rate (ARR) (Baseline up to 2.5 years)
B: Overview of Adverse Events (AE] (from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)); Overview of AE With Potential Risk of Occurrence (from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max)); Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) (from first study drug intake up to 112 days after last intake or up to the first intake in the extension study LTS6047, whichever occured first (40 weeks max))
C: The Number of T1-Gadolinium Enhancing Lesions During Months 7-9 (9 months)
D: Core Treatment Period: Overview of Failures (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled); Core Treatment Period: Time to Failure: Kaplan-Meier Estimates of the Rate of Failure at Timepoints (Core treatment period between 48 and 118 weeks depending on when the participant was enrolled)

Answer: A