TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A New Interdisciplinary Collaboration Structure in Secondary and Primary Care to Improve Medication Safety in the Elderly
Brief Summary: Suboptimal use of medications among geriatric patients is well-known problem and leads to medication errors, re-hospitalizations and death. By using a randomized controlled trial (RCT) design the investigators aim to explore a new inter-professional working structure. The working structure is based on the scientifically and clinically acknowledged integrated medicines management (IMM) model. The overall aim of the study is to explore the effect of the new working structure on the composite endpoint re-hospitalization + visit to an emergency department during 12 months after hospital discharge.


Options:
A: Medication Appropriateness Index (MAI)-Score (6 months from baseline)
B: Change in appropriateness of anticholinergic medication prescribing practices. (Two years)
C: Emergency medical visits (12 months after hospital discharge)
D: Sudden death: death of endogenous origin within 24 hours after acute onset; Cerebrovascular events: new occurrence or recurrence of a stroke or transient ischemic attack; Cardiac events: new occurrence, aggravation, or recurrence of heart failure, angina pectoris, or acute myocardial infarction; Renal dysfunction: serum creatinine ≥4.0 mg/dl, end stage renal disease, doubling of serum creatinine (however, creatinine ≤2.0 mg/dl is not regarded as an event); Vascular events: new occurrence or aggravation of dissecting aneurysm of aorta, arteriosclerotic occlusion of peripheral artery

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A New Interdisciplinary Collaboration Structure in Secondary and Primary Care to Improve Medication Safety in the Elderly
Brief Summary: Suboptimal use of medications among geriatric patients is well-known problem and leads to medication errors, re-hospitalizations and death. By using a randomized controlled trial (RCT) design the investigators aim to explore a new inter-professional working structure. The working structure is based on the scientifically and clinically acknowledged integrated medicines management (IMM) model. The overall aim of the study is to explore the effect of the new working structure on the composite endpoint re-hospitalization + visit to an emergency department during 12 months after hospital discharge.


Options:
A: Number of Potentially Inappropriate Prescriptions (PIPs). (12 months)
B: Emergency medical visits (12 months after hospital discharge)
C: Health-related quality of life as measured with 15D (16 weeks)
D: Hospitalizations and/or mortality (From Baseline to Month 18)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A New Interdisciplinary Collaboration Structure in Secondary and Primary Care to Improve Medication Safety in the Elderly
Brief Summary: Suboptimal use of medications among geriatric patients is well-known problem and leads to medication errors, re-hospitalizations and death. By using a randomized controlled trial (RCT) design the investigators aim to explore a new inter-professional working structure. The working structure is based on the scientifically and clinically acknowledged integrated medicines management (IMM) model. The overall aim of the study is to explore the effect of the new working structure on the composite endpoint re-hospitalization + visit to an emergency department during 12 months after hospital discharge.


Options:
A: Readmissions (30 days); Admissions (180 days); Emergency Department Visits (180 days); Composite Endpoint, Admissions or Emergency Department Visits (180 days)
B: Total Number of Medications (Hospital Discharge, Post-Acute Care Discharge, and 90 days after discharge from the PAC)
C: Emergency medical visits (12 months after hospital discharge)
D: Rate (%) of 30-day Post-discharge Hospitalization and ED Visits (Including Hospitals at Least Statewide) (Hospitalization to a hospital or ED visit within 30 days of discharge (checking at least all same state facilities))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Technology and Online Tools to Improve Asthma Control in Adolescents
Brief Summary: This project will fully develop and preliminarily validate CampAir, an empirically-based dynamic e-health intervention (based on the evidence-based ASMA) to assist adolescents with uncontrolled asthma to learn how to manage their illness and improve their asthma control. In addition to developing a highly novel product for adolescents with asthma, the research proposed for this project will address unique scientific questions. Despite the high asthma prevalence among adolescents, few interventions have specifically targeted adolescents. This study is innovative in that it is among the few to focus on adolescents, who are often overlooked by the healthcare system. This research will assess factors associated with successful implementation of CampAir, thereby providing new information regarding how e-health interventions can be effectively developed and implemented for use with adolescents with asthma.


Options:
A: Pulmonary functioning (FEV-1, FVC) (Measured at study entry and Months 7 (post treatment) and 12); Hospital and emergency department utilization (for asthma exacerbation) (Measured at study entry and Months 7 (post treatment) and 12)
B: Product Evaluation (Once per module (One Evaluation per week for seven weeks))
C: Night Wakenings Due to Asthma (To assess change, this measure will be taken: (1) prior to starting the trial (baseline); (2) within two weeks of completing the last module (immediate post-test); and (3) one month after completing their last module (1-month follow-up).)
D: Proportion of Eligible Children who Participate in Study (End of enrollment: estimated 2 years after beginning active enrollment.); Participant Drop-out Rates (After final outcome measures are collected: up to 2 1/2 years from beginning of active enrollment.); Session Completion Rates (After final participant has completed study: estimated 2 1/2 years after beginning active enrollement.); Program Satisfaction Survey (End of Study Participation: up to 5 months from initial enrollment.); Barriers to offering the Intervention in Selected Schools (End of enrollment: estimated 2 years after beginning active enrollment.); Child Depression Inventory (Pre and Post Intervention: baseline, up to 4 months later.); State-Trait Anxiety Inventory for Children (Pre and Post Intervention: baseline, up to 4 months later.); Perceived Stress Scale (Pre and post intervention: baseline, up to 4 months later.); Pediatric Asthma Quality of Life Questionnaire (Pre and Post Intervention: baseline, up to 4 months later.); Asthma Self-Management Scale (Pre and Post Intervention: baseline, up to 4 months later.); KIDCOPE (Pre and Post Intervention: baseline, up to 4 months later.); Measure of Current Status (MOCS - Adapted) (Pre and Post Intervention: baseline, up to 4 months later.); Change in Asthma Health from Baseline (Pre to post-intervention: baseline, up to 4 months later.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mobile Technology and Online Tools to Improve Asthma Control in Adolescents
Brief Summary: This project will fully develop and preliminarily validate CampAir, an empirically-based dynamic e-health intervention (based on the evidence-based ASMA) to assist adolescents with uncontrolled asthma to learn how to manage their illness and improve their asthma control. In addition to developing a highly novel product for adolescents with asthma, the research proposed for this project will address unique scientific questions. Despite the high asthma prevalence among adolescents, few interventions have specifically targeted adolescents. This study is innovative in that it is among the few to focus on adolescents, who are often overlooked by the healthcare system. This research will assess factors associated with successful implementation of CampAir, thereby providing new information regarding how e-health interventions can be effectively developed and implemented for use with adolescents with asthma.


Options:
A: Objective Adherence to ICS (Baseline); Change in objective adherence to ICS (Change from baseline in objective adherence to ICS at 1 month); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 2 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 3 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 4 months in intervention compared to control); Change in objective adherence to ICS (Continuous change over time from baseline in objective adherence to ICS at 5 months in intervention compared to control); Feasibility, Acceptability and Usability of the Text Messaging Website (At time of text messaging intervention); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 1 month after receiving text messages); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 2 months after receiving text messages); Feasibility, Acceptability and Usability of the Text Messaging Website (up to 3 months after receiving text messages)
B: device monitored adherence rate (up to 6 months)
C: Change from Baseline in adherence rate to entire treatment period (From baseline to end of participation (up to 3 months))
D: Product Evaluation (Once per module (One Evaluation per week for seven weeks))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Controlled Trial of Costs Associated With Anemia Therapy in Hemodialysis Patients Treated With Intravenous Darbepoetin Alfa Versus Epoetin Alfa
Brief Summary: The purpose of this study is to determine if there is a cost difference between darbepoetin alfa and epoetin alfa when used intravenously to treat anemia in hemodialysis patients.


Options:
A: Hemoglobin response rate (Weeks 1-24)
B: Cost of Erythropoiesis Stimulating Agent (12 months)
C: changes in gene-arrays, EPC and biomarkers panels (14 days, 6 and 12 months)
D: The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range (Weeks 16-28)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Association Between the Transcranial Direct Current Stimulation (tDCS) and Functional Electrical Stimulation (FES) for Upper-limb Rehabilitation After Stroke - A Randomized Clinical Trial
Brief Summary: The aim of this study is to verify the effectiveness of tDCS combined with FES on upper limb rehabilitation of post-stroke subjects with moderate and severe compromise.


Options:
A: change in function before/after tDCS (Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months)
B: Upper-limb reaching analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400) (Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up))
C: Upper Extremity Component of Fugl-Meyer Assessment (week 0, week 2, week 4)
D: Change from baseline Fugl Meyer Assessment(FMA)upper extremities subscale after intervention (Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)); Change from baseline Active joint activity after intervention (Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)); Change from baseline Muscle tone after intervention (Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: PREventive Care Infrastructure Based On Ubiquitous Sensing (PRECIOUS)
Brief Summary: The goal of the MI field test is to assess users' overall satisfaction, usability and acceptability of the PRECIOUS system, and to explore if MI in combination with gamification principles is a feasible solution to foster adherence to PRECIOUS system. Moreover, it is pursued to trigger behavior change and build up motivation to maintain sustained change towards healthy lifestyles. The field test at University Hospital Vall d'Hebron will be carried out with morbidly obese pre-diabetic patients. This pilot test will serve to explore users' acceptance of PRECIOUS system in an early stage of its development. Considering that this is a pilot test, feedback and outcomes obtained will serve to refine and adjust PRECIOUS system concept and architecture.


Options:
A: Adherence to the trial (6 months); Adherence to the intervention arms (6 months)
B: Patients' subjective assessment of usability of the PRECIOUS system (At the end of the test (Session 5, week 12)); Satisfaction with the PRECIOUS system (At the end of the test (Session 5, week 12)); User's acceptance of the PRECIOUS system (At the end of the test (Session 5, week 12)); Effectiveness of the PRECIOUS system (At the end of the test (Session 5, week 12))
C: Body Mass Index (12 months)
D: Change in Weight (Baseline, 1 month, 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: PRIMM Trial (Phone Reminder for IMMunization) in Ondo State, Nigeria
Brief Summary: The purpose of this study is to determine if in a rural setting of Ondo State, Nigeria, a customized automated telephone and email immunization reminder system will be feasible, acceptable, and significantly improve immunization utilization rates.


Options:
A: Exclusive breastfeeding (0-6 months following delivery); Immediate breastfeeding (1 hour following delivery)
B: Immunization Rates at 14 weeks (14 Weeks)
C: EPI vaccines and other health interventions coverage (1 year); Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine (1 year)
D: ANC (Assess the recommend number of ANC (4 ANC) coverage 18 months after intervention); PNC (Assess the recommend number of PNC (3 ANC) coverage 18 months after intervention); Contraceptive prevalence rate (CPR) (Assess the Contraceptive prevalence rate (CPR) at the end of intervention of 18 months.); EPI coverage (Assess the EPI vaccination coverage at the end of the intervention of 18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens
Brief Summary: This study will leverage available technologies and test strategies to impart the Universal Medication Schedule (UMS) in primary care to help patients understand, consolidate, safely use, and adhere to their complex medication regimens.


Options:
A: medication errors in the patients (Baseline, 1, 3 and 6 months)
B: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)
C: Overall Decisional Comfort (0-100, 100=no Conflict) (Day 1)
D: Medication Adherence - Pill Count (6 months after Baseline); Medication Adherence - Proper Use (6 Months after Baseline); Medication Adherence - ASK12 (6 Months after Baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: TEC4Home: Telehealth for Emergency-Community Continuity of Care Connectivity Via Home-Telemonitoring
Brief Summary: Modern technology like computers, smartphones and the Internet enable patients to measure certain health indicators, like blood pressure and body weight, from the comfort of their own homes. This information can also be shared electronically with doctors and other healthcare providers to monitor remotely. This is called home health monitoring. In TEC4Home, we are developing a home monitoring solution for patients with heart failure to support their care and recovery at home after a visit to the emergency department. We hope to show that this solution decreases revisits to the emergency department and increases quality of life for patients.


Options:
A: 180 day rehospitalization rate (at 180 days post-discharge)
B: Stroke Symptom and Response Knowledge Assessment (student) (Up to 3 days from baseline); Assessment of child's communication to parent regarding stroke symptoms. (Up to 7 days from baseline)
C: Change in number of emergency department revisits 90 day pre and 90 days post enrollment. (90 days); Change in the number of hospitalizations (90 days); Change in the length of stay (in days) (90 days); Mortality rate (90 days)
D: Rates of stillbirth (36 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: General Anesthesia Versus Sedation During Intra-arterial Treatment for Stroke
Brief Summary: In France, the annual incidence rate of acute ischaemic stroke is around 150 000 patients, 65 % of whom keep long-term disability. Several multicentric randomized controlled trials have shown the benefit of a mechanical thrombectomy in the acute phase of ischaemic stroke on functional disability, compared to a medical treatment alone (thrombolysis).

The timeliness of revascularisation is an essential factor of good prognosis. This intra-arterial treatment, associated with thrombolysis if applicable, is the reference treatment of large-vessel occlusion. The stillness of the patient is required to control the safety of the recanalization. Currently, either a general anesthesia or a sedation can be performed.

Several studies have shown a trend to superiority of the sedation but none was conducted with a high level of proof methodology.

The aim of our multicentric randomized controlled trial is to compare sedation and general anesthesia during intra-arterial thrombectomy for an acute ischaemic stroke in the anterior cerebral circulation. The main outcome will be the efficacy on the functional neurological prognosis at 3 months.


Options:
A: modified Rankin scale (mRS) 0-1 (favourable outcome) at Day 90 (at day 90)
B: Score on the modified Rankin scale (3 months)
C: modified Rankin score (post-procedural 30 days)
D: Number of Participants With a Score of 5 or 6 on the Modified Rankin Scale (mRS) (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian
Brief Summary: This is a randomized, open-label, two-arm study in patients with relapsed epithelial ovarian tumors. Patients will be randomized in a 1:1 ratio to receive olaparib or standard chemotherapy with the possibility of crossover at the time of progression.


Options:
A: Efficacy: Progression Free Survival (PFS) (An average of 30 months for each participant); Safety: Number of Evacuations Per Day (Evacuation were collected daily for the first four weeks of treatment of experimental drugs)
B: Overall Objective Response (1 year after end inclusion)
C: Progression-Free Survival (PFS) in Cohort With Germline BReast CAncer Gene (BRCA) Mutation (gBRCA) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BCRA With Homologous Recombination Deficiency-positive (HRD+) Tumors (Non-gBRCAmut HRD+) (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days); Progression-Free Survival (PFS) in Cohort With No Germline BRCA Mutation (From date of randomization to the earliest date of disease progression or death from any cause, up to 7 years, 7 months and 4 days)
D: Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS) (Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian
Brief Summary: This is a randomized, open-label, two-arm study in patients with relapsed epithelial ovarian tumors. Patients will be randomized in a 1:1 ratio to receive olaparib or standard chemotherapy with the possibility of crossover at the time of progression.


Options:
A: To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer (The time frame is 82.5 months (median duration of follow-up)); To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer (The time frame is 82.5 months (median duration of follow-up).)
B: Progression-Free Survival (8 Months on average)
C: Overall Objective Response (1 year after end inclusion)
D: Progression-free survival (Apr 2013)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian
Brief Summary: This is a randomized, open-label, two-arm study in patients with relapsed epithelial ovarian tumors. Patients will be randomized in a 1:1 ratio to receive olaparib or standard chemotherapy with the possibility of crossover at the time of progression.


Options:
A: Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.); Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study) (Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.)
B: Median Progression-free Survival (PFS) in each study arm (average of 18 months)
C: Progression-free survival based on investigator assessment using RECIST and clinical findings (Assessed within 12 months following completion of accrual)
D: Overall Objective Response (1 year after end inclusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian
Brief Summary: This is a randomized, open-label, two-arm study in patients with relapsed epithelial ovarian tumors. Patients will be randomized in a 1:1 ratio to receive olaparib or standard chemotherapy with the possibility of crossover at the time of progression.


Options:
A: Progression Free Survival (PFS) (According to Response Evaluation Criteria in Solid Tumours [RECIST]) (Radiologic scans performed at baseline then every 12 weeks (+/- 1 week) for the first 60 weeks, then every 24 weeks (+/-1 week) thereafter, assessed maximum up to 14 months.)
B: ORR (Up to 2 years); PFS (Up to 2 years)
C: Progression free survival (30 months)
D: Overall Objective Response (1 year after end inclusion)

Answer: D