TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Parallel-group, Open-label Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This is a 12-week, multicentre, randomized, open-label, 2-arm, parallel-group study designed to compare the efficacy and safety of umeclidinium inhalation powder (62.5 mcg once daily \[QD\]) administered via a novel Dry Powder Inhaler (nDPI) with glycopyrronium (44 mcg QD) administered via a Breezhaler® inhaler in subjects with COPD over 12 weeks of treatment. At the end of the run-in period, eligible subjects will be randomized in a 1:1 ratio to receive umeclidinium 62.5 mcg administered via nDPI or glycopyrronium 44 mcg administered via BREEZHALER inhaler. There will be up to 8 clinic visits conducted on an outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), Randomization at Day 1 (Visit 2), and after Randomization at Day 2 (Visit 3), Day 28 (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). The total duration of subject participation in the study will be approximately 15 weeks. The primary endpoint of the study is clinic visit trough FEV1 (forced expiratory volume in one second) on treatment Day 85. All subjects will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of open-label study medication at Visits 3 to 7.

BREEZHALER is a registered trademark of Novartis AG.


Options:
A: Change From Baseline in Trough FEV1 on Day 85 (Baseline (BL) and Day 85)
B: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
C: 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)
D: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Parallel-group, Open-label Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This is a 12-week, multicentre, randomized, open-label, 2-arm, parallel-group study designed to compare the efficacy and safety of umeclidinium inhalation powder (62.5 mcg once daily \[QD\]) administered via a novel Dry Powder Inhaler (nDPI) with glycopyrronium (44 mcg QD) administered via a Breezhaler® inhaler in subjects with COPD over 12 weeks of treatment. At the end of the run-in period, eligible subjects will be randomized in a 1:1 ratio to receive umeclidinium 62.5 mcg administered via nDPI or glycopyrronium 44 mcg administered via BREEZHALER inhaler. There will be up to 8 clinic visits conducted on an outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), Randomization at Day 1 (Visit 2), and after Randomization at Day 2 (Visit 3), Day 28 (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). The total duration of subject participation in the study will be approximately 15 weeks. The primary endpoint of the study is clinic visit trough FEV1 (forced expiratory volume in one second) on treatment Day 85. All subjects will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of open-label study medication at Visits 3 to 7.

BREEZHALER is a registered trademark of Novartis AG.


Options:
A: Change From Baseline in Trough FEV1 on Day 85 (Baseline (BL) and Day 85)
B: Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169 (Baseline and Day 169)
C: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Visit 8) (Baseline (BL) and Day 85)
D: Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI (Up to Week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sustainability of a Multidimensional Knowledge Translation Intervention to Improve Paediatric Pain Practices and Outcomes
Brief Summary: The purpose of this research study is to evaluate the effectiveness of short refresher sessions. "Pain Practice Change Boosters" given at regular intervals to sustain improved pain process (assessment and management) and clinical outcomes (pain intensity) achieved during a 15 month knowledge translation intervention, Evidence-based Practice for Improving Quality (EPIQ), in 8 children's hospitals in Canada; and to determine the factors that affect that sustainability. The CIHR Team in Children's Pain (2006-2011) evaluated the effectiveness of the EPIQ intervention in 32 hospital units (4 units at each hospital site). 16 hospital units were allocated to the intervention group and 16 units continued with standard care. The current study focuses on the 16 hospital units that implemented the EPIQ intervention only.


Options:
A: To measure analgesic effectiveness of the 5 S's (swaddling, side/stomach position, shushing, swinging, and sucking) alone and combined with sucrose, during routine immunizations at 2 and 4 month well child visits. (every 15 sec)
B: infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure
C: Pain measured on PIPP (Premature Infant Pain Profile) scale (4 week to complete)
D: Pain Process Outcomes (pain assessment) (T1 (Baseline)); Factors Influencing Sustainability: The Alberta Context Tool (ACT) (T1 (Baseline)); Pain Process Outcomes (pain assessment) (T2 (12 months following the implementation of the Booster)); Pain Process Outcomes (pain assessment) (T3 (24 months following the implementation of the Booster)); Factors Influencing Sustainability: The Alberta Context Tool (ACT) (T2 (12 months following the implementation of the Booster)); Factors Influencing Sustainability: The Alberta Context Tool (ACT) (T3 (24 months following the implementation of the Booster)); Pain Process Outcomes (pain management) (T1 (Baseline)); Pain Process Outcomes (pain management) (T2 (12 months following the implementation of the Booster)); Pain Process Outcomes (pain management) (T3 (24 months following the implementation of the Booster))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfer Modality Research Initiative - Bangladesh
Brief Summary: This is a randomized control trial in two zones of Bangladesh (north and south). Treatment is assigned at the village level where treatments are: cash transfers (north and south); cash transfers + nutrition behavior communication change (north only); food transfers (north and south); food transfers + nutrition behavior communication change (south only); food-cash split (north and south); and controls (north and south). Within treatment localities, women living in very poor households are targeted to receive benefits for two years.


Options:
A: Child anthropometry (Baseline. Up to 12 months. Up to 24 months.); Child food intake (Baseline. Up to 12 months. Up to 24 months.); Child health (Baseline. Up to 12 months. Up to 24 months.); Distribution of food intake within the household (Baseline. Up to 12 months. Up to 24 months.); Household food security (Baseline. Up to 12 months. Up to 24 months.); Maternal nutrition knowledge (Baseline. Up to 12 months. Up to 24 months.)
B: Stunting in Children at 18 mo (18 months of age)
C: body mass index (three years)
D: Body mass index (2005, 2006, 2007, 2008); nutrition behavior (2005, 2006, 2007, 2008); physical activity (2005, 2006, 2007, 2008)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfer Modality Research Initiative - Bangladesh
Brief Summary: This is a randomized control trial in two zones of Bangladesh (north and south). Treatment is assigned at the village level where treatments are: cash transfers (north and south); cash transfers + nutrition behavior communication change (north only); food transfers (north and south); food transfers + nutrition behavior communication change (south only); food-cash split (north and south); and controls (north and south). Within treatment localities, women living in very poor households are targeted to receive benefits for two years.


Options:
A: Change in physical activity (Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention)
B: Physical Activity Level (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Physical Literacy (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Dietary Intake (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.)
C: Child anthropometry (Baseline. Up to 12 months. Up to 24 months.); Child food intake (Baseline. Up to 12 months. Up to 24 months.); Child health (Baseline. Up to 12 months. Up to 24 months.); Distribution of food intake within the household (Baseline. Up to 12 months. Up to 24 months.); Household food security (Baseline. Up to 12 months. Up to 24 months.); Maternal nutrition knowledge (Baseline. Up to 12 months. Up to 24 months.)
D: Change in glycemic control, change in dietary intake (18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfer Modality Research Initiative - Bangladesh
Brief Summary: This is a randomized control trial in two zones of Bangladesh (north and south). Treatment is assigned at the village level where treatments are: cash transfers (north and south); cash transfers + nutrition behavior communication change (north only); food transfers (north and south); food transfers + nutrition behavior communication change (south only); food-cash split (north and south); and controls (north and south). Within treatment localities, women living in very poor households are targeted to receive benefits for two years.


Options:
A: Child anthropometry (Baseline. Up to 12 months. Up to 24 months.); Child food intake (Baseline. Up to 12 months. Up to 24 months.); Child health (Baseline. Up to 12 months. Up to 24 months.); Distribution of food intake within the household (Baseline. Up to 12 months. Up to 24 months.); Household food security (Baseline. Up to 12 months. Up to 24 months.); Maternal nutrition knowledge (Baseline. Up to 12 months. Up to 24 months.)
B: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
C: To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program; a physical activity skill development program; and a parent-centered dietary modification + physical activity skill development program.
D: body mass index (three years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Transfer Modality Research Initiative - Bangladesh
Brief Summary: This is a randomized control trial in two zones of Bangladesh (north and south). Treatment is assigned at the village level where treatments are: cash transfers (north and south); cash transfers + nutrition behavior communication change (north only); food transfers (north and south); food transfers + nutrition behavior communication change (south only); food-cash split (north and south); and controls (north and south). Within treatment localities, women living in very poor households are targeted to receive benefits for two years.


Options:
A: Eating habits (3 years); Physical activity (3 years); Nature relatedness (3 years)
B: Change in child adiposity from baseline measured via BMI z-score (Enrollment, 6 months, 12 months, 18 months, 24 months); Change in adult adiposity from baseline measured via BMI (Enrollment, 12 months, 24 months)
C: Intake of vegetables and fruit (One month)
D: Child anthropometry (Baseline. Up to 12 months. Up to 24 months.); Child food intake (Baseline. Up to 12 months. Up to 24 months.); Child health (Baseline. Up to 12 months. Up to 24 months.); Distribution of food intake within the household (Baseline. Up to 12 months. Up to 24 months.); Household food security (Baseline. Up to 12 months. Up to 24 months.); Maternal nutrition knowledge (Baseline. Up to 12 months. Up to 24 months.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Study of the Safety and Immunogenicity of Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV LID ΔM2-2 in RSV-Seronegative Infants and Children
Brief Summary: Respiratory syncytial virus (RSV) is a common cause of illness in infants and children around the world. This study will evaluate the safety and immune response to an RSV vaccine in RSV-seronegative infants and children.

This study is a companion study to CIR 291.


Options:
A: Frequency of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study, the first 28 days after inoculation (Measured through Day 28); Severity of vaccine-related solicited AEs that occur during the acute monitoring phase of the study, the first 28 days after inoculation (Measured through Day 28); Frequency of vaccine-related lower respiratory illness (Measured through Day 56); Proportion of participants that develop 4-fold or greater rises in RSV-neutralizing antibody titer following vaccination (Measured through Day 56)
B: Percentage of Participants Who Had a First Episode of Acute Respiratory Syncytial Virus-Associated Respiratory Illness (ARA-RI) During Respiratory Syncytial Virus (RSV) Surveillance Period in Season 1 (Day 14 after dosing through end of surveillance period (approximately 7 months))
C: Incidence of Skin and Soft Tissue Infection (SSTI) (At the end of the 20 month study); Incidence of Methicillin-resistant Staphylococcus Aureus (MRSA)-Associated SSTI (At the end of the 20 month study)
D: Number of Participants With Solicited Adverse Events (AEs) by Grade (Measured from Day 0 through Day 28); Number of Participants With Unsolicited AEs by Grade (Measured from Day 0 through Day 28); Number of Participants With Serious Adverse Events (SAEs) (Measured from Day 0 through Day 56); Number of Participants Infected With RSV Vaccine Virus (Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28 for nasal washes, and at Days 0, 56 for serum RSV-neutralizing antibodies); Peak Titer of Vaccine Virus Shed (Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28); Duration of Vaccine Virus Shedding in Nasal Washes (Measured at Days 0, 3, 5, 7, 10, 12, 14, 17, and 28. Last day positive is reported.); Number of Participants With a Greater Than or Equal to 4-fold Rise in Serum RSV-neutralizing Antibody Titer (Measured at Day 0 and Day 56); Serum Antibody Responses to RSV F Glycoprotein as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) (Measured at Day 56)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Comparison of MynxGrip Vascular Closure Device and Manual Compression for Closure After Femoral Access Angiography. The Closure Devices Used in Every Day Practice Study, CLOSE-UP III Trial
Brief Summary: Is the MynxGrip (test device) non-inferior to manuel compression (standard comparator) in the incidence of adverse access site related events in-hospital, at 30 days and at 6 months.


Options:
A: Rate of ipsilateral palpable groin hematomas with largest diameter exceeding 5 cm. (20 minutes, 1 hour and at discharge, pooled)
B: Time to Hemostasis (TTH) (From when the introducer sheath was removed to the time hemostasis was first observed); Time to Ambulation (TTA) (From when the introducer sheath was removed to 30 days post-procedure); Percentage of Patients Who Experience Any Vascular Closure Related Major Adverse Events During the 30 Days Post-procedure (From post-procedure to 30 days follow up)
C: Incidence at 30 days of the composite endpoint of serious access site related major adverse vascular events (MAVE) (30 days)
D: Composite of arterial access related complications (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Cognitive Benefits of Interactive Mental and Physical Exercise for Older Adults at Risk for or With Mild Cognitive Impairment (MCI)
Brief Summary: The purpose of this study is to clarify the benefits to brain health and thinking processes that result from different forms of exercise. This study will examine the effectiveness of cybercycling (virtual reality enhanced stationary cycling) for persons at risk for and with MCI, and compare this with the individual cognitive, behavioral, and physiological effects of physical and mental exercise alone. The Investigators hypothesis that cognitive benefit will be greatest for combined aerobic and cognitive exercise compared to physical and mental exercise alone.


Options:
A: Change from baseline in executive function at 6-months (Baseline and 6-months)
B: Global cognitive function (Change is being assessed: "baseline" and "immediately after the completion" (2 months)); Selective attention (Change is being assessed: "baseline" and "immediately after the completion" (2 months)); Visual-spatial perception (Change is being assessed: "baseline" and "immediately after the completion" (2 months))
C: Change in cognitive function after three months of exercise. (3 months)
D: Changes in Global Cognition (Both, the pre- and the post-measurements of the primary outcome measurement will take place within two weeks prior to starting or after completing the intervention.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Quality of Life in Nursing Home Residents: A Cluster Randomized Clinical Trial of Efficacy (The KOSMOS Study)
Brief Summary: Improving quality of life (QoL) in residents of nursing homes:

A cluster randomized clinical trial of efficacy - The KOSMOS study.

COSMOS (COmmunication (Advance Care Planning - ACP), Systematic pain assessment and treatment, Medication review, Occupational therapy, and Safety) is a practical intervention aimed to improve clinical and psychiatric challenges in NH patients. The COSMOS intervention combines the most effective research results to improve staff competence and patients' mental health, safety, QoL. We also aim to reduce psychotropic drug use and costs.


Options:
A: Proportion of residents receiving at least one antipsychotic medication after 12 months (12 months)
B: Agitation Behavior Mapping Instrument (ABMI) (10 days of intervention vs. 10 days of baseline)
C: Neuropsychiatric symptoms (9 months); Quality of life (9 months)
D: Antipsychotic Efficacy (Day 43)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Quality of Life in Nursing Home Residents: A Cluster Randomized Clinical Trial of Efficacy (The KOSMOS Study)
Brief Summary: Improving quality of life (QoL) in residents of nursing homes:

A cluster randomized clinical trial of efficacy - The KOSMOS study.

COSMOS (COmmunication (Advance Care Planning - ACP), Systematic pain assessment and treatment, Medication review, Occupational therapy, and Safety) is a practical intervention aimed to improve clinical and psychiatric challenges in NH patients. The COSMOS intervention combines the most effective research results to improve staff competence and patients' mental health, safety, QoL. We also aim to reduce psychotropic drug use and costs.


Options:
A: Neuropsychiatric symptoms (9 months); Quality of life (9 months)
B: symptoms related to posttraumatic stress disorder
C: The number of questions asked or the concerns expressed that elicit a medical comment by the patient or the family during the palliative care consultation. (one month)
D: Decision support quality audit using simulated patients measured by the validated and reliable Decision Support Analysis Tool (6 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Quality of Life in Nursing Home Residents: A Cluster Randomized Clinical Trial of Efficacy (The KOSMOS Study)
Brief Summary: Improving quality of life (QoL) in residents of nursing homes:

A cluster randomized clinical trial of efficacy - The KOSMOS study.

COSMOS (COmmunication (Advance Care Planning - ACP), Systematic pain assessment and treatment, Medication review, Occupational therapy, and Safety) is a practical intervention aimed to improve clinical and psychiatric challenges in NH patients. The COSMOS intervention combines the most effective research results to improve staff competence and patients' mental health, safety, QoL. We also aim to reduce psychotropic drug use and costs.


Options:
A: Effects on hospital visits (1 year)
B: Change in appropriateness of anticholinergic medication prescribing practices. (Two years)
C: Neuropsychiatric symptoms (9 months); Quality of life (9 months)
D: Complete discontinuation of the targeted potentially inappropriate medication (e.g. benzodiazepines, oxybutynin) (6 months post-intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Quality of Life in Nursing Home Residents: A Cluster Randomized Clinical Trial of Efficacy (The KOSMOS Study)
Brief Summary: Improving quality of life (QoL) in residents of nursing homes:

A cluster randomized clinical trial of efficacy - The KOSMOS study.

COSMOS (COmmunication (Advance Care Planning - ACP), Systematic pain assessment and treatment, Medication review, Occupational therapy, and Safety) is a practical intervention aimed to improve clinical and psychiatric challenges in NH patients. The COSMOS intervention combines the most effective research results to improve staff competence and patients' mental health, safety, QoL. We also aim to reduce psychotropic drug use and costs.


Options:
A: Improvement of drug prescribing (Participants will be followed for the duration of hospital stay, an expected average of 12 days)
B: Health-related quality of life (6 months)
C: Emergency medical visits (12 months after hospital discharge)
D: Neuropsychiatric symptoms (9 months); Quality of life (9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster-randomized, Non-inferiority Open-label Trial of the Impact of Supplementation Regimen on Consumption of Prenatal Calcium and Iron/Folic Acid Supplements and Adherence to Related Recommendations
Brief Summary: The World Health Organization (WHO) now recommends prenatal calcium supplementation for prevention of preeclampsia in populations with inadequate dietary intake. This study seeks to compare the effect of two dosing strategies on the amount of supplement ingested by pregnant women and adherence to related recommendations.


Options:
A: Framingham cardiovascular disease risk (12 months)
B: Amount of calcium supplement ingested (8 weeks after ANC consultation, during which recruitment into the study occurred)
C: Proportion of participants with a PrEP prescription at baseline who initiate PrEP (6 months post enrollment); Proportion of participants with a PrEP prescription at baseline who attend at least one follow-up visit and have at least one documented PrEP prescription refill during each 3-month interval (6 months post enrollment); Percentage of participants with a PrEP prescription at baseline who adhere to their PrEP regimen (6 months post enrollment)
D: unmet need (past 6 months); abstinent from alcohol and opioid use, past 30 days (past 30 days); negative consequences related to substance use (past 3 months); Functioning (past 4 weeks); Engagement (30 days of initiation); initiation (Within 14 days of index visit); heavy alcohol use (6 months)

Answer: B