TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: PONENTE: A Multicenter, Open-label, Phase 3b Efficacy and Safety Study of Benralizumab 30 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Patients With Severe Eosinophilic Asthma on High Dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Chronic Oral Corticosteroid Therapy
Brief Summary: This is a study designed to evaluate efficacy and safety of Benralizumab in reducing the Oral Corticosteroid (OCS) use in adult patients with severe asthma who are receiving OCS with or without additional asthma controller medications.


Options:
A: Mean Change From Baseline (BL) in St. George's Respiratory Questionnaire (SGRQ) Score at Week 24 (Baseline and Week 24)
B: Annualized Rate of On-treatment Exacerbations Per Year (Baseline (Week 0) to Week 172); Number of Participants With Any On-treatment Adverse Event (AE) or On-treatment Serious AE (SAE) (Baseline (Week 0) to Week 172)
C: Patients Who Achieve 100% Reduction in Daily OCS Dose (Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.)); Patients Who Achieve 100% Reduction or a Daily OCS Dose of <=5mg (Baseline to end of OCS reduction phase, an average of approximately 200 days (The duration of the OCS reduction phase may vary based on asthma exacerbations, asthma worsening, HPA integrity , or other safety issues altering the OCS titration schedule.))
D: Number of Clinically Significant Exacerbations of Asthma Per Year (From randomization (Week 0) to Week 52 or early withdrawal (EW))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Brief Summary: This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the F508del mutation (F/F) or heterozygous for F508del with an eligible residual function mutation (F/RF).


Options:
A: Absolute Change From Study Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Average of Week 4 and Week 8 (Baseline, Week 4 and Week 8 of each treatment period)
B: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 120)
C: Number of Participants With Treatment-Emergent Adverse Events (First administration (Day 1) through Follow-up (Day 43))
D: Absolute Change in Lung Clearance Index 2.5 (LCI2.5) Through Week 8 (From baseline through Week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Brief Summary: This study will evaluate the efficacy of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 through 11 years, who are homozygous for the F508del mutation (F/F) or heterozygous for F508del with an eligible residual function mutation (F/RF).


Options:
A: CFTR activity as assessed by nasal transepithelial potential difference (TEPD) (84 days)
B: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Day 1 up to Week 100)
C: Absolute Change in Lung Clearance Index 2.5 (LCI2.5) Through Week 8 (From baseline through Week 8)
D: Absolute Change From Baseline in Percent-predicted Forced Expiratory Volume in One Second (ppFEV1) at Week 48 (From Baseline to Week 48)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Compliance and Technical Assistance for Child and Adult Care Food Program in Family Child Care Homes
Brief Summary: This study evaluates the effect of a nutrition technical assistance training program for family child care home providers on the food they serve young children in their care and the food environment in their home. Half the providers will be assigned to the nutrition program and the other half will receive a comparison on environmental health.


Options:
A: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
B: Change in self-reported nutrition practices (baseline, post 3-months, post 12-months)
C: Change in BMIz (Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).)
D: Body mass index (2005, 2006, 2007, 2008); nutrition behavior (2005, 2006, 2007, 2008); physical activity (2005, 2006, 2007, 2008)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Compliance and Technical Assistance for Child and Adult Care Food Program in Family Child Care Homes
Brief Summary: This study evaluates the effect of a nutrition technical assistance training program for family child care home providers on the food they serve young children in their care and the food environment in their home. Half the providers will be assigned to the nutrition program and the other half will receive a comparison on environmental health.


Options:
A: Change in Child Physical Activity (Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.); Change in Child Dietary Intake (Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.)
B: Difference Between Interventions in Vegetable Intake (One meal per week for each intervention (Study weeks 1, 2, 3, and 4))
C: Change in self-reported nutrition practices (baseline, post 3-months, post 12-months)
D: Change in Child BMI-z score (Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned); Modified change in BMI z-score (Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: SeRenade Parent-Child Music Class Program for Families of Children With and Without ASD
Brief Summary: This pilot study examines the impact of the SeRenade Parent-Child Music Class Program, which emphasizes parent training, peer inclusion, and musical play combined with established behavioral techniques, on the development of child social engagement, positive behavior, and parental well-being.


Options:
A: Children's Communication Checklist-2 (12 weeks); Brain connectivity of frontotemporal regions (12 weeks)
B: Changes of Childhood Autism Rating Scale-2 (Pre-test 2 weeks before Day 1); Changes of Childhood Autism Rating Scale-2 (2 weeks after intervention); Changes of Childhood Autism Rating Scale-2 (4 months after intervention); Changes of Social Responsiveness Scale second edition (Pre-test 2 weeks before Day 1); Changes of Social Responsiveness Scale second edition (2 weeks after intervention); Changes of Social Responsiveness Scale second edition (4 months after intervention); In-session social behavior (Day 1); In-session social behavior (Last intervention session, approximately 12 weeks after Day 1.)
C: Motor Imitation Scale (Change from pre to post program (baseline and 12-weeks)); Actions & Gestures (Change from pre to post program (baseline and 12-weeks)); Parenting Stress Index, 4th edition Short Form (Change from pre to post program (baseline and 12-weeks)); Parenting Efficacy/Quality (Change from pre to post program (baseline and 12-weeks))
D: The Arabic Language test (Baseline,Change from Baseline at the end of 12 Months Music Therapy .)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Telehealth Cognitive Behavioral Stress Management for Adults With Cystic Fibrosis
Brief Summary: The purpose of this study to to assess the feasibility, acceptability, and satisfaction of a telehealth cognitive behavioral stress management (CBSM) intervention among adults with cystic fibrosis (CF) who exhibit elevated anxiety and/or depression symptoms.


Options:
A: Measure Change in Weight in Adults With Cystic Fibrosis (CF) Related Wasting Following Growth Hormone (GH) Therapy (14 months)
B: Feasibility (patient perspective) (Week 0 (baseline)); Feasibility (clinician perspective) (Week 8); Acceptability (patient perspective 1 of 2) (Week 8); Acceptability (patient perspective 2 of 2) (Week 8); Satisfaction (patient perspective 1 of 2) (Week 8); Satisfaction (patient perspective 2 of 2) (Week 8)
C: The primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve BMI and pulmonary function in cystic fibrosis patients who have diabetes (12 months)
D: HbA1c (2 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Monocentric Trial of Mechanical Bowel Preparation Alone vs Mechanical Bowel Preparation Combined With Oral Antibiotics Before Colorectal Resections for Cancer
Brief Summary: Investigation of the role of adding oral antibiotics to preoperative mechanical bowel preparation before colorectal surgery for cancer.


Options:
A: Surgical Site Infections (30 days)
B: Wound infection (up to 30 days after surgery)
C: Incidence of post-operative surgical site infection (SSI) including superficial/incisional, deep, and organ space, anastomotic dehiscence and leak (Up to 30 days post operation)
D: The primary endpoint of the study was anastomotic failure.

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers: International Randomized Trial
Brief Summary: Background: Preterm birth has major medical, psychological and socio-economic consequences worldwide. A recent systematic review suggests positive effects of music therapy (MT) on physiological measures of preterm infants and maternal anxiety, but methodologically rigorous studies including long-term follow-up of infant and parental outcomes are missing. Drawing upon caregivers' inherent resources, this study emphasizes caregiver involvement in MT to promote attuned, developmentally-appropriate musical interactions that may be of mutual benefit to infant and parent. This study will determine whether MT, as delivered by a qualified music therapist during neonatal intensive care unit (NICU) hospitalization and/or in home/municipal settings following discharge, is superior to standard care in improving bonding between primary caregivers and preterm infants, parent well-being and infant development.

Methods: Design: International multi-center, assessor-blind, 2x2 factorial, pragmatic randomized controlled trial. A feasibility study has been completed; ethical approval for the main trial is pending. Participants: 250 preterm infants and their parents. Intervention: MT focusing on singing specifically tailored to infant responses, will be delivered during NICU and/or during a post-discharge 6-month period. Primary outcome: Changes in mother-infant bonding until 6 months corrected age (CA), as measured by the Postpartum Bonding Questionnaire. Secondary outcomes: Mother-infant bonding at discharge and over 12 months CA; child development over 24 months; and parental depression, anxiety, and stress, and infant re-hospitalization, all over 12 months.

Discussion: This study fills a gap by measuring the long-term impact of MT for preterm infants/caregivers, and of MT beyond the hospital context. Outcomes related to highly involving parents in MT will directly inform the development of clinical practice in Scandinavia and other contexts with similar social welfare practices. By incorporating family-centered care, continuity of care, user involvement, and cultural relevance, this study can potentially contribute to improved quality of care for premature infants and their parents worldwide.


Options:
A: Change in Heart Rate Variability (Pre intervention (baseline), during the intervention and immediately after the intervention)
B: Bonding between primary caregiver and infant (6 months)
C: To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner (Longitudinal database currently funded through 3/31/2030)
D: Brain volume (40 gestational weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers: International Randomized Trial
Brief Summary: Background: Preterm birth has major medical, psychological and socio-economic consequences worldwide. A recent systematic review suggests positive effects of music therapy (MT) on physiological measures of preterm infants and maternal anxiety, but methodologically rigorous studies including long-term follow-up of infant and parental outcomes are missing. Drawing upon caregivers' inherent resources, this study emphasizes caregiver involvement in MT to promote attuned, developmentally-appropriate musical interactions that may be of mutual benefit to infant and parent. This study will determine whether MT, as delivered by a qualified music therapist during neonatal intensive care unit (NICU) hospitalization and/or in home/municipal settings following discharge, is superior to standard care in improving bonding between primary caregivers and preterm infants, parent well-being and infant development.

Methods: Design: International multi-center, assessor-blind, 2x2 factorial, pragmatic randomized controlled trial. A feasibility study has been completed; ethical approval for the main trial is pending. Participants: 250 preterm infants and their parents. Intervention: MT focusing on singing specifically tailored to infant responses, will be delivered during NICU and/or during a post-discharge 6-month period. Primary outcome: Changes in mother-infant bonding until 6 months corrected age (CA), as measured by the Postpartum Bonding Questionnaire. Secondary outcomes: Mother-infant bonding at discharge and over 12 months CA; child development over 24 months; and parental depression, anxiety, and stress, and infant re-hospitalization, all over 12 months.

Discussion: This study fills a gap by measuring the long-term impact of MT for preterm infants/caregivers, and of MT beyond the hospital context. Outcomes related to highly involving parents in MT will directly inform the development of clinical practice in Scandinavia and other contexts with similar social welfare practices. By incorporating family-centered care, continuity of care, user involvement, and cultural relevance, this study can potentially contribute to improved quality of care for premature infants and their parents worldwide.


Options:
A: Peabody Developmental Motor Scales(PDMS-2) (Two years post term age)
B: Bonding between primary caregiver and infant (6 months)
C: Parent-child interaction (12 months corrected age.)
D: Compare the costs and effectiveness of the three intervention programs to determine which one is more cost-effective for VLBW preterm infants in Taiwan. (In-hospital, 6, 12, 18 and 24 months of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-range Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation in a Long GnRH Agonist Protocol
Brief Summary: The purpose of this phase 2 dose-ranging trial is to investigate the effects of FE 999302 on parameters influencing pregnancy rates in women undergoing Controlled Ovarian Stimulation (COS) with follitropin delta in a long gonadotropin releasing hormone (GnRH) agonist protocol.

Furthermore, the study intends:

* To investigate the safety of FE 999302 in women undergoing COS with follitropin delta in a long GnRH agonist protocol.
* To investigate the potential immunogenicity of FE 999302 in subjects undergoing COS with follitropin delta in a long GnRH agonist protocol.
* To estimate the impact of body weight on FE 999302 exposure in subjects undergoing COS with follitropin delta in a long GnRH agonist protocol.


Options:
A: Frequency of Ovarian Hyperstimulation Syndrome (OHSS) (3 years)
B: Number of good-quality blastocysts on Day 5 after oocyte retrieval (On Day 5 after oocyte retrieval)
C: Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set (10-11 weeks after embryo transfer at the blastocyst stage); Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set (10-11 weeks after embryo transfer at the blastocyst stage)
D: Number of Oocytes Retrieved Per Participant (34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Engaging Working Memory and Distress Tolerance to Aid Smoking Cessation
Brief Summary: Specific Aims for this Project Are:

1. To evaluate the ability of two forms of mindfulness training, relative to a control intervention, to engage specific "triple-vulnerability" mechanistic targets that characterize low SES smokers.

   1. The investigators hypothesize that both versions of the mindfulness training will show greater target engagement than the control treatment for mechanistic targets assessed under standard smoking conditions.
   2. The investigators hypothesize that the enhanced mindfulness training, Mindfulness+IE, will show greater target engagement than the other two conditions for mechanistic targets assessed during the nicotine deprivation window.
2. To show that the hypothesized differential target engagement results in differential smoking self-control as evaluated by greater time to lapse, fewer cigarettes smoked, and different smoking topography in the McKee Lapse protocol.
3. To expand and refine the list of SOBC targets by showing the specific relationship between currently identified assays and empirically-validated alternative targets, with attention to showing which of the targeted mechanisms in which contexts are most linked to clinically-relevant outcomes assessed in the McKee protocol, and which offer redundant or non-significant prediction.


Options:
A: 30-day Point Prevalence Abstinence, Complete-case (12 months post randomization)
B: Negative Affect (1-week Post-Intervention Smoking Context); Negative Affect/Withdrawal (1-week Post-Intervention Smoking Context); N-Back Task (1-week Post-Intervention Smoking Context); Spatial Span (1-week Post-Intervention Smoking Context); Digit Span (1-week Post-Intervention Smoking Context); Anxiety Sensitivity (1-week Post-Intervention Smoking Context); Mirror-Tracing Persistence Task (1-week Post-Intervention Smoking Context); Negative Affect (1week+2days Post-Intervention Deprivation Context); Negative Affect/Withdrawal (1week+2days Post-Intervention Deprivation Context); N-Back Task (1week+2days Post-Intervention Deprivation Contex); Spatial Span (1week+2days Post-Intervention Deprivation Contex); Digit Span (1week+2days Post-Intervention Deprivation Context); Anxiety Sensitivity (1week+2days Post-Intervention Deprivation Contex); Mirror-Tracing Persistence Task (1week+2days Post-Intervention Deprivation Context)
C: Change in the maintenance of abstinence from Cessation of tobacco use through assessment interviews (self-report and CO monitor will be used), and the point prevalence (baseline and twelve months)
D: Smoking Abstinence (End of Treatment (8 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
Brief Summary: A Therapeutic Exploratory Clinical Study to evaluate the efficacy and safety of DA-8010 in Patients with Overactive Bladder and to determine the optimal dose of DA-8010


Options:
A: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12. (Week 12)
B: Change in mean number of micturitions per 24 hrs (Within a 12-week treatment period)
C: Change From Baseline in mean number of micturitions per 24 hours (12 weeks)
D: Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours (Baseline, Week 12); Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (Baseline, Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Robot-assisted Locomotor and Stair Climbing Training for Improving Mobility and Participation in Daily Activities in Persons Affected by Stroke: a Multicenter Randomized Controlled Clinical Trial
Brief Summary: Stair climbing up and down is an essential part of everyday's mobility. Physiotherapy is focused on muscle strengthening, real floor walking and stairs climbing tasks, but these methods do not stress in terms of intensity stair-climbing practice. The aims of this study is to compare whether an intensive robot-assisted stair climbing training (RASCT) is more effective than conventional physiotherapy (CP) for improving stair climbing ability, gait and postural control in stroke patients.


Options:
A: Walking ability - Functional Ambulation Category (Rehabilitation Discharge (generally 4-6 weeks, up to 8 weeks))
B: Change in 10 meter walk test from baseline in gait speed (session 0 (initial visit); session 11 (at approximately 4 weeks))
C: The time required to climb Up and Down 9 stairs (seconds) (1 day)
D: Change From Baseline in Berg Balance Scale at 4 Weeks (Baseline and 4 weeks from baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label, Randomized, Controlled Multi-Center Study of The Efficacy of Daromun (L19IL2 + L19TNF) Neoadjuvant Intratumoral Treatment Followed by Surgery and Adjuvant Therapy Versus Surgery and Adjuvant Therapy in Clinical Stage IIIB/C Melanoma Patients
Brief Summary: The trial aims to evaluate the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery and adjuvant therapy).


Options:
A: Assess the pathologic complete response rate (absence of viable tumor on histologic assessment) (5 years)
B: Recurrence Free Survival (RFS) (From date of randomization until the date of the first recurrence or date of death from any cause, whichever occurs first assessed up to 60 months.)
C: Recurrence-free survival (RFS) rate (1 year after randomization)
D: Percent of patients who actually become resectable and are resected (Following 18 weeks of combined treatment)

Answer: B