TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Darbepoetin Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants
Brief Summary: Study Hypothesis: Preterm infants administered weekly Darbe during the neonatal period will have improved neurocognitive outcome at 22-26 months compared to placebo


Options:
A: Bayley III Composite Cognitive Score (22-26 months corrected age (a median of 25 months corrected age, which corresponds to a median of 29 months calendar age in the analysis population), unless the subject died earlier)
B: Death or Neurodevelopmental Impairment (Birth to 22-26 months corrected age); Death (Birth to 22-26 months corrected age); Neurodevelopmental Impairment (at 22-26 months corrected age); Cognitive Delay (at 22-26 months corrected age); Moderate or Severe Cerebral Palsy (at 22-26 months corrected age); Severe Vision Impairment (at 22-26 months corrected age); Severe Hearing Impairment (at 22-26 months corrected age)
C: Incidence of death or major neurodevelopmental impairment (24 months of age corrected for prematurity)
D: Absolute hemoglobin concentration (24 hours of life); Percent change in hemoglobin concentration from baseline (24 hours of life)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients With Severe Asthma Uncontrolled on Standard of Care Treatment
Brief Summary: The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during the 24-week treatment in patients with uncontrolled, severe asthma with an eosinophilic phenotype. A subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal polyps. The study design has been updated to include a 56-week open label ANDHI in Practice (ANDHI IP) sub study upon the completion of the 24-week double-blind period of the ANDHI study.


Options:
A: Change From Baseline In Forced Expiratory Volume In 1 Second (FEV1) Over 16 Weeks Using Mixed Model for Repeated Measures (Day 0 (baseline, pre-dose), Weeks 4, 8, 12 and 16)
B: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL (Immediately following the first administration of study drug through Study Week 48.)
C: The primary outcome measure is the late asthmatic response (LAR) in patients treated with huMAb OX40L versus placebo (16 weeks after the first dose)
D: Annualized Rate of Asthma Exacerbations Over the Treatment Period (up to Week 24) (Baseline (Week 0) up to Week 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Developmental Screening and Nutritional Intervention of Severe Acute Malnourished Children in Southern Punjab, Pakistan
Brief Summary: i. To examine the impact of malnutrition on development quotient of children

ii. To determine the effectiveness of Ready to Use Therapeutic Food (RUTF) in improving the development quotient of severe acute malnourished children under five year of age.

iii. To investigate the outcome of Vitamin D therapeutic doses intervention with RUTF rehabilitation on growth and development of malnourished children.


Options:
A: Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels (During acute phase postburn)
B: XR healing of rickets (6 months)
C: EASI score (1 month); Investigator Global Assessment (IGA) (1 month)
D: Weight gain in children (2 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Targeted Disruption to Cancer Metabolism Through Dietary Macronutrient Modification
Brief Summary: The objective of this investigation is to examine the effects of 12 weeks of usual care plus a ketogenic diet (KD) or usual care plus dietary recommendations endorsed by the Academy of Nutrition and Dietetics (AND) in women with ovarian and endometrial cancer. Participants undergo testing at baseline and at 12 weeks; the testing consists of blood draws, questionnaires, and measures of body composition. The baseline visit also includes a meeting with a registered dietitian to discuss the guidelines of the assigned diet.

It is hypothesized that the KD group will have improved cancer outcome measures, beneficial body composition changes, reduced fasting concentrations of glucose and insulin, and higher ratings of patient satisfaction with the diet relative to the AND group.


Options:
A: Weight loss (2 years)
B: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
C: change in fasting glucose (12 weeks); change in fasting insulin (12 weeks); change in fasting beta-hydroxybutyrate (12 weeks)
D: Mean weight loss compared between the two arms (Up to 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Laboratory Classroom Study to Evaluate the Safety and Efficacy of PRC-063 Compared to Placebo in Children (6-12 Years of Age) With ADHD
Brief Summary: This is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase 3 study to evaluate the safety and efficacy of PRC-063 in the treatment of ADHD in pediatric subjects between 6 to 12 years of age.


Options:
A: Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP)-Combined Scores During the Full-Day Laboratory Classroom (Full-day Classroom - 13 hrs)
B: Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose (Hour 4 post-dose)
C: Change in pain ratings (0-100) to a suprathreshold heat pain stimulus (3.5 Minutes after end of infusion)
D: Aggression (Measured by the Overt Aggression Scale after 8 weeks of treatment); Improvement of ADHD symptoms (Measured by the Clinical Global Improvement Scale and ADHD Rating Scale after 8 weeks of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An RCT Evaluating the Implantation Potential of Vitrified Embryos Screened by Next Generation Sequencing Following Trophectoderm Biopsy, Versus Vitrified Unscreened Embryos in Good Prognosis Patients Undergoing IVF
Brief Summary: This is a two-arm parallel group randomized controlled trial at the Department of Reproductive Medicine at Ghent University Hospital. Women \>=18 and \<37 years of age undergoing their first or second IVF/ICSI treatment, with at least 2 good quality blastocysts remaining after fresh embryo transfer will be randomized to either transfer of a cryopreserved blastocyst selected based on morphology (standard treatment arm) or transfer of a cryopreserved blastocyst selected based on PGS and morphology (intervention treatment arm).


Options:
A: Impact of next generation sequencing on the embryos produced from IVF on implantation rates (2 years)
B: Ongoing pregnancy (Gestational week 20)
C: Clinical pregnancy (At 7 - 8 gestational weeks)
D: Ongoing pregnancy (12 weeks after embryo transfer for the patient)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Handling Oxygenation Targets in Adults With Acute Hypoxaemic Respiratory Failure in the Intensive Care Unit: A Randomised Clinical Trial of a Lower Versus a Higher Oxygenation Target
Brief Summary: Handling oxygenation targets (HOT) is standard of care in the intensive care unit (ICU), however the quality and quantity of evidence is low and potential harm has been reported. The aim of the HOT-ICU trial is to assess the overall benefits and harms of two levels of oxygenation targets in adult critically ill patients with acute hypoxaemic respiratory failure in the ICU.


Options:
A: Composite Primary Outcomes (30 days)
B: Daily Delta Sequential Organ Failure Assessment Score (14 days)
C: 90-days mortality (90 days)
D: Myocardial salvage index (Day 4-6 after the acute PCI)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Behavioral Activation and HIV Risk Reduction Counseling for Men Who Have Sex With Men (MSM) With Stimulant Abuse
Brief Summary: This study seeks primarily to test, in a two-arm randomized controlled trial (RCT), the efficacy of Project IMPACT, an intervention that integrates Behavioral Activation (BA) with HIV risk reduction (RR) counseling for HIV-uninfected men who have sex with men (MSM) with stimulant use disorder at risk for HIV via sexual behavior. HIV-uninfected MSM with a diagnosis of stimulant use disorder will be equally randomized to one of two study arms: (1) the Project IMPACT intervention, BA-RR counseling, which lasts ten sessions; and (2) the standard of care (SOC) comparison condition, including two equivalent sexual risk-reduction counseling sessions. Participants will be followed for one year post-randomization, with assessments at months four, eight, and 12.


Options:
A: Reduction in Condomless Anal Sex Acts (CAS) over study follow-up (Baseline, 4 month, 8 month, 12 month)
B: Addiction Severity Index Alcohol Composite (Baseline, end of treatment (month 3), 3-month post-treatment follow-up); Addiction Severity Index Drug Composite (Baseline, end of treatment (3 months), and 3-month post-treatment followup); Brief Addiction Monitor (Baseline, end of treatment (month 3), 3-month post-treatment follow-up)
C: Non-concordant unprotected anal intercourse (Baseline, 6, 12, 18, 24 weeks)
D: Percentage of Monthly Urine Samples That Are Negative for Cocaine (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Timing of Continuous Renal Replacement Therapy Initiation in Sepsis-associated Acute Kidney Injury in the Intensive Care Unit
Brief Summary: Sepsis continues to be a major global cause of both mortality and morbidity. Furthermore, the development of acute kidney injury (AKI) in sepsis increases the risk of unfavorable outcomes. Besides source control, fluid resuscitation and the use of antibiotics, application of extracorporeal renal replacement therapies (RRT) is the predominant treatment for sepsis-associated AKI (SAKI). However, the timing of initiation of RRT remains controversial. It is reported that a correlation was observed between the concentrations of circulating inflammatory cytokines and mortality in patients with septic shock. Therefore, it is hypothesis that adequate removal of inflammatory mediators from the circulation may provide a potential therapy for this devastating condition. Indeed, data from meta-analyses, observational studies and randomized controlled trial (RCT) suggests that initiating RRT in critical ill patients (including patients with sepsis and non-sepsis) at early stage may be beneficial. But in some studies, initiating RRT at early stage do not shown to improve survival compared with initiating RRT at late stage. At present, large-scale prospective RCT about the timing for initiating RRT in SAKI was still lack.The decision when to start RRT is not merely academic but may impact on outcomes. Therefore, in our study, 460 patients with SAKI at KDIGO 2 from multicenter in China will be recruited. And then the patients will be divided into early group and delayed group randomly. In the early group, continuous RRT (CRRT) was started immediately after randomization. In the delay group, CRRT was initiated if at least one of the following criteria was met: KDIGO 3, severe hyperkalemia, pulmonary edema, blood urea nitrogen level higher than 112 mg per deciliter after randomization. Overall survival at day 90 will be observed in order to understand whether different CRRT strategy would affect the outcomes of SAKI. This clinical study will be a large-scale, multi center, prospective, randomized trial about SAKI. It will help clinician choose appropriate timing to initiate CRRT and improve outcomes of SAKI.


Options:
A: Renal replacement therapy proportion (28 days)
B: We will study the feasibility of recruiting ther target population, administering the study therapies according to pre-defined protocols and following patients for clinical endpoints. (60 days)
C: 60-day All-cause Mortality (60 days)
D: overall mortality (90 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: EVIDENT3 Study: A Randomized, Controlled Clinical Trial to Reduce Inactivity and Caloric Intake in Sedentary, Overweight People Using a Smartphone Application. Study Protocol.
Brief Summary: This is a randomized clinical trial aimed at obese and sedentary subjects aged 20 to 65 years selected in urban primary care centers of 5 centers (Spain). Its objective is to evaluate the effects of the addition of an ICT tool developed for the Smartphone application and a Smartband in support of behavioral and educational recommendations to reduce weight.


Options:
A: Change in weight (6 and 12 months)
B: Percent weight loss: objective (Baseline, 6 Months); Weight (Baseline, 6 Months)
C: Weight reduction (1 year)
D: Change in weight (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: EVIDENT3 Study: A Randomized, Controlled Clinical Trial to Reduce Inactivity and Caloric Intake in Sedentary, Overweight People Using a Smartphone Application. Study Protocol.
Brief Summary: This is a randomized clinical trial aimed at obese and sedentary subjects aged 20 to 65 years selected in urban primary care centers of 5 centers (Spain). Its objective is to evaluate the effects of the addition of an ICT tool developed for the Smartphone application and a Smartband in support of behavioral and educational recommendations to reduce weight.


Options:
A: Time spent being physically active (2 months); Time spent sitting (2 months); Changes in food consumption (2 months)
B: Weight reduction (1 year)
C: Average daily sedentary minutes (4 weeks)
D: Change in length of break from sitting in minutes (baseline, 2, 4, and 6 weeks); Change in frequency of break from sitting in minutes (baseline, 2, 4, and 6 weeks); Change in minutes spent standing (baseline, 2, 4, and 6 weeks); Change in minutes spent in light intensity physical activity (baseline, 2, 4, and 6 weeks); Change in minutes spent in moderate intensity physical activity (baseline, 2, 4, and 6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: UW Quitting Using Intensive Treatment Study
Brief Summary: This research will determine whether two highly promising modifications to varenicline treatment (i.e. use of a nicotine patch adjuvant and extended 24-week duration) produce superior smoking outcomes when they are either used together or alone. Despite their promise, the proposed modifications have never been experimentally evaluated relative to standard varenicline pharmacotherapy. Thus, this innovative research will produce novel evidence regarding how best to help smokers quit, and thereby address the leading cause of preventable mortality and morbidity related to cardiovascular and pulmonary diseases.


Options:
A: To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. (8 weeks)
B: 52-Week Point-Prevalence Abstinence (Assessed 52 weeks after quit date)
C: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
D: Continuous smoking abstinence rate (Weeks 9 to 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: UW Quitting Using Intensive Treatment Study
Brief Summary: This research will determine whether two highly promising modifications to varenicline treatment (i.e. use of a nicotine patch adjuvant and extended 24-week duration) produce superior smoking outcomes when they are either used together or alone. Despite their promise, the proposed modifications have never been experimentally evaluated relative to standard varenicline pharmacotherapy. Thus, this innovative research will produce novel evidence regarding how best to help smokers quit, and thereby address the leading cause of preventable mortality and morbidity related to cardiovascular and pulmonary diseases.


Options:
A: Quit Rate (Study weeks 6 through 9)
B: 52-Week Point-Prevalence Abstinence (Assessed 52 weeks after quit date)
C: 7-Day Point Prevalence Abstinence From Smoking by Intervention (26 weeks after the target quit smoking date); 7-Day Point Prevalence Abstinence From Smoking by Nicotine Replacement Therapy (NRT) Group (26 weeks after the target quit smoking date)
D: Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco (12 weeks following start of medication)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase IV Control Trial of Single High Dose Oral Vitamin D3 (Stoss Therapy) in Pediatric Patients Undergoing HSCT to Prevent Vitamin D Deficiency and Insufficiency During Transplant
Brief Summary: Research has suggested that children with sufficient vitamin D levels undergoing hematopoietic stem cell transplant (HSCT) have improved outcomes, including lower incidences of infection and graft-versus-host disease (GVHD), as well as overall improved survival. However, supplementation in children undergoing HSCT has shown to be a challenge using standard or aggressive supplementation strategies. The primary objective of this study is to determine the safety and efficacy of a single, high dose oral vitamin D (Stoss Therapy) at the start of transplant followed by maintenance supplementation in children undergoing HSCT.


Options:
A: Safety of Stoss Therapy (100 days); Efficacy of vitamin D repletion (100 days)
B: Change in vitamin D status (Baseline and 20 weeks)
C: Number of Laboratory confirmed upper respiratory tract infections (Up to 8 months)
D: Change in CD4 percent associated with vitamin D supplementation in HIV-infected children (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Do Cardiac Health: Advanced New Generation Ecosystem - Phase 2
Brief Summary: The Do CHANGE service is designed for cardiac patients who could benefit from lifestyle change and a better disease management. The study aims to support patients with behavior change by providing them with devices and behavioral intervention in order to facilitate long-term behavior change.


Options:
A: functional capacity at 6- and 12-months after CR in pts older than 75 years randomly allocated to Home-Based exercise program or usual care. (6 and 12 months)
B: Lifestyle (3 months); Quality of Life (QoL) (3 months); Behavioral flexibility (3 months)
C: exercise tolerance (1 year); exercise tolerance (12 weeks)
D: 180 day rehospitalization rate (at 180 days post-discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Do Cardiac Health: Advanced New Generation Ecosystem - Phase 2
Brief Summary: The Do CHANGE service is designed for cardiac patients who could benefit from lifestyle change and a better disease management. The study aims to support patients with behavior change by providing them with devices and behavioral intervention in order to facilitate long-term behavior change.


Options:
A: Lifestyle (3 months); Quality of Life (QoL) (3 months); Behavioral flexibility (3 months)
B: Controlled Blood pressure (One year)
C: exercise tolerance (1 year); exercise tolerance (12 weeks)
D: Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. (Post-surgery (approximately 9 weeks after baseline))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Health Care Access With Cellular Technology: Networked and Mobile Technologies to Improve Uptake and Coverage of Vaccinations
Brief Summary: Despite the impressive economic progress in developing countries, significant proportion of young children and pregnant women living in low-resource settings remain inadequately immunized. Progressive decline in immunizations are in large part attributable to poor follow-up and compliance. National and international pediatric bodies, recommend a time sensitive schedule for childhood immunizations, boosting immunity with each subsequent cycle, leading to adequate levels of immune protection. Due to inadequate protective immunity, resulting from poor vaccination compliance, outbreaks of vaccine-preventable diseases are rampant, making childhood mortality in this group among the highest in the world. Major challenges of vaccination programs include maintaining / tracking records, linked to positive identification of individual children, and strategies to improve follow-up and compliance. Novel cellular technology based approaches targeting behavior modifications can therefore significantly impact health outcomes in these communities. In this proposal, the investigators will evaluate a novel software platform, utilizing biometric identification of subjects, paired with cell-phone reminders and compliance-linked incentives to improve uptake and coverage of primary vaccinations in young children and pregnant women.


Options:
A: Initiation of highly effective contraception, as defined by the World Health Organization. (3 months after initial enrollment)
B: Smoking Abstinence (3 months)
C: Contraceptive uptake (10 weeks postpartum; 24 weeks postpartum); Facility Delivery (Postpartum); Exclusive Breastfeeding (24 weeks postpartum)
D: Immunization Rate (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Health Care Access With Cellular Technology: Networked and Mobile Technologies to Improve Uptake and Coverage of Vaccinations
Brief Summary: Despite the impressive economic progress in developing countries, significant proportion of young children and pregnant women living in low-resource settings remain inadequately immunized. Progressive decline in immunizations are in large part attributable to poor follow-up and compliance. National and international pediatric bodies, recommend a time sensitive schedule for childhood immunizations, boosting immunity with each subsequent cycle, leading to adequate levels of immune protection. Due to inadequate protective immunity, resulting from poor vaccination compliance, outbreaks of vaccine-preventable diseases are rampant, making childhood mortality in this group among the highest in the world. Major challenges of vaccination programs include maintaining / tracking records, linked to positive identification of individual children, and strategies to improve follow-up and compliance. Novel cellular technology based approaches targeting behavior modifications can therefore significantly impact health outcomes in these communities. In this proposal, the investigators will evaluate a novel software platform, utilizing biometric identification of subjects, paired with cell-phone reminders and compliance-linked incentives to improve uptake and coverage of primary vaccinations in young children and pregnant women.


Options:
A: The Number of Condomless Sex Acts at 3-months Post-intervention (3-months post-intervention); Percent of Boys Reporting Abstinence at 3-months Post-intervention (3-months post-intervention)
B: Immunization Rate (12 months)
C: Biometrically confirmed abstinence (3-6 months); Quitline call rates (1-6 months); Knowledge as measured by survey items (1-6 months)
D: Intention to treat analysis (13 months)

Answer: B