TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Subcutaneous Insulin Glargine Versus NPH Insulin in Patients With Chronic Kidney Disease Stages III and IV: Randomized Controlled Trial.
Brief Summary: Chronic kidney disease (CKD) is one of the most common microvascular complications of diabetes mellitus, and it is the leading cause of end stage renal disease on developed countries. The CKD diagnosis and its progression require re-evaluation of hypoglycemic therapy and constant dosing adjustments, in order to optimize glycemic control and minimize its side effects. Long acting insulin analogs and its pharmacokinetics have not been studied through different stages of kidney disease and there is no consensus defining the appropriate dosing adjustment based on the glomerular filtration rate (GFR). This research project will compare the glycemic response to intensive insulin treatment with NPH insulin and basal insulin analog (insulin glargine) in type 2 diabetes (DM 2) patients with CKD stages 3 and 4. Patients and methods - Inclusion Criteria: DM 2 patients with CKD secondary to diabetic nephropathy and GFR of 15-59 ml/min/1.73m². Exclusion Criteria: Patients with systemic neoplasia, HIV, CKD or nephropathy from other etiologies, severe psychiatric disorders and pregnant women. Study design: This study consists of a randomized, cross-over, open-label controlled clinical trial. Patients will be randomly divided into two groups: GROUP 1 - insulin analog glargine once a day and GROUP 2 - NPH human insulin, three applications per day, both group will be treated with insulin lispro at mealtime. The laboratory tests will be performed at baseline and 12, 24, 36 and 48 weeks after the study start. During routine medical appointments will be analyzed self- monitoring of capillary blood glucose (SMBG) and the hypoglycemia score. After 24 weeks the basal insulin will be changed, i.e. patients using NPH insulin will receive insulin glargine and patients on insulin glargine will be changed to NPH insulin. A CGMS will be carried out at 24 and 48 weeks. Methodology: The metabolic profile will be evaluated throughout SMBG; biochemical, hormonal and hematological measurements; hypoglycemia score and CGMS. Statistical analysis will be performed using comparative descriptive analyzes, such as chi-square distribution, t-test and non-parametric tests. Analyze of data CGMS will include the area under the curve and the related statistic. Finally, logistic regression models will be adopted to evaluate the effect of the treatment on the several variables in question.


Options:
A: Difference in A1c Levels (baseline and 24 weeks); Number of Hypoglycemic Events (between 1rst and 24 weeks of each treatment arm)
B: Hemoglobin A1c Change From Baseline (Baseline to 6 months)
C: Change in HbA1c (percentage %) (Baseline to 6 Months)
D: Health Assessment, Patient treatment satisfaction and Quality-of-Life (At baseline (visit 2: randomization), at 24 weeks after the randomization (visit 7: cross over visit) and 48 weeks after the randomization (visit 12: endpoint))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-Week Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Reslizumab 110 mg Fixed, Subcutaneous Dosing in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils
Brief Summary: The primary objective of this study is to determine the effect of reslizumab (110 mg) administered subcutaneously every 4 weeks on clinical asthma exacerbations in adults and adolescents with asthma and elevated blood eosinophils who are inadequately controlled on standard-of-care asthma therapy.


Options:
A: Late airway response (LAR) area under the concentration-time curve (AUC) (percent decline in forced expiratory volume in 1 second [FEV1] over time) (Between 3 and 7 hours after allergen challenge at Day 86 after the first dose)
B: Number of Clinical Asthma Exacerbations (CAEs) During 52 Weeks of Treatment (Day 1 to Week 52)
C: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Month 12); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Month 12)
D: Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period (Baseline to end of the fixed-dose steroid treatment period (Week 24)); Percentage of Participants With at Least 1 Adverse Event (Baseline to end of the study (Week 68))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Nutrition and Physical Activity Environments in Home-based Child Care
Brief Summary: Drs. Patricia Risica (Brown University) and Kim Gans (University of Connecticut) are Dual Principal Investigators for this project. The research team will first conduct formative research using focus groups and key-informant interviews of Family Child Care Home (FCCH) providers. This formative work will inform our adaptation of components of previous evidence-based interventions to create a new innovative intervention in both English and Spanish to improve food and PA environments of Family Child Care Homes (FCCH). The intervention will integrate: a) support from peer counselors with child care experience who will serve as team leaders for groups of FCCPs; b) tailored print and video materials; and c) a set of portable active toys. A cluster-randomized trial with 132 FCCH will evaluate the effectiveness of the intervention with a Steering Committee and Community Advisory Board guiding all aspects. The Specific Aims of the study are to: 1) Conduct formative research to inform the development and adaptation of the FCCH intervention. 2) Conduct a cluster-randomized trial of the intervention's efficacy with 66 FCCH providers and a control intervention with 66 demographically-matched FCCH providers to evaluate its impact on: a) Children's overall dietary quality at FCCHs; b) Children's PA and sedentary behaviors at FCCHs; and c) the physical and social food and PA environments of FCCHs. Evaluation methods will include survey data collection of the FCCH Providers; observation of children's' dietary intake and physical activity in FCCHs; recruitment of children within the FCCH for physical and survey measurement with permission from their parents.


Options:
A: Fidelity to WISE Evidence-Based Practices using the WISE fidelity observational measure (Through study completion, an average of 2 years)
B: Change in Observed Child Dietary Intake (8 Months); Change in Measured Child Physical Activity in Child Care (8 months); Change in Observed Child Dietary Intake (12 Months); Change in Measured Child Physical Activity in Child Care (12 Months)
C: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)
D: Difference Between Interventions in Vegetable Intake (One meal per week for each intervention (Study weeks 1, 2, 3, and 4))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Nutrition and Physical Activity Environments in Home-based Child Care
Brief Summary: Drs. Patricia Risica (Brown University) and Kim Gans (University of Connecticut) are Dual Principal Investigators for this project. The research team will first conduct formative research using focus groups and key-informant interviews of Family Child Care Home (FCCH) providers. This formative work will inform our adaptation of components of previous evidence-based interventions to create a new innovative intervention in both English and Spanish to improve food and PA environments of Family Child Care Homes (FCCH). The intervention will integrate: a) support from peer counselors with child care experience who will serve as team leaders for groups of FCCPs; b) tailored print and video materials; and c) a set of portable active toys. A cluster-randomized trial with 132 FCCH will evaluate the effectiveness of the intervention with a Steering Committee and Community Advisory Board guiding all aspects. The Specific Aims of the study are to: 1) Conduct formative research to inform the development and adaptation of the FCCH intervention. 2) Conduct a cluster-randomized trial of the intervention's efficacy with 66 FCCH providers and a control intervention with 66 demographically-matched FCCH providers to evaluate its impact on: a) Children's overall dietary quality at FCCHs; b) Children's PA and sedentary behaviors at FCCHs; and c) the physical and social food and PA environments of FCCHs. Evaluation methods will include survey data collection of the FCCH Providers; observation of children's' dietary intake and physical activity in FCCHs; recruitment of children within the FCCH for physical and survey measurement with permission from their parents.


Options:
A: Change in Observed Child Dietary Intake (8 Months); Change in Measured Child Physical Activity in Child Care (8 months); Change in Observed Child Dietary Intake (12 Months); Change in Measured Child Physical Activity in Child Care (12 Months)
B: Primary Outcome Measure: BMI (6 months, 1 year, 2 year, 5 year)
C: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
D: Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Nutrition and Physical Activity Environments in Home-based Child Care
Brief Summary: Drs. Patricia Risica (Brown University) and Kim Gans (University of Connecticut) are Dual Principal Investigators for this project. The research team will first conduct formative research using focus groups and key-informant interviews of Family Child Care Home (FCCH) providers. This formative work will inform our adaptation of components of previous evidence-based interventions to create a new innovative intervention in both English and Spanish to improve food and PA environments of Family Child Care Homes (FCCH). The intervention will integrate: a) support from peer counselors with child care experience who will serve as team leaders for groups of FCCPs; b) tailored print and video materials; and c) a set of portable active toys. A cluster-randomized trial with 132 FCCH will evaluate the effectiveness of the intervention with a Steering Committee and Community Advisory Board guiding all aspects. The Specific Aims of the study are to: 1) Conduct formative research to inform the development and adaptation of the FCCH intervention. 2) Conduct a cluster-randomized trial of the intervention's efficacy with 66 FCCH providers and a control intervention with 66 demographically-matched FCCH providers to evaluate its impact on: a) Children's overall dietary quality at FCCHs; b) Children's PA and sedentary behaviors at FCCHs; and c) the physical and social food and PA environments of FCCHs. Evaluation methods will include survey data collection of the FCCH Providers; observation of children's' dietary intake and physical activity in FCCHs; recruitment of children within the FCCH for physical and survey measurement with permission from their parents.


Options:
A: 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))
B: Change in Observed Child Dietary Intake (8 Months); Change in Measured Child Physical Activity in Child Care (8 months); Change in Observed Child Dietary Intake (12 Months); Change in Measured Child Physical Activity in Child Care (12 Months)
C: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)
D: Number of centres recruited (12 months from ethical approval); Quality assurance in training achieved (12 months from ethical approval); Number of parents recruited per centre (12 months from completion of training); Intervention fidelity (24 months from completion of training); Contamination risk score (24 months from completion of training)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Nutrition and Physical Activity Environments in Home-based Child Care
Brief Summary: Drs. Patricia Risica (Brown University) and Kim Gans (University of Connecticut) are Dual Principal Investigators for this project. The research team will first conduct formative research using focus groups and key-informant interviews of Family Child Care Home (FCCH) providers. This formative work will inform our adaptation of components of previous evidence-based interventions to create a new innovative intervention in both English and Spanish to improve food and PA environments of Family Child Care Homes (FCCH). The intervention will integrate: a) support from peer counselors with child care experience who will serve as team leaders for groups of FCCPs; b) tailored print and video materials; and c) a set of portable active toys. A cluster-randomized trial with 132 FCCH will evaluate the effectiveness of the intervention with a Steering Committee and Community Advisory Board guiding all aspects. The Specific Aims of the study are to: 1) Conduct formative research to inform the development and adaptation of the FCCH intervention. 2) Conduct a cluster-randomized trial of the intervention's efficacy with 66 FCCH providers and a control intervention with 66 demographically-matched FCCH providers to evaluate its impact on: a) Children's overall dietary quality at FCCHs; b) Children's PA and sedentary behaviors at FCCHs; and c) the physical and social food and PA environments of FCCHs. Evaluation methods will include survey data collection of the FCCH Providers; observation of children's' dietary intake and physical activity in FCCHs; recruitment of children within the FCCH for physical and survey measurement with permission from their parents.


Options:
A: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
B: Body mass index (2005, 2006, 2007, 2008); nutrition behavior (2005, 2006, 2007, 2008); physical activity (2005, 2006, 2007, 2008)
C: body mass index (three years)
D: Change in Observed Child Dietary Intake (8 Months); Change in Measured Child Physical Activity in Child Care (8 months); Change in Observed Child Dietary Intake (12 Months); Change in Measured Child Physical Activity in Child Care (12 Months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Rapid Normalization of Vitamin D in Critically Ill Children: A Phase II Dose Evaluation Randomized Controlled Trial
Brief Summary: Documented roles for vitamin D in calcium homeostasis, cardiovascular and respiratory health, inflammation, innate immunity, and neuromuscular function have led to the hypothesis that deficiency might represent a modifiable risk factor for outcomes in critical illness. In recent years, dozens of adult studies have reported both high deficiency rates, and associations between lower vitamin D levels and organ dysfunction, health resource utilization, and mortality in the intensive care unit (ICU). More recently, similar observations have been made in critically ill pediatric populations. The cumulative body of basic science and clinical literature demonstrates that deficiency is common in critical illness and rapid normalization of vitamin D status could improve clinical outcomes and/or reduce health care costs. However, before conducting a phase III trial to determine whether restoration of vitamin D status improves outcomes in the PICU, the appropriate dosing regimen must be identified. Consequently, the investigators propose a phase II, double blind randomized controlled trial to determine a loading therapy dosing regimen that can safely and rapidly normalize vitamin D status in critically ill children.


Options:
A: Blood 25 Hydroxyvitamin D (25OHD) Concentrations (1 day (On admission to the pediatric intensive care unit (PICU) following CHD surgery))
B: Total number of days alive and off respiratory support in the first 28 days (28 days); Serum vitamin D concentration (Day after birth 28)
C: Vitamin D Status (7 days)
D: Number of Participants with D- deficiency or access (at 40 (+/-2 weeks) PMA (postmenstrual age)); Number of Participants with D- deficiency or access (at 4 weeks of age); Number of Participants with D- deficiency or access (At 35 (+/-2 weeks) PMA (postmenstrual age)); Number of Participants with D- deficiency or access (At 52 (+/-2 weeks) PMA (postmenstrual age))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness, Superiority and Safety of EA on OAB:Multi-center Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether electroacupuncture is effective in the treatment of overactive bladder.


Options:
A: Difference in Incontinence Impact Questionnaire (IIQ-7) scores (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Difference in Overactive Bladder Symptom Score (OABSS) (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Urogenital Distress Inventory (UDI-6) scores (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Differences in daytime frequency (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); incontinence episodes (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group); Nocturia (at baseline, 3 weeks after therapy initiation, 6 weeks after therapy initiation, and monthly intervals for 3 months from therapy initiation for the acupuncture group)
B: Change from baseline in mean frequency of micturitions per 24 hours (4, 8 weeks in treatment, 12th and 24th weeks of follow-up)
C: Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 (baseline, weeks 1-12)
D: Stress test (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effectiveness, Superiority and Safety of EA on OAB:Multi-center Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine whether electroacupuncture is effective in the treatment of overactive bladder.


Options:
A: Weight gain during pregnancy (From 14 weeks pregnancy to delivery)
B: Change from baseline in mean frequency of micturitions per 24 hours (4, 8 weeks in treatment, 12th and 24th weeks of follow-up)
C: Evaluation of subjective cure (At the end of 3 months of supervised treatment)
D: Change from baseline in average number of urinations per patient per day at Week 12

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)(MYSTIC).
Brief Summary: This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC


Options:
A: Number of subjects reporting adverse events (Screening through 90 days after the last dose of study medication); Objective response (At least 24 weeks as compared to baseline); Number of subjects experiencing dose-limiting toxicities (DLTs) (Depending upon the cohort, the DLT evaluation period is from the 1st dose of study medication until (1) the 3rd dose of MEDI4736 and tremelimumab (2) the 2nd dose of MEDI4736 and tremelimumab or (3) the 3rd dose of MEDI4736 and 2nd dose of tremelimumab)
B: Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥50% (Up to approximately 44 months); Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥20% (Up to approximately 44 months); Overall Survival (OS) in Participants With a Tumor Proportion Score (TPS) of ≥1% (Up to approximately 44 months)
C: Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy (From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).); Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy (Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).)
D: Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1 (From first dose to database lock (Up to 18 months)); Number of Participants With Dose Limiting Toxicities (DLTs) - Part 2 (9 weeks after first dose); Number of Participants With Adverse Events (AEs) - Part 2 (Deaths are from first dose to database lock (Up to 24 months). AEs and SAEs are from first dose to 30 days post last dose); Number of Participants With Laboratory Abnormalities in Hepatic Tests - Part 2 (From first dose to 30 days post last dose); Number of Participants With Laboratory Abnormalities in Thyroid Tests - Part 2 (From first dose to 30 days post last dose)

Answer: C