TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Community-based Model of Delivery of Kangaroo Mother Care for Improving Child Survival and Brain Development in Low Birth Weight Newborns
Brief Summary: While newborn and child survival remains a priority, optimal development of survivors is receiving increasing attention. Interventions that impact both survival and development should be prioritized for action. Kangaroo Mother Care (KMC) improves survival, and potentially neurodevelopment, in preterm and low birth weight infants in hospital settings but its coverage remains low. Innovation is required to allow the community-based delivery of KMC by front-line workers. This could greatly accelerate scale up and sustainability of this intervention in low resource settings.

The proposed randomized trial is planned in a setting where 40% of births take place at home. Early discharge (as early as within 12 hours of birth) is common for facility births, often at the request of families for social and cultural reasons. Many of the hospitals do not have incubators for the care of very small babies.


Options:
A: Primary Outcome Measure(s) evaluate the efficacy and cost-effectiveness of the intervention in reducing carer burden, improving behaviour problems in elderly persons with dementia and reducing the costs of illness. (by the end of the study)
B: Assessment of maternal depression (6 weeks); Assessment of maternal depression (Assessment of maternal depression at 6 months); Assessment of maternal sense of competence (6 weeks); Assessment of maternal sense of competence (Assessment of maternal sense of competence at 12 months); Assessment of mother infant bonding (6 weeks); Assessment of mother infant interaction (6 months); Assessment of newborn behaviour (6 weeks); Assessment of infant temperament (6 months); Assessment of infant temperament (Assessment of infant temperament at 12 months); Assessment of cognitive function by Bayley scale (6 months); Assessment of cognitive function by Bayley scale (Assessment of cognitive function by Bayley scale at 12 months); Assessment of home environment by PROCESS (12 months)
C: Scale name unabbreviated: "La escala de Adopción del Rol Materno (ARM) de la Doctora María del Carmen Garrido Hidalgo y la Doctora Marleny Marchán Coronado". (4 Months); Perceived Maternal Parenting Self-Efficacy (PMP S-E) by Dr. Christopher R. Barnes and Dr. Elvidina N. Adamson-Macedo: measures maternal self-efficacy. (4 months); "Perinatal Infant Care Social Support Scale" (PICSS) by Dr. Patricia Leahy-Warren: Construct: measures social support and has been widely applied in first-time mothers. (4 months); "Bond between parents and children of MSc Alix Nathalya Vargas Vásquez and Doctor Myriam Patricia Pardo Torres" (4 months)
D: Neonatal mortality from post enrolment to 28 days (From post enrolment to 28 days); Early infant mortality from post enrolment to 6 months of age (From post enrolment to 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): A Multi-center Comparative Effectiveness Trial of In-home Gamified Constraint-induced Movement Therapy for Rehabilitation of Chronic Upper Extremity Hemiparesis.
Brief Summary: The current proposal aims to conduct a multi-site randomized controlled trial comparing virtual-reality gaming delivery of Constraint Induced Movement therapy (CI therapy) with (1) traditional clinic-based CI therapy of equal total active therapy duration and (2) a control group equating the dose of in-person therapy. Individuals with chronic stroke will be randomized to one of four different interventions: (1) traditional clinic-based CI therapy (35 therapist/client contact hours), (2) therapist-as-consultant virtual reality CI therapy (5 therapist/client contact hours in the clinic and 15 hours of independent game play at home), (3) therapist-as-consultant virtual reality CI therapy with additional therapist contact via telerehabilitation (5 therapist/client contact hours in the clinic, 2.6 therapist contact hours via teleconference, and 15 hours of independent game play in the home), and (4) 5 hours of standard occupational therapy (OT) / physical therapy (PT). After 6-month follow-up, individuals assigned to standard OT/PT will cross over to a modified gaming therapy condition (a stand-alone application of the rehabilitation game without additional therapist contact).


Options:
A: Action Research Arm Test (ARAT) (End of treatment at 8 weeks post enrolment)
B: Naming ability assessed by NGA (four month post randomization)
C: Change in Arm Motor Fugl-Meyer Score From Baseline to 30 Days Post-therapy (from the Baseline Visit to the 30 Day Follow Up Visit)
D: Wolf Motor Function Test (0 to 1 months); Motor Activity Log Quality of Movement Scale (0 to 1 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: FORWARD I: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer
Brief Summary: This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian tube cancer.


Options:
A: Progression free survival (up to 18 months)
B: Overall Survival (Up to five years)
C: Progression-Free Survival (PFS), as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study (From the date of randomization until the time of death or PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)); PFS, as Assessed by BIRC Per RECIST Version 1.1 in Participants With High Folate Receptor Alpha Level (≥ 75% of Tumor Staining) (From the date of randomization until the time of death or PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm))
D: Progression Free Survival (PFS) (Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Dietary Intervention Examining Tracking With Mobile Devices Study
Brief Summary: The purpose of the study is to test the effectiveness of two different weight loss interventions. Both of these interventions will provide weight loss information through twice weekly audio podcasts. In addition to the podcasts, participants will be asked to track their diet using either a wearable device on their wrist or through an app on their smartphone.


Options:
A: Change in body weight as assessed by digital scale (6 months)
B: Percent weight loss: objective (Baseline, 6 Months); Weight (Baseline, 6 Months)
C: Change in Weight (Baseline, 1 month, 3 months)
D: Change in Weight (Baseline, 24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Malezi ne Kilimo Bora (Good Parenting and Farming) - Skilful Parenting and Agribusiness Child Abuse Prevention Study (SPACAPS)
Brief Summary: The Malezi ne Kilimo Bora ("Good Parenting and Farming" in Kiswahili) Skilful Parenting and Agribusiness Child Abuse Prevention Study is a collaboration between the University of Oxford, University of Glasgow, and the Tanzania National Medical Research Institute (NIMR). It is pilot cluster randomised controlled trial (cRCT) of a community-based intervention implemented by Investing in Children and Our Societies (ICS), an international non-governmental organization (NGO) with extensive experience operating in rural Tanzania. The overall focus of the project is to evaluate ICS's agribusiness and skilful parenting programmes' impact on the prevention of child maltreatment and improvement of child and family psychosocial and economic wellbeing (n = 8 villages, n = 16 farmer groups, n = 240 families).


Options:
A: Change in Reach (implementation) (Change from Baseline in Reach at 12 months); Cost (Cost of implementing each arm will be calculated through study completion, an average of 2 years)
B: Change in Alcohol Use Disorders Identification Test (AUDIT) Scale Score From Baseline to 6-month Post-baseline. (Baseline and 6 months post-baseline)
C: Change in Child Abuse - Parent Report (Baseline; 6-Months Follow-Up; 12-Months Follow-Up); Change in Child Abuse - Child Report (Baseline; 6-Months Follow-Up; 12-Months Follow-Up); Change in Parenting Behaviour - Adult Report (Baseline; 6-Months Follow-Up; 12-Months Follow-Up); Change in Parenting Behaviour - Child Report (Baseline; 6-Months Follow-Up; 12-Months Follow-Up)
D: Stunting (One year starting with baseline (August-September 2014) and finishing with end line (September 2015); Amendment: also measured at year two (extension) endline); Cognitive function (End line (after one year); Amendment: BSID-III at year two (extension) endline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Incidence and Severity of Parenteral Nutrition Associated Cholestasis in Neonates Subjected to Major Surgery, Using Two Mixed Intravenous Lipid Emulsions
Brief Summary: Parenteral nutrition associated cholestasis (PNAC) is a common complication of prolonged and exclusive parenteral nutrition (PN). Infants subjected to major surgery are often unable to receive enteral nutrition for a long period of time, during which they require exclusive PN. In preterm infants, hepatic immaturity is a predisposing factor. Intravenous lipid emulsions (ILE) used in PN may promote PNAC or protect against it depending on their composition. Medium chain triglycerides (MCT) may have a hepatic protective effect. Long chain triglycerides (LCT) of n-3 family may protect from PNAC. In several new-generation emulsions, the α-tocopherol content is higher than the gamma-tocopherol content, acting as an antioxidant, preventing lipid peroxidation.

The incidence and severity of PNAC in term and near-term infants subjected to corrective surgery for congenital abnormalities and needing prolonged PN using the ILE SMOFlipid® or Lipofundin® is compared. The investigators hypothesise that SMOFlipid® is more protective from PNAC than Lipofundin®.

Single-center, randomized, controlled and double-blinded trial on consecutive neonates admitted in the NICU, with gestational age of 34 weeks or over, undergoing corrective surgery of congenital anomaly of the digestive tract or indirectly affecting the digestive tract. Recruitment if PN with ILE was started within the first 48 hours after birth. Minimum intervention: exclusive PN for at least 1 week.

Main outcome: incidence of cholestasis (conjugated serum bilirubin \>1 mg/dl \[34 mmol/L\]). Severity of cholestasis evaluated by the magnitude of the serum conjugated bilirubin and serum γ-glutamyltranspeptidase (GGT). Mixed effects regression models are used to take into account the correlation structure between measures in time. Crude and adjusted odds-ratios with corresponding 95% confidence intervals are calculated.


Options:
A: Incidence of parenteral nutrition associated cholestasis (PNAC) (Participants will be followed for the duration of hospital stay (expected average 14 weeks))
B: Mean serum conjugated bilirubin (umol/L) (12 weeks)
C: Incidence of cholestasis (From recruitment to full enteral feeding per mouth (up to 90 postnatal days))
D: lipometabolism (Change from Baseline in fatty acid at 7 days and 14 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Intermittent Fasting for Metabolic Health, Does Meal Timing Matter?
Brief Summary: Obesity is a serious medical condition, the adverse consequences of which include increased risk of cardiovascular disease, diabetes mellitus, reduced fertility and cancer. The economic cost of obesity was placed at $58 billion dollars in Australia in 2008. Studies in mice and non-human primates have shown that moderate caloric restriction (CR) increases lifespan and reduces the incidence of cardiovascular disease, cancer, and type 2 diabetes. Reduced risk of chronic diseases is also observed in humans following CR. However, daily CR is difficult to maintain long term, since the body defends against weight loss by inducing "metabolic adaptation" and altering the hormonal appetite response. An emerging number of studies are examining the effects of limiting food intake to prescribed time periods per day, or every other day. Intermittent, or time restricted feeding describes a dieting approach where food is available ad libitum, however only for a limited period of time (i.e. 3-12 hours). This study will examine the effects of fasting for 15h/day and eating for 9-h per day on glycemic control and metabolic health. This study will build on the existing knowledge base in humans as to whether meal timing, rather than caloric restriction per se, is important to provide the stimulus required to improve metabolic health and reduce risk of chronic disease. Moreover, it will examine whether restricting feeding to later in the day is of lesser benefit to health.


Options:
A: Postprandial glucose response to meal test (3-hours)
B: Body Weight (Baseline to month 12)
C: Body weight (12 weeks)
D: Change in resting energy expenditure (Study day 1, 28, 43 and 70)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Extended (6-Week) Varenicline Preloading: Does it Facilitate Smoking Reduction and Cessation?
Brief Summary: SUMMARY Rationale: Worldwide, cigarette smoking carries a high mortality. Since the available cessation programs are not effective for all smokers, new strategies are necessary for tobacco control.

Primary objective: To investigate whether a 6-week varenicline preloading facilitates smoking reduction and cessation compared with the standard varenicline treatment schedule.

Design: Parallel group, double-blind, randomised controlled clinical trial. Participants: Smokers of both sexes from the general population. Methods: Participants will be randomized into two groups of treatment. Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment. Visits will be arranged at randomization, week 4, week 6 (Quit day (QD)) and at week 1, 6, 12, and 24 after QD.

Measurements: These will include vital signs, smoking history, spirometry, expired CO, salivary cotinine, nicotine dependence, and withdrawal symptoms. Primary outcome is continuous abstinence at 6 months.

Sample size: For an estimated difference of quit rates of 15% at 24 weeks (30% for group A vs. 15% for group B) 121 subjects per group are needed (Total = 242 subjects).

Statistical analysis: T tests (rational variables) and x2 test or Fisher's exact test (nominal variables) will be used as appropriate.

Expected benefits: This study might contribute to optimize the current use of varenicline.


Options:
A: Continuous abstinence (from week 7 until week 24)
B: Determine the efficacy of combined therapy (VRN+nicotine patches) versus monotherapy (VRN+placebo patches) in smoking cessation assessed as continuous abstinence rate (CAR) from week 2 to week 12. (Participants will be followed for the duration of treatment, 12 weeks.)
C: Weekly Percentage of Heavy Drinking Days (Weeks 2-13*)
D: Continuous abstinence from smoking (Six months post-quit date)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis
Brief Summary: The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS). The secondary objective of this study is to evaluate treatment effect over time in adult participants with RRMS treated with ALKS 8700.


Options:
A: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Potentially Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit (Up to 98 weeks); Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks))
B: Number of new or enlarged gadolinium contrast enhancing lesions (Gd-CELs) on monthly brain MRIs collected between Weeks 8 to 24 in daclizumab- vs. placebo-treated patients
C: Annualized Relapse Rate (ARR) at 1 Year (1 Year)
D: Adjusted Annualized Relapse Rate (ARR) During the Treatment Period (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis
Brief Summary: The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS). The secondary objective of this study is to evaluate treatment effect over time in adult participants with RRMS treated with ALKS 8700.


Options:
A: Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24. (Part I (Week 24)); Incidence of treatment-emergent adverse events and serious adverse events (Part II (Up to 4.5 years))
B: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Potentially Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks)); Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit (Up to 98 weeks); Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (From first dose to two weeks after last dose of study drug (Up to 98 weeks))
C: Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005) (Various time points from randomization up to 24 months); Time to Conversion to Multiple Sclerosis (MS) According to the McDonald Criteria (2005) (Various time points from randomization up to 36 months)
D: Confirmed Annualized Relapse Rate (up to 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Point-Of-Care Testing Assays for Early Infant in Mozambique-Cluster Randomised Trial
Brief Summary: In Mozambique, early infant HIV diagnosis (EID, i.e. HIV screening of infants under 18 months of age) is conducted using molecular diagnostics at central laboratories in Maputo, Nampula, Beira and Quelimane. However, test volumes are growing and many parts of the country do not have close access to laboratories. Test samples are transported over large distances and this can introduce testing delays, especially for patients in rural and remote areas of the country. There are now new POC EID technologies becoming available that will enable diagnosis of HIV in infants within minutes or a couple of hours on site in the clinic, operated by non technical staff and without laboratory infrastructure. This protocol describes a plan to conduct an evaluation of a Point-Of-Care (POC) Early Infant Diagnosis (EID) testing technologies that are being considered for use in Mozambique, and to pilot those technologies in order to provide more effective diagnostics and clinical care to patients. During this implementation pilot, sites are randomized to use either conventional or POC EID testing only before the inclusion of the patients in the study. No consent will be asked to the parents or guardians. A written permission will be asked to the Direção Provincial de Saúde of both provinces to implement the POC device as routine in those intervention sites. All the information that will be analyzed will be collected from the routine care and it will be analyzed as a group.


Options:
A: The proportion of HIV-positive infants initiating antiretroviral therapy within 60 days of sample collection (up to 6 months); the proportion of HIV-positive infants who initiated antiretroviral therapy that were retained in care at 90 days of follow-up. (3 months after treatment initiation)
B: Proportion of infants tested at birth (0-4 weeks); Proportion of infants tested at 6-weeks (4-12 weeks postpartum)
C: Accessibility and availability (Three months)
D: Specificity of PoC HIV test (Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID); Sensitivity of PoC HIV test (Participants are planned to be followed for the duration of 6 weeks, i.e. the time point of the current Standard of Care EID)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 24-Week Multicenter, Randomized, Open-Label, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Fumaric Acid Esters and Methotrexate in Patients With Moderate-to-Severe Plaque Psoriasis Who Are Naive to Systemic Treatment With an Extension Period
Brief Summary: The main purpose of this study is to evaluate the efficacy of ixekizumab compared to fumaric acid esters (FAE) and methotrexate (MTX) in participants with moderate-to-severe plaque psoriasis who are naive to systemic treatment.


Options:
A: Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) at Week 24 (Week 24)
B: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16)
C: Number of Participants Attaining a 90 Percent Reduction in PASI From Baseline (PASI 90) - ITT (112 and 140 days)
D: Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 (Week 48)

Answer: A