TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial to Evaluate the Effectiveness of Vibration and External Cold (Buzzy Device) for Pain Relief During Venipuncture or Intravenous Cannulation in Children With Intellectual Disability.
Brief Summary: Needle procedures are the most common and important source of pain and distress in children in the health care setting. Children with intellectual disability from any cause experience pain more frequently than healthy children. They often require venipuncture or IV cannulation for diagnostic or therapeutic procedures. Pain in this population is often unrecognised because these patients are frequently unable to self-report their pain. Now it's possible to measure pain in children with intellectual disability with specific pain scales, like NCCPC-PV (Non-Communicating Children's Pain Checklist, Post-operative Version).

The efficacy of a device combining vibration and cold for pain relief during venipuncture or IV cannulation has been recently reported in children. The device's actions are based on the Gate Control Theory, whereby cold and vibrations stimulate large fiber and inhibitory neurons to interrupt nociception. This non-pharmacologic technique for pain relief could be useful in this kind of patients in emergency department. To date, there is no study that validated Buzzy device for pain relief in children with intellectual disability.

The aim of this study is to test the effectiveness of Buzzy® (a device that provides cold and vibration), in reducing the pain during venipuncture or IV cannulation, in children with intellectual disability.


Options:
A: Child pain intensity (2 minutes after completion of the immunization series.)
B: Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS. (24 hours before surgery)
C: Faces Pain Scale-Revised (5 mins before and immediate after vaccination)
D: Pain score (NCCPC-PV scale) (intraoperative)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficiency of a Phone Coaching Program on Adherence to Continuous Positive Airway Pressure in Sleep Apnea Hypopnea Syndrome
Brief Summary: Background: Continuous Positive Airway Pressure (CPAP) remains the reference treatment for moderate to severe forms of the Sleep Apnea/Hypopnea Syndrome (SAHS). Compliance to the treatment appears to be a key factor to improving health status of these patients.

Methods: The investigators conducted a multicenter, prospective, randomized, controlled, parallel group trial of standard support completed or not within 3 months of coaching sessions for newly diagnosed SAHS patients starting CPAP therapy. The coaching session consisted of 5 sessions of telephone-based counseling by competent staff. The primary outcome was the proportion of patients using CPAP more than 3 hours per night for 4 months; the secondary outcome was mean hours of CPAP usage in the 2 groups.


Options:
A: proportion of patients using Continuous Positive Airway Pressure for more than 3 hours per night in the 2 groups (CPAP use was evaluated for 4 months)
B: CPAP Therapy Adherence (30 days post in-lab split night polysomnogram)
C: Residual Apnea Hypopnea Index (up to 12 weeks)
D: Apnea-Hypopnea Index (Baseline and 180 Days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Alive & Thrive Evaluation in Burkina Faso
Brief Summary: The time between birth and age 24 months provides a unique opportunity to impact the long-term health and development of children through improved infant and young child feeding practices. In Burkina Faso, the prevalence of exclusive breastfeeding is currently around 25% in infants younger than six months.

The purpose of this study is to evaluate whether the Alive \& Thrive intervention package, consisting of interpersonal counselling and community mobilisation activities, can increase the exclusive breastfeeding rate among infants younger than six months to at least 50% using a cluster randomised design.


Options:
A: Mean weight-for-length z-score at 15 months of age (15 months of age)
B: Exclusive Breastfeeding on the Day Preceding the Interview as Assessed by Cross Sectional Survey (Infants up to 6 months in a cross-sectional endline survey scheduled for April - July 2017)
C: Exclusive breastfeeding (6 months postpartum)
D: Maternal stress and anxiety (Baselibne to 12 weeks); Breast milk volume at 12 weeks assessed non-invasively using stable isotope techniques (12 weeks); Breast milk cortisol concentrations at 12 weeks (12 weeks); Infant behaviour measured using a 3-day diary at 12 weeks (12 weeks); Infant weight and body composition measured using stable isotopes at 12 weeks (12 weeks); Physiological changes (maternal saliva cortisol, breast milk cortisol and milk volume) before and after physiological-mini test in intervention group at 2,6 and 12 weeks. (2,6,12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Pediatric Patients With Relapsed and Refractory B-cell Acute Lymphoblastic Leukemia
Brief Summary: This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of CTL019 in pediatric patients with r/r B-cell ALL.


Options:
A: Death Within 8 Weeks of the Study Cell Infusion Thought to be Definitely or Probably Related to Chimeric Antigen Receptor (CAR) T Cell Therapy (Within 8 weeks of the study cell infusion); Dose Limiting Toxicities (30 days); Objective Response Rate of Complete Response and Partial Response (Up to 1 year); Overall Survival (Up to 1 year); Progression Free Survival (Up to 1 year)
B: Event-free survival (EFS) (Approximately 3 years)
C: Percentage of Participants With Overall Remission Rate (ORR) as Determined by Independent Review Committee (IRC) Assessment. (during the 3 months after tisagenlecleucel administration)
D: Phase I: Determination of the maximum tolerated dose (MTD); Phase II: Evaluation of preliminary efficacy of FBTA05 in combination with DLI

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This study will examine the effect of a culturally-safe two-way supportive text message intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs in a community-based setting.

The study is nested within The Cedar Project, an ongoing cohort study addressing HIV and Hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince George, British Columbia, Canada. Indigenous collaborators and investigators, collectively known as the Cedar Project Partnership, govern the entire research process.

A stratified Zelen pre-randomized design will be used to identify a random selection of cohort members to be offered the Cedar Project mHealth intervention with consent. Participants in the intervention arm will receive a package of supports, including a mobile phone and long-distance plan, weekly two-way supportive text messaging via the WelTel platform, and support from Cedar Advocates. Those drawn from the cohort study population as the comparison group will continue on in the usual Cedar Project study under its existing informed consent with no change whatsoever to their participation in the overall study.

The main outcome is an HIV propensity score, assessed at six months and one year. Secondary outcomes include HIV risk, resilience, access to drug-related services, psychological distress, and connection to culture measured at six months and one year. Primary analysis is by intention to treat.


Options:
A: Antiretroviral Therapy (ART) Adherence Levels (real time (for 9 months))
B: Attendance at Cervical Cancer Screening at clinics included in Trial (within 60 days from recruitment into study)
C: HIV propensity score (0, 6 and 12 months)
D: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF Alpha Naive Subjects With Active Radiographic Axial Spondyloarthritis
Brief Summary: The purpose of this study is to assess the efficacy of ustekinumab, in adult participants with active radiographic axial spondyloarthritis (AxSpA), who are naive to anti-TNF alpha agents, as measured by the reduction in signs and symptoms of radiographic AxSpA.


Options:
A: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24 (Week 24)
B: Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 24 (Week 24)
C: Number of Participants With Adverse Events (From Start of the Study up to Study Termination (up to 42 Weeks))
D: Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24 (Week(W) 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility Study to Identify the Optimal Adjuvant Combination Scheme of Ipilimumab and Nivolumab in Stage III Melanoma Patients
Brief Summary: This is a two-arm Phase 1b feasibility trial consisting of 20 patients receiving the combination of ipilimumab+nivolumab, either adjuvant, or split neo-adjuvant and adjuvant.


Options:
A: Overall Survival (Assessed every 3 months for 2 years, then every 6 months for 3 years)
B: The alteration in magnitude of the neo-antigen specific T cell response in the time interval pre- to post-adjuvant therapy in peripheral blood (12 weeks from baseline); Safety as measured by SUSARs. (12 weeks from baseline); The alteration in breadth of the neo-antigen specific T cell response in the time interval pre- to post-adjuvant therapy in peripheral blood (12 weeks from baseline); Feasibility as measured adherence to the timelines in the study protocol. (12 weeks from baseline)
C: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))
D: Disease-free survival

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Feasibility Study to Identify the Optimal Adjuvant Combination Scheme of Ipilimumab and Nivolumab in Stage III Melanoma Patients
Brief Summary: This is a two-arm Phase 1b feasibility trial consisting of 20 patients receiving the combination of ipilimumab+nivolumab, either adjuvant, or split neo-adjuvant and adjuvant.


Options:
A: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4.0) in Participants With Solid Tumors (Parts A and A1) (Up to 28 days in Cycle 1); Number of Participants Who Experienced an Adverse Event (AE) (Up to approximately 91 months (through Final Database cut-off date of 05-Nov-2018)); Overall Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Integrated Radiology and Oncology (IRO): Melanoma Participants (Parts B Plus D) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015)); ORR According to RECIST 1.1 as Assessed by Independent Review Committee (IRC): Non-Small Cell Lung Cancer (NSCLC) Participants (Parts C Plus F) (Up to approximately 53 months (through Interim Database cut-off date of 18-Sep-2015))
B: The alteration in magnitude of the neo-antigen specific T cell response in the time interval pre- to post-adjuvant therapy in peripheral blood (12 weeks from baseline); Safety as measured by SUSARs. (12 weeks from baseline); The alteration in breadth of the neo-antigen specific T cell response in the time interval pre- to post-adjuvant therapy in peripheral blood (12 weeks from baseline); Feasibility as measured adherence to the timelines in the study protocol. (12 weeks from baseline)
C: Response to Neoadjuvant Therapy by Therapy Arms: Clinical Response Rates (CR + PR + SD) (Evaluated after a total of 8 weeks of therapy before definitive surgery.); Response to Neoadjuvant Therapy: Overall Clinical Responses (Evaluated after a total of 8 weeks of therapy before definitive surgery.)
D: Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review (Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of a Pulmonary Rehabilitation Program on the PROactive Tool
Brief Summary: Pulmonary rehabilitation is an essential non pharmacological treatment option which reduces dyspnea sensations, increase exercise tolerance, improves health related quality of life and reduces the burden on health care resources (1). Pulmonary rehabilitation is likely an ideal intervention to validate the PROactive tool as responses to pulmonary rehabilitation are clinically significant in terms of exercise tolerance and particularly activity related symptoms. Nevertheless, the response to pulmonary rehabilitation is variable and about one out of three patients does not present a clinically important response. Pulmonary rehabilitation may therefore be an intervention that allows studying the conceptual model around the PROactive tools, anchoring the new PROs (Patient Report Outcome) to outcomes that are well known to change with rehabilitation: exercise induced symptoms, functional exercise tolerance and health related quality of life.

Study objectives

Main objectives

A primary aim is to test reliability of the paper-pencil versus the electronic scoring version of the PROactive tool in terms of assessing the effect of pulmonary rehabilitation on the components of the PROactive tool and on the mode of administration.

The secondary aim of the proposed project is to investigate the effects of a multidisciplinary outpatient hospital-based, pulmonary rehabilitation program on: i) daily physical activity (number of daily steps, vector magnitude unit and movement intensity and ii) the components of the Proactive tool.

Additional study objectives

A third aim of this project is to investigate whether the magnitude of change in daily physical activity and the components of the PROactive tool in general is associated with the magnitude of changes in frequently used rehabilitation related end-points including, functional capacity, exercise capacity and health-related quality of life following the completion of a comprehensive pulmonary rehabilitation program.

A forth aim of this project is to investigate whether the magnitude of change in daily physical activity and the components of the PROactive tool in general is associated with the magnitude of changes in physiological indices including cardiovascular and respiratory adaptations following completion of a comprehensive pulmonary rehabilitation program.


Options:
A: Proactive tool (clinical visit version) (7 days)
B: Number of exacerbations (12 months)
C: Combined number of hospitalizations and emergency department presentations (Two years)
D: Change in 6-minute walk test (Baseline, 8 weeks and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nifedipine Alone or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor: An Open Label, Randomized Comparative Effectiveness Controlled Trial
Brief Summary: Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor


Options:
A: Gestational age at delivery (before than 42 weeks of gestation)
B: Time to delivery (through study completion, approximately 1 year); Gestational age (through study completion, approximately 1 year)
C: Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation (48 hours after administration of tocolytic agent)
D: In women with singleton gestations, to contemporarily assess the efficacy of oral nifedipine versus intravenous magnesium sulfate in the acute management of preterm labor in terms of defined early and late neonatal measures (At delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Subjects With Active Radiographic Axial Spondyloarthritis
Brief Summary: The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha) refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of radiographic AxSpA.


Options:
A: Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24 (Week 24)
B: Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 24 (Week 24)
C: Number of Participants With Adverse Events (From Start of the Study up to Study Termination (up to 42 Weeks))
D: Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24 (Week(W) 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Fall Prevention and Locomotion Recovery in Post-stroke Patients: A Multimodal Training
Brief Summary: The study proposes a novel rehabilitative program for the recovery of locomotor abilities in post-acute stroke patients. The hypothesis is that a rehabilitative program which involves a biofeedback cycling training combining voluntary effort and Functional Electrical Stimulation (FES) of the leg muscles, and a biofeedback balance training is superior to usual care in improving walking abilities, disability, motor performance, and independence of post-acute stroke patients. The innovative approach is to investigate whether interventions which do not directly involve locomotor functions but movements similar in terms of kinematic patterns and neural commands (e.g. pedaling), or aimed at recovering an essential prerequisite for walking, such as postural control during upright stance, may improve and/or accelerate the recovery of walking abilities.

A single-blind randomized controlled study is carried out. Participants are post-acute stroke patients experiencing a first stroke less than 6 months before recruitment, with an adult age, a low level of spasticity of the leg muscles (Modified Ashworth scale \<2), no limitations at hip, knee, and ankle joints, and able to sit up to 30 minutes. Subjects are randomized to one of two groups, one performing the novel rehabilitative program in addition to usual care (experimental group), and one performing usual care alone (control group).

The experimental program consists of 15 sessions of FES-supported voluntary cycling training followed by 15 sessions of balance training. Both cycling and balance training are supported by a visual biofeedback in order to maximize patients' involvement in the exercise and are performed in addition to usual care.

The control group is involved in standard physical therapy which includes stretching, muscular conditioning, exercises for trunk control, standing, and walking training, and upper limb rehabilitation.

Both training programs last 6 weeks and patients are trained daily for about 90 minutes. Cycling and balance training last about 20 minutes; thus, patients in the experimental group perform only about 70 minutes of usual care.

Participants are evaluated at baseline (T1), after the end of the cycling training or after 3 weeks of usual care (post-treatment, T2), after the end of the whole intervention (post-treatment, T3), and about 6 months after the end of the intervention (follow-up, T4).


Options:
A: Gait Speed ("6 weeks")
B: Maximum torque around the knee joint; gait velocity
C: Change in Fugl-Meyer assessment of paretic upper limb motor function (baseline, after sessions, 30 and 90 days)
D: Behavioural Inattention Test (BIT) (Change in BIT score between the baseline sessions average and score measured at week 11)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED)
Brief Summary: The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.


Options:
A: Absolute change in office systolic blood pressure(SBP) (at 6 months)
B: Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events. (From baseline to 1 month post-procedure (6 months for new renal artery stenosis)); Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (From baseline to 3 months post-procedure)
C: Change in Office Systolic Blood Pressure (Baseline to 6 months post-randomization)
D: recurrence of > 30 secs of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a single ablation procedure on no antiarrhythmic drug (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED)
Brief Summary: The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the absence of antihypertensive medications.


Options:
A: To investigate the combined effect of aliskiren and valsartan on vascular structure, assessed by wall to lumen ratio of retinal arterioles, in hypertensive patients. (After 8 weeks of treatment with aliskiren versus placebo)
B: Change in Office Systolic Blood Pressure (Baseline to 6 months post-randomization)
C: Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events. (From baseline to 1 month post-procedure (6 months for new renal artery stenosis)); Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (From baseline to 3 months post-procedure)
D: daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement (3 months follow up)

Answer: C