TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical and Cost Effectiveness of a Parent Mediated Intervention to Reduce Challenging Behaviour in Pre-schoolers With Moderate to Severe Learning Disability: a Randomised Controlled Trial
Brief Summary: Children with intellectual disabilities are likely to present with challenging behaviour. Parent mediated interventions have shown utility in influencing child behaviour, although there is a paucity of UK research into challenging behaviour interventions in this population. NICE guidelines favour Stepping Stones Triple P (SSTP) as a challenging behaviour intervention and this trial aims to evaluate its clinical and cost effectiveness in preschool children with moderate to severe intellectual disabilities.The trial launched in 2017 at four sites across England, with the aim of recruiting 258 participants (aged 30-59 months). The Intervention Group receive nine weeks of SSTP parenting therapy (six group sessions and three individualised face to face or telephone sessions) in addition to Treatment as Usual (TAU) whilst the TAU group receive available services in each location. Both study groups undergo the study measurements at baseline and at four and twelve months. Outcome measures include parent reports and structured observations of behaviour. Service use and health related quality of life data is also being collected to carry out a cost effectiveness and utility evaluation. Findings from this study will inform policy regarding interventions for challenging behaviour in young children with moderate to severe intellectual disabilities.


Options:
A: Objective 1: clinical manifestations (lifetime of protocol); Objective 2: behavioral, neuropsychological, neurophysiological, and neuroanatomical correlates (lifetime of protocol); Objective 3: genetic and familial correlates (lifetime of protocol)
B: Child Behaviour Check List (CBCL) (12 months)
C: Aberrant Behavior Checklist scale (6 months)
D: To examine between-group differences in clinical, behavioral, genetic, neuroanatomical, and neurophysiological variables (20 years); To examine associations between irritability and clinical, behavioral, genetic, neuroanatomical, and neurophysiological variables (20 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Supplementation of Vitamin D in Preterm Infants- Monitored Therapy vs Standard Therapy. A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine wheather the monitored vitamin D (vit D) therapy is safer and more effective than standard therapy in pretrem infants.


Options:
A: 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))
B: The number of days of detectable milk vitamin D concentrations (28 days)
C: Differences in maternal bone mass changes postpartum between supplemented and placebo groups (2, 5 and 12 months postpartum); Differences in fetal growth and infant bone mass between supplemented and placebo groups (2nd and 3rd trimester gestation and 2 mo postpartum)
D: 25(OH)D Plasma Concentrations (18 weeks gestation for mother); 25(OH)D Plasma Concentrations (28 weeks gestation for mother); 25(OH)D Plasma Concentrations (36 weeks gestation for mother); 25(OH)D Plasma Concentrations (16 weeks post-partum for mother & infant)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Supplementation of Vitamin D in Preterm Infants- Monitored Therapy vs Standard Therapy. A Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine wheather the monitored vitamin D (vit D) therapy is safer and more effective than standard therapy in pretrem infants.


Options:
A: length of hospital stay (3 to 5 days)
B: Plasma concentrations of 25-hydroxyvitamin D, parathyroid hormone, alkaline phosphatase (end of winter)
C: Mean Annual Rate of Respiratory Events (Up to 2 years)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Cluster Randomized Control Trial to Assess the Impact of Active Learning on Child Activity, Attention Control, and Academic Outcomes: The Texas I-CAN Trial
Brief Summary: Background: Active learning is designed to pair physical activity with the teaching of academic content. This has been shown to be a successful strategy to increase physical activity and improve academic performance. The existing designs have confounded academic lessons with physical activity. As a result, it is impossible to determine if the subsequent improvement in academic performance is due to: (1) physical activity, (2) the academic content of the active learning, or (3) the combination of academic material taught through physical activity.

Methods / Design: The Texas I-CAN project is a 3-arm, cluster randomized control trial in which 28 elementary schools were assigned to either control, math intervention, or spelling intervention. As a result, each intervention condition serves as an unrelated content control for the other arm of the trial, allowing the impact of physical activity to be separated from the content. That is, schools that perform only active math lessons provide a content control for the spelling schools on spelling outcomes. This also calculated direct observations of attention and behavior control following periods of active learning.

Discussion: This design is unique in its ability to separate the impact of physical activity, in general, from the combination of physical activity and specific academic content. This, in combination with the ability to examine both proximal and distal outcomes along with measures of time on task will do much to guide the design of future, school-based interventions.


Options:
A: Physical activity level (one school week); Time on task (change in time on task from baseline to 15 minutes post academic lesson); Acute academic achievement (change in math and language arts scores from Baseline to 2 weeks); Long-term math achievement (Change in math achievement scores from Baseline to 7 months); Long-term language arts achievement (Change in language arts achievement from Baseline to 7 months)
B: Change in minutes spent in moderate to vigorous physical activity in after school programs from baseline to end of intervention (7 months) and 1 year after end of intervention. (Baseline, end of intervention (7 months), 1 year after intervention)
C: Blood pressure (6 months)
D: pedometer-derived step count (baseline and every 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Electroacupuncture to Mirabegron on Symptoms of Overactive Bladder in Women Who Have Failed Anti-Cholinergic Therapy
Brief Summary: This study compares electroacupuncture to mirabegron for treatment of overactive bladder (OAB) symptoms in women who have failed treatment with anticholingeric therapy.


Options:
A: Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 (baseline, weeks 1-12)
B: Change in number of micturition episodes per 24 hours (Before treatment (baseline), 8 week (post-treatment) and 12 week (follow-up))
C: 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)
D: Stress test (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Electroacupuncture to Mirabegron on Symptoms of Overactive Bladder in Women Who Have Failed Anti-Cholinergic Therapy
Brief Summary: This study compares electroacupuncture to mirabegron for treatment of overactive bladder (OAB) symptoms in women who have failed treatment with anticholingeric therapy.


Options:
A: Urogenital Distress Inventory (UDI-6) (baseline to 6 or 8 weeks); Incontinence Impact Questionnaire (IIQ-7) (baseline to 6 or 8 weeks)
B: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)
C: Fecal Incontinence Quality of Life (FIQOL) (baseline (2-weeks post delivery) to completion (12-weeks post delivery))
D: 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)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
Brief Summary: The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.


Options:
A: Change in Target Lesion Individual Component Scores for Erythema, Scaling and Thickness Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Change in Target Lesion TOTAL Score (Sum of Erythema + Scaling + Thickness) Compared to Baseline (Baseline, Days 8, 15, 22, 28 and 56); Number of Participants With Treatment Emergent Adverse Events (3 months); Pharmacokinetics Parameter : Skin Flux of INCB018424 (Days 8, 15, 22, and 28); Pharmacokinetics Parameter : Bioavailability of INCB018424 (Days 8, 15, 22, and 28)
B: The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1) (Week 16); The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75) (Baseline and Week 16)
C: Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 (Week 48)
D: Percentage of Participants Who Achieved >75 or Higher (Psoriasis Area and Severity Index) PASI Score at 12 Weeks (12 weeks); Percentage of Participants Who Achieved (Investigator's Global Assessment) IGA Score of 0 or 1 (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
Brief Summary: The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.


Options:
A: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo (12 weeks)
B: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 (Part A) (Week 16); Percentage of Participants Achieving Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 (Part A) (Week 16); Percentage of Participants Who Were Re-Randomized to Receive Either Adalimumab or Risankizumab in Part B Achieving PASI90 at Week 44 (Part B) (Week 44)
C: Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 (Week 48)
D: Psoriasis Area and Severity Index (PASI) 75 Response and Investigators' Global Assessment (IGA) Mod 2011 0 or 1 Response (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis
Brief Summary: The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.


Options:
A: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16); Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16)
B: Percentage of Participants With Moderate to Severe Plaque Psoriasis Who Achieved Psoriasis Area and Severity Index (PASI) 90 at Week 16 (Week 16)
C: Percent improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12 (12 weeks)
D: Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 (Week 48)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of Contact Phase Activation During Hemodialysis Using Different Dialysis Membranes: a Prospective Randomized Crossover Study
Brief Summary: Every patient included in the study will undergo 3 standardised hemodialysis treatments, each using a different dialysis membrane (PMMA, PS, AN69ST). The order of the membranes used will be randomized.

During each conventional and standardised hemodialysis treatment, 6 blood samples will be taken at different time points (T0, T5, T15, T30, T90, T240) to evaluate coagulation activation (TAT, PF1+2, d-dimers, TF) and, more specifically, activation of the contact phase pathway of coagulation (kallikrein, fXIa, fXIIa).


Options:
A: Clotting of the dialysis session (During first dialysis session_Dialysis duration: 4 hours)
B: change in dialysis adequacy (every midweek dialysis session through study duration, ie 2x4 weeks)
C: Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding (Randomization up to Month 15/Final Visit)
D: Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma kallikrein. (Blood samples are taken before hemodialysis treatment start and 5minutes (min), 15min, 30min, 90min and 240min after hemodialysis treatment start.); Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIa. (Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.); Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIIa. (Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Open Label, Randomised, Controlled, Multi-Centre Study To Assess the Efficacy and Safety of Savolitinib Versus Sunitinib in Patients With MET-Driven, Unresectable and Locally Advanced, Or Metastatic Papillary Renal Cell Carcinoma (PRCC)
Brief Summary: This study is designed for patients diagnosed with MET-driven, unresectable and locally advanced or metastatic Papillary Renal Cell Carcinoma. The purpose of this study is to see if an investigational new anti-cancer medication, savolitinib, is effective in treating patients with MET-driven PRCC, how it compares with another medication frequently used to treat this disease called sunitinib, and what side effects it might cause.


Options:
A: Overall Survival (From date of subject randomization to date of death; assessed up to 42 months or until 290 deaths have been accrued on study)
B: Progression-Free Survival (PFS): Independent-Assessment (Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012))
C: Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) (RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.)
D: Time to progression (7-11 months expected)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Neonatal Abstinence Syndrome With Clonidine Versus Morphine as Primary Therapy
Brief Summary: The purpose of this study is to show non-inferiority between two medications used for medical treatment of withdrawal seen in Neonatal Abstinence Syndrome (NAS), Clonidine and Morphine Sulfate (used in routine care) on length of treatment for NAS .


Options:
A: Number of Participants Administered Morphine Treatment (Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 days); Cumulative Pharmacological Treatment- Morphine Dose (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Hospitalization Length of Stay (Day of life infants discharged home, which is an expected mean of 21 days.); Hospitalization Length of Stay for Untreated Infants (Day of life untreated infants discharged home, which is an expected mean of 21 days.); Hospitalization Length of Stay for Treated Infants (Day of life treated infants discharged home, which is an expected mean of 21 days.); Length of Pharmacological Treatment-Duration (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Trajectory of Symptom Severity Among Treated Infants (Day of life infant started morphine treatment); Velocity of Weight Gain (Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days); Neurobehavioral Outcomes Assessment (6 month and 12 months of life)
B: Length of treatment for neonatal abstinence syndrome (duration of the treatment)
C: Child's Head Circumference Measurement (Measured at Birth) (birth); Child's Length of Hospital Stay (delivery until hospital discharge (min=2 days, max=79 days)); Number of Children Requiring Treatment for Neonatal Abstinence Signs (NAS) (From birth until hospital discharge (min=4 days, max=10, depending on site)); Child's Peak Daily Total NAS Score (minimum twice daily from birth until NAS no longer measured (min=10 days)); Total Amount of Morphine Sulfate That a Neonate Receives to Treat NAS (Start of NAS treatment until discontinuation of NAS treatment (min=0 days, max=76 days))
D: Length of treatment (From initiation of medical treatment through last dose of medication given, up to 100 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Stepped Care for Suicide Prevention in Teens and Young Adults
Brief Summary: This randomized controlled trial will evaluate two approaches to achieving the aspirational goal of Zero Suicide within a health system: 1) Zero Suicide Best Practices initiated through a zero suicide quality improvement initiative within a health system; and 2) Zero Suicide Best Practices plus an innovative stepped care for suicide prevention intervention for adolescents and young adults that matches treatment intensity with risk levels for suicide/self-harm. ..


Options:
A: Suicide attempts (measured by the Columbia Suicide Severity Rating Scale) (6-months); Suicidal ideation (measured by the Beck Suicide Scale (BSS)) (6-months)
B: Repeat Suicide Attempts (1, 2, and 3 months)
C: Suicide Attempt Behavior (12-month observation period)
D: To explore in patients with BPD the effect of quetiapine on psychotic-like symptoms and severity of psychiatric symptoms (assessed at each visit for 8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Stepped Care for Suicide Prevention in Teens and Young Adults
Brief Summary: This randomized controlled trial will evaluate two approaches to achieving the aspirational goal of Zero Suicide within a health system: 1) Zero Suicide Best Practices initiated through a zero suicide quality improvement initiative within a health system; and 2) Zero Suicide Best Practices plus an innovative stepped care for suicide prevention intervention for adolescents and young adults that matches treatment intensity with risk levels for suicide/self-harm. ..


Options:
A: Difficulties in Emotion Regulation Scale (DERS) (1-past week); Barrat Impulsiveness Scale (BIS-11) (1-past week)
B: Rate of suicide attempts (Annual)
C: Change in frequency of self-harm (suicidal and non-suicidal) behaviours over time as measured by the Suicide Attempt Self-Injury Interview (SASII) (Administered pre-treatment and every three months until 24 months)
D: Suicide Attempt Behavior (12-month observation period)

Answer: D