TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis- An Investigator-initiated, Phase IV, Randomised Double-blind Multi-centre Trial of the Benefits and Harms of Aripiprazole Versus Quetiapine in Children and Adolescents With Psychosis
Brief Summary: The benefits and harms of antipsychotics are relatively well studied in adults. However, there is a lack of scientifically valid studies regarding the benefits and harms of antipsychotics in children and adolescents with psychosis.

The main objective of the TEA trial is to compare the efficacy and adverse reactions of two antipsychotics (quetiapine versus aripiprazole) in children and adolescents between 12-17 years of age with psychotic symptoms on psychopathology, cognitive deficits, and daily functioning. Furthermore, the trial will focus on adverse reaction profiles of the two antipsychotics as well as early predictors of later sustained clinical effects of these antipsychotics.


Options:
A: Knowledge, risk perception, stigma, perceived control (immediately post intervention and 1 month post intervention)
B: Change in PTSD symptom severity with the PSS-I the Post-traumatic Stress Disorder Scale- Interview (PSS-I) post-treatment at 6- and 12-month follow-up (8, 18 and 25- month follow-up); Change in Attraction to violence with the Appetitive Aggression Scale (AAS) post-treatment at 6- and 12-month follow-up (8, 18 and 25- month follow-up); Change in Methylation Pattern of the Glucocorticoid Receptor promoter region via saliva samples (8, 18 and 25- month follow-up); Change in Self-committed violence with the AAS offense list (8, 18 and 25- month follow-up); Influence of Social Acknowledgement with Social Acknowledgement Questionnaire (SAQ) (8, 18 and 25- month follow-up); Influence of drug abuse related to violence on number of offenses with the offense checklist (from the AAS) (8, 18 and 25- month follow-up); Change in Epigenetic Markers (methylation patterns) of violence in the androgen receptor promoter region via saliva samples (8, 18 and 25- month follow-up)
C: Psychopathology: improvement on PANSS positive scale (PANSS 'Positive and Negative Syndrome Scale') (12 weeks)
D: Post-traumatic Stress Disorder (chronic) by CAPS scores. (Four months, seven months, 14 moths, two years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis- An Investigator-initiated, Phase IV, Randomised Double-blind Multi-centre Trial of the Benefits and Harms of Aripiprazole Versus Quetiapine in Children and Adolescents With Psychosis
Brief Summary: The benefits and harms of antipsychotics are relatively well studied in adults. However, there is a lack of scientifically valid studies regarding the benefits and harms of antipsychotics in children and adolescents with psychosis.

The main objective of the TEA trial is to compare the efficacy and adverse reactions of two antipsychotics (quetiapine versus aripiprazole) in children and adolescents between 12-17 years of age with psychotic symptoms on psychopathology, cognitive deficits, and daily functioning. Furthermore, the trial will focus on adverse reaction profiles of the two antipsychotics as well as early predictors of later sustained clinical effects of these antipsychotics.


Options:
A: Psychopathology: improvement on PANSS positive scale (PANSS 'Positive and Negative Syndrome Scale') (12 weeks)
B: Treatment emergent adverse events over 12 months. (Weekly)
C: The change from survey day 1 to first visit in Clinical Global Impression score (3 weeks)
D: Change in ADHD-RS-IV Total Score From Baseline (Visit 2) to the End of the Double-Blind Phase (Visit 3) (From baseline (visit 2) to end of of Double-Blind phase (visit 3))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Vitamin D on Balance in Persons With PD
Brief Summary: A trial to measure the effects of vitamin D (versus a placebo) on balance, gait, falls, strength, and cognition in persons with Parkinson's disease.


Options:
A: Change of Berg Balance Scale (BBS) (15 minutes/session; measured at weeks 0, 6, and 12 of the experiment)
B: Falls rate (6 months post intervention)
C: Level of Physical Activity based on the LAPAQ questionnaire (Average of 6, 12, 18 and 24 months)
D: Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3) (Baseline, 16 weeks); Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration (Baseline and 16 weeks); Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work) (Baseline, 16 weeks); Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6) (Baseline, 16 weeks); Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work) (Baseline, 16 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Patient Understanding of Preeclampsia
Brief Summary: Participants counseled with the preeclampsia educational tool will have a better understanding of preeclampsia than those not counseled using the tool.


Options:
A: Iodine deficiency (36 weeks of pregnancy); Iodine deficiency (24 weeks of pregnancy)
B: Improved understanding of preeclampsia (one week)
C: Increase in parent knowledge, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Increase in parent skills, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Decrease in parental high-risk behaviors, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum; Increase in parental-child involvement, measured at baseline, 2 weeks post-partum, 6 months post-partum and 12 months post-partum
D: Sexually transmitted disease (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Rapid repeat pregnancy (Measured at Month 12 postpartum); Sexual risk behavior (Measured at 2nd and 3rd trimesters and Months 6 and 12 postpartum); Perinatal outcomes (e.g., birth weight, gestational age) (Measured at Months 6 and 12 postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of GMI-1070, A Pan-Selectin Inhibitor, In Subjects Hospitalized For Sickle Cell Vaso-Occlusive Crisis
Brief Summary: GMI-1070 is a new drug that may reduce the stickiness of cells in the blood. The purpose of this study is to evaluate whether GMI-1070 can reduce the time it takes for pain to go away in patients with vaso-occlusive crisis (also known as a sickle cell pain crisis). The study will also collect information on the safety of GMI-1070, how much of the drug is in the blood and urine, and if there are any other effects when used in patients who are in the hospital for a sickle cell pain crisis.


Options:
A: 1) Major Bleeding Episodes (Up to 35 days); Change in Platelet Count (Up to 35 days)
B: Patient controlled analgesia (PCA)diamorphine or morphine consumption (4 days)
C: To determine whether there is a difference in time to first occurrence of a large improvement in daily average pain intensity between a High Demand/Low Infusion (HDLI) dosing vs. Low Demand/High Infusion (LDHI) dosing for parenteral opioid. (Pain Intensity will be assessed 3 times a day between the hours of 7 AM and 7 PM on each day of the hospital stay)
D: Reduction in time to resolution of vaso-occlusive crisis (Up to 7 days or resolution)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis
Brief Summary: This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.


Options:
A: Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) (Baseline to Week 24)
B: Pharmacokinetics (PK) (Cmax, AUClast, AUCinf, t1/2, systemic clearance, and volume of distribution) following IV administration (169 days); Pharmacokinetics (PK) [Cmax, tmax, AUC (0-4wk), t1/2 for last dose only, R[AUC(0-4wk)] following SC administration (211 days); Plasma concentrations of golimumab following IV administration (169 days); Plasma concentrations of golimumab following SC administration (211 days)
C: Change From Baseline in the Volume Transfer Rate From the Blood Plasma to the Enhancing Synovium (Ktrans) (Baseline and week 14)
D: Percentage of patients with ACR 20 response (Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis
Brief Summary: This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.


Options:
A: American college of Rheumatolofy (ACR)-20 responder rate at Week 24
B: N/A
C: Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) (Baseline to Week 24)
D: Percentage of Patients With an Improvement of at Least 50% in American College of Rheumatology (ACR) Score (ACR50) From Baseline at Week 24 (Baseline to Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis
Brief Summary: This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.


Options:
A: Number of patients who achieve a DAS28 < 3.2 (0, 1, 3, 6, 9, 12 and 24 months (DAS28))
B: Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) (Baseline to Week 24)
C: Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR (Day 85); Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A (Length of study (through Day 85))
D: Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 52 (Baseline and 52 Weeks); Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 (Baseline and Week 52)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis
Brief Summary: This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where continued treatment with methotrexate was considered inappropriate. Patients were randomized to receive either tocilizumab 8 mg/kg intravenously (iv) every 4 weeks plus placebo subcutaneously (sc) every 2 weeks, or adalimumab 40 mg sc every 2 weeks plus placebo iv every 4 weeks. Treatment was anticipated to last 24 weeks. With regard to the blind, the study nurse was unblinded due to the nature of the treatment administration, but the investigator and the patient remained blinded.


Options:
A: EULAR individual response (12 months)
B: Change From Baseline to Week 24 in the Disease Activity Score 28 (DAS28) (Baseline to Week 24)
C: Double-blind Period: Mean Synovitis Scores at Baseline As Measured by the Rheumatoid Arthritis Clinical Trials 6 (OMERACT 6) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) (At baseline); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Planned Analysis Using Non-Parametric ANCOVA (Baseline to Day 113); Double-blind Period: Mean Change From Baseline in OMERACT 6 Wrist Synovitis Score: Post Hoc Sensitivity Analysis Using Parametric ANCOVA Analysis (Baseline to Day 113)
D: Mean 48-week Change in DAS28 (48 weeks after baseline assessment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Pilot Study of Positive End-Expiratory Pressure (PEEP) in Acute Respiratory Distress Syndrome(ARDS): Individualized According to the Best Compliance or Fixed According to Fraction of Inspired Oxygen (FiO2) Applied
Brief Summary: Randomized controlled pilot trial in 70 patients with Acute Respiratory Distress Syndrome (ARDS) ventilated with low tidal volumes and limitation on airway pressure at 35 centimeters of water (cmH2O), to compare two different methods of selecting the level of Positive End-Expiratory Pressure (PEEP) to be applied: according to fraction of inspired oxygen (FiO2) needed or individualized according to the best compliance. Primary objective was evolution of arterial oxygenation during the 28 days. Secondary objectives were to measure its effects on hemodynamic parameters, 28-day mortality, number of ventilator-free days at day 28, Intensive Care Unit (ICU) and hospital stay, number of multiple-organ dysfunction-free days and a multivariate analysis of 28 day-mortality.


Options:
A: Mortality rate (at day 90)
B: Development of ARDS (28 days)
C: Arterial Oxygenation (28 days)
D: Hospital Mortality

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: 17-alpha-Hydroxyprogesterone Caproate (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM), Double-blinded Randomized Clinical Trial
Brief Summary: The objective of the study is to determine if a weekly dose of 17 hydroxyprogesterone caproate (17P, Makena®) given to women with preterm rupture of the membranes will:

1. increase the probability of continuing the pregnancy until a favorable gestational age.
2. increase the interval between randomization and delivery.
3. decrease neonatal morbidity.


Options:
A: Gestational Age at Delivery (Measured from day of last menstrual cycle to day of birth and measured in weeks.)
B: Spontaneous delivery before 34 completed weeks (238 days) of gestation.
C: The incidence of delivery < 34 weeks, in the study group versus the control group (Participants will be followed until 3 weeks after delivery)
D: Number of Participants Delivering Before 37 Weeks Gestation (Delivery before 37 weeks gestation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Community-based Intergenerational Oral Health Promotion In Rural America
Brief Summary: The purpose of this study is to determine whether giving brief motivational interviewing counseling during the prenatal and/or postnatal period(s) will increase utilization of preventive dental care and improve the oral health of rural, low-income pregnant and postpartum women and their children, and to increase the number of home oral health practices taken by these women to prevent caries in their young children.


Options:
A: Serum 25OH-vitamin D levels (90 days after start of treatment)
B: Exclusive Breastfeeding Rates in Burkina Faso (at 3 months of age); Infant Morbidity, 2 Week Diarrhoea Prevalence (at 3 months of age); Exclusive Breastfeeding Rates in Uganda (at 3 months of age); Exclusive Breastfeeding Rates in South Africa (at 3 months of age)
C: Blood Glucose, levels of glucose in blood (Postprandial 0-180 min after breakfast); Insulin, levels of insulin in blood (Postprandial 0-180 min after breakfast); Appetite hormones, levels of Peptide YY (PYY) in blood (Postprandial 0-180 min after breakfast); Markers of colonic fermentation, levels of hydrogen in breath (Postprandial 0-180 min after breakfast); Inflammation markers, levels of Interleukin-6 (IL-6) in blood (Postprandial 0-180 min after breakfast)
D: Visiting the dentist during pregnancy and up to two months postpartum for the mother and visiting the dentist before 18 months for the child. (During pregnancy and up to two months post partum (mother); up to 18 months (child))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Three Doses of Aclidinium Bromide Compared to Placebo and to an Active Comparator All Administered Twice Daily by Inhalation in Patients With Stable Moderate and Severe Chronic Obstructive Pulmonary Disease (COPD).
Brief Summary: The present trial is conducted to further assess the efficacy by means of serial spirometry, safety and tolerability of three doses of aclidinium bromide administered twice a day compared to previously approved BID drug, formoterol 12 µg, and placebo in patients with moderate to severe chronic obstructive pulmonary disease (COPD).after 7 days on treatment. Every treatment period is 7-days long and there is a 5 to 7-days wash-out period in between them. The trial starts with a run in phase of 11 to 17-days duration and it ends up with a follow up contact 14-days after last treatment dose.


Options:
A: Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) (Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks)
B: Change From Baseline in Forced Expiratory Volume in First Second (FEV1) Area Under Curve (AUC) 0-12h at Day 7 on Treatment (Day 7)
C: Trough FEV1 (L) at 28 Weeks on Treatment (28 weeks); Trough FEV1 (L) at 12 Weeks on Treatment (12 weeks)
D: Trough FEV1 (L) at 28 Weeks on Treatment (Week 28); Trough Forced Expiratory Volume in the First Second (FEV1) (L) at 12 Weeks on Treatment (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Study to Evaluate the Efficacy of 1,25(OH)2D3 (Calcitriol) Versus Placebo in Recent Onset Type 1 Diabetes(IMDIAB XIII)
Brief Summary: Reduction in vitamin D levels has been reported in subjects with recent onset type 1 diabetes. Several studies suggest that vitamin D supplementation in early childhood decreases the risk of developing type 1 diabetes, therefore vitamin D deficiency might play a role in the disease pathogenesis. We investigated whether the supplementation of the active form of vitamin D (calcitriol) in subjects with recent-onset type 1 diabetes can protect residual beta cell function evaluated by C peptide and improve glycaemic control as evaluated by HbA1c and insulin requirement.

Thirty-four subjects (age range 11-35 years, median 18 years) with recent-onset type 1 diabetes (\<12 weeks duration) and high basal C-peptide \>0.25 nmol/l were randomized in a double-blind trial to calcitriol (the active form of vitamin D, 1.25-dihydroxyvitamin D3 \[1,25-(OH)2D3\] ) at the dose of 0.25 ug/day or placebo, and followed up for 2 years.


Options:
A: Serum calcium (at each dose change)
B: N/A
C: median time to next exacerbation. (1 year)
D: C peptide

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The purpose of this study is to determine whether mesalamine is effective vs. placebo in the prevention of diverticulitis flares in a 24-months follow-up.

The primary end-point of the study is the incidence of diverticulitis flares. Will be made a clinical diagnosis of uncomplicated diverticulitis: fever, leukocytosis, abdominal pain and altered intestinal motility.


Options:
A: Percent of Subjects Without Recurrence of Diverticulitis (Up to 104 weeks)
B: Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon (one year)
C: discharge without complications +/- antibiotic therapy (Within 30 days after discharge)
D: diverticulitis relapse (24 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Childhood Cancer Survivor Study
Brief Summary: The Childhood Cancer Survivor Study (CCSS) will investigate the long-term effects of cancer and its associated therapies. A retrospective cohort study will be conducted through a multi-institutional collaboration, which will involve the identification and active follow-up of a cohort of approximately 50,000 survivors of cancer, diagnosed before 21 years of age, between 1970 and 1999 and 10,000 sibling controls. This project will study children and young adults exposed to specific therapeutic modalities, including radiation, chemotherapy, and/or surgery, who are at increased risk of late-occurring adverse health outcomes. A group of sibling controls will be identified and data collected for comparison purposes.


Options:
A: -To evaluate the efficacy and safety of doxorubicin with or without dexrazoxane; -To determine the efficacy of hyperfractionated radiation plus standard intrathecal chemotherapy compared with intensive intrathecal chemotherapy alone in standard risk patients.; -To compare the relative efficacy and toxicity of E.coli and Erwinia asparaginase; -To compare the relative efficacy and toxicity of cranial radiation delivered in once-daily versus twice-daily fractions in high risk patinets.
B: Diffusing capacity of the lungs for carbon monoxide (DLCO) (One year post therapy)
C: Left ventricular function and measures of pathologic remodeling (i.e., thickness-to-dimension ratio) assessed using standard 2-dimensional, M-mode, and Doppler echocardiogram (Baseline); Differences in serum biomarkers (particularly cardiac troponins and natriuretic peptides) (Baseline)
D: To characterize survivors' health outcomes with respect to disease-, treatment, and genetic-related factors. (25 years)

Answer: D