TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Short-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder
Brief Summary: The objective of this study is to investigate the efficacy and safety of aripiprazole orally administered over a period of 8 weeks in pediatric patients with Autistic Disorder


Options:
A: Change in Mullen Scales of Early Learning - Expressive Language Raw Score (From baseline visit to six-month visit); Change in Mullen Scales of Early Learning - Combined Age Equivalent Score (From baseline visit to six-month visit)
B: Change in Clinical Global Impressions (CGI) Global Improvement (Change from Baseline at 8 Weeks); Change in Clinical Global Impressions (CGI) Global Improvement (Change from Open-Label Baseline at 8 Weeks); Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC) (Change from Baseline at 8 Weeks.); Change in Lethargy Subscale of the Aberrant Behavior Checklist (ABC) (Change from Open-Label Baseline at 8 Weeks)
C: Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score (baseline, 8 weeks after dosing)
D: Developmental Neuropsychological Assessment (NEPSY) Apraxia and Repetition of Nonsense Words Subtests (Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial)); Expressive Vocabulary Test (EVT) (Baseline, Week 12, Week 24 (Measuring change from Baseline, middle of trial and end of trial))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Short-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder
Brief Summary: The objective of this study is to investigate the efficacy and safety of aripiprazole orally administered over a period of 8 weeks in pediatric patients with Autistic Disorder


Options:
A: Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score (baseline, 8 weeks after dosing)
B: Vineland Adaptive Behavior Scales, Third Edition (Vineland-3) - Social Domain (16 weeks)
C: Clinical Global Impression-Improvement Scale (CGI-I) (Baseline to 12 weeks)
D: Change From Baseline in Aberrant Behavior Checklist Irritability Subscale (ABC-I) (Baseline and 7 days.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Short-term Administration Study of Aripiprazole in Children and Adolescents (Age: 6 to 17 Years) With Autistic Disorder
Brief Summary: The objective of this study is to investigate the efficacy and safety of aripiprazole orally administered over a period of 8 weeks in pediatric patients with Autistic Disorder


Options:
A: N/A
B: The primary measure will be a global composite derived by calculating the z scores on each measure other than CGI from published norms (or from the baseline descriptives, then averaging the z scores of the various outcome measures for each individual. (Baseline, weeks 2, 4, 6, 8, 10,12, and 14.)
C: Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score (baseline, 8 weeks after dosing)
D: Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6 (Baseline to 6 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Achieving Energy Balance in Overweight Post Partum Teens
Brief Summary: This proposal will test Balance Adolescent Lifestyle Activities and Nutrition Choices for Energy (BALANCE), a multilevel intervention administered through Parents as Teachers (PAT) and designed to reduce overweight in postpartum teens. The intervention will focus on the replacement of 'obesogenic' patterns (such as high soda intake, excess portion size, and sedentary activity) with 'energy' patterns (such as water consumption, appropriate portion size, and walking).


Options:
A: Change in Body Mass Index Z-score (9 months)
B: Increase physical activity (2010); Increase the intake of fiber (2010); Decrease fat intake (2010); Decrease television and other screen time (2010); Decrease obesity (2010)
C: BMI change at 6 month post assessment (Baseline and 6 month post assessment); BMI change at 1 year post assessment (Baseline to 1 year post assessment)
D: Change in BMI Percentile (baseline and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Achieving Energy Balance in Overweight Post Partum Teens
Brief Summary: This proposal will test Balance Adolescent Lifestyle Activities and Nutrition Choices for Energy (BALANCE), a multilevel intervention administered through Parents as Teachers (PAT) and designed to reduce overweight in postpartum teens. The intervention will focus on the replacement of 'obesogenic' patterns (such as high soda intake, excess portion size, and sedentary activity) with 'energy' patterns (such as water consumption, appropriate portion size, and walking).


Options:
A: Number of students obtaining lunch per day by National School Lunch Program (NSLP) eligibility (5 months); Number of fruits and vegetables served per day (5 months)
B: BMI change at 6 month post assessment (Baseline and 6 month post assessment); BMI change at 1 year post assessment (Baseline to 1 year post assessment)
C: Change in Body Mass Index from to baseline to 1 and 2 years (0-1-2 years); Change in overweight and obesity status according to IOTF norms (up to 2 years); Change in BMI Z score from baseline to one and two years (up to 2 years)
D: Change in Body Mass Index Percentage (BMI%) (Change from Baseline to 12-Month Post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 12-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 15-Week Post intervention); Social Skills (15-Week Post); Academic Performance (15-Week Post); Change in Body Mass Index Percentile (%) (Change from Baseline to 6-Month post intervention); Change in Healthy Lifestyle Behaviors (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 6-Month Post intervention); Change in Depression and Anxiety Symptoms (Change from Baseline to 12-Month Post intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia and LDL-C Higher or Equal to 160mg/dL With Their Lipid-Modifying Therapy
Brief Summary: Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points
* To evaluate the effects of alirocumab on other lipid parameters
* To evaluate the safety and tolerability of alirocumab


Options:
A: Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
B: Percent Change From Baseline in Calculated LDL-C at Week 24 - ITT Analysis (From Baseline to Week 52)
C: Percent Change From Baseline in LDL-C at Week 52 (Baseline and Week 52)
D: Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) (Up to approximately 9 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia and LDL-C Higher or Equal to 160mg/dL With Their Lipid-Modifying Therapy
Brief Summary: Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.

Secondary Objectives:

* To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points
* To evaluate the effects of alirocumab on other lipid parameters
* To evaluate the safety and tolerability of alirocumab


Options:
A: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent--to--Treat (ITT) Analysis (From Baseline to Week 52)
B: Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 (Baseline, Week 12)
C: Percent Change From Baseline in Calculated LDL-C at Week 24 - ITT Analysis (From Baseline to Week 52)
D: Percent Change From Baseline in LDL-C at Week 52 (Baseline and Week 52)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rapid Effects of the DPP-4 Inhibitor Linagliptin on Monocyte Polarization and Endothelial Progenitor Cells in Type 2 Diabetic Patients With and Without Chronic Renal Failure. A Randomized Cross-over Trial Versus Placebo
Brief Summary: Diabetes mellitus is characterized by chronic low grade inflammation, which is worsened by the co-existence of renal failure.

One key aspect of chronic inflammatory diseases is the alteration in the polarization profile of circulating monocyte-macrophage cells.

Namely, monocytes-macrophages can exist in a pro-inflammatory (M1) polarized form or an anti-inflammatory (M2) polarized state. Alterations in the M1/M2 balance is thought to contribute to inflammation within atherosclerotic lesions and visceral adipose tissue which, in turn, can worsen cardiovascular disease and metabolic features in type 2 diabetic patients.

M1 and M2 are regulated by a complex interplay of soluble signaling molecules, many of which are substrate of the enzyme DPP-4 (dipeptidyl peptidase-4). Therefore, inhibition of DPP-4 can affect the M1/M2 polarization balance.

In this clinical trial, the investigators will test whether the DPP-4 inhibitor Linagliptin, compared to placebo, modifies the M1/M2 balance in type 2 diabetic patients with and without chronic renal failure.

In addition, we will test whether DPP-4 inhibition with Linagliptin acutely affects endothelial progenitor cells (EPCs), which are vasculoprotective cells implicated in the pathobiology of diabetic complications.


Options:
A: Percentage of Participants With First Confirmed Cardiovascular (CV) Event of Major Adverse Cardiovascular Event (MACE) Plus (Per Protocol Population) (Up to 5 years); Percentage of Participants With First Confirmed CV Event of Major Adverse Cardiovascular Event (MACE) Plus (Intent to Treat Population) (Up to 5 years)
B: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks (baseline, 24 weeks)
C: Hemoglobin A1c (A1C) Changes From Baseline at Week 24 (Baseline, Week 24); A1C Changes From Baseline at Week 24 - Open Label Cohort (Baseline, Week 24)
D: M1/M2 polarization balance (day 5)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy of P6 Acupressure in Reducing Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy. - a Randomized, Double-blinded, Placebo Controlled Study.
Brief Summary: The aim of this study is to investigate if P6 acupressure may reduce postoperative nausea and vomiting in neurosurgical patients undergoing craniotomy.


Options:
A: the mean infusion rate of intraoperative remifentanil and propofol (during operation)
B: Postoperative nausea and vomiting (24 hours)
C: N/A
D: Postoperative nausea and vomiting (Postperative nauea and vomiting are registred regularly 0-48 hours postperatively.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures
Brief Summary: The purpose of this study is to confirm the efficacy and safety of perampanel compared to placebo in patients with refractory partial-onset seizures


Options:
A: Median Percent Change in Primary Generalized Tonic Clonic Seizure Frequency (PGTC) Per 28 Days During the Titration and Maintenance Periods (Combined) Relative to Baseline (Prerandomization) - (for Core Study) (Baseline (4 or 8 weeks), Titration (4 weeks), and Maintenance (13 weeks)); 50% Responder Rate for Primary Generalized Tonic Clonic Seizure During Maintenance - LOCF - (for Core Study) (Baseline (4 or 8 weeks) and Maintenance (13 weeks)); 50% Responder Rate in Primary Generalized Tonic-Clonic Seizure Frequency Per 28 Days Relative to the Core Study Prerandomization Phase - (for Extension Phase) (Week 1 of perampanel treatment to date of last dose of perampanel in the Extension Phase)
B: Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline) (Baseline, Week 19)
C: Change From Baseline to Week 19 in Cognition Drug Research (CDR) System Global Cognition Score (Core Study) (Baseline (Visit 2/Week 0 Evaluation) and Week 19 LOCF (last observation carried forward))
D: Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases) (Baseline (Pre-randomization) through Week 19)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Exposure, Safety and Local Tolerance Study Comparing the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis
Brief Summary: Relative Bioavailability Comparison study


Options:
A: Percentage of Participants With Psoriatic Arthritis (PsA) Based on Physical Examination, Medical History and Laboratory Results (Week 0 through Week 8)
B: Proportion of patients achieving an ACR20 response. (48 weeks)
C: Dose-Normalized AUC[0-Inf] for MTX (24 Hour period); Dose-Normalized AUC[0-24] for MTX (24 Hour period); Dose-Normalized Cmax for MTX (24 Hour period)
D: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14 (Week 14)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Exposure, Safety and Local Tolerance Study Comparing the Relative Bioavailability of Oral Methotrexate and the VIBEX™ MTX Device in Adult Subjects With Rheumatoid Arthritis
Brief Summary: Relative Bioavailability Comparison study


Options:
A: Dose-Normalized AUC[0-Inf] for MTX (24 Hour period); Dose-Normalized AUC[0-24] for MTX (24 Hour period); Dose-Normalized Cmax for MTX (24 Hour period)
B: Mean 48-week Change in DAS28 (48 weeks after baseline assessment)
C: Number of Participants Who Achieved American College of Rheumatology (ACR) 50 Response at Week 24 (Week 24); Change From Baseline in Total Van Der Heijde Modified Sharp (vdH-S) Score at Week 52 (Baseline and Week 52)
D: Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate (At 12 Weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)
Brief Summary: Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute deep vein thrombosis (DVT).

The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.


Options:
A: Post thrombotic syndrome (percentage of patients with PTS) one year following the acute thrombotic event. (one year)
B: Patency after 6 months (6 months); Post-thrombotic syndrome after 2 years (yrs) (2 years)
C: Composite of rate of extension of distal DVT to proximal deep veins (includes ipsilateral extension or new contralateral proximal DVT) or symptomatic PE at 6 weeks (6 weeks); Rate of post-thrombotic syndrome (PTS) (1 year)
D: Major bleedings defined as overt bleeding associated with: A fall in hemoglobin of ≥2 g/dL; or a transfusion of ≥2 units of packed red blood cells or whole blood; or occurrence at a critical site (after approximately 2 years or 30 days after stop of therapy); Number of patients with symptomatic recurrent venous thromboembolic events (after approximately 2 years or 30 days after stop of therapy); All cause mortality (after approximately 2 years or 30 days after stop of therapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Community Study of the Effectiveness of Misoprostol for PPH Treatment at the Community Level (Home Births Attended by Primary Care Unit Staff) in Etay El Barood and Kafr El Dawar Districts (El Beheira Governorate), Egypt
Brief Summary: This randomized controlled community-based trial will assess the effectiveness of administration of 800 mcg sublingual misoprostol with standard of care vs. placebo with standard of care for postpartum hemorrhage treatment at the community level, primarily home births attended by primary health care unit (PHU) staff in Etay El Barood and Kafr El Dawar districts (El Beheira governorate), Egypt. Standard of care per national guidelines in this setting is referral to a higher level health facility.


Options:
A: Change in hemoglobin measurement of >2 g/dL pre- to -post-delivery. (Before delivery (at onset of labor), after delivery (2 to 4 days after delivery))
B: Hb of greater than or equal to 2 g/dl from pre- to post-delivery (3-5 days after delivery)
C: Maternal or Perinatal death or morbidity (within 42 days of pregnancy)
D: Need for additional treatment after initial PPH study treatment (all additional interventions recorded following initial uterotonic treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Hand Hygiene Promotion Activities: Effect on Intestinal Parasitic Infections and Anaemia Among School-aged Children in Eastern Tigray, Ethiopia: a Factorial Randomised Controlled Trial
Brief Summary: Impact exerted by intestinal parasitic infections is much higher in developing countries. School-aged children are at higher risk from the burden of disease, because they specially have many parasitic infections. The poor health results in deficits in physical and cognitive development and educational achievements. Nowadays, there is huge commitment among the global community to control intestinal parasitic infections and to improve nutritional status of young children in developing countries.

Large-scale anthelminthic drug administration through vertical control programmes is still required for the foreseeable future and is, therefore, recommended by the World Health Organization (WHO). However, due to the inevitability of re-infection in endemic areas, children need to be treated regularly, and once morbidity control is consolidated, the strategy must shift to transmission control emphasising access to clean water and adequate sanitation. To lower dependency on 'drug only' approach and to enhance sustainability, from the onset of control activities, complementary measures should be implemented, that depend on available resources.

Therefore, the investigators are proposing to undertake a randomised controlled trial to assess the impact of simple and easy-to-do hand hygiene intervention packages (hand washing with soap and hand finger nail clipping) on intestinal parasitic infection prevalence, intensity and re-infection rates and on haemoglobin concentration and anaemia prevalence rates among 6-15 years old schoolchildren. Our results will provide solid evidence on if and how hand hygiene practice affects infection prevalence and re-infection rates, as well as, anaemia prevalence among the highly vulnerable age group.


Options:
A: Length-for-Age Z-scores (Measured 24 months after intervention); Diarrhea Prevalence (Measured 12 and 24 months after intervention)
B: Reduction in hookworm prevalence and intensity of infection in intervention arm (6 months)
C: - Proportion of intestinal parasitic re-infection rates among intervention and control groups (six months); - Proportion of intestinal parasite load (mean eggs per gram) among intervention and control groups (six months)
D: Diarrhea in Children Under 5 (one year after the intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized, Double-blind, Controlled Pilot Study on Safety of Hypertonic Saline as Preventive Inhalation Therapy in Newborns and Infants With Cystic Fibrosis
Brief Summary: The purpose of this study is to assess whether 6% hypertonic saline (HS) is a safe and effective preventive therapy in newborns and infants with cystic fibrosis (CF).


Options:
A: Change in Mucociliary Clearance Rate (Baseline versus after completion of 4 week treatment period)
B: Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) (At the end of each 2-week treatment period); Safety: Number of Participants With Adverse Events During Each Treatment Period (4 Weeks)
C: Number of patients in both treatment groups with adverse events (AEs) and serious adverse events (SAEs) (during the 52 week treatment period)
D: Change in FEV1 Percentage Predicted From Baseline (14 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing Children's Cognitive and Brain Health Through Physical Activity Training
Brief Summary: The objective of this study is to use a randomized controlled design to determine whether cardiorespiratory fitness training improves neurocognitive function and academic performance during preadolescent development.


Options:
A: NeuroCognitive Assessment (Change from baseline, 36 - 40 weeks); Structural Magnetic Resonance Imaging (Change from baseline, 36 - 40 weeks); Functional Magnetic Resonance Imaging (Change from baseline, 36 - 40 weeks); Academic Achievement (Change from baseline, 36 - 40 weeks); Eye Tracking (Change from baseline, 36 - 40 weeks); Task Performance (Change from baseline, 36 - 40 weeks)
B: Changes in Academic Achievement in Elementary Students (Baseline to 3 Years)
C: Intake of nutrients; Serum lipid and lipoprotein concentrations; Growth and development; Smoking; Physical activity level and fitness; Intima-media thickness of arteries and rate of NO-induced vasodilatation
D: Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (Baseline, 24 months); Change in Waist Circumference (Baseline, 78 months); Prevalence of Acanthosis Nigricans (Baseline, 24 months); Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (Baseline, 78 months); Change in Waist Circumference (Baseline, 24 months); Prevalence of Acanthosis Nigricans (Baseline, 78 months)

Answer: A