TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The BRAIN ICU Study: Bringing to Light the Risk Factors and Incidence of Neuropsychological Dysfunction in ICU Survivors
Brief Summary: The primary purpose of this proposal will be to identify potentially modifiable risk factors of long-term cognitive impairment (i.e. development of delirium and exposure to sedative and analgesic medications) in ICU patients. The investigators will quantify the independent contribution of these risk factors to the incidence of long-term cognitive impairment, controlling for other established risk factors including age, pre-existing cognitive impairment, and apolipoprotein E (apoE) genotype. Quantifying the contributions of these modifiable risk factors will pave the way for the development of preventive and/or treatment strategies to reduce the incidence, severity and/or duration of long-term cognitive impairment and improve functional recovery for patients with critical illness.


Options:
A: Total Number of Days in Hospital (Within 60 days of randomization)
B: Percentage of Participants With Freedom From Clinical or Radiographic Central Nervous System (CNS) Infarction (up to 10 days post procedure)
C: N/A
D: Incidence of Delirium (Participants will be followed for the duration of the hospital stay, an average of 5 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The BRAIN ICU Study: Bringing to Light the Risk Factors and Incidence of Neuropsychological Dysfunction in ICU Survivors
Brief Summary: The primary purpose of this proposal will be to identify potentially modifiable risk factors of long-term cognitive impairment (i.e. development of delirium and exposure to sedative and analgesic medications) in ICU patients. The investigators will quantify the independent contribution of these risk factors to the incidence of long-term cognitive impairment, controlling for other established risk factors including age, pre-existing cognitive impairment, and apolipoprotein E (apoE) genotype. Quantifying the contributions of these modifiable risk factors will pave the way for the development of preventive and/or treatment strategies to reduce the incidence, severity and/or duration of long-term cognitive impairment and improve functional recovery for patients with critical illness.


Options:
A: Feasibility: Study adherence (1 year)
B: N/A
C: Tower Test (3 months post hospital discharge)
D: time to successful extubation (This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Parental Skills and Enhancing Attachment in Early Childhood
Brief Summary: Child psychological/behavioural disorders such as withdrawal may persist when the psychosocial context is unfavourable. Health promotion strategies (Olds' paradigm) have proved their efficacy in vulnerable populations. CAPEDP project sets out to evaluate a program of home visits in France


Options:
A: Maternal life-course (reflected in reduced total public benefit expenditures for SNAP, AFDC/TANF, and Medicaid). (through first child age 18); Cognitive, language, and academic functioning among first-born children. (at youth age 18); Youth depression and anxiety (at youth age 18); Youth gang membership, arrests, convictions, and self-reported antisocial behavior, especially for crimes involving interpersonal violence. (at youth age 18); Youth risk for HIV infection, pregnancies, births, use of substances, and SUDs. (at youth age 18.)
B: Child cognitive development, behavior, and health (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years); Child social-emotional development (At-risk sample: Up to 6 years; Not-at risk sample: Up to 1 year); Child depression (At-risk sample: Up to 8 years; Not-at risk sample: Up to 2 years)
C: Mothers' scores on a postnatal depression scale (baseline, and when the child is 3, 6 and 12 months old) (baseline, and when the child is 3, 6 and 12 months old); Parental competencies (when the child is 3, 12 and 18 months old) (when the child is 3, 12 and 18 months old); Child mental health (when the child is 18 and 24 months old) (when the child is 18 and 24 months old)
D: The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at baseline); The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at 3 weeks postpartum); The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at 3 months postpartum); The primary outcome measure is to evaluate the effectiveness in a randomized controlled trial of a patient education intervention to reduce depressive symptoms among Black and Hispanic postpartum women. (Measured at 6 months postpartum)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sleep and Tolerability of Extended Release Dexmethylphenidate vs. Mixed Amphetamine Salts: A Double Blind, Placebo Controlled Study (SAT STUDY)
Brief Summary: The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there are differences in sleep and other side effects, such as changes in mood or loss of appetite, which can occur with stimulant medications. A third purpose is to determine if there are differences in the characteristics of individuals who respond better to either of the medications.

This research is being done because the investigators do not know if one of these two commonly used treatments is better tolerated than the other. Children and adolescents with ADHD often have a hard time sitting still, playing quietly, finishing things they start, paying attention, waiting their turn, and not distracting others. These medications improve these symptoms, but sometimes affect sleep, appetite, or mood.

It is hypothesized that at effective and frequently prescribed doses, Adderall will be associated with insomnia, more stimulant side effects, and decreased tolerability during an acute trial relative to Focalin.


Options:
A: Baseline Complex Network connectivity before treatment - using electrodes signal correlation (P-value) (0 minutes); Baseline Complex Network connectivity after treatment - using electrodes signal correlation (P-value) (90 minutes)
B: Sleep Start Time, and End Time as Determined by Actigraph and Sleep Diary Over 8 Weeks. (8-10 weeks); Sleep Duration (8-10 weeks)
C: CGI -S - ADHD rating scale (Father) (Change from Screening at 8 weeks.); Conners Adult ADHD Rating Scale - Self Report (Father) (Change from Screening at 8 weeks.); Conners Other Report (about Father) (Change from Screening at 8 weeks); Barkley Functional Impairment Rating Scale (Father) (Change from Screening at 8 weeks.); Conners Parent (completed by parent about child) (Change form Screening at 8 weeks.); Conners Teacher Rating Scale (completed by teacher about child) (Change from Screening at 8 weeks.)
D: Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP)-Combined Scores During the Full-Day Laboratory Classroom (Full-day Classroom - 13 hrs)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Xylitol Adult Caries Trial (X-ACT)
Brief Summary: The purpose of the trial is to determine the extent to which daily use of xylitol lozenges reduces the appearance of new caries lesions in adults who tend to experience such lesions (i.e., caries-active adults).


Options:
A: new decayed surfaces (1 year)
B: MS colonization (2 years)
C: caries reduction (3 years)
D: combined root and coronal D2FS (dental caries) increment (3 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Study to Investigate the Bleeding Profile and the Insertion Easiness in Women Inserted With a Second Consecutive MIRENA for Contraception or Menorrhagia
Brief Summary: The purpose of this study is to assess the bleeding pattern during the last 3 months of the first MIRENA® and the first year of the second MIRENA® use.


Options:
A: Pain (3 months)
B: Pain During IUD Insertion at Various Time Points (See Description for Time Points) (During IUD insertion (see above description for which time points))
C: Primary efficacy variable will be bleeding profile (Screening, entry (60-90 days after screening), month 3 and 6, year 1,2,3,4 and 5)
D: Mean Pain Score During IUD Insertion (Day 1)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Federal Study of Adherence to Medications in the Elderly (FAME)
Brief Summary: The purpose of this study is to determine the effect of a comprehensive pharmacy care program on medication adherence and persistence, blood pressure, and LDL cholesterol.


Options:
A: Life quality evaluation of both groups (control and intervention) at 0, 7, 13, and 19 months from the beginning of the inclusion filled in by the patient or his/her main caregiver (husband or wife, a friend...) thanks to a closed envelope given by the GP (at 0, 7, 13 and 19 months from the beginning of the incusion)
B: Safety: All-cause mortality (6 weeks); Safety: Readmission for any of CHF, unstable angina, arrhythmia, re-infarction, revascularization, stroke, or major bleeding requiring transfusion (6 weeks); Feasibility: Proportion of patients in the intervention group discharged within 72 hours ("feasible" if >= 70%); Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 3 days of discharge ("feasible" if >= 80%); Feasibility: Proportion of patients in the intervention group who saw nurse practitioner within 5 days of discharge ("feasible" if >= 90%)
C: Change in proportion of pills taken compared to baseline (0-2months) at 8months; Between-group comparison of medication persistence at 14months
D: Medication Appropriateness Index (MAI)-Score (6 months from baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Federal Study of Adherence to Medications in the Elderly (FAME)
Brief Summary: The purpose of this study is to determine the effect of a comprehensive pharmacy care program on medication adherence and persistence, blood pressure, and LDL cholesterol.


Options:
A: Adherence to Antidepressant Medication (At 3 and 6 months)
B: BP at 6 months (6 months)
C: Change in proportion of pills taken compared to baseline (0-2months) at 8months; Between-group comparison of medication persistence at 14months
D: Blood Pressure Control (9 Months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Federal Study of Adherence to Medications in the Elderly (FAME)
Brief Summary: The purpose of this study is to determine the effect of a comprehensive pharmacy care program on medication adherence and persistence, blood pressure, and LDL cholesterol.


Options:
A: Change in proportion of pills taken compared to baseline (0-2months) at 8months; Between-group comparison of medication persistence at 14months
B: Adherence to Cardioprotective Medications (Clopidogrel, Statins, Beta Blockers, ACE-inhibitor/ARB) (12-months)
C: Adherence to the decision to use or not to use statins
D: Proportion of patients receiving AAS, an ACE inhibitor and a statin among those without contraindications to any of these drugs Adherence to treatment measured by: Morinsky-Green test and Pill accountability. (18 months); Adherence to treatment measured by the Morisky-Green questionnaire (18 months); Treatment adherence measured by: Morisky-Green test: (Good adherence score 16-20) at 1 and 9 months. (18 months); Treatment adherence measured by: Pill counts at 1-4-9 months. (Good adherence 80-110% PC) (18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Federal Study of Adherence to Medications in the Elderly (FAME)
Brief Summary: The purpose of this study is to determine the effect of a comprehensive pharmacy care program on medication adherence and persistence, blood pressure, and LDL cholesterol.


Options:
A: Change in proportion of pills taken compared to baseline (0-2months) at 8months; Between-group comparison of medication persistence at 14months
B: Medication adherence; Exacerbation of heart failure; Health-related quality of life
C: Impact of personalized risk information (baseline); Impact of personalized risk information (3 month)
D: Adherence; Self-efficacy; Quality of life

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Federal Study of Adherence to Medications in the Elderly (FAME)
Brief Summary: The purpose of this study is to determine the effect of a comprehensive pharmacy care program on medication adherence and persistence, blood pressure, and LDL cholesterol.


Options:
A: Change in proportion of pills taken compared to baseline (0-2months) at 8months; Between-group comparison of medication persistence at 14months
B: Change in Quality of Life (one year after baseline assessment); Change in Caregiver Burden (one year after baseline assessment); Change in Behavioral and Psychological Symptoms of Dementia (one year after baseline assessment); Change in Medical Treatment With Antidementia Drugs (one year after baseline assessment); Reduction of Potential Inapropriate Medication (PIM) (one year after baseline assessment)
C: Number Who Discontinued Medication Within First 6 Study Months (Measured at Six Months)
D: Adherence to blood pressure medications; Blood pressure control

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control
Brief Summary: This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.


Options:
A: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Baseline (BL) and Day 85)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85) (End of treatment (Week 12 + 1 day, Day 85))
C: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
D: Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1) (Change from Baseline to 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control
Brief Summary: This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.


Options:
A: Pre-dose and 1-hour post-dose FEV1 over the 6 months treatment period
B: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
C: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
D: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control
Brief Summary: This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.


Options:
A: Trough Forced Expiratory Volume in one second (FEV1) response determined at the end of the 12- week treatment period (week 12)
B: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Endpoint (13 weeks)); Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1 (Baseline to Endpoint (13 weeks))
C: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
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: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control
Brief Summary: This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.


Options:
A: First Occurrence of (Moderate or Severe) COPD Exacerbation (52 weeks)
B: Trough Forced Expiratory Volume in 1 Second (FEV1). (12 weeks)
C: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
D: Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84) (Baseline to Day 84 (Early Withdrawal))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control
Brief Summary: This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
B: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
C: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85) (End of treatment (Week 12 + 1 day, Day 85))
D: Trough Forced Expiratory Volume in 1 Second (FEV1) Assessed by Spirometry 24 Hour Post Dose After 12 Weeks of Treatment (after 12 weeks of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control
Brief Summary: This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.


Options:
A: Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment (4 hour period following inhalation of study treatment)
B: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
C: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
D: Percentage of patients experiencing an exacerbation (6 months); Percentage of patients hospitalized for a COPD exacerbation (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind Study Evaluating the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Comparison to Etanercept Alone or Methotrexate Alone in Rheumatoid Arthritis Patients.
Brief Summary: To compare the therapeutic and radiographic effects and safety between etanercept, methotrexate, and the etanercept/methotrexate combination in patients with rheumatoid arthritis.


Options:
A: Proportion of subjects achieving a good or moderate DAS28 response (as defined by the EULAR28 response criteria) at Week 12
B: The objective of this study is to evaluate the therapeutic response including radiographic changes and safety of etanercept alone, methotrexate (MTX) alone, and the combination of etanercept and MTX in patients with rheumatoid arthritis (RA)
C: The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6. (12 months); Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5. (12 months)
D: American College of Rheumatology 20 Response (ACR20) (12 weeks)

Answer: B