TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Memantine Versus Donepezil in Mild to Moderate Alzheimer's Disease. A Randomized Trial With Magnetic Resonance Spectroscopy.
Brief Summary: It is well known that in the brain of the patients with Alzheimer's disease there is a glutamatergic hyperstimulation leading to neuronal death. Memantine is a low affinity antagonist of NMDA glutamate receptors. The use of this drug in the early phases of the disease could provide neuroprotective effects and delay of progression. The effects of memantine should be compared to those of donepezil, which is the most prescribed anticholinesterase drug.


Options:
A: ADAScog/11 (change from Baseline to 12 months of treatment)
B: to assess the efficacy of Memantine in improving memory deficit in MS patients using the SRT scale (6 months)
C: Change in the Paced Auditory Serial Addition Test and the California Verbal Learning Test II (multivariate end-point) after 15 weeks of treatment.
D: Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain. (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Expanded Prenatal Testing Options and Informed Choice
Brief Summary: The proposed study will determine the impact of providing complete information about all prenatal tests for chromosomal disorders to racially/ethnically and sociodemographically diverse women of all ages and allowing them to make informed choices regarding which tests - if any - to undergo. Specifically, we propose to update a validated prenatal testing decision-assisting tool ("PT Tool") to incorporate new screening options and make it more accessible to lower literacy and culturally diverse populations. We then will conduct a randomized controlled trial comparing the effect of an "informed free choice" approach consisting of providing complete information regarding and access to all prenatal testing options to that of usual care among a diverse population of pregnant women.


Options:
A: Prenatal test use (9 months)
B: The following dependant variables were measured in this study;; Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and; LDL-cholesterol levels and test rates in the 12 months post-intervention.
C: Fecal Occult Blood Test (FOBT) completion rate (4 months)
D: Receipt of colorectal cancer screening (24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1.6 to 2.4 g Asacol® Therapy QD Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative Colitis
Brief Summary: The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen.


Options:
A: Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI) (6 months)
B: Number of Participants Who Achieved Clinical Remission at Day 56 (Baseline up to Day 56)
C: Period 1: Clinical and Endoscopic Remission (Week 8); Period 2: Clinical Response, Open-Label Extended Induction (Week 16); Period 3: Clinical Remission (Week 38)
D: Fecal Calprotectin Level <50µg/g (6 weeks after randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Open Label Pilot Study of the Efficacy of Dexmedetomidine and Haloperidol in Ventilated Patients With ICU-associated Agitation and Delirium
Brief Summary: The purpose of the study is to determine whether dexmedetomidine is a more effective medication than haloperidol in the treatment of agitation and delirium in patients receiving mechanical ventilation in an intensive care unit. Haloperidol is a medication conventionally used for this purpose.

The investigators will study only patients who have recovered from their illness to the point that, were it not for agitation and delirium, they would no longer require mechanical ventilation.

The investigators hypothesize that patients receiving dexmedetomidine will be able to discontinue mechanical ventilation earlier than those receiving haloperidol.


Options:
A: Days Free of Delirium and Coma (Admission through day 8 of stay)
B: The percentage of time spent within the protocol specified sedation range (Richmond Agitation-Sedation Scale [RASS] range of -2 to +1) (Preinfusion, Treatment period: every 10min for 30min, 1 & 4 hr after infusion starts, every 4 hrs, prior to end of infusion & extubation. Follow-up Period (48hrs): every 10min for 1st 30min after drug discontinuation, 1, 4, 8,12, 24 & 48 hr post infusion)
C: Individual Physical Function and Mental Health domains from SF-36 (for participants who complete the phone surveys); 6-minute walk distance and memory evaluation (for participants who attend the study visits) (Measured at Months 6 and 12)
D: Time from the commencement of treatment to extubation (days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Open Label Pilot Study of the Efficacy of Dexmedetomidine and Haloperidol in Ventilated Patients With ICU-associated Agitation and Delirium
Brief Summary: The purpose of the study is to determine whether dexmedetomidine is a more effective medication than haloperidol in the treatment of agitation and delirium in patients receiving mechanical ventilation in an intensive care unit. Haloperidol is a medication conventionally used for this purpose.

The investigators will study only patients who have recovered from their illness to the point that, were it not for agitation and delirium, they would no longer require mechanical ventilation.

The investigators hypothesize that patients receiving dexmedetomidine will be able to discontinue mechanical ventilation earlier than those receiving haloperidol.


Options:
A: Days alive and free of delirium and coma (delirium and coma free days) (enrollment to day 21)
B: decrease in delirium rating scale and clinical global improvement (7 days)
C: Ventilator-free hours (7 days following randomisation)
D: Time from the commencement of treatment to extubation (days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Diabetes Care for Korean Americans
Brief Summary: The purpose of this study is to assess the feasibility and efficacy of a culturally-tailored, comprehensive behavioral intervention program specially designed for linguistically challenged ethnic minority immigrant populations (Korean Americans) with type 2 DM.


Options:
A: Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT (Up to 1 week after the transplant education day)
B: HbA1c (30 Weeks)
C: Participant attends cervical cancer screening (Within 7 months of the intervention)
D: To determine the effect of a phosphorus additives educational intervention on serum phosphorus levels. (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Methylphenidate Transdermal System (MTS) in the Treatment of Adult ADHD
Brief Summary: This study will look at the effectiveness of Methylphenidate Transdermal System (MTS) in treating adult ADHD. MTS has received FDA approval for childhood ADHD but this is the first trial for adult ADHD. Subjects will experience two screening visits and one baseline visit. Those who meet admission criteria will enter the double-blind phase. This will involve two 4-week treatment periods one of which will involve the use of MTS and the other a placebo patch. Subjects who complete the double-blind phase will be allowed to enter a 180-day, open-label MTS phase designed to assess long-term effects.


Options:
A: Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Score (AISRS) Over Time Using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Fourth Edition for Diagnosis (Baseline, endpoint (42 days or early discontinuation))
B: Wender Reimherr Adult Attention Deficit Disorder Scale (Double-blind endpoints during MTS and placebo arms)
C: Monitoring adverse events, blood pressure, pulse, and weight throughout the study; ECG at Screening, Baseline, 1 week after upward dose titration, Months 3, 6, 9, 12 or Early Termination; Laboratory tests Screening, Month 6, Month 12 or Early Termination
D: Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) (Treatment duration for OL extended from 52 wks to 72 wks (International Amendment 2) or 108 wks in Germany. Treatment duration for double-blind (DB) randomized withdrawal: 4 weeks); Change From DB Baseline in Conners' Adult ADHD Rating Scale (CAARS) Total Score at DB Endpoint (DB baseline, DB endpoint)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluate the Reactogenicity & Immunogenicity of 1 or 2 Booster Administrations of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults Aged Between 19 & 61 Years
Brief Summary: The present study is designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate vaccine. Fifty new subjects who did not participate in a primary study (106750, NCT00309634) will be recruited. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00309634)


Options:
A: Safety (local and systemic reactogenicity, laboratory tests and AEs. (6 months)
B: To provide information concerning the immunogenicity of an inactivated, split-virion influenza vaccine (21 Days pot-vaccination)
C: Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain (At Day 0); Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain (At Day 21); Number of Seroconverted Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain (At Day 21); Seroconversion Factor (SCF) for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain (At Day 21); Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain (At Day 0); Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain (At Day 21); Number of Subjects With Any and Grade 3 Solicited Local Symptoms (During the 7-day (Days 0-6) post-vaccination period following each dose and across doses); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (During the 7-day (Days 0-6) post-vaccination period following each dose and across doses); Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) (During the 21-day (Days 0-20) follow-up period after the first vaccination and 30-day (Days 0-29) follow-up period after the second vaccination); Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) (During the 30-day (Days 0-29) follow-up period after the first vaccination); Number of Subjects With Serious Adverse Events (SAEs) (During the entire study period (From Day 0 up to Month 24))
D: Safety (28 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-center, Withdrawal Study Comparing MCI-196 v.s Placebo Following A 12-Week Dose Titration Period With MCI-196 in Stage V Subjects on Dialysis With Hyperphosphatemia
Brief Summary: This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.


Options:
A: serum phosphorus (weeks 5-24)
B: Change in Transferrin Saturation (TSAT) From Baseline to End of Treatment (12 Weeks); Change in Serum Phosphorus Levels From Baseline to End of Treatment (12 Weeks)
C: Total phosphorus bound and entrapped per piece of chewing gum (60 minutes)
D: The Change in Serum Phosphorus From Week 12 to Week 16 (4 weeks (Week 12 to Week 16))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Insulin Detemir on Glucose Control in Ageing Subjects With Type 2 Diabetes.
Brief Summary: This trial is conducted in Europe. The aim of the trial is to compare insulin detemir once daily to NPH insulin once daily as measured by blood sugar control in ageing subjects with type 2 diabetes naive to previous insulin therapy.


Options:
A: Percentage Change in Trunk Fat Mass (Defined as Peripheral Fat Ratio) (week 0, week 26); Absolute Change in Trunk Fat Mass (week 0, week 26)
B: The change in liver fat content and visceral fat mass (After 26 weeks of treatment)
C: Hemoglobin A1c Change From Baseline (Baseline to 6 months)
D: Change in Glycosylated Haemoglobin (HbA1c) at Month 7 (week 0, month 7)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Evaluate Combined Patching-Atropine for Residual Amblyopia
Brief Summary: This study is designed to evaluate the effectiveness of treatment of residual amblyopia in children ages 3 to \< 10 years with visual acuity of 20/32 to 20/63 in the amblyopic eye. The study is a randomized clinical trial comparing intensive treatment (42 hours per week of patching plus daily atropine) with a control group that will have rapid weaning of existing treatment followed by spectacle correction only (if needed). The primary objective is to determine if this intensive treatment will improve visual acuity in patients with residual amblyopia.

The primary outcome assessment is amblyopic eye visual acuity at 10 weeks.

The primary analytic approach for the amblyopic eye acuity will be a treatment group comparison of the proportion of patients with at least two lines of visual acuity improvement.


Options:
A: Visual acuity in the amblyopic eye (6 months)
B: Distribution of Amblyopic Eye Visual Acuity at 10 Weeks (10 Weeks); Mean (SD) Distribution of Visual Acuity at 10 Weeks (10 Weeks); Distribution of Amblyopic Eye Visual Acuity Change From Baseline to 10 Weeks (baseline to 10 Weeks); Mean (SD) Change in Visual Acuity in the Amblyopic Eye at the 10 Week Primary Outcome Exam (baseline to 10 Weeks)
C: Distribution of Visual Acuity in the Amblyopic Eye at 17 Weeks (17 weeks); Mean Visual Acuity in the Amblyopic Eye at 17 Weeks (17 weeks); Distribution of Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks (Baseline to 17 weeks); Mean Change in Visual Acuity in the Amblyopic Eye From Baseline to 17 Weeks (Baseline to 17 weeks)
D: Visual acuity improvement

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up
Brief Summary: This study examined whether self-efficacy promoted adherence to Pelvic Floor Muscle Training (PFMT) and Bladder Training (BT) in women aged 55 and older.


Options:
A: treatment failure (use of drug therapy for symptom control, surgical intervention, symptom deterioration of 3 points or more measured with the I-PSS, acute urinary retention, or death)
B: Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity. (Baseline and 3 months)
C: Mean number of incontinence episodes (Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline)
D: Adherence to PMFT and BT (self efficacy) were measured through questionnaires and 3-day voiding diaries. (Every 6 months for 4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Self Care to Prevent Urinary Incontinence (UI): A Four-Year Follow-up
Brief Summary: This study examined whether self-efficacy promoted adherence to Pelvic Floor Muscle Training (PFMT) and Bladder Training (BT) in women aged 55 and older.


Options:
A: To assess the well being of the women trought the proportion of women with back pain and stress urinary incontinence (The outcome will be that the pregnant women will be interview at an average of up to 30 days after delivery)
B: Evaluation of subjective cure (At the end of 3 months of supervised treatment)
C: Adherence to PMFT and BT (self efficacy) were measured through questionnaires and 3-day voiding diaries. (Every 6 months for 4 years)
D: Urogenital Distress Inventory (UDI-6) (baseline to 6 or 8 weeks); Incontinence Impact Questionnaire (IIQ-7) (baseline to 6 or 8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cognitive and Emotional Impairment After Stroke
Brief Summary: Cognitive and emotional symptoms are often seen in the acute phase of a stroke. The prevalence of such symptoms later and the mechanisms explaining the symptoms are not fully known. The causes of poststroke dementia are likely to be multifactorial (Cerebrovascular Diseases 2006). The investigators want to include all patients with first ever stroke without significant cognitive decline prior to the stroke (IQCODE cut-off 3,7) and follow them up for one year. At baseline we will make stroke classifications, measure neurological deficits according to NIHSS, evaluate cognitive and emotional function and make registrations of vascular risk factors, including precerebral color duplex scan with measurement of IMT in CCA. The investigators will then randomize the patients into multifactorial vascular-risk-factor-intervention in the hospital or care as usual in the primary health care. 8-12 months after stroke onset, survivors will undergo new examinations to evaluate neurological, cognitive and emotional functions, as well as MRI and SPECT.


Options:
A: Effects of vascular risk-factor-intervention on changes in TMTA, ten-words-test and HAD (8-12 months after stroke onset)
B: Composite of fatal and non-fatal stroke (During the study period)
C: Sudden death: death of endogenous origin within 24 hours after acute onset; Cerebrovascular events: new occurrence or recurrence of a stroke or transient ischemic attack; Cardiac events: new occurrence, aggravation, or recurrence of heart failure, angina pectoris, or acute myocardial infarction; Renal dysfunction: serum creatinine ≥4.0 mg/dl, end stage renal disease, doubling of serum creatinine (however, creatinine ≤2.0 mg/dl is not regarded as an event); Vascular events: new occurrence or aggravation of dissecting aneurysm of aorta, arteriosclerotic occlusion of peripheral artery
D: Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event (For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.]))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, 1 Week, Dose Comparison Study to Evaluate the Efficacy, Safety, and Tolerability of MPC-004 in Patients With an Acute Gout Flare
Brief Summary: This study is a multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-comparison to determine the efficacy and safety of a standard-dose of colchicine (4.8 mg) versus low-dose colchicine (1.8 mg) or placebo for acute gout flares.


Options:
A: Recurrence rate at 18 months (18 m onths)
B: Postpericardiotomy syndrome (12 months)
C: Iranian Behcet's Disease Dynamic Activity Measurement (IBDDAM) (8 months)
D: Responders (24 hours after baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomized, Placebo Controlled Trial Assessing the Effects of Ezopiclone on the Quality of Overnight Polysomnography and CPAP Titration
Brief Summary: Patients often have difficulty sleeping during overnight sleep testing in a lab environment. The purpose of this study is to determine if taking a sleep aid will improve sleep and therefore the quality of the sleep study.


Options:
A: TST (6 weeks)
B: Latency to persistent sleep measured by polysomnography (4 weeks)
C: diagnostic yield of PSG (during overnight study); total sleep time (during overnight study); wake after sleep onset (during overnight study); sleep latency (during overnight study); sleep efficiency (during overnight study); total arousal index (during overnight study); respiratory disturbance index at highest CPAP level (during overnight study)
D: Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS). (Baseline (Day 0) to Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled,Dose-Escalation Study to Evaluate the Safety and Tolerability of Multiple-Dose Subcutaneous Administration of MEDI-528, A Humanized Anti-Interleukin-9 Monoclonal Antibody,When Administered to Adults With Mild Persistent Asthma
Brief Summary: The primary objective of this study is to evaluate the safety and tolerability of escalating multiple SC doses of MEDI-528 in adult patients with mild persistent asthma.


Options:
A: Change From Baseline in the Mean Asthma Control Questionnaire (ACQ) Score at Day 92 (Day 1 and 92)
B: Maximum Number of Asthma Symptom Days (Weeks 12-60: 12 months of assessments starting 12 weeks after the initiation of study treatment.)
C: Incidence of Adverse Events (Days 0 - 150); Incidence of Abnormal Troponin Levels (Days 0, 14, 28, 56, 84, and 150); Incidence of Abnormal Clinically Significant Electrocardiogram (ECG) Results (Days -14 to -1, 14, 28, 56, 84, and 150); Incidence of Abnormal Clinically Significant Magnetic Resonance Imaging (MRI) Results (Days -14 to -1 and 28); Incidence of Serious Adverse Events (Days 0 - 150)
D: Change (%) From Baseline in FcεRI (High-affinity IgE Receptor) Expression on Blood Basophils and Dendritic Cells After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16); Change (%) From Baseline in Mean Fluorescence Intensity of FcεRI After 16 Weeks of Treatment With Omalizumab as Compared With Placebo (Baseline and Week 16)

Answer: C