TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb Randomized, Double-Blind, Multicenter, Placebo-Controlled, Dose Optimization, Crossover, Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Brief Summary: To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult workplace environment (AWE) setting


Options:
A: Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks (Baseline and 7 weeks)
B: Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment. (Baseline, and the Endpoint (average of weeks 5, 6, 7).)
C: Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase (2, 4, 8, 10, 12 and 14 hours post-dose on Day 7)
D: The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Baseline (following ADHD medication washout of 7-28 days)); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 1); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 2); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 3); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 4); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 5); The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV) (Week 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb Randomized, Double-Blind, Multicenter, Placebo-Controlled, Dose Optimization, Crossover, Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Brief Summary: To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult workplace environment (AWE) setting


Options:
A: Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase (2, 4, 8, 10, 12 and 14 hours post-dose on Day 7)
B: Change in ADHD-Rating Scale 5 (ADHD-RS-5) Total Score From Baseline to Month 2 Among Patients Treated With Adhansia XR (Baseline to Month-2)
C: 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)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIIb Randomized, Double-Blind, Multicenter, Placebo-Controlled, Dose Optimization, Crossover, Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Brief Summary: To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult workplace environment (AWE) setting


Options:
A: Clinician-administered ADHD-rating scale (ADHD-RS) performed using adult DSM-IV prompts (weekly over a period of 4 weeks)
B: Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase (2, 4, 8, 10, 12 and 14 hours post-dose on Day 7)
C: Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Area Under the Steady-state Plasma Concentration-time Curve (AUC) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing)
D: Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS) (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Thrice Weekly Intermittent Short Course Antituberculosis Chemotherapy in Tuberculosis Patients With and Without HIV Infection
Brief Summary: Tuberculosis (TB) is the most common opportunistic infection among HIV infected persons living in developing countries. Directly observed treatment, short-course (DOTS) is the internationally recommended strategy for the treatment of TB. However, the efficacy of DOTS for the treatment of HIV-associated TB is not well studied. This study aims to compare the efficacy of thrice weekly DOTS in HIV-infected versus HIV-negative patients with TB.


Options:
A: Cure rate (6 months)
B: Number of Patients Converted to Sputum Culture Negative in Each Arm, With Data Censored at 4 Months. (Sputum smear conversion or max 4 months after the start of Linezolid therapy.)
C: Stage 1:Percentage of patients with culture conversion in liquid media at 8 weeks post randomisation. (8 weeks post randomisation); Stage 1: Percentage of patients who discontinue treatment for any reason or die (8 weeks post randomisation); Stage 2: Percentage of patients with an unfavourable outcome (failure, death, recurrence, loss to follow-up) (72 weeks post-randomisation)
D: Cumulative rate of serious adverse events - SAEs (measured as the number of SAEs per person days) during the period of study therapy and the four weeks of post-study therapy follow-up. (the period of study therapy (generally 16 weeks) plus the four weeks of post-study therapy follow-up.); Proportion of patients in each arm who complete 80% of the proposed regimen (90 doses) within 18 weeks of treatment initiation. (within 18 weeks of treatment initiation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Montelukast on the Airway Remodeling in Asthma Patients: Physiological-radiological Correlation
Brief Summary: The distal lung contributes to asthmatic airway remodeling which is observed from early onset of the disease. Cysteinyl leukotrienes (CysLT) play important role in the pathogenesis of airway remodeling and antileukotrienes work to exert a certain degree of anti-inflammatory effect. The cysteinyl leukotriene antagonist Montelukast has been in vivo shown to significantly inhibit ovalbumin induced airway smooth muscle hyperplasia and subepithelial fibrosis in sensitized mice. This study aims to evaluate if Montelukast could reverse airway remodeling in asthma patients by a non-invasive approach-HRCT.


Options:
A: Morning Peak Expiratory Flow
B: To evaluate distal airway function using high-resolution CT and lung function test (6 months)
C: Asthma Control (8 weeks (from Week 0 to Week 8))
D: Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population (Baseline to Endpoint (weeks 3-4)); Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population (Baseline to Endpoint (weeks 3-4))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Hemodialysis Patients With Chronic Renal Anaemia
Brief Summary: This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia. Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the erythropoietin stimulating agent \[ESA\] dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per deciliter (g/dL). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.


Options:
A: hemoglobin variability (2 years)
B: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
C: Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range (Week 17 up to Week 24)
D: Median Time to First Cardiovascular Event (Up to 4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy
Brief Summary: Pernicious anemia develops in 50% of total gastrectomized due to gastric cancer patients. Lack of intrinsic factor, which is secreted by parietal cell from stomach wall causes deficiency of cobalamin, which, in final, causes pernicious anemia. Thus, patients who had undergone total gastrectomy needs to be provided externally with cobalamin. Until now, intramuscular injection of cyanocobalamin has been the choice of treatment for cobalamin deficiency, but it has demerits in that it causes discomfort of coming to the hospital to get an injection, and in its high costs.

However, in pernicious anemia in old age and absorption disorder patients, it has been reported that oral administration of cobalamin had effect of elevating serum vitamin B12. Thus, this study was designed to prove the effect of oral administration of vitamin B12 in total gastrectomized patients with cobalamin deficiency.


Options:
A: Serum vitamin B12 (1,2 and 3 months after administration of medicine)
B: Change from Cobalamin level standardization (1 year)
C: To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).
D: Biochemical response to vitamin B12 substitution (Day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
Brief Summary: The purpose of this study is to evaluate the efficacy, safety and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.


Options:
A: 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)
B: 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)
C: 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)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Randomized, Placebo-Controlled Study of Perioperative Administration of Olanzapine to Prevent Postoperative Delirium in Joint Replacement Patients
Brief Summary: In this study we wanted to determine if perioperative administration of olanzapine prior to knee or hip replacement surgery in high risk patients would prevent the onset of postoperative delirium.


Options:
A: incidence of delirium (days in hospital)
B: Percentage of Participants With Delirium Using the CAM Over Time (Baseline, hospital interviews, weeks 2, 4 and 6)
C: Duration of delirium (3 months)
D: Number of Participants With the Presence of Delirium as Assessed by the Confusion Assessment Method (Postoperative days up to hospital discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
Brief Summary: The purpose of this study is to evaluate the safety, efficacy and tolerability of perampanel when given as an adjunctive therapy in subjects with refractory partial seizures.


Options:
A: 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)
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: 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)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome Subjects With Unstable Angina/Non-ST-Elevation Myocardial Infarction Who Are Medically Managed
Brief Summary: This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).


Options:
A: Percentage of Participants With a Composite Endpoint of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke (Randomization through end of study (30-month visit))
B: Diabetic nephropathy (Four years); Combined cardiovascular endpoint (Eight years); Total mortality (13 years); Years of life years gained (21 years)
C: Cardiovascular events (five years (median)); Cerebral vascular events (five years (median)); Aortic and peripheral vascular events, which needs internal medicine and/or surgical medical treatment (five years (median))
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: AID-trial:A Randomized Clinical Trial Comparing the Effect on Repeated Self-harm of Assertive Intervention and Standard Treatment After Deliberate Self-harm
Brief Summary: Background

Previous suicide attempts is a high-risk factor with a repetition rate between 12-30 percent. Compliance with after treatment is often poor. A systematic review by Hawton, 1999 states a lack of evidence on psychosocial interventions due to selections bias or statistical power.

Objective

The aim is to investigate if assertive outreach, incorporating hands-on guidance and motivational support of compliance with follow-up treatment after suicide attempts is able to reduce the frequency of non-fatal and fatal suicide acts in a one-year follow-up period.

Method and Design

A randomized, controlled intervention trial in a prospective design. The patients included will be randomized to either standard treatment (n = 120) or intervention treatment (N = 120), representing 6 - 8 assertive outreach contacts with a research nurse after suicide attempts or deliberate self-harm. The outreach contacts are thought of as supporting and guiding home visits towards compliance with after care or follow-up treatment Inclusion criteria Males and females, aged 12 years or older with a recent suicide attempt or act of deliberate self-harm, living independently and not diagnosed with severe mental illness (psychosis, severe dementia)

Outcome

The primary outcome measure is repeated fatal suicidal act (fatal or non fatal)assessed by the Danish Cause of Death Register and the rate of repeated suicide attempts/deliberate self-harm registered in the medical records by the collaborating wards and units in their routine procedure of treating people applying for help in relation to suicidal behavior.


Options:
A: Repeated fatal or non fatal suicidal act (one year)
B: Knowledge of PTSD and effectiveness in correcting faulty, trauma-related beliefs (Measured post-treatment and at 6- and 12-month follow-ups); Depression, anxiety, and other psychiatric symptoms (Measured post-treatment and at 6- and 12-month follow-ups); PTSD diagnoses and symptom severity (Measured post-treatment and at 6- and 12-month follow-ups)
C: Change from baseline on the Self-Injurious Thoughts and Behaviors Interview-Short Form (self-report) at follow-up (Pre-assessment and post-assessment (after intervention or two weeks from baseline))
D: Reduced Self-harm (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: AID-trial:A Randomized Clinical Trial Comparing the Effect on Repeated Self-harm of Assertive Intervention and Standard Treatment After Deliberate Self-harm
Brief Summary: Background

Previous suicide attempts is a high-risk factor with a repetition rate between 12-30 percent. Compliance with after treatment is often poor. A systematic review by Hawton, 1999 states a lack of evidence on psychosocial interventions due to selections bias or statistical power.

Objective

The aim is to investigate if assertive outreach, incorporating hands-on guidance and motivational support of compliance with follow-up treatment after suicide attempts is able to reduce the frequency of non-fatal and fatal suicide acts in a one-year follow-up period.

Method and Design

A randomized, controlled intervention trial in a prospective design. The patients included will be randomized to either standard treatment (n = 120) or intervention treatment (N = 120), representing 6 - 8 assertive outreach contacts with a research nurse after suicide attempts or deliberate self-harm. The outreach contacts are thought of as supporting and guiding home visits towards compliance with after care or follow-up treatment Inclusion criteria Males and females, aged 12 years or older with a recent suicide attempt or act of deliberate self-harm, living independently and not diagnosed with severe mental illness (psychosis, severe dementia)

Outcome

The primary outcome measure is repeated fatal suicidal act (fatal or non fatal)assessed by the Danish Cause of Death Register and the rate of repeated suicide attempts/deliberate self-harm registered in the medical records by the collaborating wards and units in their routine procedure of treating people applying for help in relation to suicidal behavior.


Options:
A: Suicide Events (1 year)
B: Self-stigma related to suicide attempt (2 weeks)
C: Repeated fatal or non fatal suicidal act (one year)
D: Frequency of non-suicidal self-injurious thoughts and behaviors (Daily (up to 126 days))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: AID-trial:A Randomized Clinical Trial Comparing the Effect on Repeated Self-harm of Assertive Intervention and Standard Treatment After Deliberate Self-harm
Brief Summary: Background

Previous suicide attempts is a high-risk factor with a repetition rate between 12-30 percent. Compliance with after treatment is often poor. A systematic review by Hawton, 1999 states a lack of evidence on psychosocial interventions due to selections bias or statistical power.

Objective

The aim is to investigate if assertive outreach, incorporating hands-on guidance and motivational support of compliance with follow-up treatment after suicide attempts is able to reduce the frequency of non-fatal and fatal suicide acts in a one-year follow-up period.

Method and Design

A randomized, controlled intervention trial in a prospective design. The patients included will be randomized to either standard treatment (n = 120) or intervention treatment (N = 120), representing 6 - 8 assertive outreach contacts with a research nurse after suicide attempts or deliberate self-harm. The outreach contacts are thought of as supporting and guiding home visits towards compliance with after care or follow-up treatment Inclusion criteria Males and females, aged 12 years or older with a recent suicide attempt or act of deliberate self-harm, living independently and not diagnosed with severe mental illness (psychosis, severe dementia)

Outcome

The primary outcome measure is repeated fatal suicidal act (fatal or non fatal)assessed by the Danish Cause of Death Register and the rate of repeated suicide attempts/deliberate self-harm registered in the medical records by the collaborating wards and units in their routine procedure of treating people applying for help in relation to suicidal behavior.


Options:
A: Repeated fatal or non fatal suicidal act (one year)
B: Patient Satisfaction Questionnaire ((baseline) Assessment taking place immediately after completion of intervention)
C: Suicide Events (1 year)
D: Time to Fatal or Non-fatal Suicide Attempt or Self-Harm (18 Months after randomization)

Answer: A