TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Titration Followed by a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Tolerability, and Safety of Oxymorphone Extended Release Tablets in Opioid-Naïve Patients With Chronic Low Back Pain
Brief Summary: The purpose of this study is to evaluate the analgesic efficacy and safety of oxymorphone extended release in non-cancer patients with chronic low back pain.


Options:
A: Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase. (Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase.)
B: No primary efficacy variable was defined in report. Protocol variables measured included: Total daily dose of OROS hydromorphone, daily use of rescue medication, daily pain relief scores, and time/number of steps needed for dose stabilization.
C: Change in pain intensity from baseline (pre-randomization) to last assessment.
D: The primary outcomes include incidence of adverse events, changes in laboratory measures, results of physical exams, and results of 12-Lead ECG.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Rectal and Oral Omeprazole Treatment of Gastroesophageal Reflux in Infants With Esophageal Atresia or Congenital Diaphragmatic Hernia; A Pharmacodynamic and Pharmacokinetic Study.
Brief Summary: The purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic hernia.


Options:
A: The primary objective of the study is to evaluate the safety of once daily treatment with esomeprazole in relieving GERD-associated symptoms in pediatric patients 1 to 11 years of age, inclusive.; The primary outcome variables include assessment of changes from baseline in medical history, physical examination, clinical laboratory evaluations, and adverse events.
B: Peak Concentration (Cmax) (1 day); Time to Peak Concentration (Tmax) Profile (1 day); Disposition Half-life (1 day); Area Under the Concentration-time Curve (AUC) (1 day); Apparent Oral Clearance (CL/F) (1 day); Pantoprazole Plasma Concentration After Multiple-Dose Oral Administration (7 days); Intragastric pH (7 days); Median Intragastric pH (7 days); Percentage of Time Intragastric pH Was >4 (7 days); Mean Intraesophageal pH (7 days); Median Intraesophageal pH (7 days); Percentage of Time That Intraesophageal pH Was <4 (7 days); Normalized Area of Gastric Hydrogen Ion Activity Over Time (7 days); Normalized Area of Esophageal Hydrogen Ion Activity Over Time (7 days)
C: Maximum Observed Plasma Concentration (Cmax) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Time to Reach Maximum Observed Plasma Concentration (Tmax) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Plasma Decay Half-Life (t1/2) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Apparent Oral Clearance (CL/F) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Terminal-Phase Volume of Distribution (Vz/F) (Predose (0 hour), and 0.5, 1, 2, 4, 6, 12 hours postdose); Plasma Concentrations After Multiple Doses (Hours 2 and 4 on Day 7)
D: Therapeutic efficacy (24 hour)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Trial to Establish the Effects of Early Intensive Blood Pressure Lowering on Death and Disability in Patients With Stroke Due to Acute Intracerebral Haemorrhage
Brief Summary: The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.


Options:
A: Combination death and dependency, according to a 3-6 scores on the modified Rankin Score. (3 months)
B: The primary outcome is cerebral blood flow in the perihematoma region, measured with CT perfusion, 2 hours after randomization. (2 hours post randomization)
C: A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS) (90 days)
D: Death or major disability (defined by the modified Rankin scale) at 6 months (6 months); The composite event "vascular" death, myocardial infarction, or stroke during the first 6 months (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Trial to Establish the Effects of Early Intensive Blood Pressure Lowering on Death and Disability in Patients With Stroke Due to Acute Intracerebral Haemorrhage
Brief Summary: The purpose of the study is to determine whether lowering high blood pressure levels after the start of a stroke caused by bleeding in the brain (intracerebral haemorrhage) will reduce the chances of a person dying or surviving with a long term disability. The study will be undertaken in two phases: a vanguard phase in 400 patients, to plan for a main phase in 2000 patients.


Options:
A: The main outcome measurement will be the modified Rankin scale at 3 months after the SAH, compared between patients who were randomized to induced hypertension and patients who were randomized to no induced hypertension. (assessed three months after the SAH)
B: Combination death and dependency, according to a 3-6 scores on the modified Rankin Score. (3 months)
C: Our primary endpoint is to determine the feasibility of the pilot study within the ICU setting and collect preliminary estimates for sample size calculations. (6 months)
D: Cerebral vasospasm-related morbidity and mortality of all-causes as defined by the protocol (Within 6 weeks post-aSAH)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Lamotrigine Versus Lithium in Subjects With Bipolar Affective Disorders - a Randomised Study of Prophylactic Effect
Brief Summary: The purpose of this study is to compare lamotrigine with lithium in the long term treatment of bipolar disorder in terms of new episode preventive potentials.


Options:
A: Bipolar Inventory of Symptoms Scale (BISS) (Change from Baseline to 26 weeks)
B: Time to Withdrawal From Study (Randomization to Study Withdrawal (up to Week 26))
C: Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) (8 Weeks)
D: Time to a new mood episode after having succeeded the first 6 month of treatment and reached monotherapy with study drug at that point. New episode defined as symptoms requiring treatment or admission (or suicide).

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in breast-fed preterm infants

Background:

Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants. Human milk and preterm formulas contain DHA and AA, but at lower concentrations than required to approximate utero accretion rate.

Objective:

To evaluate the effect of a high dose DHA and AA supplement to breast-fed preterm infants in the early neonatal period. Primary endpoints are neurodevelopment at 6 and 20 months of age.

Design:

A randomized double-blind placebo-controlled study is carried out in four Norwegian neonatal centers.

Subjects and methods:

Infants with birth weight \< 1.5 kg are randomized to either an intervention or a control group. All infants receive fortified human milk, and a daily dose of 0.5 ml study oil per 100 ml milk. Infants in the intervention group receive oil with DHA and AA (Formulaid, Martek, USA), while the control oil contains vegetable oil without DHA or AA. Blood samples are collected at birth (cord), and at start and stop of the intervention. Plasma is analyzed for fatty acid pattern using high performance liquid chromatography.


Options:
A: Cognitive development
B: Calcium absorption (18 days)
C: plasma phospholipid fatty acid composition (28 days after intervention start); visually evoked potentials (48 weeks and 56 weeks postconceptional age)
D: time of achieving the four gross motor development milestones (4, 8 and 12 months of age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early vs Late Introduction of Antiretroviral Therapy in Naive HIV-infected Patients With Tuberculosis in Cambodia
Brief Summary: In Cambodia the prevalence of both tuberculosis (TB) and Human Immunodeficiency Virus (HIV) infection is high. Data suggest that aggressive management of HIV infection, which includes Anti-Retroviral Therapy (HAART) during treatment of TB, decreases both morbidity and mortality. On the other hand, the use of HAART for patients with TB may cause severe complications due to drug-drug interactions, and occasionally a temporary exacerbation of symptoms. These reactions may be particularly severe when HAART is started soon after the start of TB treatment.

The proposed study aims to determine the optimal time to initiate HAART in previously untreated HIV-infected adult patients with TB and low CD4 cell counts.


Options:
A: Uptake of initial and repeat HIV counselling and testing (Feasibility phase) (14 months); Uptake of ARV treatment among HIV-infected individuals (Feasibility phase) (14 months); HIV infection incidence (4 years after enrolment initiation)
B: Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients (14 days)
C: Survival, recurrence of presenting OI/bacterial infection (BI) or incidence of new AIDS-defining events, and HIV-1 plasma viral load at Week 48
D: Survival rate (At the end of the study)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Examination and Treatment of Elderly After a Fall- an Analysis in a Medical Technology Evaluation Perspective
Brief Summary: Falls and injurious falls are common among elderly people. The aim of the study is to test a model of multifactorial fall intervention in a Danish population of elderly sustaining a fall. Focus is on prevention of further falls, patients views on fall prevention and a cost-effectiveness analysis.


Options:
A: Primary outcomes are number of falls and falls rates as well as number and incidence of injurious falls measured by monthly fall calendars (24 months)
B: Number of falls and injurious falls in 12 months
C: number of falls (24 months)
D: Quality of life (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Examination and Treatment of Elderly After a Fall- an Analysis in a Medical Technology Evaluation Perspective
Brief Summary: Falls and injurious falls are common among elderly people. The aim of the study is to test a model of multifactorial fall intervention in a Danish population of elderly sustaining a fall. Focus is on prevention of further falls, patients views on fall prevention and a cost-effectiveness analysis.


Options:
A: Number of falls and injurious falls in 12 months
B: Falls incidence rate (6 months)
C: health costs after 18 months (baseline 18 month control); falls after 18 months (daily records, analysis after 18 months); Bone parameters after 6, 12 and 18 months (baseline, 6, 12, 18 month-control)
D: Cognitive Performance of Executive Function (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multi-Centre, Randomised, Double-Blind Comparison of Intravenous Dexmedetomidine With Propofol/Midazolam for Continuous Sedation (24 Hours to 14 Days) of Ventilated Patients in Intensive Care Unit
Brief Summary: The study aims to demonstrate that dexmedetomidine is non-inferior to current best practice sedation with propofol/midazolam and daily sedation stops, in maintaining a target depth of sedation in long-stay intensive care unit (ICU) patients, and that dexmedetomidine, compared with current best practice, reduces the length of ICU stay.


Options:
A: Time receiving mechanical ventilation, total intensive care and hospital length of stay.
B: Length of mechanical ventilation and ICU stay. Mortality
C: Duration of Mechanical Ventilation; ICU and Hospital Lengths of stay
D: Proportion of time during sedative infusion with a Richmond Agitation Sedation Scale (RASS) score within the individually-prescribed target range; Time from ICU admission to discharge

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multi-Centre, Randomised, Double-Blind Comparison of Intravenous Dexmedetomidine With Propofol/Midazolam for Continuous Sedation (24 Hours to 14 Days) of Ventilated Patients in Intensive Care Unit
Brief Summary: The study aims to demonstrate that dexmedetomidine is non-inferior to current best practice sedation with propofol/midazolam and daily sedation stops, in maintaining a target depth of sedation in long-stay intensive care unit (ICU) patients, and that dexmedetomidine, compared with current best practice, reduces the length of ICU stay.


Options:
A: Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required (RASS score will be assessed approximately 2 hourly during the treatment period and during the 48-hour follow-up period); Duration of mechanical ventilation the number of days the patient receives mechanical ventilation will be recorded (This variable will be dependent on the individual patient and the number of days they require mechanical ventilation .)
B: Time receiving mechanical ventilation, total intensive care and hospital length of stay.
C: Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required. (2 hourly and before each rescue treatment dose during the treatment period and the 48-hour follow-up); Duration of mechanical ventilation (Start and stop times of mechanical ventilation while the patient is treated in the ICU)
D: Proportion of time during sedative infusion with a Richmond Agitation Sedation Scale (RASS) score within the individually-prescribed target range; Time from ICU admission to discharge

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase III Trial of Conventional Paclitaxel and Carboplatin Versus Dose Dense Weekly Paclitaxel and Carboplatin in Patients With Newly Diagnosed Stage II-IV Mullerian Carcinoma
Brief Summary: The purpose of the study is to compare progression-free survival of conventional paclitaxel and carboplatin vs weekly paclitaxel and carboplatin in patients with newly diagnosed stage II-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer.


Options:
A: Progression Free Survival (PFS) Using Investigator Assessment According to Modified Response Evaluation Criteria in Solid Tumours (RECIST 1.1) (Radiologic scans performed at baseline then every 12 weeks up to 156 weeks, then every 24 weeks thereafter until objective radiological disease progression. DCO: 17 May 2018)
B: Progression Free Suvaival (During the protocol treatment then 18 months from the last day of the protocol treatment)
C: N/A
D: quality of life (weekly for the first 9 weeks of therapy, then every 3 weeks until the completion of therapy); progression free survival (every 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of Pioglitazone in the Treatment of Non-alcoholic Steatohepatitis (NASH)
Brief Summary: To determine the role of pioglitazone in the treatment of nonalcoholic steatohepatitis (NASH) in patients with glucose intolerance or type 2 diabetes mellitus (T2DM).


Options:
A: Liver histology (Kleiner criteria, Hepatology 2005) (6 months.)
B: Serum adipocytokines levels (52 weeks)
C: Grade of steatosis as judged by repeat biopsy (6 mo)
D: Major Cardiovascular Events (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Role of Pioglitazone in the Treatment of Non-alcoholic Steatohepatitis (NASH)
Brief Summary: To determine the role of pioglitazone in the treatment of nonalcoholic steatohepatitis (NASH) in patients with glucose intolerance or type 2 diabetes mellitus (T2DM).


Options:
A: Liver Histology (Using Kleiner et al Criteria, Hepatology 2005) (At 18 months)
B: Liver histology (Kleiner criteria, Hepatology 2005) (6 months.)
C: Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction (Up to 5 years)
D: Prevention of Type 2 Diabetes (2.4 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder Outpatients With Current Stimulant Dependence
Brief Summary: The purpose of this study is to determine whether quetiapine or risperidone are effective in treating mood symptoms, drug cravings and use in bipolar disorder with concurrent cocaine or methamphetamine dependence.


Options:
A: Acute efficacy: Change in Young Mania Rating Scale (YMRS) total score from baseline to endpoint of 3 weeks of acute treatment period.
B: Change Over Time in Frequency of Heavy Drinking Days (Used to Evaluate Treatment Efficacy) (6 months)
C: Mean Relapse Free Period(Risperidone LAI Versus Quetiapine) (Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier))
D: Mood symptom improvement. (Baseline to exit); Cocaine or methamphetamine cravings and use. (Baseline to exit)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cornell Translational Behavioral Science Research Consortium: Hypertension Qualitative Study
Brief Summary: To explore the meaning, causes and treatment of hypertension in eligible patients. In addition the cultural, social, and psychological factors that either facilitate or serve, as barriers to behavioral change will be illuminated in this patient population.


Options:
A: N/A
B: 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)
C: Low-density Lipoprotein Cholesterol (Measured at 1 year); Systolic Blood Pressure (Measured at 1 year); HbA1c (Measured at 1 year)
D: Change in Glycemic Control (HbA1c) (6 months (baseline to 6 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Cornell Translational Behavioral Science Research Consortium: Hypertension Qualitative Study
Brief Summary: To explore the meaning, causes and treatment of hypertension in eligible patients. In addition the cultural, social, and psychological factors that either facilitate or serve, as barriers to behavioral change will be illuminated in this patient population.


Options:
A: N/A
B: Change in Glycemic Control (HbA1c) (6 months (baseline to 6 months))
C: Adherence to ART and HIV RNA suppression (6,12 months)
D: 20-Item Symptom Checklist Depression Scale (Measured at baseline and after 6 months of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-center Phase II Trial of Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy (SMA CARNI-VAL Trial)
Brief Summary: This is a multi-center trial to assess safety and efficacy of a combined regimen of oral valproic acid (VPA) and carnitine in patients with Spinal Muscular Atrophy (SMA) 2 to 17 years of age. Cohort 1 is a double-blind placebo-controlled randomized intention to treat protocol for SMA "sitters" 2 - 8 years of age. Cohort 2 is an open label protocol for SMA "standers and walkers" 3 - 17 years of age to explore responsiveness of efficacy outcomes. Outcome measures will include blood chemistries, functional testing, pulmonary function testing, electrophysiological evaluations, PedsQL quality of life assessment, quantitative assessments of survival motor neuron (SMN) mRNA from blood samples, growth and vital sign parameters. Six centers will enroll a total of 90 patients.


Options:
A: Safety Labs (-4 wks, 0, 2 wks, 3 mo, 6 mo, 9 mo, 12 mo for safety labs; throughout for AEs); Efficacy, Measured Through Motor Function Assessments (-4wks, 0, 3 mo, 6 mo, 12 mo); Modified Hammersmith Change From Baseline to 6 Months (0 months, 6 months)
B: Percent of Participants Who Achieved Improvement in Motor Milestones as Assessed by Section 2 of the HINE at the Last Visit (Day 1352 or Early Termination)
C: Number of Participants That Experienced One Grade III or Higher Unanticipated, Treatment-related Toxicity That Presents With Clinical Symptoms and Requires Medical Treatment (2 years)
D: Laboratory Safety Data (-2 weeks, + 2 weeks, 3 months, 6 months); Anthropometric Measures of Nutritional Status (Body Mass Index [BMI] Z-scores, Weight for Length Ratios, Lean/Fat Mass Via DEXA, Growth Parameters, and Triceps Skinfold Measures) (-2 weeks, time 0, 3 months, 6 months)

Answer: A