TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Clonidine in the Treatment of Neonatal Abstinence Syndrome: A Prospective, Double Blind, Randomized Controlled Trial
Brief Summary: To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.


Options:
A: Days of Treatment With Opioid Medication (From date of randomization until the date of last opioid dose or date of death from any cause, whichever came first, assessed up to 12 months)
B: Length of treatment for neonatal abstinence syndrome (duration of the treatment)
C: Sublingual Buprenorphine safety and tolerability in the neonate (Index hospitalization)
D: Change in Heart Rate (Change in average heart rate over the 20 minute sessions (both control and music therapy)); Change in Heart Rate Variability (Change in average heart rate variability over the 20 minute sessions (both control and music therapy)); Change in Sleeping Patterns (Change in phase of sleep over the 20 minute sessions (both control and music therapy)); Change in Feeding Patterns (Time from feeding to onset of sleep over the 20 minute session (both control and music therapy)); Morphine Utilization (From day of birth through day of discharge, up to 6 months); Total Length of Stay (From day of birth through day of discharge, up to 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Double-blind Phase III Study of RAD001 10 mg/d Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumor (NET)
Brief Summary: The purpose of this study was to evaluate progression free survival in those participants assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned to placebo plus Best Supportive Care in Advanced Neuroendocrine Tumors of pancreatic origin.


Options:
A: Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology (Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010)
B: Probability of Participants Remaining Event-Free in Progression-Free Survival (PFS) Based on Central Radiology Assessment (From date of randomization to progression or death, whichever comes first, assessed up to 27 months)
C: Percentage of Days With Subcutaneous Octreotide as Rescue Medication (16-week DB phase)
D: Progression Free Survival (PFS) (up to approx. 18 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Olanzapine in the Treatment of Patients With Bipolar I Disorder, Depressed: A Randomized, Double-Blind Comparison With Placebo
Brief Summary: The purpose of this study is to assess whether olanzapine is superior to placebo in patients with bipolar depression.


Options:
A: Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase) (Baseline, Endpoint (Week 6))
B: Change in Weight From Baseline (Baseline and 52 weeks); Percent of Subjects Who Lost More Than 5% of Body Weight From Baseline (52 weeks)
C: Change from baseline in weight at week eight (Baseline and week eight)
D: Mean Change From Baseline to 52 Weeks in Body Mass Index (BMI) for All Participants (Baseline, 52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Italian Elderly ACS Study
Brief Summary: A randomized study comparing an early aggressive with an initially conservative strategy in patients \>74 y.o. with non-ST-elevation acute coronary syndrome.

This study had generated a secondary one:

"Causes of death in elderly patients with Non-ST-Elevation Acute Coronary Syndrome; predictors of in-hospital and follow-up death"


Options:
A: Composite of Death, Myocardial (re-) Infarction, or Stroke (180 days)
B: The composite of all-cause mortality, myocardial (re)infarction, disabling stroke and re-hospitalization for cardiovascular causes or severe bleeding within 1 yr. (1 year)
C: Net Adverse Clinical Event (30-day)
D: peak creatine kinase- MB level (5 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The DESTINY Trial: a Prospective Randomized Multicenter Trial Comparing the Implant of a Drug Eluting Stent (XIENCE V, Abbott Vascular) vs. a Bare Metal Stent (MULTILINK VISION, Abbott Vascular) in the Critically Ischemic Lower Leg
Brief Summary: The Destiny trial compares the use of bare metal stent systems with drug eluting stent systems in the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia. It will be investigated whether there is a difference in 12 month angiographic patency of the stented area using the 2 different stent systems.


Options:
A: Angiographic patency, defined as angiographic binary in-stent restenosis rate (>50% stenosis). (one year)
B: Rate of sustained clinical improvement at 12 months follow up. Sustained clinical improvement is defined as: Upward shift of at least +1 (for Rutherford category 3) or +2 (for Rutherford categories 4 and 5) on the Rutherford scale. (12 months)
C: In-Segment Binary Restenosis (12-months)
D: The primary endpoint will be primary patency of the treated site at 6 months. Primary patency is defined as <50% loss of luminal diameter at the treated site on CT arteriography (CTA) without re-intervention in the interim. (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi Center Dose Ranging Study of Solifenacin Succinate in Combination With Tamsulosin Hydrochloride Compared With Solifenacin Succinate Monotherapy and Tamsulosin Hydrochloride Monotherapy in Males With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH)
Brief Summary: The study will examine the efficacy,safety and tolerability of combination therapy of tamsulosin and solifenacin compared to placebo and monotherapy of tamsulosin and solifenacin in the treatment of males with LUTS associated with BPH.


Options:
A: Change From Baseline to End of Treatment in Total International Prostate Symptom Score (Baseline and Week 12); Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS]) (Baseline and Week 12)
B: Assess whether the combination of solifenacin succinate and tamsulosin hydrochloride provides improved efficacy compared to tamsulosin hydrochloride alone in males with LUTS associated with BPH (12 weeks)
C: Patient Perception of Bladder Condition at 12 weeks of treatment
D: Patient Perception of Treatment Benefit at Week 12:; Treatment benefit, treatment satisfaction, and willingness to continue treatment questions at week 12

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Study, to Assess the Safety and Tolerability of 28 Days Treatment With NVA237 (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This study assessed the safety/tolerability of 28 days of treatment with NVA237 100 µg and 200 µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD).


Options:
A: FEV1 AUC0-3h Response at 12 Weeks; Defined as Change From Baseline to Week 12 (baseline and 12 weeks); Trough FEV1 Response at 12 Weeks; Defined as Change From Baseline to Week 12 (baseline and 12 weeks)
B: Forced Expiratory Volume in 1 second measured at 2 h post dosing following 24 weeks treatment
C: Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (28 days)
D: Change From Baseline in Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) (0-12 Hours (h)) (baseline (BL), 12 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Protocolized Care for Early Septic Shock
Brief Summary: The ProCESS study is large, 5-year, multicenter study of alternative resuscitation strategies for septic shock. The study hypothesizes that there are "golden hours" in the initial management of septic shock where prompt, rigorous, standardized care can improve clinical outcomes.


Options:
A: Efficacy and Safety of Dopamine Versus Norepinephrine in Septic Shock (28 days)
B: 28 Day mortality (28 Day)
C: Hospital Mortality (prior to discharge or 60 days, whichever comes first)
D: The Primary Endpoint of This Study Will be Day 30 Mortality. (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate Contraceptive Efficacy, Cycle Control, Safety and Acceptability of a Monophasic Combined Oral Contraceptive (COC) Containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2), Compared to a Monophasic COC Containing 3 mg Drospirenone (DRSP) and 30 µg Ethinyl Estradiol (EE)
Brief Summary: The primary purpose of this study is to assess contraceptive efficacy, vaginal bleeding patterns (cycle control), general safety and acceptability of the nomegestrol acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) in a large group of women aged 18-50 years.


Options:
A: Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles)); Number of In-treatment Pregnancies (With +14 Day Window) Per 100 Woman Years of Exposure (Pearl Index) (1 year (13 cycles))
B: Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain (baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days))
C: Change in Visual Analog Scale (VAS) Score (Baseline and 6 months)
D: Doppler indices of uterine artery blood flows. (up to 10 minutes)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Single-arm, Phase 2 Study of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma
Brief Summary: To evaluate the overall response rate and safety and tolerability of carfilzomib in subjects with relapsed and refractory multiple myeloma.

Patients must have received prior treatment with bortezomib and either thalidomide or lenalidomide and be refractory to their last treatment.


Options:
A: Time to Progression (TTP) (Up to 1 year and 4 months (From date of first participant randomization [20 December 2004] up to interim analysis cut-off date [28 April 2006]))
B: The primary objective is to analyze and compare the efficacy, the response rate, the CR and the response rate duration of both induction treatments and both maintenance treatments (5 years)
C: Best Overall Response Rate (ORR) (A0: Subjects evaluated for disease response on Day 24 of Cycles 2, 4, 6, 9, and 12. Onset of response measured on Day 15 of Cycle 1. A1: Subjects evaluated for disease response on Day 15 of Cycle 1, Day 1 of Cycles 2 through 12 and at End of Study.)
D: Number of Patients With Overall Response (Complete Response + Partial Response) (Over 4 cycles (prior to the addition of dexamethasone))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic Esophagitis
Brief Summary: Evaluate clinical effectiveness of oral montelukast compared to placebo on prevention of dysphagia and food impaction in patients with EE.

Also evaluate tolerance and safety of oral montelukast in treatment of EE.


Options:
A: Percentage of Participants Who Attained Remission. (3 months)
B: evaluate effectiveness of oral montelukast in treatment of EE. (6 months)
C: Absolute Change From Baseline in Straumann Dysphagia Instrument (SDI) Patient Reported Outcome (PRO) Total Score at Week 10 (Baseline, Week 10)
D: Watson Dysphagia Scale Score (WDS) (Two months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Treating Depression in African American Elders: A Community-Academic Partnership
Brief Summary: The specific primary aims of the study are to:

1. Test the immediate effect of the intervention at 4-months on depression in urban African American older adults (primary trial outcome; between group comparison). Hypothesis: Participants in the intervention group will report fewer depressive symptoms in comparison to control group participants receiving usual care.
2. Test the maintenance effect of the intervention at 8-months on depression (within group comparison). Hypothesis: Participants in the intervention group will maintain reduced symptom presentation from 4 to 8 months.
3. Evaluate acceptability (social validity) of the intervention and extent of engagement in activities by study participants (both intervention and wait-list control subjects).

A secondary aim of this study is to assess the feasibility of conducting a clinical trial embedded in a community service setting and its dissemination using a community-academic partnership. We also propose three exploratory aims. First, we seek to evaluate the mechanisms of action, or pathways, by which treatment gains are obtained (Gitlin et al., 2000). Given that behavioral activation represents conceptually the key active ingredient of the proposed intervention, we plan to evaluate its mediational effect. Second, we seek to evaluate whether the intervention has a differential treatment effect based on a study participant's gender, age, and living arrangement (alone or with others). Given that previous research suggests that participant characteristics may moderate depressive symptoms and treatment outcomes, these exploratory analyses will provide insight as to whether this particular treatment benefits some groups more than others. Third, we seek to evaluate whether the intervention has short and long-term effects on quality of life, functional difficulty, and self-efficacy to manage day-to-day tasks. Previous research has shown that depressive symptoms exacerbate functional decline such that minimizing distress may have the added value of enhancing function and perceived efficacy for this group over time.


Options:
A: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
B: Adjusted Change in Pain-related Function (Roland Disability Score) (12 months)
C: Depression (Baseline, t2, t3)
D: Recovery from Common Mental Disorder (defined by ICD10) (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vascular Events In Noncardiac Surgery Patients Cohort Evaluation (VISION) Study
Brief Summary: The investigators' study has 4 primary objectives. Among patients undergoing noncardiac surgery the investigators will determine: (1) the incidence of major perioperative vascular events; (2) the optimal clinical model to predict major perioperative vascular events; (3) the proportion of patients with perioperative myocardial infarctions that may go undetected without perioperative troponin monitoring; and (4) the relationship between postoperative troponin measurements and the 1 year risk of vascular death.


Options:
A: For our first objective (i.e., the incidence of major perioperative vascular events) our primary outcome is major vascular events (i.e., a composite of vascular death, nonfatal myocardial infarction, nonfatal cardiac arrest, and nonfatal stroke) (30 days post surgery.)
B: Change from baseline endothelial function (reactive hyperemia index) at 4 days postoperatively (baseline before operation, 4 hours postoperatively and daily assessments day 1-4 after surgery.)
C: Major Adverse Cardiac and Cerebrovascular Events (MACCEs) (up to 90 days after surgery)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients
Brief Summary: In critically ill patients, a strategy aimed at an early delivery of full caloric support, with a combination of Enteral Nutrition (EN) and Parenteral Nutrition (PN) (in conditions preventing hyperglycemia and overfeeding), results in shorter ICU and hospital stay and less morbidity as compared to a strategy using only EN.


Options:
A: Time receiving mechanical ventilation, total intensive care and hospital length of stay.
B: To determine whether standardized rehabilitation therapy will decrease hospital length of stay. (5 years)
C: Length of stay in ICU and length of stay in the hospital. (2 years)
D: Hospital mortality (during hospitalization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients
Brief Summary: In critically ill patients, a strategy aimed at an early delivery of full caloric support, with a combination of Enteral Nutrition (EN) and Parenteral Nutrition (PN) (in conditions preventing hyperglycemia and overfeeding), results in shorter ICU and hospital stay and less morbidity as compared to a strategy using only EN.


Options:
A: mortality
B: Rate of non-response to empiric antimicrobial treatment (5 days)
C: 90-day mortality (90 day)
D: Length of stay in ICU and length of stay in the hospital. (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients
Brief Summary: In critically ill patients, a strategy aimed at an early delivery of full caloric support, with a combination of Enteral Nutrition (EN) and Parenteral Nutrition (PN) (in conditions preventing hyperglycemia and overfeeding), results in shorter ICU and hospital stay and less morbidity as compared to a strategy using only EN.


Options:
A: Length of stay in ICU and length of stay in the hospital. (2 years)
B: Incidence of new infection during ICU stay (during ICU stay and up to 90 days post-randomization); Duration of ICU dependency (crude stay days and time to alive discharge from ICU) (during ICU stay and up to 90 days post-randomization)
C: ICU-Free Days (Study day 28)
D: Reduction of inflammation (during ICU stay to day 5); duration of dependency on intensive care (days in ICU) (time in ICU)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients
Brief Summary: In critically ill patients, a strategy aimed at an early delivery of full caloric support, with a combination of Enteral Nutrition (EN) and Parenteral Nutrition (PN) (in conditions preventing hyperglycemia and overfeeding), results in shorter ICU and hospital stay and less morbidity as compared to a strategy using only EN.


Options:
A: Length of stay in ICU and length of stay in the hospital. (2 years)
B: 28 day mortality in all the non-responders to ACTH (< or = 9 mcg/dl or 250 nmol/L post ACTH) (28 days)
C: Rate of non-response to empiric antimicrobial treatment (5 days)
D: mortality

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients
Brief Summary: In critically ill patients, a strategy aimed at an early delivery of full caloric support, with a combination of Enteral Nutrition (EN) and Parenteral Nutrition (PN) (in conditions preventing hyperglycemia and overfeeding), results in shorter ICU and hospital stay and less morbidity as compared to a strategy using only EN.


Options:
A: Length of stay in ICU and length of stay in the hospital. (2 years)
B: Enteral nutrition (14 days); Intra-abdominal pressure (14 days)
C: Rate of patients with death or major disability (modified Rankin scale score ≥3) (3 months after enrollment)
D: Number of ventilator-free days (VFD) (Measured at Day 28); Mortality before hospital discharge, with unassisted breathing (Measured at Days 60 and 90)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients
Brief Summary: In critically ill patients, a strategy aimed at an early delivery of full caloric support, with a combination of Enteral Nutrition (EN) and Parenteral Nutrition (PN) (in conditions preventing hyperglycemia and overfeeding), results in shorter ICU and hospital stay and less morbidity as compared to a strategy using only EN.


Options:
A: Documented Infection Rate (20 days)
B: Total energy amount delivered (First 7 days of the study period)
C: To compare ventilator associated pneumonia rates in patients receiving early enteral feeding without residual gastric volume (RGV) monitoring and in patients with RGV monitoring (until weaning of mechanical ventilation (average : 14 days))
D: Length of stay in ICU and length of stay in the hospital. (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients
Brief Summary: In critically ill patients, a strategy aimed at an early delivery of full caloric support, with a combination of Enteral Nutrition (EN) and Parenteral Nutrition (PN) (in conditions preventing hyperglycemia and overfeeding), results in shorter ICU and hospital stay and less morbidity as compared to a strategy using only EN.


Options:
A: Duration of mechanical ventilation (Participants are followed until ICU discharge); Need for intubation in patients treated with non-invasive mechanical ventilation (Participants are followed until ICU discharge); Length of ICU stay (Participants are followed until ICU discharge)
B: Diagnosis of CIPNM (June 2009)
C: Length of stay in ICU and length of stay in the hospital. (2 years)
D: Mortality rates (measured at time of hospital discharge or 60 days after study entry)

Answer: C