TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicentre, Prospective, Randomised, 2-arm Study to Assess the Impact of Ferric Carboxymaltose on Exercise Capacity in Chronic Heart Failure Patients With Iron Deficiency
Brief Summary: The purpose of this study is to confirm that treatment with IV ferric carboxymaltose improves exercise capacity, physical functioning and quality of life in patients with iron deficiency and chronic heart failure.


Options:
A: Change in Peak VO2 (mL/kg/min) from baseline to Week 24 (Week 24)
B: Iron bio-availability from oral iron supplementation (%) (up to 4 weeks); Serum hepcidin concentrations (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 19, 21, 23, 25 and 27 days)
C: Iron bio-availability (%) from oral iron supplementation (3x 120 mg) (3 days); Serum hepcidin concentrations on the 1st day of iron supplementation (1 day); Iron bio-availability (%) from oral iron supplementation (6x 60 mg) (6 days); Serum hepcidin concentrations on the 2nd day of iron supplementation (2 days); Serum hepcidin concentrations on the 3rd day of iron supplementation (3 days); Serum hepcidin concentrations on the 4th day of iron supplementation (4 days); Serum hepcidin concentrations on the 5th day of iron supplementation (5 days); Serum hepcidin concentrations on the 6th day of iron supplementation (6 days)
D: To assess the efficacy of a single intravenous (IV) administration of FCM (1,000 mg) compared with placebo in improving fatigue symptoms in IDNA women of child bearing age. (Day 56)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Videolaryngoscope vs Classic Laryngoscope in Teaching Neonatal Endotracheal Intubation: a Randomized Controlled Trial.
Brief Summary: Every year thousands of neonates born in North America need extensive resuscitation which often includes endotracheal intubation (ETI). In these situations, Pediatricians assume the role of Neonatal Resuscitation Program (NRP) providers and are responsible of the ETI procedure. They acquire this skill during residency training in the Neonatal Intensive Care Unit (NICU) and the delivery room. Difficulties in performing neonatal ETI lie in the small size of the mouth and airway of the neonate, and their particular anatomy of the larynx. This limited visibility represents a challenge even for the experienced clinician. Recently, a new videolaryngoscope (VL) technique has been introduced to the adult and pediatric medical fields as described respectively by Kaplan et al. and Weiss et al. In 2009, Vanderhal et al. reported a preliminary experience in the newborn population. Video assisted intubation could be a method of choice in teaching neonatal ETI.

To the best of our knowledge, there is no human study comparing the VL to the classic laryngoscope (CL) for acquiring the skill of neonatal ETI in the NICU.

This study aims:

1. To assess if the videolaryngoscope is superior to the classic laryngoscope in acquiring the neonatal endotracheal intubation skill in the Neonatal Intensive Care Unit; and
2. To assess if once the skill is acquired with the videolaryngoscope this experience is transferable to the use of the classic laryngoscope by showing a persistent difference in success rate in favor of the videolaryngoscope group.

The hypothesis are

1. Primary hypothesis:

   In the Neonatal Intensive Care Unit, use of the videolaryngoscope will increase success rate of endotracheal intubation by 20% compared to the classic laryngoscope. Later, acquired experience from the videolaryngoscope will be transferable to the use of the classic laryngoscope by showing a persistent difference in success rate of 20% in favor of the videolaryngoscope group.
2. Secondary hypothesis We expect that the videolaryngoscope will decrease time to intubation, and decrease rate of esophageal and right bronchial main stem intubations. It will also improve teaching of endotracheal intubations to pediatric residents by helping supervisors recognize problems related to intubation and by improving residents' level of confidence in performing the skill.


Options:
A: Time to Intubation (Assessed intraoperatively at time of intubation)
B: Number of Participants With Success in the First Attempt (at the time of intubation)
C: Success rate (5 minutes)
D: Endotracheal intubation success rate. (5 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Computer-based Telephone Counseling Improve Long-term Adherence to Strength Training in Elders With Knee Osteoarthritis (OA)?
Brief Summary: The purpose of this research is to determine whether computer-based telephone counseling will improve adherence to strength training in a population of elders with knee osteoarthritis.


Options:
A: Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4 (baseline and 4 weeks); Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4 (baseline and 4 weeks)
B: Self-report measure of exercise adherence over the last 3-months on a numeric rating scale (24 month)
C: Numerical rating scale of pain (NRS) : (collected at baseline up to 3 months after therapy)
D: Recruitment Rate (Baseline); Feasibility of Assessment Procedures: completion rate (Through study completion (16 weeks)); Retention Rate (Through study completion (16 weeks)); Feasibility of Research Assistant (RA) Training: rating (Baseline); Monitoring Treatment Fidelity (Through study completion (16 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Dulaglutide on Major Cardiovascular Events in Patients With Type 2 Diabetes: Researching Cardiovascular Events With a Weekly INcretin in Diabetes (REWIND)
Brief Summary: The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular events and other serious outcomes in persons with type 2 diabetes, when added to their anti-hyperglycemic regimen.


Options:
A: Progression of Albuminuria (Up to 3 years)
B: Weighted mean glucose (24 weeks)
C: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
D: Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Dulaglutide on Major Cardiovascular Events in Patients With Type 2 Diabetes: Researching Cardiovascular Events With a Weekly INcretin in Diabetes (REWIND)
Brief Summary: The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular events and other serious outcomes in persons with type 2 diabetes, when added to their anti-hyperglycemic regimen.


Options:
A: Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome) (From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years))
B: The First 3-point Major Adverse Cardiovascular Events (3P-MACE) (From randomization until individual day of trial completion, up to 432 weeks)
C: HbA1c Change From Baseline at Week 52 (Baseline and week 52); HbA1c Change From Baseline at Week 104 (Baseline and week 104)
D: Change in left ventricular (LV) Mass by Cardiac MRI at 52 weeks (Baseline and 52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: OPTImal CArdiac REhabilitation (OPTICARE)Following Acute Coronary Syndromes: A Randomized, Controlled Trial to Investigate the Benefits of an Expanded Educational and Behavioural Intervention Program.
Brief Summary: The objective is to investigate whether in acute coronary syndrome patients the cardiac risk profile will improve with 2 new extended cardiac rehabilitation interventions and if these patients maintain healthier life style habits and a more active life style compared to patients randomized to standard cardiac rehabilitation.


Options:
A: Direct Cardio-respiratory fitness (16 weeks)
B: Reduction of the SCORE Risk Score (6 months after the intervention)
C: Peripheral blood gene expression (baseline); Peripheral blood gene expression (6wks after starting 12week exercise training (or conventional care)); peripheral blood gene expression (12 weeks after exercise training (or conventional care)); Peripheral blood gene expression (24 weeks after starting 12 weeks exercise training programme)
D: the percentage change from baseline to 6 months (%Δ) in echocardiographic LV end-diastolic volume index (LVEDVi) (baseline and 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: OPTImal CArdiac REhabilitation (OPTICARE)Following Acute Coronary Syndromes: A Randomized, Controlled Trial to Investigate the Benefits of an Expanded Educational and Behavioural Intervention Program.
Brief Summary: The objective is to investigate whether in acute coronary syndrome patients the cardiac risk profile will improve with 2 new extended cardiac rehabilitation interventions and if these patients maintain healthier life style habits and a more active life style compared to patients randomized to standard cardiac rehabilitation.


Options:
A: Change from Baseline in self-management adherence at 3 and 6 months (3 and 6 months following intervention)
B: Reduction of the SCORE Risk Score (6 months after the intervention)
C: Health-related Quality of Life (SF-36v2-acute Form) (9 weeks)
D: Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) (Measured as events occur during the lifespan of the trial.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major: a Randomized, Controlled Trial
Brief Summary: This study aims to investigate the use of amlodipine, a drug that blocks the uptake of calcium into cells, in the prevention and treatment of iron overload in patients with thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas and other organs, blocking these channels might help to prevent the accumulation of iron in these tissues. The study will follow 60 patients with thalassemia major: 30 will receive amlodipine and 30 will serve as controls receiving placebo in a randomized double-blind fashion. Patients will be monitored through one year. Monitoring will occur through the measurement of blood ferritin as well as live and heart T2\* by MRI initially, at 6 and 12 months.


Options:
A: Heart Failure (1yr); Arrhythmia (1yr)
B: Change From Baseline in Liver Iron Concentration (LIC) at 96 Weeks (Baseline and 96 weeks)
C: Myocardial T2* values (msec) (6 and 12 months)
D: Efficacy of amlodipine in retarding rate of myocardial iron deposition (Assessed by change in T2* times) (At baseline, and then at 6 months and 12 months from the start of the study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Amlodipine in the Prevention and Treatment of Iron Overload in Patients With Thalassemia Major: a Randomized, Controlled Trial
Brief Summary: This study aims to investigate the use of amlodipine, a drug that blocks the uptake of calcium into cells, in the prevention and treatment of iron overload in patients with thalassemia major. Since iron uses the same calcium channels to enter the heart, pancreas and other organs, blocking these channels might help to prevent the accumulation of iron in these tissues. The study will follow 60 patients with thalassemia major: 30 will receive amlodipine and 30 will serve as controls receiving placebo in a randomized double-blind fashion. Patients will be monitored through one year. Monitoring will occur through the measurement of blood ferritin as well as live and heart T2\* by MRI initially, at 6 and 12 months.


Options:
A: Change From Baseline in Liver Iron Concentration (LIC) at 96 Weeks (Baseline and 96 weeks)
B: Efficacy of amlodipine in retarding rate of myocardial iron deposition (Assessed by change in T2* times) (At baseline, and then at 6 months and 12 months from the start of the study)
C: Area Under the Curve of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Half-Life of Deferasirox (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Volume of Distribution/Bioavailability of Deferasirox After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose); Clearance/Bioavailability of Deferasirox in Patients With Poor Response to Deferasirox Compared to Patients With Good Response After a Dose of 35 mg/kg (0, 1, 2, 4, 6, 8, 12, and 24 hours post dose.)
D: Myocardial T2* values (msec) (6 and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Week Study to Evaluate the Effect of Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) 100/25 mcg Inhalation Powder Delivered Once Daily Via a Novel Dry Powder Inhaler (NDPI) on Arterial Stiffness Compared With Tiotropium Bromide 18 mcg Delivered Once Daily Via a HandiHaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
Brief Summary: This study is designed to evaluate the effect of fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) Inhalation Powder once daily (QD) on arterial stiffness compared with Tiotropium QD over 12 week treatment period in subjects with COPD and aortic pulse wave velocity (aPWV) \> 12.0 m/s at Visit 1. Arterial stiffness will be measured as aPWV. This is a comparator, randomised, double-blind, double-dummy, parallel group, multi-centre study. Subjects who meet the eligibility criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment period. There will be an approximate 7-day Follow-up period after the treatment period.


Options:
A: Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks (Week 8)
B: Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84) (Baseline to Day 84 (Early Withdrawal))
C: Aera under curve FEV1 AUC 0-12h (day 1 and 7 of treatment period)
D: Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (Baseline and at Week 24)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 12 Week Study to Evaluate the Effect of Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) 100/25 mcg Inhalation Powder Delivered Once Daily Via a Novel Dry Powder Inhaler (NDPI) on Arterial Stiffness Compared With Tiotropium Bromide 18 mcg Delivered Once Daily Via a HandiHaler in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
Brief Summary: This study is designed to evaluate the effect of fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) Inhalation Powder once daily (QD) on arterial stiffness compared with Tiotropium QD over 12 week treatment period in subjects with COPD and aortic pulse wave velocity (aPWV) \> 12.0 m/s at Visit 1. Arterial stiffness will be measured as aPWV. This is a comparator, randomised, double-blind, double-dummy, parallel group, multi-centre study. Subjects who meet the eligibility criteria at Screening and meet the randomization criteria at the end of a 2-week Run-In period will enter a 12-week treatment period. There will be an approximate 7-day Follow-up period after the treatment period.


Options:
A: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 (Week 12 + 1 day, Day 85)
B: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 11 Hours 45 Minutes Post-dose at the End of the Study (Week 12, Day 84) (From 5 minutes to 11 hours 45 minutes post-dose at the end of the study (Week 12, Day 84))
C: First Occurrence of (Moderate or Severe) COPD Exacerbation (52 weeks)
D: Mean Change From Baseline (BL) in Aortic Pulse Wave Velocity (aPWV) at the End of the 12-week Treatment Period (Day 84) (Baseline to Day 84 (Early Withdrawal))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Exploratory Pilot Study of Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level
Brief Summary: The purpose of this study is to learn the effects of brentuximab vedotin (SGN-35), an investigational medication, on patients with cutaneous T cell lymphoma (CTCL), specifically mycosis fungoides (MF) and Sezary syndrome (SS). Despite a wide range of therapeutic options, the treatments are associated with short response duration, thus this condition is largely incurable. This investigational drug may offer less toxicity than standard treatments and have better tumor specific targeting.


Options:
A: Overall Response Rate (ORR) (2 years)
B: Response (complete clinical [CCR] and partial resp. [PR]) rate by Tumor Burden Index for cutaneous disease and appearance or disappearance of lesions for noncutaneous disease every 8 wks during treatment and then every 12 wks until progression
C: Progression Free Survival (From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months)
D: Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4) (Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Novel Prosocial Online Support Group for Distressed Breast Cancer Survivors
Brief Summary: The investigators hypothesize that breast cancer survivors participating in a prosocial online support group will have a significantly lower mean level of psychological symptoms (anxiety/depression) and higher mean level of sense of purpose post-intervention than participants in a standard online support group.


Options:
A: Psychosocial aspect (Changes in psychosocial aspects from baseline to 12 months post diagnosis)
B: To assess whether MBSR favorably influences psychological status (anxiety, perceived stress, depression), quality of life, and immune status (among post-treatment breast cancer survivors) (6 weeks)
C: Hospital Anxiety and Depression Scale (change from baseline to one month post-intervention)
D: To evaluate the efficacy of the MBSR(BC) program in improving psychological and physical symptoms, quality of life and measures of immune function and a stress hormone (cortisol) (Baseline, 6 weeks and 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Efficacy, Safety, Tolerability and Pharmacokinetics Study of AVI-4658(Eteplirsen),in the Treatment of Ambulant Subjects With Duchenne Muscular Dystrophy
Brief Summary: This study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of AVI-4658 (eteplirsen) in both 50.0 mg/kg and 30.0 mg/kg doses administered over 24 weeks in subjects diagnosed with Duchenne muscular dystrophy (DMD).


Options:
A: Cardiac Ejection Fraction as Measured by Echocardiogram (12 month visit)
B: Number of Surviving Participants That Completed the Study (5 Years); Six Minute Walk Test (6 Months); Cardiopulmonary Exercise Testing (6 Months); Kansas City Cardiomyopathy Questionnaire (KCCQ) (6 Months)
C: Change in the Number (%) of Dystrophin Positive Fibers (After 12 weeks for 4 patients who received 50 mg/kg and 2 patients who received placebo. After 24 weeks for 4 patients who received 30 mg/kg and 2 patients who received placebo.)
D: Change in Cardiac Left Ventricular End-systolic Volume (LVESV) by Cardiac Magnetic Resonance (CMR) Imaging. (6 months compared to baseline)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on Out of School Nutrition and Physical Activity Environments
Brief Summary: The purpose of this study is to design and conduct research to tailor out of school time evaluation materials so they are applicable to various settings in Boston, are efficient in that minimal resources and time are used, and are useful to participants.


Options:
A: Food and energy intake (Food weight (grams) and energy (kcal) (Once a week for four weeks)
B: Physical Activity Level (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Physical Literacy (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.); Dietary Intake (The intervention spans a period of 6 months. Outcomes are measured before and after intervention.)
C: BMI and aerobic fitness (1 schoolyear)
D: Change in physical activity (Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on Out of School Nutrition and Physical Activity Environments
Brief Summary: The purpose of this study is to design and conduct research to tailor out of school time evaluation materials so they are applicable to various settings in Boston, are efficient in that minimal resources and time are used, and are useful to participants.


Options:
A: Change in proportion of children meeting physical activity policy (Baseline, Fall of Year 2, and Fall of Year 3)
B: N/A
C: Change in minutes spent in moderate to vigorous physical activity in after school programs from baseline to end of intervention (7 months) and 1 year after end of intervention. (Baseline, end of intervention (7 months), 1 year after intervention)
D: Change in physical activity (Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study on Out of School Nutrition and Physical Activity Environments
Brief Summary: The purpose of this study is to design and conduct research to tailor out of school time evaluation materials so they are applicable to various settings in Boston, are efficient in that minimal resources and time are used, and are useful to participants.


Options:
A: Change in intake of the target vegetable (Change in intake of the target vegetable from Baseline to day 14)
B: Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life (2 years)
C: Change in Observed Child Dietary Intake (8 Months); Change in Measured Child Physical Activity in Child Care (8 months); Change in Observed Child Dietary Intake (12 Months); Change in Measured Child Physical Activity in Child Care (12 Months)
D: Change in physical activity (Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention)

Answer: D