TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV Multicenter, Randomized, Open Label, Two-Period, Crossover Study in Patients With Cystic Fibrosis to Evaluate the Comparable Efficacy and Safety of Pulmozyme Delivered by the eRapid Nebulizer System
Brief Summary: This phase IV, multicenter, randomized, open-label, two-period crossover study will evaluate the comparable efficacy and safety of Pulmozyme (dornase alfa) delivered by the eRapid nebulizer system in patients with cystic fibrosis. Patients who have been receiving Pulmozyme once daily chronically for at least 6 months will continue to receive Pulmozyme once daily for a run-in period of 2 weeks using the Pari LC Plus nebulizer. Patients will then be randomized to receive in a crossover design Pulmozyme once daily for two treatment periods of 2 weeks each using either the Pari LC Plus or the eRapid nebulizer. Anticipated time on study treatment is 6 weeks.


Options:
A: Change in Absolute FEV1 From Baseline Over 26 Weeks (26 weeks)
B: Computed Tomography Evidence of Less Sinus Disease (baseline and 1 year); Improvement in Appearance of Nasal Passages/Sinuses (baseline and 1 year)
C: Number of Participants Eligible to be Assessed for Sub-study Enrollment (2-week run-in period)
D: Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) (At the end of each 2-week treatment period); Safety: Number of Participants With Adverse Events During Each Treatment Period (4 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV Multicenter, Randomized, Open Label, Two-Period, Crossover Study in Patients With Cystic Fibrosis to Evaluate the Comparable Efficacy and Safety of Pulmozyme Delivered by the eRapid Nebulizer System
Brief Summary: This phase IV, multicenter, randomized, open-label, two-period crossover study will evaluate the comparable efficacy and safety of Pulmozyme (dornase alfa) delivered by the eRapid nebulizer system in patients with cystic fibrosis. Patients who have been receiving Pulmozyme once daily chronically for at least 6 months will continue to receive Pulmozyme once daily for a run-in period of 2 weeks using the Pari LC Plus nebulizer. Patients will then be randomized to receive in a crossover design Pulmozyme once daily for two treatment periods of 2 weeks each using either the Pari LC Plus or the eRapid nebulizer. Anticipated time on study treatment is 6 weeks.


Options:
A: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase (12 weeks)
B: To determine the effects of 400 mg twice-daily administration of IDPM on FEV1 in patients with CF compared to control (6 months)
C: FEV1
D: Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) (At the end of each 2-week treatment period); Safety: Number of Participants With Adverse Events During Each Treatment Period (4 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV Multicenter, Randomized, Open Label, Two-Period, Crossover Study in Patients With Cystic Fibrosis to Evaluate the Comparable Efficacy and Safety of Pulmozyme Delivered by the eRapid Nebulizer System
Brief Summary: This phase IV, multicenter, randomized, open-label, two-period crossover study will evaluate the comparable efficacy and safety of Pulmozyme (dornase alfa) delivered by the eRapid nebulizer system in patients with cystic fibrosis. Patients who have been receiving Pulmozyme once daily chronically for at least 6 months will continue to receive Pulmozyme once daily for a run-in period of 2 weeks using the Pari LC Plus nebulizer. Patients will then be randomized to receive in a crossover design Pulmozyme once daily for two treatment periods of 2 weeks each using either the Pari LC Plus or the eRapid nebulizer. Anticipated time on study treatment is 6 weeks.


Options:
A: FEV1
B: Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) (At the end of each 2-week treatment period); Safety: Number of Participants With Adverse Events During Each Treatment Period (4 Weeks)
C: The change in LCI from baseline to end of treatment in rhDnase treated patients versus patients receiving placebo (The duration of the patient's involvement in the study (approximately 3 months))
D: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IV Multicenter, Randomized, Open Label, Two-Period, Crossover Study in Patients With Cystic Fibrosis to Evaluate the Comparable Efficacy and Safety of Pulmozyme Delivered by the eRapid Nebulizer System
Brief Summary: This phase IV, multicenter, randomized, open-label, two-period crossover study will evaluate the comparable efficacy and safety of Pulmozyme (dornase alfa) delivered by the eRapid nebulizer system in patients with cystic fibrosis. Patients who have been receiving Pulmozyme once daily chronically for at least 6 months will continue to receive Pulmozyme once daily for a run-in period of 2 weeks using the Pari LC Plus nebulizer. Patients will then be randomized to receive in a crossover design Pulmozyme once daily for two treatment periods of 2 weeks each using either the Pari LC Plus or the eRapid nebulizer. Anticipated time on study treatment is 6 weeks.


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) (At the end of each 2-week treatment period); Safety: Number of Participants With Adverse Events During Each Treatment Period (4 Weeks)
C: Change in forced expiratory volume in the first second of a forced expiratory maneuver (FEV1) compared to baseline (FEV1 - forced expiratory volume in the first second of a forced expiratory maneuver by standard spirometry)
D: Mean Total Administration Time (days 22 through 28 (cycle 1), days 78 through 84 (cycle 2))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Supervised Physical Exercise on Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus
Brief Summary: The purpose of this study is to evaluate the effect of supervised physical exercise on endothelial function and number of endothelial progenitor cells (EPCs) in patients with systemic lupus erythematosus, as well as evaluate the effect of supervised physical exercise on endothelium derived growth factor (VEGF) levels, disease activity, quality of life, fatigue, perceived exertion and cardiopulmonary exercise test variables.


Options:
A: Peak oxygen uptake (VO2peak) (12-weeks)
B: Lipid profile - Plasma levels of total cholesterol (mg/dl), VLDL-chol (mg/dl) HDL-chol (mg/dl), LDL-chol (mg/dl), triglycerides (mg/dl), Apolipoprotein AI and AII (mg/dl) and Apolipoprotein B (mg/dl) (3 months); Insulin sensitivity as measured by the Hyperinsulinemic-Euglycemic Clamp (3 months); Cytokine response - Plasma levels of TNF-α (pg/ml), IL-6 (pg/ml), IFN-type I (pg/ml), IL-10 (pg/ml)and IL-1ra (pg/ml) (3 months)
C: Endothelial function and endothelial progenitor cells (EPCs) number (16 weeks)
D: Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24. (Baseline, 24 weeks); Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index) (0 to 52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III,Randomized,Open Label Study Comparing Simultaneous Versus Sequential Use of Adjuvant Chemotherapy and GnRHa up to 2-3 Years for ≤ 45 Year Old Pre-menopausal Hormone Receptor-positive Breast Cancer
Brief Summary: The present study is a randomized open-label -phase III study that aims to compare the efficacy and safety of the adjuvant chemotherapy with simultaneous or sequential application of Zoladex up to 2-3 years for ≤ 45 year old premenopausal hormone receptor-positive breast cancer.


Options:
A: Rate of Premature Ovarian Failure at 2 Years (2 years)
B: Disease-free Survival (5-year estimate reported at a median follow-up of 72 months)
C: Resumption of menstruation (1 year)
D: Chemotherapy-induced early menopause as measured by follicle-stimulating hormone, 17 beta estradiol levels, and menstrual activity resumption at 1 year following the completion of chemotherapy

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase Ⅲ Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension Patients
Brief Summary: Previous studies suggest that combinations of existing therapies may be effective for pulmonary arterial hypertension (PAH). However, all of these studies are sequential combination therapy, for example, by adding sildenafil to previously prescribed bosentan. This kind of therapy model is not enough for PAH patients, especially those with New York Heart Association (NYHA) class Ⅲ and Ⅳ. In this randomized, multicenter study, the investigators evaluate the safety and efficacy of combining inhaled iloprost, a prostacyclin analog, with the endothelin receptor antagonist bosentan in treatment naive patients with PAH by comparing with bosentan monotherapy. Efficacy endpoints include change from baseline in 6-min-walk distance (6-MWD), modified (NYHA) functional class, hemodynamic parameters, and time to clinical worsening.


Options:
A: Assessment of hemodynamic parameters after single oral dose of ACT-293987. (17 weeks); Proof-of-concept assessment of the efficacy of ACT-293987 in subjects with PAH by measuring the change from baseline in the PVR at Week 17 compared to placebo. (17 weeks)
B: change from baseline in 6-min-walk distance (6-MWD) (12 weeks)
C: Six Minute Walk Distance (6MWD) (Baseline and 16 Weeks)
D: 6-minute Walk Distance (6MWD) (Baseline and 16 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase Ⅲ Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension Patients
Brief Summary: Previous studies suggest that combinations of existing therapies may be effective for pulmonary arterial hypertension (PAH). However, all of these studies are sequential combination therapy, for example, by adding sildenafil to previously prescribed bosentan. This kind of therapy model is not enough for PAH patients, especially those with New York Heart Association (NYHA) class Ⅲ and Ⅳ. In this randomized, multicenter study, the investigators evaluate the safety and efficacy of combining inhaled iloprost, a prostacyclin analog, with the endothelin receptor antagonist bosentan in treatment naive patients with PAH by comparing with bosentan monotherapy. Efficacy endpoints include change from baseline in 6-min-walk distance (6-MWD), modified (NYHA) functional class, hemodynamic parameters, and time to clinical worsening.


Options:
A: Change from Baseline to End of Study in 6MWT distance. A mean difference from placebo of at least 35 m is considered clinically relevant. (16 weeks)
B: The primary objective of this trial is to demonstrate that tezosentan, a dual ERA, reduces the incidence of clinically relevant right ventricular failure in patients with pre-operative pulmonary hypertension, due to left heart disease, undergoing CPB. (During weaning from CPB)
C: change from baseline in 6-min-walk distance (6-MWD) (12 weeks)
D: The primary endpoint is a fall in pulmonary vascular resistance (PVR) of 20% over 16 weeks. (16 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin Uniject in Senegal
Brief Summary: This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor


Options:
A: Mean change in hemoglobin (during 3rd trimester and 1-3 days postpartum)
B: the amount of blood loss in third and fourth stages of labor (The end of the delivery to 2 hours after birth.)
C: Occurrence of post partum hemorrhage > 500mL in 1 hour (1 HOUR)
D: The change in hemoglobin as a measure of blood loss. The change in hemoglobin is defined as the difference between the predelivery hemoglobin value and the postpartum value (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin Uniject in Senegal
Brief Summary: This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor


Options:
A: Maximal uterine tone (within the first 5 minutes after cord clamping)
B: Incidence of acute postpartum hemorrhage: blood loss ≥ 500 ml within two hours of delivery
C: Amount of bleeding (1 hour)
D: Mean change in hemoglobin (during 3rd trimester and 1-3 days postpartum)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Effectiveness Study of Percutaneous Catheter-based Renal Sympathetic Denervation in Patients With Drug-resistant Hypertension and Symptomatic Atrial Fibrillation
Brief Summary: To study whether renal sympathetic denervation(RSD) is safe and effective in patients with drug-resistant hypertension and symptomatic atrial fibrillation.


Options:
A: Anti-arrhythmic Drug (AAD)-Free Single-procedure Freedom From Atrial Fibrillation Recurrence (up to 12 months)
B: Change in Office Systolic Blood Pressure (Baseline to 6 months post-randomization)
C: Change in atrial fibrillation burden (from Baseline and 12 months)
D: To document that renal denervation achieved via the delivery of RF energy is safe, and not associated with clinically significant adverse events, in patients with refractory hypertension. (3 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Effectiveness Study of Percutaneous Catheter-based Renal Sympathetic Denervation in Patients With Drug-resistant Hypertension and Symptomatic Atrial Fibrillation
Brief Summary: To study whether renal sympathetic denervation(RSD) is safe and effective in patients with drug-resistant hypertension and symptomatic atrial fibrillation.


Options:
A: Change in systolic blood pressure (ABPM mean value) (6 months)
B: To provide confirmation that renal denervation is safe and feasible. (3 years)
C: recurrence of > 30 secs of atrial tachyarrhythmia, including AF and left atrial flutter/tachycardia, after a single ablation procedure on no antiarrhythmic drug (1 year)
D: Change in atrial fibrillation burden (from Baseline and 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-label, Randomized, Active Comparator-Controlled, Adaptive Parallel-group Phase 2 Study to Assess the Safety and Efficacy of Multiple Doses of ISIS 416858 Administered Subcutaneously to Patients Undergoing Total Knee Arthroplasty
Brief Summary: The purpose of this study is:

* To assess the safety and efficacy profile of ISIS-FXIRx, including incidence of bleeding and VTE, in patients undergoing total knee arthroplasty.
* To compare the efficacy and safety profile of ISIS-FXIRx in patients who achieve less than or equal to 0.2 U/mL FXI activity levels to that of enoxaparin.


Options:
A: Primary efficacy outcome (up to 12 days post-surgery)
B: Assess the safety of the factor Xa inhibitor apixaban versus a vitamin-K antagonist phenprocoumon in patients with NVAF and ESKD on hemodialysis. (1-60 months)
C: Number of open fibres in the dialyzer (17 weeks)
D: Number of Participants Experiencing ISTH (International Society on Thrombosis and Haemostasis) Major or Clinically Relevant Non-major Bleeding (Randomization up to Month 15/Final Visit)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Insecticide Resistance in Anopheles Arabiensis on the Effectiveness of Malaria Vector Control in Sudan
Brief Summary: The purpose of the study is to determine whether long lasting insecticidal nets and indoor residual insecticide spraying, alone or in combination, are effective for controlling insecticide resistant anopheles mosquitoes for malaria prevention.


Options:
A: Difference in prevalence of malaria infection in children 0.5-14 years between intervention arms (up to 36 months); Difference in Entomological Inoculation Rate (up to 36 months)
B: Prevalence of malarial infection in children 6 months to 10 years (9 months post randomisation)
C: Malaria Incidence (3 years)
D: Cost per case averted in children five years of age and under at health facility level by adding Actellic-IRS (24 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of Insecticide Resistance in Anopheles Arabiensis on the Effectiveness of Malaria Vector Control in Sudan
Brief Summary: The purpose of the study is to determine whether long lasting insecticidal nets and indoor residual insecticide spraying, alone or in combination, are effective for controlling insecticide resistant anopheles mosquitoes for malaria prevention.


Options:
A: Difference in prevalence of malaria infection in children 0.5-14 years between intervention arms (up to 36 months); Difference in Entomological Inoculation Rate (up to 36 months)
B: Annual clinical malaria incidence rate (Clinical malaria will be monitored for up to 60 months)
C: Prevalence of malarial infection in children 6 months to 10 years (9 months post randomisation)
D: Malaria Incidence (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Multifactorial, Evidence-based Program of Screening, Risk Modification and Physical Therapy to Prevent Falls Among Vulnerable Elderly Recently Discharged From Hospital to the Community.
Brief Summary: Background: Falls are the leading cause of injury among older adults in Singapore, but falls among the elderly can be preventable and the risks are predictable. Translating this understanding of falls etiology into an integrated clinical and public health program that is accessible to the elderly is a critical health services delivery challenge.

Hypothesis: An evidence-based program of screening, risk modification and physical therapy delivered in a community setting will reduce recurrent falls incidence among a high-risk group of elderly recently discharged to the community.

Methodology: This randomized controlled trial targets patients seen at Emergency Department (ED) for a fall or fall-related injuries who are at least 65 years old and will be discharged to home. Upon signing the informed consent form, the participants will be followed up for nine months from the baseline assessment during which the participants are randomized into either a control or the intervention group. The participants in the intervention group will be provided with a multifactorial program of screening, risk modification and physical therapy focused on progressive strength, balance, and gait training either as an individualized program or a group setting in the community for the first three months from the date of randomization. The number of recurrent falls will be monitored via a falls prevention diary maintained by (or for) each participant.


Options:
A: The number of fallers who have fallen at least once during the 9-month study period (9 months)
B: Incidence of falls and injurious falls
C: Falls events (6-months)
D: rate of falls (12 months); proportion of fallers (12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Multifactorial, Evidence-based Program of Screening, Risk Modification and Physical Therapy to Prevent Falls Among Vulnerable Elderly Recently Discharged From Hospital to the Community.
Brief Summary: Background: Falls are the leading cause of injury among older adults in Singapore, but falls among the elderly can be preventable and the risks are predictable. Translating this understanding of falls etiology into an integrated clinical and public health program that is accessible to the elderly is a critical health services delivery challenge.

Hypothesis: An evidence-based program of screening, risk modification and physical therapy delivered in a community setting will reduce recurrent falls incidence among a high-risk group of elderly recently discharged to the community.

Methodology: This randomized controlled trial targets patients seen at Emergency Department (ED) for a fall or fall-related injuries who are at least 65 years old and will be discharged to home. Upon signing the informed consent form, the participants will be followed up for nine months from the baseline assessment during which the participants are randomized into either a control or the intervention group. The participants in the intervention group will be provided with a multifactorial program of screening, risk modification and physical therapy focused on progressive strength, balance, and gait training either as an individualized program or a group setting in the community for the first three months from the date of randomization. The number of recurrent falls will be monitored via a falls prevention diary maintained by (or for) each participant.


Options:
A: Falls rate (6 months post intervention)
B: Cognitive Performance of Executive Function (12 months)
C: Change in gait variability (6 months)
D: The number of fallers who have fallen at least once during the 9-month study period (9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Surgical Site Infection Rates of Two Different Skin Closure Methods Used in Obese Patients After Cesarean Delivery
Brief Summary: The aim of this study is to determine the surgical site infection rate and patient satisfaction for subcuticular versus interrupted mattress suture in closure of skin at Cesarean delivery in obese patients.


Options:
A: Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery. (4-8 weeks post-surgery)
B: Surgical site infection (30 days after the operative procedure)
C: Perfusion of Wound Closure (Surgical Point of Care)
D: Mean Score on Cosmetic Outcome Visual Analog Scale (VAS) (30 days (+/- 5) post-operative)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Study of the Effects of Diet and Behavioral Interventions on Health in Diabetics
Brief Summary: The study is a small pilot, designed to provide data regarding the feasibility and acceptability of conducting such a study on a larger scale. The present study is a randomized controlled clinical trial comparing two mindfulness-based lifestyle modification programs to help people manage diabetes and lose weight, one using on a low-carbohydrate diet (LC) and the other using a moderate-carbohydrate diet promoted by the American Diabetes Association (ADA). Intervention content will include information about nutrition (carbohydrate restriction or American Diabetes Association recommended diet) and emotion regulation and mindful eating strategies.


Options:
A: Cardiovascular Disease Prevention based on dietary approach. (Two years)
B: Liver fat (Sept 2008)
C: Fat mass, lean mass, bone mass (BMD, BMC), total mass (measured via DXA scan) (Measured at weeks 0, 8 and 16)
D: Hemoglobin A1c (Change from baseline to 3 months)

Answer: D