TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of a Home-based Pulmonary Telerehabilitation Program on Muscle Function and Quality of Life Following Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Brief Summary: COPD impacts a significant proportion of the Veteran population. Acute exacerbations, or flare-ups, of COPD are associated with impaired muscle function and worse quality of life. Pulmonary rehabilitation, a formal exercise program for patients with lung disease that includes both endurance and strength training exercises, has been shown to improve muscle function and quality of life after an acute exacerbation of COPD. However, lack of geographically accessible rehabilitation facilities and/or transportation issues are often barriers to pulmonary rehabilitation attendance in the Veteran population. This study will assess the feasibility and impact of an eight-week, three sessions per week, home-based, pulmonary telerehabilitation program in Veterans with COPD following hospitalization for an acute exacerbation of their lung disease. We will measure adherence and satisfaction with the program and muscle strength, physical activity, quality of life, and exercise tolerance pre and post-intervention in Veterans randomized to the pulmonary telerehabilitation arm versus Veterans randomized to the control arm who do not participate in pulmonary rehabilitation.


Options:
A: To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of COPD related re-hospitalizations in the intervention versus the control group . (12 months); To determine the impact of the intervention initiated after hospital discharge from a COPD exacerbation on the rate of the composite outcome, COPD related hospitalizations or death in the intervention versus the control group. (12 months)
B: Quadriceps Muscle Strength Testing Change (measured at baseline and at ten weeks); Six Minute Walk Test (measured at baseline and at ten weeks); Health-related Quality of Life Assessments Change (measured at baseline and ten weeks); Participant Satisfaction Survey (measured at ten weeks (study completion))
C: Hospital readmission rate (all cause) (90 days)
D: Change in the distance walked at a 6MWT measured at week 12 (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Administration of Prazosin to Prevent PTSD After Sexual Assault
Brief Summary: This study plans to learn more about whether taking the medication, Prazosin, immediately and during the weeks immediately following a traumatic event can help to reduce the risk of developing posttraumatic stress disorder (PTSD). Early post traumatic event sleep disturbance predicts the later development of PTSD. Prazosin has shown some effectiveness in reducing trauma related nightmares and sleep disturbance. We hypothesize that regulating sleep immediately after a sexual assault will reduce PTSD and diminish symptoms.


Options:
A: 50% diminution or stabilization of CAPS score after 3 and 6 months (after 3 and 6 months of patient's inclusion)
B: Change in PTSD symptoms and severity - Clinician-Administered PTSD Scale - 5 (CAPS-5) (The full interview takes 45-60 minutes to administer and will be given at baseline, at approximately 31 days post event, and at three months.)
C: Reduction in Pain (between pre-treatment EMS assessment (baseline) and at 30-minutes post-treatment)
D: Prevention of whiplash syndrome according to validated scales of pain and neck motion disability. (Six months following the motor vehicle accident.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol and L-Carnitine Compared to Standard PD Solutions in Continuous Ambulatory Peritoneal Dialysis (CAPD)
Brief Summary: Prospective, randomized, controlled clinical trial. The aim is to compare the effects of the peritoneal dialysis solution IPX15, containing glucose (0.5%), xylitol (1.5%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 2.5% glucose PD solution), for the nocturnal exchange with the PD solution IPX07, containing glucose (0.5%), xylitol (0.7%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 1.5% glucose PD solution), for the diurnal (short dwell) exchanges. Planned total recruitment is 40 patients with stable end-stage renal disease (ESRD) treated by continuous ambulatory peritoneal dialysis (CAPD). Treatment duration will be 4 weeks plus a 4 weeks safety follow up with no treatment.


Options:
A: Daily ultrafiltration volume (28 days)
B: Change in weight (Baseline and 6 months); Change in fat free body mass (Baseline and 6 months); Change in serum albumin concentration (Baseline and 6 months); Change in serum prealbumin concentration (Baseline and 6 months)
C: lipid profile (at sixteen weeks after admission)
D: The primary outcome measure is the number of intradialytic complications in each of the three study groups, only during the first study phase. (4 weeks for one study phase)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the Efficacy of Radial Artery Catheterization in Three Different Regions in Intensive Care Patients
Brief Summary: In this prospective, randomized, open-labeled study, the intensive care patients will be selected for ultrasound-guided cannulation of the radial artery in three different regions. Patients will be divided into three groups with simple randomization. The first group will be determined as 'G1' and the radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. On the second group (G2), radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. On the third group (G3), radial arterial catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane interference. Whether there is a difference in the duration of use of arterial cannula, first entry success rates, duration of intervention, number of procedures, the number of cannulas used and the effects on early and late complications and advantages between the groups will be investigated.


Options:
A: First pass success rate (1 year); Final/ultimate success rate of an intervention (1 year)
B: Duration of Use of Arterial Cannula (During Procedure)
C: Incidence of major vascular complications (up to 30 days post-procedure)
D: Number of Attempts (Immediately during procedure. (up to 30 minutes))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the Efficacy of Radial Artery Catheterization in Three Different Regions in Intensive Care Patients
Brief Summary: In this prospective, randomized, open-labeled study, the intensive care patients will be selected for ultrasound-guided cannulation of the radial artery in three different regions. Patients will be divided into three groups with simple randomization. The first group will be determined as 'G1' and the radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. On the second group (G2), radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. On the third group (G3), radial arterial catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane interference. Whether there is a difference in the duration of use of arterial cannula, first entry success rates, duration of intervention, number of procedures, the number of cannulas used and the effects on early and late complications and advantages between the groups will be investigated.


Options:
A: Time Needed to Correctly Insert the Arterial or Midline Catheter. (Immediately following intervention (within 2 hours))
B: Only one attempt at arterial puncture was necessary (yes/no) (Day 0 - end of procedure)
C: Duration of Use of Arterial Cannula (During Procedure)
D: Time to Successful Radial Arterial Catheterization (up to 5 minutes)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of the Efficacy of Radial Artery Catheterization in Three Different Regions in Intensive Care Patients
Brief Summary: In this prospective, randomized, open-labeled study, the intensive care patients will be selected for ultrasound-guided cannulation of the radial artery in three different regions. Patients will be divided into three groups with simple randomization. The first group will be determined as 'G1' and the radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. On the second group (G2), radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. On the third group (G3), radial arterial catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane interference. Whether there is a difference in the duration of use of arterial cannula, first entry success rates, duration of intervention, number of procedures, the number of cannulas used and the effects on early and late complications and advantages between the groups will be investigated.


Options:
A: Success rate (at first attempt, as average 5 min)
B: Successful rate without extra vascular damage (Through study completion, an average of 1 year.)
C: Participants With Successful Common Femoral Artery Cannulation, as Determined by Femoral Angiography (Immediately, during procedure.)
D: Duration of Use of Arterial Cannula (During Procedure)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma (ZUMA-14)
Brief Summary: The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in combination with rituximab, as measured by assessment of response rates in adult participants with relapsed/refractory large B-cell lymphoma.


Options:
A: Complete Response (CR) Rate Per the International Working Group (IWG) Lugano Classification as Determined by Study Investigators (First infusion date up to maximum duration of 32.7 months)
B: Safety and toxicity assessment of study treatment (Up to day 42 after the T cell infusion); Feasibility assessment of study treatment (Up to 5 years)
C: Phase 1 Study: Number of Participants Experiencing Adverse Events (AEs) Defined as Dose Limiting Toxicities (DLTs) (First infusion date of axicabtagene ciloleucel up to 30 days); Phase 2 Pivotal Study (Cohorts 1 and 2): Overall Response Rate (ORR) as Assessed by Investigator Per Revised International Working Group (IWG) Response Criteria for Malignant Lymphoma (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 7.7 years)); Phase 2 Safety Management Study (Cohort 3): Percentage of Participants With Treatment-Emergent Cytokine Release Syndrome (CRS) and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 6.8 years)); Phase 2 Safety Management Study (Cohort 4): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 5.4 years)); Phase 2 Safety Management Study (Cohort 5): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 4.4 years)); Phase 2 Safety Management Study (Cohort 6): Percentage of Participants With Treatment-Emergent CRS and Neurologic Toxicities by Severity Grades (First infusion date of axicabtagene ciloleucel up to last follow-up visit (maximum duration: 4.1 years))
D: Incidence of adverse events (Up to 15 years); Maximum tolerated dose (MTD) as determined by dose limiting toxicity (DLT) (Up to 30 days post-infusion)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-Arm, Multicenter Phase 2 Study of BGB-A317 in Patients With Previously Treated PD-L1+ Locally Advanced or Metastatic Urothelial Bladder Cancer
Brief Summary: This was a single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of the anti- programmed cell death-1(PD-1) monoclonal antibody BGB-A317 in participants with PD-L1+, locally advanced or metastatic Urothelial Bladder Cancer (UBC) who have progressed during or following a platinum-containing regimen


Options:
A: To Assess the Efficacy of Durvalumab + Tremelimumab Combination Therapy Versus SoC in Terms of OS in Full Analysis Set (From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).); To Assess the Efficacy of Durvalumab Monotherapy Versus SoC in Terms of OS in PD-L1-High Analysis Set (From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).)
B: Objective Response Rate ( ORR ) (60 months)
C: Percentage of Participants With Adverse Events (AEs) (Baseline up to end of study (up to approximately 6 years))
D: Objective Response Rate (ORR) as Assessed by Independent Review Committee (IRC) (From the date of first dose up to approximately 2 years and 2 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Home-based Delivery of the Contraceptive Implant in Postpartum Guatemalan Women: a Cluster-randomized Trial
Brief Summary: Abstract

Background: Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth.

Methods: This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided.

Discussion: A barrier to postpartum contraception is access to medications and devices. The study removes some access barriers (distance, time, cost) by providing contraception in the home. The community nurses were trained to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town, which is about an hour away by vehicle. Therefore, the study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within three months of childbirth. The potential implications of this study include: nurses may be able to be trained to safely provide contraceptives, including place implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period.


Options:
A: Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery (3 years)
B: score on Hospital Consumer Assessment of Healthcare Provers and Systems (HCAPS) survey (2 months)
C: Number of Participants With Implant Use at Three Months (Three months)
D: Change in Post-natal depression (6 weeks following child birth)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Time Restricted Feeding and Metabolic Rhythms
Brief Summary: Current guidelines for the prevention and treatment of obesity focus on caloric restriction diets and increasing physical activity, but long-term compliance to these strategies is poor. The timing of meal intake relative to the light-dark and sleep-wake cycle is rarely considered in metabolic health; and modifying meal timing is likely easier to implement in daily life than reducing caloric intake and/or increasing physical activity. This project will test whether restricting the timing of energy intake to a short-defined period during wakefulness can be used to improve fuel utilization patterns and enhance circadian rhythms in metabolic tissues to optimize health.


Options:
A: Total fat oxidation in response to eTRF (Week 1 or Week 5); Total fat oxidation in response to mTRF (Week 1 or Week 5); Insulin sensitivity in response to eTRF (Week 1 or Week 5); Insulin sensitivity in response to mTRF (Week 1 or Week 5); Glucose control in response to eTRF (Week 1 or Week 5); Glucose control in response to mTRF (Week 1 or Week 5)
B: Endothelium Dependent Dilation (6 weeks)
C: Change in Glucose Tolerance (Before and after 5 weeks on each feeding schedule)
D: Weight loss (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Folic Acid Supplementation in Children With Sickle-Cell Disease: A Randomized Double-Blind Cross-Over Trial
Brief Summary: Folic acid supplementation (1mg/d) is the standard recommendation for Canadian children with Sickle cell disease (SCD), even though it can provide up to six times the recommended intake amount for healthy children. There is growing concern that too much folic acid can be detrimental to health as high folate levels and circulating unmetabolized folic acid (UMFA), which occurs in blood with doses of folic acid as low as 0.2mg/d, have been associated with accelerated growth of some pre-cancerous cells, and altered DNA methylation and gene expression.

To inform the efficacy and potential harm of high-dose folic acid supplementation in Canadian children with SCD, a double-blind randomized controlled cross-over trial is proposed. Children with SCD (n=36, aged 2-19 y) will be recruited from BC Children's Hospital and randomized to initially receive 1 mg/d folic acid or a placebo for 12-weeks (wk). After a 12-wk washout period, treatments will be reversed.


Options:
A: Gardos Channel Activity (12 weeks after randomization); Nitric Oxide (12 weeks after randomization); Mean Corpuscular Hemoglobin Concentration (12 weeks after randomization)
B: The Number of Occurrences of Sickle Cell Crises (48 weeks)
C: Time-to-crisis Resolution (From study drug delivery to last IV opioid treatment (up to 2 months))
D: Red Blood Cell Folate Concentration (12 weeks); Red Blood Cell Folate Concentration (36 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multicenter, Multi-country, Open-label, Randomized, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Desidustat Versus Darbepoetin for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) Who Are Not on Dialysis
Brief Summary: This is a phase III, multicenter, multi-country, open-label, randomized, active-controlled clinical trial to evaluate the efficacy and safety of Desidustat versus Darbepoetin for the treatment of anemia in patients with CKD who are not on dialysis. The study will be conducted over a period of up to 30 weeks.


Options:
A: Change From Baseline in Hemoglobin (Hgb) at Week 4 (Baseline (Week -4, Week-2 and Day 1) and Week 4)
B: Hemoglobin level (24 weeks)
C: Modeled Hemoglobin (Hgb) Change From Baseline (Pre-dose on Day 1) at 4 Weeks of Treatment (Baseline (pre-dose on Day 1) and up to week 4)
D: Percentage of Participants Achieving a Successful Hemoglobin Response (Weeks 19 and 20)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjuvant Nivolumab or Ipilimumab + Nivolumab Determined By Pathological Response To A Single Dose Of Neoadjvuant Nivolumab
Brief Summary: Subjects with resectable melanoma will receive neoadjuvant nivolumab followed by surgical resection. Post-operatively, subjects will receive open-label treatment with up to 1 year of adjuvant nivolumab or ipilimumab plus nivolumab as determined by pathologic response at the time of resection.


Options:
A: Recurrence Free Survival (RFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population (Date of randomization to first date of recurrence or death or last available disease assessment with RFS data up to 5 years. Median follow-up was 2.7 years.); Number of Participants With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population (Date of randomization to first date of recurrence or death or last available disease assessment with RFS data upto 5 years. Median follow-up was 2.7 years.); Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population (At years 1, 2, and 3)
B: Relapse-free survival (RFS) (Up to 1 year)
C: Event-free survival (EFS) (Up to 4 years)
D: Recurrence-Free Survival (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjuvant Nivolumab or Ipilimumab + Nivolumab Determined By Pathological Response To A Single Dose Of Neoadjvuant Nivolumab
Brief Summary: Subjects with resectable melanoma will receive neoadjuvant nivolumab followed by surgical resection. Post-operatively, subjects will receive open-label treatment with up to 1 year of adjuvant nivolumab or ipilimumab plus nivolumab as determined by pathologic response at the time of resection.


Options:
A: Safety of patients as measured by the adherence to the timelines in the study protocol (6 months); Feasability of patients as measured by the adherence to the timelines in the study protocol (6 weeks)
B: Best Response Rate (Partial Response [PR] + Complete Response [CR]) (Up to 12 years)
C: Overall Survival (Survival was assessed every 3 months if patient is < 2 years from study entry. Every 6 months is patient is 2-5 years from study entry.)
D: Recurrence-Free Survival (1 year)

Answer: D