TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Reticulocyte Dynamic and Related Hemoglobin Variability in Hemodialysis Patients Treated With Darbepoetin Alfa and C.E.R.A.: a Randomized Controlled Trial
Brief Summary: Background: In a simulation based on a pharmacokinetic model we demonstrated that increasing the erythropoiesis stimulating agents (ESAs) half-life or shortening their administration interval decreases hemoglobin variability. The benefit of reducing the administration interval was however lessened by the variability induced by more frequent dosage adjustments. The purpose of this study was to analyze the reticulocyte and hemoglobin kinetics under different ESAs and administration intervals in a collective of chronic hemodialysis patients.

Methods: The study was designed as an open-label, randomized, four-period cross-over investigation, including 30 patients under chronic hemodialysis at the regional hospital of Locarno (Switzerland) in September 2009 and lasting 2 years. Four treatment strategies (C.E.R.A. every 4 weeks Q4W and every 2 weeks Q2W, Darbepoetin alfa Q4W and Q2W) were compared with each other. The mean square successive difference of hemoglobin, reticulocyte count and ESAs dose was used to quantify variability. We distinguished a short- and a long-term variability based respectively on the weekly and monthly successive difference.


Options:
A: hemoglobin variability (2 years)
B: Hemoglobin response rate (Weeks 1-24)
C: Percentage of patients maintaining average Hb concentration within target range (10-12g/dL) during evaluation period. (Weeks 16-24)
D: Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb or Within Target Range During the Efficacy Evaluation Period (EEP) (At Weeks -4, -3, -2, -1, 0; pre-dose (0 hours) and immediately before dialysis (minimum 3 sessions per week) during Weeks 18, 20, 22, 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reticulocyte Dynamic and Related Hemoglobin Variability in Hemodialysis Patients Treated With Darbepoetin Alfa and C.E.R.A.: a Randomized Controlled Trial
Brief Summary: Background: In a simulation based on a pharmacokinetic model we demonstrated that increasing the erythropoiesis stimulating agents (ESAs) half-life or shortening their administration interval decreases hemoglobin variability. The benefit of reducing the administration interval was however lessened by the variability induced by more frequent dosage adjustments. The purpose of this study was to analyze the reticulocyte and hemoglobin kinetics under different ESAs and administration intervals in a collective of chronic hemodialysis patients.

Methods: The study was designed as an open-label, randomized, four-period cross-over investigation, including 30 patients under chronic hemodialysis at the regional hospital of Locarno (Switzerland) in September 2009 and lasting 2 years. Four treatment strategies (C.E.R.A. every 4 weeks Q4W and every 2 weeks Q2W, Darbepoetin alfa Q4W and Q2W) were compared with each other. The mean square successive difference of hemoglobin, reticulocyte count and ESAs dose was used to quantify variability. We distinguished a short- and a long-term variability based respectively on the weekly and monthly successive difference.


Options:
A: Median Time to First Cardiovascular Event (Up to 4 years)
B: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline to Weeks 29-36)
C: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 29-36)
D: hemoglobin variability (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study of VTX-2337 in Combination With Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Brief Summary: The purpose of this study is to compare the overall survival of patients treated with VTX-2337 + pegylated liposomal doxorubicin (PLD) versus those treated with PLD alone in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer.

VTX-2337, a small molecule agonist of Toll-like Receptor 8 (TLR8), activates multiple components of the innate immune system and is being developed as a novel therapeutic agent for use in oncology. Experimental data obtained in an animal model of ovarian cancer supports the combination of VTX-2337 with PLD. In this model, the combination of VTX-2337 and PLD resulted in a significant reduction in tumor growth compared to either agent alone and an increase in the number of T lymphocytes infiltrating the tumor. The combination of PLD and VTX-2337 has been tested in a small number of women with ovarian cancer in a Phase 1b study and appears to be generally well-tolerated.


Options:
A: Proportion of patients with objective response rate with recurrent endometrial cancer with mutated ARID1A (3 years); Proportion of patients with objective response rate with recurrent ovarian cancer with mutated ARID1A (3 years)
B: 90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference product (2 cycles)
C: Overall Survival (OS) (From date of randomizationrandomization to date of death from any cause assessed up to 40 months); Progression-free survival (From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months)
D: Overall Survival (Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Phase II Study of VTX-2337 in Combination With Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Brief Summary: The purpose of this study is to compare the overall survival of patients treated with VTX-2337 + pegylated liposomal doxorubicin (PLD) versus those treated with PLD alone in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer.

VTX-2337, a small molecule agonist of Toll-like Receptor 8 (TLR8), activates multiple components of the innate immune system and is being developed as a novel therapeutic agent for use in oncology. Experimental data obtained in an animal model of ovarian cancer supports the combination of VTX-2337 with PLD. In this model, the combination of VTX-2337 and PLD resulted in a significant reduction in tumor growth compared to either agent alone and an increase in the number of T lymphocytes infiltrating the tumor. The combination of PLD and VTX-2337 has been tested in a small number of women with ovarian cancer in a Phase 1b study and appears to be generally well-tolerated.


Options:
A: Progression-free Survival by Independent Review Committee (Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 years)
B: Progression Free Survival (PFS) (Radiologic scans performed at weeks 9 and 18 (+/-1 week) and every 12 weeks thereafter relative to the date of randomisation until the primary analysis (approximately 20 months))
C: Progression Free Survival (2 years)
D: Overall Survival (Survival is measured from date of enrollment and randomization on the study until death from any cause, or if alive at last contact, date of last contact.)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre Randomised Controlled Trial of an Open Lung Strategy Including Permissive Hypercapnia, Alveolar Recruitment and Low Airway Pressure in Patients With Acute Respiratory Distress Syndrome.
Brief Summary: Some people develop the condition called acute respiratory distress syndrome (ARDS). This is a condition where the lungs have become injured from one of a number of various causes, and do not work as they normally do to provide oxygen and remove carbon dioxide from the body. This can lead to a reduced amount of oxygen in the patient's bloodstream. Patients with ARDS are admitted to the intensive care unit (ICU) and need help with their breathing by being connected to a ventilator (breathing machine). ARDS can lead to injury in other organs of the body causing other problems but also death.

Over the past few years, reducing the size of each breath delivered by the ventilator in conjunction with the use of an occasional sustained deep breath called a "recruitment manoeuvre" have been used to try to prevent further damage to the lungs in people with ARDS. This ventilator strategy (termed the PHARLAP strategy) has been shown in a small research study to have some beneficial effects without causing any obvious harm, when compared to a current best practice ventilator strategy. The main beneficial effects of the PHARLAP strategy were to increase the amount of oxygen in the blood and to reduce markers of inflammation (the body reacting to a disease process) in the body. This study was too small to make a strong conclusion, so this study will be much larger and will assess whether patients who have developed ARDS are better off when we use the PHARLAP strategy. Three hundred and forty patients will be enrolled into this study in multiple ICUs across Australia and New Zealand.

The study hypothesis is that the PHARLAP strategy group will have a higher number of ventilator free days at day 28 than the control group.


Options:
A: Number of Ventilator Free Days at Day 28 Post Randomisation (28 days post randomisation)
B: Mortality rate (at day 90)
C: Development of ARDS (28 days)
D: Oxygenation as measured by the PO2/FiO2 (P/F) ratio (72 hours from enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vaccine Hesitancy Intervention--Provider (VHIP)
Brief Summary: The primary aim of this trial is to test the effectiveness of an intervention to train primary care physicians to determine if it leads to decreased parental vaccine hesitancy.


Options:
A: Parental Vaccine Hesitancy Measure (Change from Baseline in Parental Hesitancy at 6 months)
B: 6 month % change in HPV vaccination (≥ 1 dose), control vs. each intervention arm (efficient or participatory), 11-12 year olds (Baseline, month 6)
C: Receipt of influenza vaccine during pregnancy (Participants will be followed for the remaining duration of their pregnancy, which will range from approximately 2 weeks to 7 months depending upon their gestation at enrollment.)
D: Improved immunization coverage (At the completion of all recruitment and follow ups which will take an average time of 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Sensitive Periods in Human Flavor Learning
Brief Summary: The goals of the proposed research are to specify the timing and consequences of the sensitive period for flavor learning in infants who are being breastfed or formula fed. The investigators will conduct a randomized within- and between-subject study of women and their infants during a 15-month window.


Options:
A: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)
B: Percent of children overweight or obese (BMI ≥ 85th%) at 2 years of life (2 years)
C: Vegetable Flavor Acceptance [Infants' Intake] (6- to 10-month-old weaned infants (3 separate test days )); Taste Liking Ratings of Vegetable Flavors [Mothers]. (Monthly, 0.5 to 4.5 months); Vegetable Flavor Acceptance (Infants' Rate of Feeding) (6- to 10-month-old weaned infants (3 separate test days))
D: change in adiposity (baseline, 6 month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sensitive Periods in Human Flavor Learning
Brief Summary: The goals of the proposed research are to specify the timing and consequences of the sensitive period for flavor learning in infants who are being breastfed or formula fed. The investigators will conduct a randomized within- and between-subject study of women and their infants during a 15-month window.


Options:
A: Change in Percentage of Children Meeting Physical Activity Policy (Spring of Year 1, Year 2, and Year 3)
B: 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)
C: Vegetable Flavor Acceptance [Infants' Intake] (6- to 10-month-old weaned infants (3 separate test days )); Taste Liking Ratings of Vegetable Flavors [Mothers]. (Monthly, 0.5 to 4.5 months); Vegetable Flavor Acceptance (Infants' Rate of Feeding) (6- to 10-month-old weaned infants (3 separate test days))
D: Increase physical activity (2010); Increase the intake of fiber (2010); Decrease fat intake (2010); Decrease television and other screen time (2010); Decrease obesity (2010)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Sensitive Periods in Human Flavor Learning
Brief Summary: The goals of the proposed research are to specify the timing and consequences of the sensitive period for flavor learning in infants who are being breastfed or formula fed. The investigators will conduct a randomized within- and between-subject study of women and their infants during a 15-month window.


Options:
A: Change in Child Physical Activity (Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.); Change in Child Dietary Intake (Approximately 10-13 months. Baseline will be collected over a 2-month period, followed by a 9 month intervention. Then follow-up assessment will be collected over a 2 month period.)
B: Stunting in Children at 18 mo (18 months of age)
C: Fruit and Vegetable Consumption, servings per week (3 weeks); Perceived Behavioral Control scale score (3 weeks); Attitudes scale score (3 weeks); Intrinsic Motivation scale score (3 weeks); Fruit and vegetable consumption, servings per week (5 weeks); Perceived Behavioral Control scale score (5 weeks); Attitudes scale score (5 weeks); Intrinsic Motivation scale score (5 weeks)
D: Vegetable Flavor Acceptance [Infants' Intake] (6- to 10-month-old weaned infants (3 separate test days )); Taste Liking Ratings of Vegetable Flavors [Mothers]. (Monthly, 0.5 to 4.5 months); Vegetable Flavor Acceptance (Infants' Rate of Feeding) (6- to 10-month-old weaned infants (3 separate test days))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison of Efficacy of Losartan/Spironolactone and Losartan/Enalapril on Urinary Albumin Excretion, Estimated Glomerular Filtration Rate, and Blood Pressure in Patients With Type 2 Diabetes Nephropathy
Brief Summary: The detrimental effects of aldostrone are not adequately arrested by the use of angiotensin converting enzyme (ACE), angiotensin II receptor blocker (ARB) or a combination of both. Recent evidence has provided robust evidence that aldostrone escape plays an important role in this regard. It is believed that aldostrone escape occurs quite commonly with reports indicating prevalence rates as high as 22% with ARBs and 40% with ACE inhibitors. In a trial of patients with diabetes and hypertension it was shown that treatment of aldostrone escape with spironolactone 25 mg daily for three months significantly reduces proteinuria. A number of other trials have similarly observed that addition of spironolactone to an ACE inhibitor based regimen provides additional benefits on proteinuria reduction, blood pressure control, and prevention of glomerular filtration rate (GFR) decline. Most of the available trials in this regard are of short duration (e.g. three months), and have added spironolactone to an ACE or ACE+ARB based regimen (the so-called triple blockade). Currently, evidence evaluating efficacy of a combined ARB+spironolactone regimen compared with conventional double RAS blockade (i.e. ACE+ARB) is lacking. Hence, this randomized open label trial was initiated to determine the effects of addition of spironolactone 25 mg daily to losartan over a period of 18 months.


Options:
A: Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints (Year 1, Year 2, Year 3, Year 4, Year 5)
B: Urinary albumin excretion (18 months)
C: Changes in left ventricular mass on cardiac MRI and arterial stiffness (assessed by pulse wave velocity). (9 months)
D: Change of serum potassium (4 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Family-Based Juvenile Drug Court Services
Brief Summary: The objective of the proposed study is to adapt and implement an efficacious adolescent substance abuse treatment, Multidimensional Family Therapy (MDFT), within the juvenile drug court service system. Additionally, the investigators will also examine the extent to which MDFT can enhance the effectiveness of existing juvenile drug court services in terms of decreasing drug use, delinquent behavior and arrests and improving school and vocational outcomes. The study design is a fully randomized controlled trial.


Options:
A: Treatment Progress (6 months)
B: Graduation from juvenile drug court (Collected once at 12 months from intake/baseline.); Change in substance use (Baseline at the begining of the study, and then at 6, 12, 18, and 24 months after baseline); Change in delinquency (Baseline, and then at 6, 12, 18, and 24 months after baseline); Change in Mental health symptoms (Baseline, 6, 12, 18 and 24 months after baseline); Change in Family functioning (Baseline, 6, 14, 18, and 24 months after baseline); Length of treatment (Collected once, at 12 months after baseline); Change in arrests (12 months before intake through 24 months after intake); Change in substance use (Intake, 6, 12, 18, 24 months after intake); Change in substance use (Intake, 6, 12, 18 and 24 months after intake)
C: Change From Baseline in Days Homeless Out of the Previous 6 Months as Measured at 25 Weeks (Baseline-25 weeks); Change From Baseline in Treatment Adherence Score as Measured at 25 Weeks (Baseline-25 weeks); Change From Baseline in Adherence Attitude Score as Measured by the Drug Attitude Inventory (DAI) at 25 Weeks (Baseline-25 weeks); Change From Baseline in Treatment Adherence Behavior Score as Measured by the Morisky Medication Rating Scale at 25 Weeks (Baseline-25 weeks); Change From Baseline in Adherence Attitude Score as Measured by the Attitude Toward Medication Questionnaire (AMQ) at 25 Weeks (Baseline-25 weeks)
D: Post-Release Opioid Relapse (Four weeks post-release)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Family-Based Juvenile Drug Court Services
Brief Summary: The objective of the proposed study is to adapt and implement an efficacious adolescent substance abuse treatment, Multidimensional Family Therapy (MDFT), within the juvenile drug court service system. Additionally, the investigators will also examine the extent to which MDFT can enhance the effectiveness of existing juvenile drug court services in terms of decreasing drug use, delinquent behavior and arrests and improving school and vocational outcomes. The study design is a fully randomized controlled trial.


Options:
A: N/A
B: Graduation from juvenile drug court (Collected once at 12 months from intake/baseline.); Change in substance use (Baseline at the begining of the study, and then at 6, 12, 18, and 24 months after baseline); Change in delinquency (Baseline, and then at 6, 12, 18, and 24 months after baseline); Change in Mental health symptoms (Baseline, 6, 12, 18 and 24 months after baseline); Change in Family functioning (Baseline, 6, 14, 18, and 24 months after baseline); Length of treatment (Collected once, at 12 months after baseline); Change in arrests (12 months before intake through 24 months after intake); Change in substance use (Intake, 6, 12, 18, 24 months after intake); Change in substance use (Intake, 6, 12, 18 and 24 months after intake)
C: Predicted Probability Derived From the Generalized Linear Mixed Model of Opioid Urine Test Positive Results Over Time (1, 3, 6, and 12 months post-release from incarceration); Predicted Probability Derived From the General Linear Mixed Model of Entry Into Treatment for Opioid Use Disorder on the Methadone Treatment Exposure Form (30 days post-release from incarceration)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Learning and Coping Strategies in Cardiac Rehabilitation - A Randomised Controlled Parallel Group Study
Brief Summary: Background: It is well known that cardiac rehabilitation has potential to reduce morbidity and mortality, but not all patients complete CR. This LC-REHAB trial aims to compare the effect of a new patient education method called learning and coping strategies to that of standard care.

Design: Randomised controlled trial, 1:1 ratio. Participants: Patients above 18 years newly hospitalised with either ischaemic heart disease or heart failure.

Setting: Three hospital Units in Central Denmark Region. Intervention: Cardiac rehabilitation with addition of learning and coping strategies which include participation of experienced patients as co-educators, clarifuing interviews, and inductive teaching style.

Control arm: Standard care cardiac rehabilitation with a decuctive teaching style.

Outcomes: Adherence to cardiac rehabilitation, morbidity, mortality, risk factors, lifestyle, health related quality of life, return to work.


Options:
A: All-cause mortality (within 5 years of enrollment)
B: Adherence to cardiac rehabilitation (After 8 weeks of cardiac rehabilitation); Morbidity and mortality (Three or four years after last patient into trial)
C: The primary-endpoint is empowerment to reach self-care goals after 5 years (At baseline and after 5 years)
D: Within patient change in the Paffenbarger Exercise and Physical Activity Index (basline, at 2-month intervals(2, 4, 6, 8, 10-months) and closeout)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Learning and Coping Strategies in Cardiac Rehabilitation - A Randomised Controlled Parallel Group Study
Brief Summary: Background: It is well known that cardiac rehabilitation has potential to reduce morbidity and mortality, but not all patients complete CR. This LC-REHAB trial aims to compare the effect of a new patient education method called learning and coping strategies to that of standard care.

Design: Randomised controlled trial, 1:1 ratio. Participants: Patients above 18 years newly hospitalised with either ischaemic heart disease or heart failure.

Setting: Three hospital Units in Central Denmark Region. Intervention: Cardiac rehabilitation with addition of learning and coping strategies which include participation of experienced patients as co-educators, clarifuing interviews, and inductive teaching style.

Control arm: Standard care cardiac rehabilitation with a decuctive teaching style.

Outcomes: Adherence to cardiac rehabilitation, morbidity, mortality, risk factors, lifestyle, health related quality of life, return to work.


Options:
A: Adherence to cardiac rehabilitation (After 8 weeks of cardiac rehabilitation); Morbidity and mortality (Three or four years after last patient into trial)
B: Participation in cardiac rehabilitation (4 months)
C: Quality of life (At inclusion (baseline), change from baseline at 3, 6 and 12 months)
D: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)

Answer: A