TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Reduce the Disparity in Live Donor Kidney Transplantation
Brief Summary: The main purpose of this study is to learn which educational method is most helpful to patients and their family members when they consider whether to pursue live donor kidney transplantation.

Patients who are eligible for a kidney transplant usually get information in the transplant clinic about two types of kidney transplants - one where the kidney comes from a dead donor and one where the kidney comes from a healthy living donor. Patients are given this information by a transplant nurse or doctor and then encouraged to discuss it with family members and friends.

In this study, we are trying to see if changing how and where we give patients this information makes a difference in how patients and their family members think about live donor kidney transplantation. So, we are looking at whether getting the information in the transplant clinic - either alone or in a group - is the same or different than getting the same information in your home.

The study is only recruiting African American patients. This is being done because African Americans have a higher likelihood of developing chronic kidney disease and needing a kidney transplant than patients of other races. However, they wait longer for a kidney transplant and die at a higher rate on the waiting list because they are less likely than other patients to receive a live donor kidney transplant. We want to see which educational approach works best with African American patients and their families.


Options:
A: Change in Body mass index (BMI) (Baseline, 6 and 9 month follow-up.)
B: Behavior change (6 month -12 months post-partum)
C: The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants. (one year)
D: Change in HIV viral suppression (Assessed at 4 month follow up (FU), 12 month FU)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Reduce the Disparity in Live Donor Kidney Transplantation
Brief Summary: The main purpose of this study is to learn which educational method is most helpful to patients and their family members when they consider whether to pursue live donor kidney transplantation.

Patients who are eligible for a kidney transplant usually get information in the transplant clinic about two types of kidney transplants - one where the kidney comes from a dead donor and one where the kidney comes from a healthy living donor. Patients are given this information by a transplant nurse or doctor and then encouraged to discuss it with family members and friends.

In this study, we are trying to see if changing how and where we give patients this information makes a difference in how patients and their family members think about live donor kidney transplantation. So, we are looking at whether getting the information in the transplant clinic - either alone or in a group - is the same or different than getting the same information in your home.

The study is only recruiting African American patients. This is being done because African Americans have a higher likelihood of developing chronic kidney disease and needing a kidney transplant than patients of other races. However, they wait longer for a kidney transplant and die at a higher rate on the waiting list because they are less likely than other patients to receive a live donor kidney transplant. We want to see which educational approach works best with African American patients and their families.


Options:
A: The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants. (one year)
B: Deceased Donor Kidney Transplant (DDKT) and Living Donor Kidney Transplant (DDKT) Knowledge (9 months)
C: Proportion of participants who consent to donate organs (1 Day)
D: Number of Participants With Live Kidney Donor Activation Events (24 months post randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Trial to Reduce the Disparity in Live Donor Kidney Transplantation
Brief Summary: The main purpose of this study is to learn which educational method is most helpful to patients and their family members when they consider whether to pursue live donor kidney transplantation.

Patients who are eligible for a kidney transplant usually get information in the transplant clinic about two types of kidney transplants - one where the kidney comes from a dead donor and one where the kidney comes from a healthy living donor. Patients are given this information by a transplant nurse or doctor and then encouraged to discuss it with family members and friends.

In this study, we are trying to see if changing how and where we give patients this information makes a difference in how patients and their family members think about live donor kidney transplantation. So, we are looking at whether getting the information in the transplant clinic - either alone or in a group - is the same or different than getting the same information in your home.

The study is only recruiting African American patients. This is being done because African Americans have a higher likelihood of developing chronic kidney disease and needing a kidney transplant than patients of other races. However, they wait longer for a kidney transplant and die at a higher rate on the waiting list because they are less likely than other patients to receive a live donor kidney transplant. We want to see which educational approach works best with African American patients and their families.


Options:
A: The primary outcome for this study is the proportion of enrolled patients with live donor kidney transplants. (one year)
B: Change in blood pressure measurement at baseline and at one year follow-up (Baseline and one year follow-up)
C: referral to a nephrologist (12 months)
D: Number of Participants With Live Kidney Donor Activation Events (24 months post randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Up-down Determination of the ED90 of Oxytocin Infusions for the Prevention of Postpartum Uterine Atony in Parturients Undergoing Cesarean Delivery
Brief Summary: This study is designed to determine the minimum effective dose (ED90) of infusions of oxytocin for the prevention of uterine atony / postpartum hemorrhage and the need for additional uterotonics, in low risk parturients presenting for an elective CD.

The primary outcome measure is the response of effective uterine contraction as either satisfactory or unsatisfactory as determined by the obstetrician blinded to the oxytocin infusion dose. Secondary outcomes will include need for additional uterotonics, calculated intra-operative blood loss and presence of oxytocin related adverse effects.


Options:
A: the amount of blood loss in third and fourth stages of labor (The end of the delivery to 2 hours after birth.)
B: The primary outcome measure is the response of effective uterine contraction as either satisfactory or unsatisfactory as determined by the obstetrician blinded to the oxytocin infusion dose. (3 minutes)
C: Incidence of acute postpartum hemorrhage: blood loss ≥ 500 ml within two hours of delivery
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: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Up-down Determination of the ED90 of Oxytocin Infusions for the Prevention of Postpartum Uterine Atony in Parturients Undergoing Cesarean Delivery
Brief Summary: This study is designed to determine the minimum effective dose (ED90) of infusions of oxytocin for the prevention of uterine atony / postpartum hemorrhage and the need for additional uterotonics, in low risk parturients presenting for an elective CD.

The primary outcome measure is the response of effective uterine contraction as either satisfactory or unsatisfactory as determined by the obstetrician blinded to the oxytocin infusion dose. Secondary outcomes will include need for additional uterotonics, calculated intra-operative blood loss and presence of oxytocin related adverse effects.


Options:
A: Fetal plasma copeptin concentration (30 min after delivery)
B: 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)
C: Uterine tone. (2 minutes)
D: The primary outcome measure is the response of effective uterine contraction as either satisfactory or unsatisfactory as determined by the obstetrician blinded to the oxytocin infusion dose. (3 minutes)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized Trial Of Simultaneous Pancreatic Cancer Treatment With Enoxaparin and ChemoTherapy (PROSPECT)
Brief Summary: To evaluate the safety and efficacy of chemotherapy with or without enoxaparin. This study is powered to decrease the DVT/ VTE events rate from 10% to 3% with enoxaparin in the experimental arm.

N=540pts, dropout-rate 15%, power 80 %, two sided, significant level 5%


Options:
A: Percentage of Patients With Venous Thromboembolisms (12 weeks); Percentage of Patients Who Experienced Clinically Significant Bleeding Events. (13 weeks)
B: Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or VTE-related Death (From randomization up to 3 days after last study drug injection); Time-to-first Occurrence of VTE or VTE-related Death (Cumulative Incidence Function) (From randomization up to 3 days after last study drug injection)
C: DVT/TVE event rate (After 12 events and after 24 events or after 540 pts recruited)
D: efficacy: progression-free survival in months (measurements of the size of the effect will be done using the Kaplan Meier method and the difference between the means of this time) (efficacy); safety: will be the incidence, during randomized treatment period (from day 1 to the last day of treatment + 7 days), of major bleedings. (safety)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized Trial Of Simultaneous Pancreatic Cancer Treatment With Enoxaparin and ChemoTherapy (PROSPECT)
Brief Summary: To evaluate the safety and efficacy of chemotherapy with or without enoxaparin. This study is powered to decrease the DVT/ VTE events rate from 10% to 3% with enoxaparin in the experimental arm.

N=540pts, dropout-rate 15%, power 80 %, two sided, significant level 5%


Options:
A: Incidence of venous thromboembolism reduction
B: Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death (From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first)
C: DVT/TVE event rate (After 12 events and after 24 events or after 540 pts recruited)
D: Progression Free Survival (during chemotherapy and follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Vitamin D Supplementation Prevent Bone Loss in Persons With MS? A Randomised, Placebo-controlled, Single-centre Study
Brief Summary: Several studies have shown that bone mineral density (BMD) at the femoral neck decreases with increasing physical handicap (EDSS-score) in MS patients. Possible explanations are less weightbearing exercise or less UV-exposure resulting in reduced vitamin D generation in the skin. Prevention of osteoporosis is a high priority, because treatment of the established disease remains sub-optimal.

We have designed a double-blind randomised controlled trial of two years' duration including 90-100 persons with MS age 18-50 to assess whether supplementation with vitamin D, given as a weekly dose of 20,000 IU cholecalciferol, can prevent bone loss.

The primary objective of this study is to determine changes in BMD over the 2 year study period comparing treatment and placebo groups.

The most important secondary objective is to determine cytokine profiles in blood samples. We will also assess parameters related to vitamin D status and physical performance.


Options:
A: Measure: the proportion of patients with P-PTH< 20 ng/l and S-OH(D)2 > 85 nmol/l at 6 and 12 months (one year)
B: Occurrence and severity of Interferon beta related Flu Like Symptoms and Injection Site Reactions. (One year)
C: Changes in BMD over the 2 year study period comparing treatment and placebo groups (2 years)
D: Serum calcium (at each dose change)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Milk, Whey and Casein on Weight Loss and Risk Markers of Metabolic Syndrome in Overweight Children
Brief Summary: Milk contains a vast number of bioactive components that have been suggested to have a positive impact on human health, of special interest is the effects related to metabolic syndrome and obesity but the effect of the individual milk components is not clear. This study examine whether it is beneficial for overweight and obese children to increase the intake of skim milk, or whey or casein in relation to bodyweight and markers of MS.

The participants will be randomized to receive skim milk, whey milk drink, casein milk drink or mineral water for 3 mo. They will be examined at baseline, end of intervention and followed up 3 month later.


Options:
A: decreased dietary fat intake; increased vegetable consumption; increased self-reported leisure physical activity
B: Employee purchases of healthy (green-labeled) items (6 months)
C: This investigation is an equivalency trial to determine whether weight loss differs between subjects consuming beverages containing no calorie sweeteners as compared to water drinkers at 12 weeks. (Data will be measured at 12 weeks.)
D: body composition and markers for metabolic syndrome (e.g.fasting insulin, glucose, lipid profile, CRP, PAI-1, tPA) (at baseline, after intervention and body composition 3 mo after end of intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Hydrotherapy in Pain and Quality of Sleep's Cycles in Preterm Newborn on Neonatal Intensive Care Units
Brief Summary: Researchers suggest that the protection of the cycles of sleep is essential for neurodevelopment, learning, memory and preservation of brain plasticity to the individual's life. Recent research shows that technical bath promote reduction of crying, anxiety and improves the behavior of newborns.


Options:
A: Physiological and behavioral parameters were assessed by Brazelton's neonatal behavior assessment scale, and the pain was evaluated by NFCS scale. The mean of Brazelton's scale was reduced after the procedures from 5,88 ± 0.35 to 1,38 ± 0.74, p < 0.001. (At two years)
B: pain response to vaccination with Prevnar and Pentacel, as measured by The Modified Behavioral Pain Scale (MBPS) and the Visual Analogue Scale (VAS) (Immediately after vaccination)
C: technical quality of the LP, classified as success or failure. (immediate)
D: level of COMFORT with videotaped COMFORT behavior scale (first 24 hours postoperative)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Hydrotherapy in Pain and Quality of Sleep's Cycles in Preterm Newborn on Neonatal Intensive Care Units
Brief Summary: Researchers suggest that the protection of the cycles of sleep is essential for neurodevelopment, learning, memory and preservation of brain plasticity to the individual's life. Recent research shows that technical bath promote reduction of crying, anxiety and improves the behavior of newborns.


Options:
A: infant pain response, as measured by facial grimacing and changes in heart rate and oxygen saturation during the procedure
B: Physiological and behavioral parameters were assessed by Brazelton's neonatal behavior assessment scale, and the pain was evaluated by NFCS scale. The mean of Brazelton's scale was reduced after the procedures from 5,88 ± 0.35 to 1,38 ± 0.74, p < 0.001. (At two years)
C: recovery after inguinal hernia surgery = time to restore normal activities after surgery (one week)
D: Hypersensitivity to pain (At 15 month vaccination (Visit 5))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Comparison of Warm Water Infusion in Lieu of Air Insufflation vs. Air Insufflation for Aiding Colonoscopy Insertion in Sedated Patients Undergoing Colorectal Cancer (CRC) Screening and Surveillance.
Brief Summary: Compared with the conventional (air) method, patients examined by the study (water) method have lower pain scores and require less medication but have similar cecal intubation rate and willingness to repeat future colonoscopy.


Options:
A: Cecal intubation success rate (up to ten months)
B: number of patients undergoing complete unsedated colonoscopy (6 months)
C: Increments of medications used for sedation (duration of procedure)
D: Number of Patients Undergoing Complete Unsedated Colonoscopy (6-9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Multicenter Randomized Controlled Study of Rosuvastatin for Prevention of Contrast Induced Acute Kidney Injury in Patients With Diabetes and Slight to Moderate Renal Insufficient
Brief Summary: The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced acute kidney injury (CIAKI). Major risk factors for CIAKI include older age, diabetes mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a patient with CKD it amplifies the risk of CIAKI.

The aim of this multicenter prospective, randomized, controlled study is to evaluate whether statins treatment during the perioperative period would reduce the risk of CIAKI in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography or noncoronary angiography, and evaluate the influence of such potential benefit on short-term outcome.


Options:
A: An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure (72 h)
B: First Co-Primary Outcome (30 days post CABG surgery); Second co-primary outcome (5 years after CABG)
C: Number of Participants With Acute Kidney Injury (postoperative day 2); Number of Participants With Delirium (while in ICU (about 2 days))
D: To evaluate the effect of high dose atorvastatin in STEMI - 30 Days MACE(death, myocardial infarction, target vessel revascularization) (30 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Varenicline Adherence and Outcomes in Homeless Smokers
Brief Summary: the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit smoking.


Options:
A: Participants Abstinent From Cigarettes (Two years)
B: Smoking abstinence rate (At 12 months); Cost-effectiveness (At 12 months)
C: 7-day point prevalence abstinence from smoking (6 months after enrollment)
D: 7-Day Point Prevalence Abstinence From Smoking for 6 Months (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Varenicline Adherence and Outcomes in Homeless Smokers
Brief Summary: the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit smoking.


Options:
A: 7-day point prevalence abstinence from smoking (6 months after enrollment)
B: Number of Participants With Biochemically-verified Smoking Abstinence, Assessed 14 Times Over 8 Weeks (Point-in-time abstinence assessed in a repeated fashion 14 times over the 8-week study period)
C: CO-verified Smoking Status at 26 Weeks (7-day smoking abstinence at week 26 follow-up)
D: Breath carbon monoxide (Throughout study - one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Varenicline Adherence and Outcomes in Homeless Smokers
Brief Summary: the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit smoking.


Options:
A: Long-term Smoking Abstinence (30-day Point Prevalence Abstinence) (6 months after enrollment)
B: 7-day point prevalence of smoking six months following completion of the intervention protocol (nine months post randomization). (2 years)
C: 7-day point prevalence abstinence from smoking (6 months after enrollment)
D: Air Nicotine Levels (Measured at Baseline, 3, 6 and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Varenicline Adherence and Outcomes in Homeless Smokers
Brief Summary: the purpose of the study is to see if varenicline in combination with motivational counseling helps homeless cigarette smokers quit smoking.


Options:
A: 7-day Point Prevalence Abstinence From Cigarettes (24 months)
B: 7-day point prevalence abstinence from smoking (6 months after enrollment)
C: N/A
D: Biochemically confirmed 7-day point-prevalence abstinence at 6-month (6-month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b, Randomized, Partially Blind (Open Label Warfarin), Active-Controlled (Warfarin), Multicenter Study, To Evaluate The Safety And Efficacy In 2 Doses Of Apixaban In Comparison To Warfarin, Administered For 12 Weeks In Subjects With NVAF
Brief Summary: To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.


Options:
A: Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (on-treatment period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up); Compare Edoxaban to Warfarin for Superiority for Composite of Stroke and Systemic Embolic Events (SEE). (overall study period 2.5 years of median study drug exposure and 2.8 year of median follow-up)
B: Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period (Baseline to Week 12)
C: Incidence of major and clinically relevant non-major bleeding events (Double-blind treatment period (variable, up to 16 months))
D: Composite of all fatal or non-fatal strokes or non central nervous system (CNS) systemic embolic events (SE) (From randomization up to the end of the treatment period (minimum of 6 months))

Answer: B