TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Phase III Trial Comparing Immediate Versus Deferred Nephrectomy in Patients With Synchronous Metastatic Renal Cell Carcinoma
Brief Summary: RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving sunitinib malate after surgery may kill any tumor cells that remain after surgery. It is not yet known whether undergoing immediate surgery or surgery after sunitinib malate is more effective in treating patients with metastatic kidney cancer.

PURPOSE: This randomized phase III trial is studying immediate surgery to see how well it works compared with surgery after sunitinib malate in treating patients with metastatic kidney cancer.


Options:
A: Overall Survival (OS) (Baseline up to Month 80)
B: Progression-free Survival (Randomization until progression (up to 2 years))
C: Progression-free Survival (PFS) by Independent Imaging Review (IIR) (From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to data cutoff date 28 Aug 2020 (up to approximately 46 months))
D: Overall progression-free survival

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial on the Effect of Intermittent Pedicle Clamping Using 15 or 30 Minutes Ischemic Intervals During Liver Surgery
Brief Summary: In order to prevent excessive blood loss during liver surgery, an intermittent Pringle manoeuvre (IPM) can be applied. This implies a temporary clamping of the portal vein and hepatic artery in the hepatoduodenal ligament in order to occlude hepatic inflow. The optimal duration of the IPM is unknown. This randomized controlled trial aimed to analyse differences in hepatocellular damage after 15 minutes or 30 minutes IPM during liver surgery for primary or secondary liver tumours.


Options:
A: N/A
B: Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes (10 minutes)
C: Proportion of patients with hemostasis 3 minutes after application of the haemostat product (3 minutes)
D: Hepatocellular Damage Reflected by Liver Fatty-acid Binding Protein (L-FABP) Levels (L-FABP area under curve from start of surgery up until postoperative day 3)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Oxepa in Multiple Trauma: Prospective, Randomized, Comparative, Double-blind, Controlled Clinical Study
Brief Summary: This is a single-center, prospective, randomized, comparative, double-blind controlled clinical study mend to assess the effect of enteral feeding with Oxepa (a fish oil-based nutrition), compared to an isocaloric control, on oxygenation and clinical outcomes in mechanically ventilated trauma patients.

The study population will be adults admitted to the ICU due to multiple-trauma or head trauma as a result of a gun shut, motor vehicle accidents, fall, workplace accident etc.


Options:
A: Oxygenation (PO2/FIO2 ratio) (2 years)
B: Primary Objective (24 months)
C: Clinician Administered PTSD Scale (CAPS) (Up to 7 months)
D: Diagnostic Interview Schedule for Children and Adolescents (DICA) - Parent (Baseline to Week 24); Diagnostic Interview for Children and Adolescents (DICA) - Child (Baseline to Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: A comparator study to assess safety and efficacy of Flutiform® compared with symbicort turbohaler in asthma patients with moderate to severe persistent, reversible asthma.


Options:
A: Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12)
B: non-inferiority in the efficacy of FlutiForm® (baseline to the end of the 12 week treatment)
C: Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8 (Baseline and Week 8)
D: Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death) (From Day 1 up to 6 months); Number of Participants With at Least One Asthma Exacerbation Over the 6-month Study Treatment Period (From Day 1 up to 6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing CRC Screening in Primary Care Settings
Brief Summary: Colorectal cancer screening remains lower than optimal. The purpose of this study was to test the efficacy of phone-based motivational interviewing versus tailored communication versus usual care in increasing CRC screening in primary care clinics.


Options:
A: Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening (18 months)
B: The following dependant variables were measured in this study;; Diabetes medical error in the 12 months post-intervention, Glycated hemoglobin (A1c) values and A1c test rates in the 12 months post-intervention, and; LDL-cholesterol levels and test rates in the 12 months post-intervention.
C: The difference between groups in the change in parent and nurse ratings of specific communication skills and professionalism behaviors from baseline to follow-up (average 5 months later)
D: completing CRC screening test (1 and 6 months post education)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Sitagliptin Add-on Therapy and Insulin Dose Increase Therapy for Uncontrolled Type 2 Diabetes on Insulin Therapy
Brief Summary: It is well established that inhibition of dipeptidyl peptidase (DPP)-IV reduces glucose levels and preserves pancreatic beta cell function in patients with type 2 diabetes. DPP-IV inhibitors stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon secretion from pancreas by increasing incretin (GLP-1) levels. Recent studies reported that combination therapy with DPP-IV inhibitors and other oral antidiabetic medication have additive or synergistic effects in lowering glycose level, preserving beta-cell mass and function as well as enhancing insulin sensitivity. However, there have been few studies about the glucose lowering effect of DPP-IV inhibitors in patients with type 2 diabetes on insulin treatment.

The researchers hypothesized that DPP-IV inhibitor add-on therapy to insulin treatment may have favorable effects on glucose control and endogenous insulin secretory function in type 2 diabetic patients. The researchers plan to compare between sitagliptin (DPP-IV inhibitor) add-on therapy and insulin dose increase therapy in uncontrolled type 2 diabetes on insulin treatment.


Options:
A: Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population (Baseline and every study visit up to 24 weeks); Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population (Baseline and every study visit up to 24 weeks)
B: HbA1c at each visit (28 Weeks)
C: The change of HbA1C (24weeks)
D: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Non-inferiority, Double-blind, Unicenter Clinical Trial With Two Treatment Arms - Test Group With Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia
Brief Summary: The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia.


Options:
A: Mean Subjective Sleep Diary Derived Total Sleep Time (TST) (Postnaprosyn baseline, Week 1, week 2, week 4)
B: Incidence of Adverse Events (Up to 25 weeks (24 weeks treatment period & 1 week follow-up))
C: Latency To Persistent Sleep (LPS) (10 days (5 intervals of two consecutive nights)); Sleep Latency (SL) (10 days (5 intervals of two consecutive nights))
D: Latency to persistent sleep measured by polysomnography (4 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Aldosterone Blockade in Chronic Kidney Disease. Influence on Arterial Stiffness and Kidney Function
Brief Summary: Patients with Chronic Kidney Disease (CKD) have a poor prognosis primarily due to cardiovascular disease. The cardiovascular risk can be assessed by measurements of arterial stiffness. A decrease in stiffness has been shown to decrease the risk of cardiovascular disease as well as death. Most of the CKD population also have hypertension and the control of blood pressure is one of the corner stones in inhibition of disease progression. Using drugs that specifically block the renin-angiotensin-system for blood pressure control has been shown to have a beneficial impact on inhibition of progression beyond that of the achieved blood pressure control. It has been reported that inhibition of the hormone aldosterone has a positive effect on survival in patients with heart failure, hypertension and diabetic as well as on-diabetic nephropathy.

This study undertakes the investigation of the influence on arterial stiffness of adding an aldosterone receptor inhibitor to the medication CKD patients are already taking. Besides the primary end point which is Pulse wave velocity (PWV), arterial stiffness is also quantified thorough ambulatory blood pressure measurements.


Options:
A: Albuminuria (Screening, (Low-risk: year 1, 2 and 3), (high-risk: week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156))
B: Changes in left ventricular mass on cardiac MRI and arterial stiffness (assessed by pulse wave velocity). (9 months)
C: Pulse wave velocity (24 weeks); Pulse Wave velocity (12 weeks); Pulse wave velocity (baseline)
D: Ratio of UACR at Day 90 to UACR at Baseline (Baseline and Day 90±2)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant
Brief Summary: This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).


Options:
A: Progression-free Survival by Independent Review (Up to approximately 4 years)
B: Progression free survival (5 years)
C: progression-free survival (PFS) (3 year)
D: Progression-free survival

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant
Brief Summary: This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).


Options:
A: progression-free survival (PFS) (3 year)
B: Progression Free Survival (5 years)
C: To evaluate if patients resistant to the initial treatment for residual PET-positive masses after the first two courses of ABVD (PET-2 positive), can be salvaged by early shift to high-dose chemotherapy supported by stem cell rescue. (4 years)
D: Progression-free Survival by Independent Review (Up to approximately 4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-controlled, Parallel Group Study Evaluating the Safety and Efficacy of SPD489 on Executive Function (Self-Regulation) Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Reporting Clinically Significant Impairment of Real-World Executive Function Behavior.
Brief Summary: The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo on executive function (self-regulation) behaviors in adults with ADHD who report clinically significant impairment of executive function behavior in their everyday environment, as measured by the self-report Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score.


Options:
A: Participants Experiencing Collisions During "Surprise Events" in Driving Simulator (6 weeks)
B: Change From Baseline in Subject-reported Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at up to 10 Weeks (Baseline and up to 10 weeks)
C: Percent of Treatment Failures at up to 6 Weeks (Up to 6 weeks)
D: Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Area Under the Steady-state Plasma Concentration-time Curve (AUC) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing); T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC (0 through 96 hours after dosing)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Active-Control, Phase 3B Study to Evaluate the Cardiovascular Safety of Febuxostat and Allopurinol in Subjects With Gout and Cardiovascular Comorbidities
Brief Summary: The purpose of this study is to see whether subjects with gout who receive febuxostat or allopurinol for up to 9 years have a higher rate of serious heart and blood vessel complications (major cardiovascular events).


Options:
A: Subjects With a Serum Urate (sUA) < 6.0 mg/dL by Month 6. (6 months)
B: Proportion of Subjects With an sUA Level That is < 6.0 mg/dL (6 Months, analysis after all subjects complete 12 months)
C: Percentage of Participants With Primary Major Adverse Cardiovascular Events (MACE) Composite (75% Interim Analysis) (Up to last dose of study drug (approximately 83 months)); Percentage of Participants With Primary MACE Composite (Final Analysis) (Up to last dose of study drug (approximately 83 months))
D: Percentage of Participants Experiencing ≥ 1 Gout Flare During Phase 3 (Phase III of the study (weeks 49-72 of study duration))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Observational Study of Safety and Effectiveness Following Administration of Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine
Brief Summary: This observational study will evaluate the safety and effectiveness following administration of adjuvanted Swine Origin A (H1N1) Pandemic Subunit Egg Derived Vaccine through both an ad hoc active monitoring system and a passive surveillance of hospitalization in a large cohort.


Options:
A: Safety of Flu Egg Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine by estimating the incidence of reported Adverse Events, Serious Adverse Events or Adverse Events of Special Interest in a cohort of actively monitored vaccinated subjects (Within 3 weeks and 6 weeks after vaccine administration)
B: Safety and tolerability of FLU-v (Measurements will be taken at screening, then up to 21 days post-vaccination)
C: Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessment). (Duration of study.); Proportion of subjects in each dose group achieving a serum neutralizing antibody titer of greater than or equal to 40 against the influenza A/H7N7 virus. (28 days after receipt of the second dose of vaccine (approximately Day 56).); Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group and serum hemagglutination inhibition (HAI) antibody titers in each group. (1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine.)
D: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C). (Days 1- 8); Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 15); Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 29); Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus (Day 1, Day 57)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Nurse-led Hypertension Clinic in Two Inner City General Practices: Randomised Controlled Trial
Brief Summary: The investigators will do a trial in two general practices to see if the introduction of a blood pressure clinic staffed by a specialist nurse supported by visiting consultant improves blood pressure control compared to usual care.


Options:
A: Blood Pressure Control (Baseline, 6 months, 12 months, 18 months); Mean Systolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months); Mean Diastolic Blood Pressure (Baseline, 6 months, 12 months, 18 months, 54 months)
B: The change in HbA1c from baseline to week 26 (6 months)
C: Change in systolic blood pressure (6 months)
D: Comparison of difference in change in systolic BP between enhanced care and usual care (24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study of the Use of Chartis System to Optimize Subject Selection for Endobronchial Lung Volume Reduction (ELVR) in Subjects With Heterogeneous Emphysema
Brief Summary: Use of the Chartis® Assessment System prior to EBV Treatment


Options:
A: Meters: 6 Minute Walk Test - Change From Baseline to 12 Months Follow up (baseline through 12 months follow up)
B: Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC) (12 and 24 weeks following treatment)
C: 6-month improvement of the 6-minute walk test (6 months)
D: Lung Volume Change (30 Days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Postoperative Blood Transfusion for Frail Elderly With Hip Fracture - a Clinical Randomized Controlled Trial
Brief Summary: Elderly with hip fractures are often frail and discharged from hospital after few days of hospitalisation. Hip fracture surgery is often associated with blood loss, where the patient is at risk of developing anaemia. Low haemoglobin level reduces the body's oxygen transport which causes impaired functional ability and strain on vital organs. Acute anaemia is worse tolerated in elderly, than in younger patients. Therefore this study aims to investigate whether there are effects of an expanded indication for blood transfusion in the frail elderly.


Options:
A: Functional ability (Measured 10 days after surgery + repeated measurement during 90 days after surgery)
B: To compare mortality between groups 28 day after ICU admission (28 days after ICU admission)
C: Enrollment rate (Time Frame: 6 months); Non-adherence (30 days)
D: Occurrence of a composite endpoint (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Postoperative Blood Transfusion for Frail Elderly With Hip Fracture - a Clinical Randomized Controlled Trial
Brief Summary: Elderly with hip fractures are often frail and discharged from hospital after few days of hospitalisation. Hip fracture surgery is often associated with blood loss, where the patient is at risk of developing anaemia. Low haemoglobin level reduces the body's oxygen transport which causes impaired functional ability and strain on vital organs. Acute anaemia is worse tolerated in elderly, than in younger patients. Therefore this study aims to investigate whether there are effects of an expanded indication for blood transfusion in the frail elderly.


Options:
A: A composite endpoint of all-cause post-randomization mortality, myocardial infarction (MI), coronary revascularization, acute renal failure, or post-randomization ischemic stroke up to 90 days after randomization. (90 days after randomization)
B: Functional ability (Measured 10 days after surgery + repeated measurement during 90 days after surgery)
C: Composite end-point of mortality and severe complication (30 days)
D: Cost-effectiveness ratio at 30 days (30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Postoperative Blood Transfusion for Frail Elderly With Hip Fracture - a Clinical Randomized Controlled Trial
Brief Summary: Elderly with hip fractures are often frail and discharged from hospital after few days of hospitalisation. Hip fracture surgery is often associated with blood loss, where the patient is at risk of developing anaemia. Low haemoglobin level reduces the body's oxygen transport which causes impaired functional ability and strain on vital organs. Acute anaemia is worse tolerated in elderly, than in younger patients. Therefore this study aims to investigate whether there are effects of an expanded indication for blood transfusion in the frail elderly.


Options:
A: Recruitment: screening (One year); Recruitment: consent (One year); Recruitment: enrolment (One year)
B: Functional ability (Measured 10 days after surgery + repeated measurement during 90 days after surgery)
C: Percentage compliance of q2weekly hemoglobins (3 months)
D: Incidence of Blood Stream Infection (1 week after randomization and weekly thereafter through discarge from hospital)

Answer: B