TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: The BeST Trial: A Randomized Phase II Study of VEGF, RAF Kinase, and mTOR Combination Targeted Therapy (CTT) With Bevacizumab, Sorafenib, and Temsirolimus in Advanced Renal Cell Carcinoma
Brief Summary: This randomized phase II trial studies different combinations of bevacizumab, temsirolimus, and sorafenib tosylate to see how well they work compared with bevacizumab alone in treating patients with kidney cancer that has spread to other places in the body. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab and sorafenib tosylate may stop the growth of tumor cells by blocking blood flow to the tumor. Temsirolimus and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving different combinations of bevacizumab, sorafenib tosylate, and temsirolimus may be more effective than bevacizumab alone in treating metastatic kidney cancer.


Options:
A: Progression-Free Survival (PFS), Core Radiology Assessment (Day 28 of each 6-week cycle: duration of treatment phase); Progression-Free Survival (PFS), Investigator's Assessment (Day 28 of each 6-week cycle: duration of treatment phase)
B: Percentage of Participants With Disease Progression as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death From Any Cause in Programmed Death-Ligand 1 (PD-L1)-Selected Population (Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)); Progression-Free Survival (PFS) as Determined by the Investigator According to RECIST v1.1 in PD-L1-Selected Population (Baseline until documented PD or death, whichever occurred first (until data cut-off date 29 September 2017, up to approximately 24 months)); Percentage of Participants Who Died of Any Cause in ITT Population (Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months)); Overall Survival (OS) in ITT Population (Baseline until death from any cause (until data cut-off date 14 February 2020, up to approximately 57 months))
C: Progression-free Survival (PFS) (Assessed every 2 cycles for the first 12 cycles, then every 3 cycles until treatment discontinuation, then every 8 weeks until disease progression or up to 5 years)
D: Progression Free Survival (PFS) Per Independent Central Radiology Review (Until disease progression or discontinuation of treatment due to unacceptable toxicity up to 30-Jun-2014 (discontinuation))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomised Trial Comparing Intraoperative Topical Quixil and Intravenous Tranexamic Acid, in Reduction of Blood Loss Following Primary Hip & Knee Joint Replacement Surgery.
Brief Summary: We will compare the effectiveness of Quixil and Tranexamic acid in reducing bleeding during hip and knee joint replacements.


Options:
A: Blood loss as calculated from change in haematocrit
B: Perioperative Blood Loss (5 days after surgery); Total Hemoglobin Loss (5 days after surgery)
C: Blood Loss (Post operative day 3)
D: Total blood loss after operation (From the operation to the postoperative day 3 or 4); Decrease of hemoglobin level after operation (From the operation to the postoperative day 14)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled Crossover Trial of Valacyclovir for Suppression of HSV and HIV Shedding in HIV-1, HSV-2 Coinfected Men Who Have Sex With Men (MSM).
Brief Summary: Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The evidence suggests that that HSV is an important cofactor in HIV transmission.

The trial's purpose is to assess the reduction in HIV shedding associated with valacyclovir for suppression of HSV-2 reactivation.

This proof-of-concept, randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected men, assessed the effects of daily valacyclovir on HIV-1 levels in the plasma and rectal mucosa secretions.


Options:
A: Cure of syphilis defined as a negative reactive serologic test for syphilis (RPR) titer or greater than or equal to a 4-fold (2 dilution) decrease in RPR titer at 6 months following treatment and resolution of all signs and symptoms of syphilis. (Month 6.)
B: Serologically confirmed HIV infection (Throughout study)
C: Plasma HIV-1 levels and HIV-1 mucosal shedding (18 weeks)
D: Reduction in anogenital HIV-1 shedding with suppression of HSV-2 reactivation. (18 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Protocol H8 for a Prospective Controlled Trial in Clinical Stage I-II Supradiaphragmatic Hodgkin's Disease. Evaluation of Treatment Efficacy and (Long Term) Toxicity in Three Different Prognostic Subgroups [H8 Trial]
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with combination chemotherapy may kill more cancer cells. It is not yet known whether radiation therapy is more effective with or without combination chemotherapy in treating patients with Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works with or without combination chemotherapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.


Options:
A: Overall survival; Reduction of late treatment-related toxicity; Maintenance of failure-free survival rate
B: N/A
C: Progression-free survival
D: Progression free survival (PFS) (5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Protocol H8 for a Prospective Controlled Trial in Clinical Stage I-II Supradiaphragmatic Hodgkin's Disease. Evaluation of Treatment Efficacy and (Long Term) Toxicity in Three Different Prognostic Subgroups [H8 Trial]
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with combination chemotherapy may kill more cancer cells. It is not yet known whether radiation therapy is more effective with or without combination chemotherapy in treating patients with Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works with or without combination chemotherapy in treating patients with previously untreated stage I or stage II Hodgkin's lymphoma.


Options:
A: Overall survival; Reduction of late treatment-related toxicity; Maintenance of failure-free survival rate
B: Freedom from first progression at 5 years (After a median of 5 years from start of the study)
C: N/A
D: Event-free survival (from randomization to early discontinuation of protocol treatment, no CR/CRu after 8 cycles, relapse, progression or death)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A 1-Year Safety Study of Medium and High Doses of Mometasone Furoate/Formoterol Combination Formulation and Medium and High Doses of Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Medium to High Doses of Inhaled Glucocorticosteroids
Brief Summary: The purpose of this study is to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F MDI 400/10 mcg BID and two doses of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID and 500/50 mcg BID) in subjects with persistent asthma who require maintenance treatment on inhaled glucocorticosteroids (ICS); evaluator-blind.

In addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (AUC), of MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, F/SC MDI 250/50 mcg BID, and F/SC MDI 500/50 mcg BID will be evaluated.


Options:
A: Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 12 in Forced Expiratory Volume (Liters) in 1 Second (FEV1) (Baseline to Week 12)
B: The Number of All Randomized Subjects Reporting Adverse Events (AEs). (1 year)
C: Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period (Day 1 to Week 26 of the Treatment Period)
D: Change From Baseline in Weighted-mean 24-hour Serial Forced Expiratory Volume in One Second (FEV1) at Week 12 (Baseline and Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Multi-center Trial of NovoTTF-100A Compared to Best Standard of Care in Patients With Progressive or Recurrent GBM
Brief Summary: The study is a randomized, controlled trial, designed to test the efficacy and safety of a new medical device, the NovoTTF-100A. The device is an experimental, portable, battery operated device for chronic treatment of patients with recurrent or progressive glioblastoma multiforme (GBM) using alternating electric fields (termed TTFields).


Options:
A: Progression Free Survival (PFS) (Baseline at 6 weeks and then every 6 weeks to discontinuation)
B: Progression Free Survival (up to 142 weeks)
C: The primary end point was 6-month progression-free survival rate (PFS-6) (6 months)
D: Overall Survival (2 years from initiation of accrual)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The AESOPUS Study: Ultrasound Findings to Adjust the Duration of Anticoagulation in Patients With Deep Vein Thrombosis
Brief Summary: Prospective controlled randomized clinical trial. Consecutive patients with acute proximal deep vein thrombosis (DVT) of the lower extremities, with or without contemporary manifestations of pulmonary embolism, are randomized to receive either a fixed duration of anticoagulant therapy (three months in patients with DVT secondary to transitory risk factors, six months in patients with idiopathic DVT) or a flexible duration of anticoagulant therapy, according to the persistence of residual thrombi, as shown by leg veins ultrasonography (up to 1 year in patients with secondary DVT, up to 2 years in those with idiopathic DVT). All patients are followed up to three years to assess the development of (objectively documented) recurrent thromboembolism. The rate of recurrent thromboembolism is compared between the two study groups, as well as the rate of major bleeding complications occurring during anticoagulation.


Options:
A: The main efficacy outcome is objectively confirmed recurrent thromboembolism from randomization up to completion of 33 months of follow-up. (33 months)
B: Confirmed recurrent proximal deep vein thrombosis and/or pulmonary embolism at 18 months follow up; Confirmed major bleeding events at 18 months follow up
C: Death due to DVT/PE; Failures of resolution, extension or recurrence of DVT and/or PE during and after treatment.; Number of major haemorrhages.
D: Recurrent Venous Thromboembolism; major and minor haemorrhage; death

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Comparison of Atomoxetine Hydrochloride and Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents With Autism Spectrum Disorder
Brief Summary: The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD (Autism Spectrum Disorder).


Options:
A: Change in Aberrant Behavior Checklist (ABC) Irritability Subscale Score at Week 6 (Baseline to 6 Weeks)
B: ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score (Baseline and 8 weeks)
C: Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents (week 10); Percentage of Participants Who Were Autism Spectrum Disorder Respondents (week 10)
D: Social Responsiveness Scale (SRS) Change (Completed at Baseline and Week 11); Social Responsiveness Scale (SRS) at Follow-Up (Completed at Week 22)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Comparison of Atomoxetine Hydrochloride and Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents With Autism Spectrum Disorder
Brief Summary: The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD (Autism Spectrum Disorder).


Options:
A: Aberrant Behavior Checklist - Social Withdrawal Subscale (Phase 1 - Week 4 and 12, Phase 2 - Week 4 and 8)
B: ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score (Baseline and 8 weeks)
C: Efficacy of Intranasal Oxytocin vs. Placebo on Measures of Social Function (12 and 24 weeks)
D: Number of Participants Reporting Improvement on the Clinical Global Impression (Baseline to end of study (week 15)); Change in Aberrant Behaviors as Measured by the Aberrant Behavior Checklist Scores (Baseline and End of Study (week 15))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind Comparison of Atomoxetine Hydrochloride and Placebo for Symptoms of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents With Autism Spectrum Disorder
Brief Summary: The purpose of this study is to determine whether atomoxetine is effective in reducing ADHD (Attention Deficit/Hyperactivity Disorder) symptoms in children and adolescents with ASD (Autism Spectrum Disorder).


Options:
A: N/A
B: ADHD Rating Scale-IV-Parent Version: Investigator Scored - Total Score (Baseline and 8 weeks)
C: N/A
D: Clinical Global Improvement (Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease. A Multicenter, Prospective, Randomized Controlled Trial.
Brief Summary: The primary purpose of this study is to evaluate the long term effects of the polymer-based slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior rotablation, in an angiographically well defined group of patients with complex calcified coronary lesions.


Options:
A: In-stent late lumen loss (9 months)
B: Primary Safety Endpoint (Day 0 through 6 Months); Primary Effectiveness Endpoint: Technical Success (Day 0)
C: The primary endpoint will be primary patency of the treated site at 6 months. Primary patency is defined as <50% loss of luminal diameter at the treated site on CT arteriography (CTA) without re-intervention in the interim. (6 months)
D: Safety: Freedom from death at 30 days post-procedure. Effectiveness: Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure. (30 Day, 6 Month, and 12 Month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Inpatient Initiation of Carvedilol and Nurse Management on Health Outcomes in Vulnerable Heart Failure Patients (ECHO Study): a Randomized Trial
Brief Summary: The purpose of our study was to determine if a strategy of starting a heart medication (Beta-blocker) before patients leave the hospital and then being seen by a nurse manager would reduce subsequent hospitalizations compared to usual care.

Hypothesis: A nurse-directed heart failure management program with inpatient initiation of beta blockers will improve health outcomes in a vulnerable, predominantly Hispanic and African American population.


Options:
A: Adherence; Self-efficacy; Quality of life
B: Average number of missed pills per cycle (3 months)
C: N/A
D: Primary outcome: heart failure hospitalizations, time to death or hospitalization

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Labor and Delivery Teamwork Intervention Trial
Brief Summary: A cluster-randomized controlled trial was conducted at 7 intervention and 8 control hospitals to evaluate the effect of teamwork training on the occurrence of adverse outcomes and processes of care in labor and delivery.


Options:
A: The primary outcome was the proportion of deliveries at greater than or equal to 20 weeks gestation in which one or more adverse maternal and/or neonatal outcomes occurred (Adverse Outcome Index).
B: increase the proportion of institutional deliveries in intervention vs. control clusters (Up to 15 months)
C: Knowledge test by written test as multiple-choice questions (MCQ). (The participants will get a knowledge test at the training day they will participate in. Ten training days will be conducted in a 3 months period)
D: all-cause neonatal mortality among preterms/low birth weight newborns (28-days after facility-based delivery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Labor and Delivery Teamwork Intervention Trial
Brief Summary: A cluster-randomized controlled trial was conducted at 7 intervention and 8 control hospitals to evaluate the effect of teamwork training on the occurrence of adverse outcomes and processes of care in labor and delivery.


Options:
A: Difference in differences: change in use of oxytocin for prevention of postpartum hemorrhage (Baseline, Midline (6 months), Endline (12 months))
B: Composite of either >28 week / >1000 gram stillbirth or 7 day neonatal mortality rate (7 days post delivery)
C: Neonatal mortality (7 days)
D: The primary outcome was the proportion of deliveries at greater than or equal to 20 weeks gestation in which one or more adverse maternal and/or neonatal outcomes occurred (Adverse Outcome Index).

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Improving Outcomes in Diabetic Nephropathy
Brief Summary: Kidney disease affects about one out of three people with diabetes mellitus, a common medical problem. Treatment of kidney disease with medications that lower blood pressure can slow the kidney disease but there is no known cure. This study is designed to test the hypothesis that certain combination-based blood pressure lowering regimens (of FDA approved medications) are better than single agent-based regimens for lowering blood pressure and further slowing or preventing progression of this incurable disease


Options:
A: Proteinuria reduction (bi-monthly)
B: Change in 24 hour urine albumin to creatinine ratio after 12 months of treatment
C: Albuminuria (Screening, (Low-risk: year 1, 2 and 3), (high-risk: week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156))
D: Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First (Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Sugar-Sweetened Beverage Consumption in Overweight Adolescents
Brief Summary: The primary aim of this study is to examine the effect of a multi-component intervention, designed to reduce consumption of sugar-sweetened beverages, on weight gain, total energy intake, and diet quality in adolescents. The secondary aim is to evaluate whether outcomes of the intervention differ between adolescents for whom 100% fruit juice vs. other products (i.e., soda, fruit punch, lemonade, iced tea, coffee drinks, energy drinks, sports drinks) constitutes the primary source of sugar from beverages.


Options:
A: body mass index (change from baseline to 12 months)
B: Frequency of binge eating; weight
C: Body mass index (BMI) (Change through 2 years)
D: To evaluate the effect, at 12 months, of the 3 intensities of the PACEi-DP intervention on Body Mass Index (BMI) among male & female adolescents. (baseline, 6 mo, 12 mo)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Sugar-Sweetened Beverage Consumption in Overweight Adolescents
Brief Summary: The primary aim of this study is to examine the effect of a multi-component intervention, designed to reduce consumption of sugar-sweetened beverages, on weight gain, total energy intake, and diet quality in adolescents. The secondary aim is to evaluate whether outcomes of the intervention differ between adolescents for whom 100% fruit juice vs. other products (i.e., soda, fruit punch, lemonade, iced tea, coffee drinks, energy drinks, sports drinks) constitutes the primary source of sugar from beverages.


Options:
A: Changes in BMI z-score (Measured at Month 12)
B: N/A
C: Percent Body Fat (Baseline and One year)
D: Body mass index (BMI) (Change through 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Impact of 3-year Lifestyle Intervention on Postprandial Glucose Metabolism: the SLIM Study
Brief Summary: To evaluate the effect of a 3-year diet- and exercise lifestyle intervention, based on general public health recommendations, on glucose tolerance, insulin resistance and metabolic cardiovascular risk factors in Dutch subjects with impaired glucose tolerance (IGT).


Options:
A: First Occurrence of a Severe Cardiovascular Event (up to 11 years)
B: 2-hour glucose levels; insulin resistance
C: incidence rate of DM (Follow-up in 12 months)
D: Change in weight from baseline (12- and 24-months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Intensive Diet and Exercise for Arthritis
Brief Summary: The purpose of this study is to compare the effects of a calorie-restricting diet, exercise, and a combination of both in reducing knee inflammation and compressive forces in obese and overweight adults with knee osteoarthritis (OA).


Options:
A: Change in the intensity of daily pain. (The treatment will be 5 daily sessions.The pain level will be assessed before treatment, after each session and at the end of treatment.Totaling six days.); Change in the pressure pain threshold. (The pressure pain threshold will will be evaluated before and after 5 daily sessions of treatment.Totaling six days.)
B: Numerical Pain Rating Scale (NPRS) (Time 0 - baseline); Numerical Pain Rating Scale (NPRS) (Time 1 - after 10min of the baseline); Numerical Pain Rating Scale (NPRS) (Time 2 - after 72 hours of baseline)
C: Inflammatory biomarkers (Measured at 0, 6, and 18 months (analyzed at 18 months)); Knee joint loads (Measured at 0, 6, and 18 months)
D: Recruitment Rate (Baseline); Feasibility of Assessment Procedures: completion rate (Through study completion (16 weeks)); Retention Rate (Through study completion (16 weeks)); Feasibility of Research Assistant (RA) Training: rating (Baseline); Monitoring Treatment Fidelity (Through study completion (16 weeks))

Answer: C