TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prophylaxis of Chronic Graft-versus-host Disease (cGvHD) With or Without Anti-T-lymphocyte-globulin (ATG Fresenius) Prior Allogeneic Peripheral Stem Cell Transplantation From HLA-identical Siblings After Myeloablative Conditioning in Patients With Acute Leukemia: A Randomized Phase III-study
Brief Summary: This multicenter, prospective phase III-study is to compare the administration of ATG FRESENIUS to the NON-administration of ATG FRESENIUS in a myeloablative conditioning regimen followed by allogeneic hematopoeitic stem cell transplantation from an HLA-identical sibling in patients with acute Leukemia. This clinical trial is to show that the administration of ATG FRESENIUS reduces the risk of chronic Graft-versus-Host disease after allogeneic stem cell transplantation from HLA-identical siblings.


Options:
A: Efficacy of Ruxolitinib Versus Investigator's Choice Best Available Therapy (BAT) in Participants With Moderate or Severe Steroid Refractory Chronic Graft Versus Host Disease (SR-cGvHD) Assessed by Overall Response Rate (ORR) at the Cycle 7 Day 1 Visit (Cycle 7 Day 1 (each cycle was comprised of 4 weeks))
B: Percentage of Participants With Grade II-IV Acute GVHD Between the 2 Groups (180 days after HCT)
C: Freedom from Chronic GVHD (12 months post transplant)
D: comparison of cumulative incidence of chronic GvHD (limited or extensive) after allogeneic SCT from HLA-identical siblings with or without anti-T-lymphocyte-globulin at 2 years after transplantation (2 years after transplantation)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Trial to Assess Response Adapted Therapy Using FDG-PET Imaging in Patients With Newly Diagnosed, Advanced Hodgkin Lymphoma
Brief Summary: RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before, during, and after chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET/CT imaging is effective in assessing response to chemotherapy in patients with newly diagnosed Hodgkin lymphoma.

PURPOSE: This randomized phase III trial is studying FDG-PET/CT imaging to see how well it works in assessing response to chemotherapy in patients with newly diagnosed stage II, stage III, or stage IV Hodgkin lymphoma.


Options:
A: progression-free survival (PFS) (3 year)
B: Progression Free Survival (5 years)
C: 3-year progression-free survival (3 years)
D: Progression free survival (PFS) (5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Trial to Assess Response Adapted Therapy Using FDG-PET Imaging in Patients With Newly Diagnosed, Advanced Hodgkin Lymphoma
Brief Summary: RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before, during, and after chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET/CT imaging is effective in assessing response to chemotherapy in patients with newly diagnosed Hodgkin lymphoma.

PURPOSE: This randomized phase III trial is studying FDG-PET/CT imaging to see how well it works in assessing response to chemotherapy in patients with newly diagnosed stage II, stage III, or stage IV Hodgkin lymphoma.


Options:
A: 3-year progression-free survival (3 years)
B: Progression-free survival
C: Event-free survival (treatments evaluation)
D: Response (24 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Phase III Trial to Assess Response Adapted Therapy Using FDG-PET Imaging in Patients With Newly Diagnosed, Advanced Hodgkin Lymphoma
Brief Summary: RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before, during, and after chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET/CT imaging is effective in assessing response to chemotherapy in patients with newly diagnosed Hodgkin lymphoma.

PURPOSE: This randomized phase III trial is studying FDG-PET/CT imaging to see how well it works in assessing response to chemotherapy in patients with newly diagnosed stage II, stage III, or stage IV Hodgkin lymphoma.


Options:
A: 3-year progression-free survival (3 years)
B: Overall survival; Reduction of late treatment-related toxicity; Maintenance of failure-free survival rate
C: Event-free survival (from randomization to early discontinuation of protocol treatment, no CR/CRu after 8 cycles, relapse, progression or death)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL
Brief Summary: The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.


Options:
A: Progression-Free Survival (PFS) (From initiation of treatment up to follow-up period (up to 3 years))
B: Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab (Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.)
C: 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))
D: Overall Survival (OS) (Baseline up to Month 80)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Safety and Efficacy of Eltrombopag to Reduce the Need for Platelet Transfusion in Thrombocytopenic Subjects With Chronic Liver Disease Undergoing Elective Invasive Procedures
Brief Summary: The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an invasive procedure. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events and medical resource utilisation will be monitored during this time and for up to 30 days after undergoing an invasive procedure to help further evaluate clinical benefit.


Options:
A: Proportion of patients submitted to blood components transfusion - i.e. fresh frozen plasma, platelets and/or cryoprecipitate - before central venous catheterization (Day of randomization)
B: Point Of Care (POC) Transfusion Algorithm Cardiac Study (2.5 years)
C: 24-hour Mortality (First 24 hours after ED admission); 30-day Mortality (First 30 days after ED admission); Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE) (From time of ED admission, for up to 72 hours)
D: Number of Participants With Chronic Liver Disease and Thrombocytopenia (Platelets <50 Gi/L) Who do Not Require a Platelet Transfusion Prior to, During, and up to 7 Days Following Elective Invasive Procedures (Prior to, during, and up to seven days following elective invasive procedures (Study Days 16-19); therefore, this covers a time period from Baseline to Day 26)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing HIV Disease-Specific Provider Alerts: A Randomized Controlled Informatics Trial Comparing Electronic Health Record (EHR) vs. Non-EHR Provider Alerts
Brief Summary: The purpose of this study is to determine whether alerts independent of the ambulatory health record are more effective in eliciting physician responses and therefore have greater impact on HIV disease outcomes than traditional static alerts.


Options:
A: Referral for Implantable Cardioverter Defibrillator (6 months)
B: Change in CD4 count (Throughout study)
C: a designated health care proxy (12 months after intervention made available); initial bone density scan (12 months after intervention made available); administration of annual influenza vaccine (12 months after intervention started); administration of pneumococcal vaccine (12 months after the start of the intervention)
D: Change in screening and assessment of childhood obesity at the point of care, including BMI, blood pressure, and laboratory screening, and provision of nutrition and physical activity counseling (Baseline and 1 Year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Cost Comparison of Cardiac MRI Use in ED Patients With Chest Pain
Brief Summary: The purpose of this study is to investigate the best way to evaluate patients with chest pain in the emergency department. It compares receiving treatment in an observation unit with admission to the hospital. Patients treated in the observation unit will undergo cardiac Magnetic Resonance Imaging (MRI) testing. Patients treated with hospital admission will undergo the testing their doctor determines is best for them. All patients will undergo follow up to find out if they have had any heart related events.


Options:
A: Objective cardiac testing (stress testing or cardiac imaging) within 30 days (30 Days)
B: All cause mortality (90 days)
C: The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days. (Index Hospitalization through 90 days)
D: Cost of Index Hospitalization (Emergency Department (ED) arrival through hospital discharge, median length of stay was 28.1 hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Center Randomized Clinical Trial Comparing Weaning From Mechanical Ventilation With Computer-driven System vs Usual Care in Children
Brief Summary: The purpose of this study is to determine whether a computer-driven system (Smartcare/PS) decreases weaning duration from mechanical ventilation when compared to usual care in children.


Options:
A: achieving target sedation level (Patients will receive study drug for a maximum of 120 hours (5 days))
B: Length of weaning from mechanical ventilation that corresponds to the time from Time 0 to the first extubation. (first extubation or 28 days)
C: All-cause Mortality (At day 28 after the beginning of mechanical ventilation)
D: time to successful extubation (This will be the length of time that the patient remains on continuous infusions of sedation and/or analgesia in the ICU. At 60 days, all study interventions will terminate, but patients will be followed for outcomes.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Center Randomized Clinical Trial Comparing Weaning From Mechanical Ventilation With Computer-driven System vs Usual Care in Children
Brief Summary: The purpose of this study is to determine whether a computer-driven system (Smartcare/PS) decreases weaning duration from mechanical ventilation when compared to usual care in children.


Options:
A: Total ventilation time during intensive care unit stay.
B: Length of weaning from mechanical ventilation that corresponds to the time from Time 0 to the first extubation. (first extubation or 28 days)
C: Duration of mechanical ventilation (up to 4 weeks); duration of ICU stay (up to 4 weeks); duration of hospital stay (up to 8 weeks)
D: " not acceptable " zone of ventilation (During the four hours of the study protocol); " not acceptable " zone of ventilation (During the 4 hours of the protocol)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase II Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Children and Infants After BCG Vaccination at Birth
Brief Summary: This study is designed to evaluate the safety of the TB vaccine MVA85A in healthy children and infants in South Africa. A single vaccination with MVA85A has been shown to be safe and highly immunogenic in a wide range of subjects in previous clinical trials. In this trial,we will vaccinate 24 children with 5 x 10\^7pfu of MVA85A and three groups of 36 infants with 2.5 x 10\^7, 5 x 10\^7 or 1 x 10\^8 pfu.

Participants will be identified from the general population living in Worcester, Western Cape, South Africa


Options:
A: Safety of MVA85A. Both local and systemic adverse events will be monitored, including a daily diary card for the first week. Blood will be taken at day 7 and day 28 for biochemistry and haematology. (3 months)
B: Safety (1 year)
C: Safety of a single intradermal injection of 5 x 107pfu MVA85A (One year)
D: To assess the safety of a new tuberculosis vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime, to healthy volunteers, who have previously been vaccinated with BCG (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double Blinded Randomized Controlled Trial for the Management of Pediatric Community Acquired Skin Abscesses - To Treat or Not to Treat With Antibiotics
Brief Summary: The purpose of this study is to determine if antibiotics are required in the management of skin abscess following incision and drainage.


Options:
A: Clinical Cure Rate at Test of Cure (TOC) (MITT Population) (8-15 days after the end of treatment); Clinical Cure Rate of Ceftaroline Compared With That of Vancomycin Plus Aztreonam Treatment at TOC in the Clinically Evaluable (CE) Population (8-15 days after last dose of study drug)
B: Treatment Failures at 7 Days (7 days)
C: Skin Abscess Resolution (10-14 days)
D: Recurrence Rates of Abscesses (30 days after incision and drainage)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablets in Patients With Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo With an Additional Reference Arm Evaluating Entocort®EC
Brief Summary: This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period.

After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules.


Options:
A: Clinical remission defined as a Mayo Clinic Score (MCS) </= 2 with no individual subscore exceeding 1 point (Week 10)
B: Change in Mayo score at Day 57 compared with Screening (Day 57)
C: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 (Week 52)
D: Clinical and Endoscopic Remission. (8 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablets in Patients With Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo With an Additional Reference Arm Evaluating Entocort®EC
Brief Summary: This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis. The study will compare budesonide-MMX™ 6 mg and budesonide-MMX™ 9 mg tablets to placebo and to Entocort® 3 x 3 mg capsules, in four parallel groups of patients over an 8 week treatment period.

After the screening visit, patients will enter a washout period of 2 days, then they will be randomised to the following four treatment groups: budesonide-MMX™ tablets (6 mg), budesonide-MMX™ tablets (9 mg), Entocort® capsules (3 x 3 mg) and placebo (tablets and capsules), all administered once a day after breakfast. Hence, each patient will receive, in the morning after breakfast, either one budesonide-MMX™ 6 mg or budesonide MMX™ 9 mg tablet and 3 placebo Entocort® matching capsules, or three Entocort® 3 mg capsules and one placebo budesonide-MMX™ matching tablet, or one placebo budesonide-MMX™ matching tablet and three placebo Entocort® matching capsules.


Options:
A: Clinical and Endoscopic Remission. (8 weeks)
B: The proportion of patients with clinical response, defined as a decrease from baseline in the Mayo score by = 30% and = 3 points, with a decrease in the rectal bleeding subscore of = 1 or a rectal bleeding subscore of 0 or 1, at week 8.
C: Clinical and Endoscopic Remission. (8 weeks)
D: Rate of clinical remission (defined by CAI <= 4, with stool frequency and rectal bleeding subscores of ´0´) at week 8 (LOCF) (week 8 (LOCF))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg.
Brief Summary: The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.


Options:
A: Rate of clinical remission (defined by CAI <= 4, with stool frequency and rectal bleeding subscores of ´0´) at week 8 (LOCF) (week 8 (LOCF))
B: Clinical and Endoscopic Remission. (8 weeks)
C: Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal (7, 14, 21, 28, 56 days)
D: Period 1: Clinical and Endoscopic Remission (Week 8); Period 2: Clinical Response, Open-Label Extended Induction (Week 16); Period 3: Clinical Remission (Week 38)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg.
Brief Summary: The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.


Options:
A: Clinical and Endoscopic Remission. (8 weeks)
B: Primary efficacy criterion: remission after 8 weeks of treatment, defined on the basis of the UC-DAI score less than or equal to 1 (12 weeks)
C: To Achieve Clinical Remission in Subjects With Active Ulcerative Colitis (UC). (6 weeks)
D: Rate of clinical remission

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg.
Brief Summary: The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.


Options:
A: Proportion of subject who were relapse free after 6 months of treatment (6 months)
B: Clinical and Endoscopic Remission. (8 weeks)
C: Percentage of Participants With Clinical Response (Week 8)
D: Safety and tolerability of AVX-470 over 28 days of treatment (5 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg.
Brief Summary: The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.


Options:
A: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 (Week 52)
B: Clinical and Endoscopic Remission. (8 weeks)
C: Clinical and Endoscopic Remission. (8 weeks)
D: Rate of clinical remission (defined by CAI <= 4, with stool frequency and rectal bleeding subscores of ´0´) at week 8 (LOCF) (week 8 (LOCF))

Answer: B