TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Randomized, Stratified and Controlled Clinical Trial With Split-virion, Adjuvanted and Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Adults, Elders, Adolescents and Children
Brief Summary: The primary safety objective of this study is to assess the safety of split- virion inactivated H1N1 vaccine with and without adjuvant when administered at the 7.5,15 or 30 mcg dose. The primary immunogenicity objective is to assess the antibody response following each dose of split- virion inactivated A(H1N1) vaccine with and without adjuvant. Participants will include up to 2200 healthy persons age 3 and older who have no history of novel influenza H1N1 2009 infection or novel influenza H1N1 2009 vaccination. This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females, aged 3 years and older. Subjects will be stratified by elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years), elders and adolescents will be randomized into 5 dose groups (adjuvanted H1N1 vaccine of 7.5,15 or 30 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose), children will be randomized into 4 dose groups (adjuvanted H1N1 vaccine of 7.5 or 15 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose), adults will be randomized into 6 dose groups (adjuvanted H1N1 vaccine of 7.5,15 or 30 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose or placebo), 110 subjects per dose and age stratum will be to receive intramuscular influenza H1N1 vaccine. The H1N1 vaccine will be administered at Day 0 and Day 21. Following immunization, safety will be measured by assessment of adverse events through 21 days following the last vaccination (Day 42 for those receiving both doses), serious adverse events and new-onset chronic medical conditions through 6 months post the final vaccination (Day 180 after second vaccination), and reactogenicity to the vaccine for 8 days (Day 0-7) following each vaccination. Immunogenicity testing will be hemagglutination inhibiting (HAI) on serum obtained on the day 21 of each vaccination (prior to vaccination), on Day 21 after first vaccination, and 21 days following the second vaccination (Day 42).


Options:
A: The primary study endpoint was the comparison of efficacy of CAIV-T versus placebo against culture-confirmed influenza-illness caused by community-acquired influenza subtypes that were antigenically similar to those contained in the vaccine.
B: cardiovascular death (12 months)
C: Incidence ratio for acute MI (28 days)
D: Hemagglutination inhibition antibody titer (D0,D21,D35)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
Brief Summary: The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.


Options:
A: Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Baseline and 12 weeks)
B: Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure: PASI 75 (Psoriasis Area and Severity Index) . (12 wks); Efficacy of Secukinumab Compared to Placebo in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Measure:IGA (Investigator's Global Assessment) Mod 2011 With a 0 or 1 Response at Week 12 (12 wks)
C: Number of Patients Experiencing One or More Adverse Events Occurring From Week 0 Through Week 12 (from week 0 to week 12)
D: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 (Week 16)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
Brief Summary: The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.


Options:
A: Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Baseline and 12 weeks)
B: Percentage of Participants With Physician Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 16 (Week 16)
C: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)
D: Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) (Week 12); Number of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: PASI) (Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
Brief Summary: The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.


Options:
A: Proportion of Subjects Achieving a PASI-75 at 12 Weeks at Each of the 3 Dose Levels of Voclosporin. (Twelve Weeks)
B: Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Baseline and 12 weeks)
C: Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Psoriasis Area Severity Index (PASI) 100 at Week 12 (12 Weeks)
D: Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 (Baseline and Week 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
Brief Summary: The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.


Options:
A: Percentage of Participants With Psoriasis Area Severity Index (PASI) 75 at Week 12 (12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Success Score (Score of 0 or 1) at Week 12 - Comparison to Placebo (12 weeks)
B: Percentage of Participants With Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" at Week 16 (Week 16); Percentage of Participants Achieving at Least a 75% Reduction in PASI (PASI75) at Week 16 (Week 16)
C: Number of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75% Improvement at Week 12 (Week 12)
D: Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Baseline and 12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
Brief Summary: The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.


Options:
A: Dose-response Efficacy Profile of AMG 827 Compared With Placebo as Measured by the Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12 (Baseline and 12 weeks)
B: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement (Week 12); Percentage of PASI Improvement From Baseline to 12 Week Endpoint (Baseline to Week 12)
C: Proportion of patients with at least 75% improvement in PASI from baseline (PASI75) at Week 16. (Baseline to week 16)
D: Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest (From Day 169 to Day 729); Short-term Period: Number of Participants With ACR 20 Response at Day 169 (At Day 169 from Baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial to Reduce Pneumonia in Nursing Home Residents
Brief Summary: The purpose of this study is to test the effectiveness of an enhanced oral hygiene protocol in preventing pneumonia among nursing home residents.


Options:
A: Swallowing function (Baseline, 5 weeks and 6 months post-intervention)
B: Change in plaque scores over course of trial (Three week in-hospital rehabilitation period)
C: Pneumonia (2.5 years)
D: Rate of ventilator associated pneumonia (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Randomised Controlled Trial of Early Goal-directed Therapy in Patients Presenting to the Emergency Department With Severe Sepsis in Australasia
Brief Summary: The ARISE RCT is a multi-centre, randomised, controlled trial of EGDT compared to standard care in patients with severe sepsis presenting to the ED. The study will be conducted in multiple sites with 1600 patients enrolled into the study.

Hypothesis to be tested: EGDT, compared to standard Australasian resuscitation practice, reduces 90-day all-cause mortality in patients presenting to the ED with severe sepsis.


Options:
A: Standing Dose of Norepinephrine Which is Required to Maintain a Mean Arterial Pressure (MAP) of 65 mmHg - Hour 1 (1 hour after initiation of angiotensin II (ATII)); Standing Dose of Norepinephrine Which is Required to Maintain a MAP of 65 mmHg - Hour 2 (2 hours after initiation of ATII)
B: The primary outcome measure for the study is death from all causes (90 days)
C: 28 day survival
D: Systemic and regional hemodynamics (during the first 12 hours from the onset of septic shock)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: New Acute Treatment for Stroke - The Effect of Remote PERconditioning
Brief Summary: This study is a blinded randomized study. Randomization for treatment/not treatment with remote perconditioning takes place during transportation to the hospital. This is because the investigators' hypothesis states that remote perconditioning is neuro-protective and the effect is proportionally larger with early treatment. As the size of the effect is unknown, the investigators will use multiple magnetic resonance imaging (MRI) scans to determine the size of a potential neuro-protective effect.

The aims of this study are:

1. To describe method of remote perconditioning in clinical practice regarding feasibility. Pros and cons and potential limitations.
2. To estimate the size of the effect of remote perconditioning in combination with recombinant tissue plasminogen activator (rtPa) treatment within four and a half hours of onset of symptoms.


Options:
A: Number of Patients With Cerebrovascular Events, Cardiovascular Events or Death. (Within six months after carotid artery stenting); Participants Who Got New Diffusion-weighted Imaging (DWI) Lesions on Post-treatment Magnetic Resonance Imaging (MRI) Scans. (Within 48 hours after carotid artery stenting.)
B: Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated. (February 2012)
C: Extent of periinterventional myocardial injury as reflected by the geometric mean of the area under the curve (AUC) for troponin I serum concentrations (72 hours postinterventionally after TAVI)
D: In-hospital death (Postoperative 30 days); Myocardial infarction (Postoperative 30 days); Stroke (Postoperative 30 days); Respiratory failure (Postoperative 30 days); Renal dysfunction (Postoperative 30 days); Renal failure (Postoperative 30 days); Cardiogenic shock (Postoperative 30 days); Gastrointestinal complication (Postoperative 30 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: New Acute Treatment for Stroke - The Effect of Remote PERconditioning
Brief Summary: This study is a blinded randomized study. Randomization for treatment/not treatment with remote perconditioning takes place during transportation to the hospital. This is because the investigators' hypothesis states that remote perconditioning is neuro-protective and the effect is proportionally larger with early treatment. As the size of the effect is unknown, the investigators will use multiple magnetic resonance imaging (MRI) scans to determine the size of a potential neuro-protective effect.

The aims of this study are:

1. To describe method of remote perconditioning in clinical practice regarding feasibility. Pros and cons and potential limitations.
2. To estimate the size of the effect of remote perconditioning in combination with recombinant tissue plasminogen activator (rtPa) treatment within four and a half hours of onset of symptoms.


Options:
A: Impact of RIPC on length of hospital stay. (Assessed through post-operative hospitalization.)
B: Plasma Creatine Concentration of the Recipients (within the first 3days after the operation); Urinary Output of the Recipients Postoperatively (within the first 3days after the operation); Plasma Concentration of NGAL in the Recipients (within the first 24hours after the operation)
C: Salvage index (%): Difference in infarct growth (PWI-DWI) after 24 hours among patients treated with preconditioning and those not treated. (February 2012)
D: Area Under the Curve of CK - MB release (baseline to 72h since admission)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of Immediate Versus Standard Antiretroviral Therapy for HIV-infected Adults Presenting With Cryptococcal Meningitis
Brief Summary: The goal of this randomized clinical trial is to compare early versus standard timing of initiation of antiretroviral therapy (ART) with respect to clearance of Cryptococcus neoformans from cerebrospinal fluid (CSF) among HIV-infected adults with Cryptococcal Meningitis.

The investigators hypothesize that early ART mediates more rapid clearance of C. neoformans from CSF, as manifested by a greater rate of decrease in C. neoformans colony forming units (CFUs) during the first 28 days after initiating antifungal treatment.

Secondary hypotheses are that recovery of pathogen specific cellular immunity directed at C. neoformans, as manifested by increases in the number and function of C. neoformans-specific peripheral blood mononuclear cells is associated with 1) ART and 2) pathogen clearance. In addition, patients randomized to the intervention arm will have more rapid clearance of antigen levels in CSF and serum and will have a lower incidence of grade 3 and 4 Adverse events.


Options:
A: Number of Grade 3-5 Adverse Experiences That Are Definitely or Probably Related to Study Drug (Day 100); Number of Dose-limiting Toxicities Attributed to Treatment Regimens (Day 100)
B: Mortality (2 years)
C: Change in the CSF CFUs between the immediate and standard ART initiation groups (4 weeks)
D: Mortality (26 weeks from study entry)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of Immediate Versus Standard Antiretroviral Therapy for HIV-infected Adults Presenting With Cryptococcal Meningitis
Brief Summary: The goal of this randomized clinical trial is to compare early versus standard timing of initiation of antiretroviral therapy (ART) with respect to clearance of Cryptococcus neoformans from cerebrospinal fluid (CSF) among HIV-infected adults with Cryptococcal Meningitis.

The investigators hypothesize that early ART mediates more rapid clearance of C. neoformans from CSF, as manifested by a greater rate of decrease in C. neoformans colony forming units (CFUs) during the first 28 days after initiating antifungal treatment.

Secondary hypotheses are that recovery of pathogen specific cellular immunity directed at C. neoformans, as manifested by increases in the number and function of C. neoformans-specific peripheral blood mononuclear cells is associated with 1) ART and 2) pathogen clearance. In addition, patients randomized to the intervention arm will have more rapid clearance of antigen levels in CSF and serum and will have a lower incidence of grade 3 and 4 Adverse events.


Options:
A: Change in the CSF CFUs between the immediate and standard ART initiation groups (4 weeks)
B: Mortality (2 years)
C: Composite Endpoint of AIDS, Serious Non-AIDS Diagnoses, and All-cause Mortality (full follow-up, 9.3 years)
D: Mortality (26 weeks from study entry)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Clinical Trial of Immediate Versus Standard Antiretroviral Therapy for HIV-infected Adults Presenting With Cryptococcal Meningitis
Brief Summary: The goal of this randomized clinical trial is to compare early versus standard timing of initiation of antiretroviral therapy (ART) with respect to clearance of Cryptococcus neoformans from cerebrospinal fluid (CSF) among HIV-infected adults with Cryptococcal Meningitis.

The investigators hypothesize that early ART mediates more rapid clearance of C. neoformans from CSF, as manifested by a greater rate of decrease in C. neoformans colony forming units (CFUs) during the first 28 days after initiating antifungal treatment.

Secondary hypotheses are that recovery of pathogen specific cellular immunity directed at C. neoformans, as manifested by increases in the number and function of C. neoformans-specific peripheral blood mononuclear cells is associated with 1) ART and 2) pathogen clearance. In addition, patients randomized to the intervention arm will have more rapid clearance of antigen levels in CSF and serum and will have a lower incidence of grade 3 and 4 Adverse events.


Options:
A: Change in the CSF CFUs between the immediate and standard ART initiation groups (4 weeks)
B: Survival, recurrence of presenting OI/bacterial infection (BI) or incidence of new AIDS-defining events, and HIV-1 plasma viral load at Week 48
C: Mortality (2 years)
D: Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients (14 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single Centre, Randomised, Placebo-controlled, Four-way Cross Over Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK573719 and GW642444 as Monotherapies and Concurrently in Healthy Japanese Subjects
Brief Summary: GW642444 is a potent and selective long-acting beta2 agonist; GSK573719 is a long-acting, inhaled, muscarinic receptor antagonist (or anticholinergic) bronchodilator. Both are in development as once daily (QD) monotherapies for the treatment of Chronic Obstructive Pulmonary Disease (COPD). Development of these two inhaled drugs as a combination therapy is also planned and would have potential for improved efficacy and patient benefit as they both work through different receptor pathways and the combined bronchodilatory effect might be additive.

This study is a randomised, double blind, placebo-controlled, four-way crossover study which will assess the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of GSK573719 and GW642444 in sixteen healthy Japanese subjects. Subjects will receive four possible treatments as single inhaled doses, receiving the two monotherapies separately, the monotherapies concurrently, and placebo.

Blood samples for PK analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of heart rate, blood pressure, ECG and twenty-four hour Holter monitoring, potassium, safety laboratory data and review of adverse events.


Options:
A: Change From Baseline in Trough FEV1 on Day 85 (Baseline (BL) and Day 85)
B: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) at Day 85 (Day 85)
C: adverse events, cardiac and ECG parameters, vital signs, lung function and clinical laboratory safety assessments (From dosing to 24hr post-dose)
D: Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period (From the first dose of study medication up to 52 weeks); Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period (From the first dose of study medication up to 52 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study
Brief Summary: Intravenous cyclophosphamide is considered to be the standard of care for treatment of proliferative lupus nephritis. However, its use is limited by potentially severe toxic effects. Cyclosporine A has been suggested to be an efficient and safe treatment alternative to cyclophosphamide. In a randomized, multicenter, open-label, controlled trial the investigators sought to compare the efficacy of oral cyclosporine A with intravenous pulse cyclophosphamide to induce durable remission in patients with lupus nephritis III-IV.


Options:
A: Time to First Confirmed Complete Renal Response (CRR) During the Short-term (Double-blind) Period (Day 1 (randomization) to 12 months.)
B: N/A
C: To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN (18 months)
D: renal remission and renal response (at the end of induction (month 9) and maintenance (month 18) phase)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mastering Hospital Antibiotic Resistance, a Cluster Randomized Intervention Study in Intensive Care Units Throughout Europe (Work Package 3)
Brief Summary: Colonization of patients with Antimicrobial Resistant Bacteria (AMRB) like Methicillin Resistant Staphylococcus Aureus (MRSA), Vancomycin-Resistant Enterococcus (VRE) and Extended-Spectrum Beta-Lactamases (ESBL) enterobacteriaceae leads to infections; and ultimately to adverse outcomes (eg prolonged hospital stay, death). This is an urgent problem in Europe, especially in Intensive Care Units (ICUs).

In this trial, colonization of patients with these AMRB will be assessed in the baseline period (6m). In phase 2 the effect of a Hygiene Improvement Program, including Chlorhexidine body washings and a Hand Hygiene training program, will be assessed (6m). In phase 3 units will be randomized to either Active Surveillance with Chromagar based tests or a Molecular based tests.

Study Hypothesis: the abovementioned interventions will reduce ICU-acquired colonization rates with MRSA, VRE and ESBL.


Options:
A: Colonization with MRSA, VRE and ESBL (On admission); Colonization with MRSA, VRE and ESBL (During ICU stay)
B: Number of Subjects With Single Negative Polymerase Chain Reaction (PCR) Result and 3 Negative Culture Assays (1 year); Completion of Screening Protocol in Both Trial Arms (1 year); Discontinuation of Contact Precautions in Both Trial Arms (1 year)
C: N/A
D: Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date (9 months)

Answer: A