TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Study of DOXIL/CAELYX (Doxorubicin HCL Liposome Injection) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
Brief Summary: The purpose of this study is to evaluate time to progression, overall survival, response rate and safety for the two open-label treatment groups; DOXIL/CAELYX in combination with VELCADE vs. VELCADE monotherapy.


Options:
A: Number of Patients With Combined Complete Response and Very Good Partial Response (Up to 48 weeks or until disease progression)
B: To compare the CR rate (with negative or positive immunofixation) obtained with VAD or the Velcade®/dexamethasone combination used as induction treatment in patients up to the age of 65 with newly diagnosed MM, at the end of this induction treatment
C: Time to progression
D: Time to Progression (TTP) (Up to 1 year and 4 months (From date of first participant randomization [20 December 2004] up to interim analysis cut-off date [28 April 2006]))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia
Brief Summary: The purposes of this study are to assess similarities and differences in the efficacy (how well the drug works), safety, and side effects of olanzapine and aripiprazole in patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder.


Options:
A: The primary objective of this study is to test the hypothesis that olanzapine is superior to aripiprazole in the reduction of symptoms of agitation in acutely ill patients with schizophrenia, as measured by mean change in the; Positive and Negative Syndrome Scale Excited Component (PANSS-EC) over 5 days of treatment (4 continuous 24 hr treatment exposures). The null hypothesis of the study is that there is no difference between olanzapine and; aripiprazole in reducing agitation.
B: The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score (Data collected from baseline to day 85)
C: N/A
D: Number of participants tranquil or alseep at four hours after the intevention

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo Controlled, Double Blind Trial of the Effect of Combined Therapy With Deferoxamine and Deferiprone on Myocardial Iron in Thalassemia Major Using Cardiovascular Magnetic Resonance
Brief Summary: Thalassemia major is a genetic disorder affecting hemoglobin synthesis, rendering individuals dependent upon lifelong blood transfusions. Consequently, iron overload occurs and patients have shortened life expectancy with the most common cause of death being heart failure. This trial tests whether the combination of traditional therapy (deferoxamine) with a newer drug (deferiprone) will prove more effective in removing cardiac iron than deferoxamine alone.


Options:
A: difference between multiple observations of the serum ferritin concentrations (five-year treatment)
B: Demonstrate non-inferiority to deferoxamine in its effects on liver iron content (LIC)
C: Clinical efficacy (Iron balance and liver iron concentration) (At baseline and at 12 months)
D: Myocardial T2*

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Factorial Study of the Co-Administration of MK0431 and Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Brief Summary: The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).


Options:
A: Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 52 weeks)
B: Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 26 weeks)
C: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 (Week 24)
D: Hemoglobin A1c (A1C) Changes From Baseline at Week 24 (Baseline, Week 24); A1C Changes From Baseline at Week 24 - Open Label Cohort (Baseline, Week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Trial of Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis
Brief Summary: This research study is being done to evaluate the safety of BHT-3009 alone and when combined with atorvastatin (Lipitor) in patients with multiple sclerosis (MS).


Options:
A: The time to first documented relapse (months 4, 6, 9, 12, and every 3 months from months 18-39)
B: Evaluate safety of BHT-3009 alone and when combined with atorvastatin in patients with multiple sclerosis.; Determine dose of BHT-3009 and regimen for phase II testing.
C: number of MRI contrast enhancing lesions (treatment months 6 to 9 compared to baseline)
D: attack number (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI)
Brief Summary: Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpose of this study is to determine the effectiveness of rituximab in treating patients with WG and MPA.

Study hypothesis: Rituximab is not inferior to conventional therapy in its ability to induce disease remission by Month 6.


Options:
A: disease free survival (four years after diagnosis)
B: Disease Remission (6 months post-randomization)
C: Proportion of patients with CMV reactivation and time to CMV reactivation (Over 12 month period)
D: Safety/Efficacy; Frequency of severe adverse events in each arm. Hypothesis based upon NIH data was a rate of 6% severe adverse event with methotrexate compared to 30% with azathioprine (24% in one study on RA and 46% in one study on Sjögren syndrome).; Evaluation was planned after the last included patient has completed the assigned trial regimen (after 12 months of maintenance regimen or because of drug withdrawal).

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Double-blind, Randomized, Parallel-group Evaluation of LAMICTAL Extended-Release Adjunctive Therapy in Patients With Primary Generalized Tonic-Clonic Seizures
Brief Summary: This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of Primary Generalized Tonic-Clonic (PGTC) seizures. LAMICTAL extended-release is an investigational drug. Placebo tablets look like LAMICTAL extended-release tablets but do not contain active medication. In this study, LAMICTAL extended-release or placebo tablets will be added to current seizure treatments.


Options:
A: Bioequivalence for generic 1 compared to generic 2 (18 months)
B: Percent Change From Baseline in Weekly Primary Generalized Tonic-clonic (PGTC) Seizure Frequency During the Entire Double-Blind Treatment Phase (Baseline through end of Double-Blind Treatment Phase (up to Week 19))
C: Changes in seizure frequency (12 weeks of stimulation)
D: Bioequivalence for generic 1 compared to generic 2 (18 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Percentage of Participants P Aeruginosa-free After Completion of the First Treatment Cycle (Day 29)
C: Time to a Protocol-defined Pulmonary Exacerbation (Over the 18-month study period)
D: Change in P. Aeruginosa Density (from baseline to end of treatment (28 days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Absolute Mean Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 24 (baseline through 24 weeks)
C: Development and evaluation of the CFAbd-Score (initially named JenAbdomen CF-Score), a CF-specific PROM following FDA recommendations (7 years); Development and evaluation of a diary for assessment and quantification of abdominal symptoms, a CF-specific PROM following FDA recommendations (7)
D: Changes in Burkholderia spp. density in expectorated sputum and/or induced sputum. (28 days, i.e. at start and end of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: The change in LCI from baseline to end of treatment in rhDnase treated patients versus patients receiving placebo (The duration of the patient's involvement in the study (approximately 3 months))
B: Number of Participants Eligible to be Assessed for Sub-study Enrollment (2-week run-in period)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Stability of Lung Function: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) (At the end of each 2-week treatment period); Safety: Number of Participants With Adverse Events During Each Treatment Period (4 Weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Change in forced expiratory volume in 1 second (FEV1) (%predicted) (Baseline to 3 months and Baseline to 6 months); Change in peak oxygen uptake (% predicted) (Baseline to 3 months and Baseline to 6 months); Change in number of steps per day (Baseline to 3 months and Baseline to 6 months)
C: Treatment Adherence (10 months)
D: Lung Clearance Index (90 minutes post treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: The primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve BMI and pulmonary function in cystic fibrosis patients who have diabetes (12 months)
C: HbA1c (2 years)
D: Second-phase insulin response during GPA test (5 hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Change of Sweat Chloride Content From Baseline (Baseline, at day 14 and day 28 in study part 1)
B: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 52); Part B: Safety and Tolerability as Assessed by Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 86)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Change in lung functions determined at 0,3,6,12,18,24 months; Change in exercise capacity determined at 0,3,6,12,18,24; months; Change in physical activity determined at 0,3,6,12,18,24 months; Change in quality of life determined at 0,3,6,12,18,24 months
C: Lung function (FEV1, FVC, FEF25-75)
D: Medication Adherence (12 Months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Change in forced expiratory volume in 1 second (FEV1; in % predicted using the average of two baseline measurements) from baseline to 6 months in the intervention group compared to controls. (baseline and 6 months)
B: Change in forced expiratory volume in 1 second (FEV1) (%predicted) (Baseline to 3 months and Baseline to 6 months); Change in peak oxygen uptake (% predicted) (Baseline to 3 months and Baseline to 6 months); Change in number of steps per day (Baseline to 3 months and Baseline to 6 months)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Change in FEV1 (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Hospital Length of Stay (Admission to Discharge)
B: Lung Clearance Index (90 minutes post treatment)
C: Difference in the number of respiratory exacerbations during the 1 year study period (1 year)
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Absolute Change From Baseline (Day 1) in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24 (Day 1, Through Week 24)
C: Safety as Determined by Adverse Events (AEs) (Start of study drug through the Follow-up Visit (Up to Day 56)); Change in Sweat Chloride From Baseline Through Study Day 28 for Group 1-5b (Baseline through Day 28); Change in Sweat Chloride From Baseline Through Study Day 28 for Group 6 (Baseline through Day 28); Change in Sweat Chloride From Baseline Through Study Day 28 for Group 7 (Baseline through Day 28)
D: Safety assessments based on clinical evaluations, laboratory assessments, and adverse events. (28 Days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Percent Coefficient of Fat Absorption (CFA%) (Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Coefficient of Fat Absorption (%) (5 days)
D: To evaluate the efficacy of NM-BL compared to placebo in patients with Exocrine Pancreatic Insufficiency (EPI) due to CF, where the primary variable is coefficient of fat absorption (CFA%) (72 hrs)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: weight of sputum that was expectorated (12 months)
B: Hospital Length of Stay (Admission to Discharge)
C: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
D: Mean percentage change in forced expiratory volume in one second (FEV1) (7days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Hospital Length of Stay (Admission to Discharge)
B: Sputum weight (wet) expectorated during, up to 30 minutes after treatment and the 24 hour total weight (24 hours)
C: weight of sputum that was expectorated (12 months)
D: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
B: Exercise behavior (3 & 6 Months)
C: Change in lung functions determined at 0,3,6,12,18,24 months; Change in exercise capacity determined at 0,3,6,12,18,24; months; Change in physical activity determined at 0,3,6,12,18,24 months; Change in quality of life determined at 0,3,6,12,18,24 months
D: Daily step count (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).


Options:
A: Clinically Significant Laboratory Abnormalities. (28 Days)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Day 28-30 (Baseline and End of treatment (Day 28-30))
D: Pulmonary Function Test: Forced Expiratory Volume in 1 Second (FEV1) (Baseline to168 days)

Answer: B