TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Double-Blind Study Of Ceftobiprole Versus Linezolid Plus Ceftazidime In The Treatment Of Nosocomial Pneumonia
Brief Summary: The purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the water-soluble prodrug \[form\] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia.


Options:
A: Clinical Cure Rate at the End-of-treatment (EOT) Visit (End-of-treatment (Day 10 or Day 11))
B: Percentage of Participants With Clinical Response in Clinically Evaluable (CE) Population at Test-of-Cure (TOC) Visit (Up to Day 24 to 35 (10 to 21 days after last day of therapy [LDOT]))
C: Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) (7 to 14 days after the end of therapy (EOT))
D: Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) (7 to 14 days after the end-of-therapy (EOT))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Open-Label, Phase 3 Study to Compare the Safety and Effectiveness of Doripenem Versus a Comparator Antibiotic in Hospital-Acquired Pneumonia
Brief Summary: The purpose of this study is to compare the safety and effectiveness of doripenem in patients with hospital-acquired pneumonia (HAP).


Options:
A: Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) (7 to 14 days after the end of therapy (EOT))
B: Clinical response rate at the early follow-up visit.
C: Clinical Cure Rate at the End-of-treatment (EOT) Visit (End-of-treatment (Day 10 or Day 11))
D: Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) (7 to 14 days after the end-of-therapy (EOT))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-Controlled, Double-blind, Randomized, Parallel Study of the Efficacy and Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation
Brief Summary: The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).


Options:
A: Average intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse at the end of the treatment period (Week 12) for both doses of dapoxetine
B: Average Intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse at the end of the treatment period (Week 12)
C: Average Intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse, at the end of the treatment period (week 24)
D: Average intravaginal ejaculatory latency time (IELT), as measured by stopwatch during sexual intercourse, between last 2 visits during the treatment period

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-Controlled, Double-Blind, Randomized, Parallel Study Of The Efficacy And Safety Of Dapoxetine HCl In The Treatment Of Rapid Ejaculation
Brief Summary: The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).


Options:
A: The Average Intravaginal Ejaculatory Latency Time (IELT) at Week 12 (Baseline, Week 12)
B: Average Intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse, at the end of the treatment period (week 24)
C: Average intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse at the end of the treatment period (Week 12) for both doses of dapoxetine
D: Average intravaginal ejaculatory latency time (IELT), as measured by stopwatch during sexual intercourse, between last 2 visits during the treatment period

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Correction of Hemoglobin and Outcomes In Renal Insufficiency
Brief Summary: The purpose of this study is to compare the outcomes of patients with chronic kidney disease (CKD) randomly assigned to 2 treatment groups, which differ only in their targeted hemoglobin levels. This study will test the primary hypothesis that the level of anemia correction with once weekly dosing of PROCRITÂ® (Epoetin alfa) in patients with chronic kidney disease will decrease mortality and cardiovascular morbidity.


Options:
A: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
B: Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen (From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21))
C: changes in gene-arrays, EPC and biomarkers panels (14 days, 6 and 12 months)
D: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period (Baseline, Week 29 to Week 36)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Correction of Hemoglobin and Outcomes In Renal Insufficiency
Brief Summary: The purpose of this study is to compare the outcomes of patients with chronic kidney disease (CKD) randomly assigned to 2 treatment groups, which differ only in their targeted hemoglobin levels. This study will test the primary hypothesis that the level of anemia correction with once weekly dosing of PROCRITÂ® (Epoetin alfa) in patients with chronic kidney disease will decrease mortality and cardiovascular morbidity.


Options:
A: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
B: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period (Baseline, Week 29 to Week 36)
C: Cost of Erythropoiesis Stimulating Agent (12 months)
D: Time to All Cause Death or First Hospitalization for Worsening Heart Failure (From randomization to the end of study; maximum time on study was 73 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Correction of Hemoglobin and Outcomes In Renal Insufficiency
Brief Summary: The purpose of this study is to compare the outcomes of patients with chronic kidney disease (CKD) randomly assigned to 2 treatment groups, which differ only in their targeted hemoglobin levels. This study will test the primary hypothesis that the level of anemia correction with once weekly dosing of PROCRITÂ® (Epoetin alfa) in patients with chronic kidney disease will decrease mortality and cardiovascular morbidity.


Options:
A: Change in hemoglobin (Hb) from baseline to the end of the study; Primarily interested in the change in Hb between Q2W vs Q4W groups. Protocol Addendum: Hb change from baseline to end of open-label extension (no more than 36 weeks)
B: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
C: Median Time to First Cardiovascular Event (Up to 4 years)
D: Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22 (From baseline through Week 22)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Correction of Hemoglobin and Outcomes In Renal Insufficiency
Brief Summary: The purpose of this study is to compare the outcomes of patients with chronic kidney disease (CKD) randomly assigned to 2 treatment groups, which differ only in their targeted hemoglobin levels. This study will test the primary hypothesis that the level of anemia correction with once weekly dosing of PROCRITÂ® (Epoetin alfa) in patients with chronic kidney disease will decrease mortality and cardiovascular morbidity.


Options:
A: Occurrences of red blood cell transfusion (from study day 29 (week 5) to week 17)
B: Change in the patient-reported Pediatric Quality of Life Inventory (PedsQL Inventory) from baseline to the last assessment.
C: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
D: Incidence of adverse events (throughout study)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Correction of Hemoglobin and Outcomes In Renal Insufficiency
Brief Summary: The purpose of this study is to compare the outcomes of patients with chronic kidney disease (CKD) randomly assigned to 2 treatment groups, which differ only in their targeted hemoglobin levels. This study will test the primary hypothesis that the level of anemia correction with once weekly dosing of PROCRITÂ® (Epoetin alfa) in patients with chronic kidney disease will decrease mortality and cardiovascular morbidity.


Options:
A: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
B: Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA) (Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first); Time to All-cause Mortality or End Stage Renal Disease (ESRD) (Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first)
C: Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP (EEP (Week 16 to Week 24))
D: Median Time to First Cardiovascular Event (Up to 4 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Correction of Hemoglobin and Outcomes In Renal Insufficiency
Brief Summary: The purpose of this study is to compare the outcomes of patients with chronic kidney disease (CKD) randomly assigned to 2 treatment groups, which differ only in their targeted hemoglobin levels. This study will test the primary hypothesis that the level of anemia correction with once weekly dosing of PROCRITÂ® (Epoetin alfa) in patients with chronic kidney disease will decrease mortality and cardiovascular morbidity.


Options:
A: Local pain due to s.c. injection (by VAS). (After each injection)
B: The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)
C: Median Time to First Cardiovascular Event (Up to 4 years)
D: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 25-36)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Omega-3 Fatty Acid Treatment of 174 Patients With Mild to Moderate Alzheimer's Disease (OmegAD): a Randomized Double-blind Trial
Brief Summary: Memory loss and difficulties with thinking associated with Alzheimer's disease (AD) may be due to a deficiency in the brain of a fatty acid named DHA. The aim of this trial is to see if dietary supplementation with a preparation, rich in DHA, will halt cognitive impairment in AD patients


Options:
A: Cognition measured according to ADAS-cog, MMSE scales
B: N/A
C: Rate of Change on the ADAS-Cog 11. (Baseline, 6, 12, 18 months); Rate of Change on CDR-SOB (18 months)
D: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Mini-Mental State Examination Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Neuropsychiatric Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Caregiver Activity Survey Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The HMO Research Network CERT: Acute Myocardial Infarction
Brief Summary: The primary goal of this study is to evaluate the effectiveness of direct-to-patient mailings designed to increase patient's adherence to prescribed beta-blockers following an acute myocardial infarction (AMI).

Prior to developing patient materials, focus groups were conducted with patient who had previously suffered an acute myocardial infarction (AMI) to identify the issues and information that patients felt were important to include in our materials as well as the best way to present the information. Additionally, patient materials were "pre-tested" with AMI patients to ensure that the materials were clear and easy to read and that the key messages were understood.


Options:
A: Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date (9 months)
B: Number of ICU Patients Who Acquire VRE or MRSA (9 months)
C: 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)
D: Invasive Infection (Participants will be followed during their NICU hospitalization, an expected average of 3 months); Necrotizing enterocolitis (NEC) (Participants will be followed for their entire NICU hospitalization, which is an average of 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The HMO Research Network CERT: Acute Myocardial Infarction
Brief Summary: The primary goal of this study is to evaluate the effectiveness of direct-to-patient mailings designed to increase patient's adherence to prescribed beta-blockers following an acute myocardial infarction (AMI).

Prior to developing patient materials, focus groups were conducted with patient who had previously suffered an acute myocardial infarction (AMI) to identify the issues and information that patients felt were important to include in our materials as well as the best way to present the information. Additionally, patient materials were "pre-tested" with AMI patients to ensure that the materials were clear and easy to read and that the key messages were understood.


Options:
A: major cardiovascular events (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal cardiac arrest) (30 days)
B: A composite of all-cause mortality, recurrent MI, revascularisation with PCI or CABG, ischemic stroke, incident heart failure, malignant ventricular arrhythmia, or resuscitated cardiac arrest. (Estimated follow-up min 6 months - max 6.25 years)
C: Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date (9 months)
D: Death and the composite outcome of death, non-fatal reinfarction or stroke

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Double-blind Placebo-controlled Trial to Evaluate the Impact of Vitamin A on Maternal Mortality in Ghana
Brief Summary: Main objectives: To evaluate the impact of weekly vitamin A supplementation (VAS) to women of reproductive age (15-45 years) on maternal mortality in rural Ghana, and to compare this with the impact on overall mortality.

Hypotheses:

1. Weekly supplementation with vitamin A (7000 µg retinol equivalent \[RE\]) to reproductive age women will reduce maternal deaths by 33%.
2. This impact will be achieved by reductions in both pregnancy-related and non-pregnancy-related deaths.
3. There will be a reduction in non-maternal deaths, similar in size to that in maternal non-pregnancy related deaths.

Outcome measures: Maternal mortality rate, and overall mortality rate. Deaths will be identified through monthly demographic surveillance, and classified as maternal (pregnancy-related, non-pregnancy-related) or non-maternal using verbal autopsies.


Options:
A: Vitamin A status changes (After the intervention, which is approximately 3 months.)
B: L:M ratio at 1.5 months (1.5 months)
C: intestinal parasitic infections (6 months)
D: Pregnancy-related mortality and all cause mortality (Continuous)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Double-blind Placebo-controlled Trial to Evaluate the Impact of Vitamin A on Maternal Mortality in Ghana
Brief Summary: Main objectives: To evaluate the impact of weekly vitamin A supplementation (VAS) to women of reproductive age (15-45 years) on maternal mortality in rural Ghana, and to compare this with the impact on overall mortality.

Hypotheses:

1. Weekly supplementation with vitamin A (7000 µg retinol equivalent \[RE\]) to reproductive age women will reduce maternal deaths by 33%.
2. This impact will be achieved by reductions in both pregnancy-related and non-pregnancy-related deaths.
3. There will be a reduction in non-maternal deaths, similar in size to that in maternal non-pregnancy related deaths.

Outcome measures: Maternal mortality rate, and overall mortality rate. Deaths will be identified through monthly demographic surveillance, and classified as maternal (pregnancy-related, non-pregnancy-related) or non-maternal using verbal autopsies.


Options:
A: All-cause, Pregnancy-related Mortality (Deaths during pregnancy through 12 weeks postpartum)
B: Pregnancy-related mortality and all cause mortality (Continuous)
C: Weight, length and Rohrer index at birth, and gestational duration in single pregnancies. (At birth); Mortality, morbidity and growth during the first year of life (Monthly during infancy)
D: cell-free viral load and/or cell-associated proviral load in breast milk (Delivery, 3 months, and 6 months after delivery); concentration of vitamins A, B12, and E in breast milk (Delivery, 3 months, and 6 months post-delivery); subclinical mastitis (Delivery, 3 months, and 6 months after delivery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Double-blind Placebo-controlled Trial to Evaluate the Impact of Vitamin A on Maternal Mortality in Ghana
Brief Summary: Main objectives: To evaluate the impact of weekly vitamin A supplementation (VAS) to women of reproductive age (15-45 years) on maternal mortality in rural Ghana, and to compare this with the impact on overall mortality.

Hypotheses:

1. Weekly supplementation with vitamin A (7000 µg retinol equivalent \[RE\]) to reproductive age women will reduce maternal deaths by 33%.
2. This impact will be achieved by reductions in both pregnancy-related and non-pregnancy-related deaths.
3. There will be a reduction in non-maternal deaths, similar in size to that in maternal non-pregnancy related deaths.

Outcome measures: Maternal mortality rate, and overall mortality rate. Deaths will be identified through monthly demographic surveillance, and classified as maternal (pregnancy-related, non-pregnancy-related) or non-maternal using verbal autopsies.


Options:
A: Breast milk immune regulators (Four months)
B: Change in carotenoids in serum and breast milk (1 and 3 weeks)
C: Seric retinol (six months)
D: Pregnancy-related mortality and all cause mortality (Continuous)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Double-blind Placebo-controlled Trial to Evaluate the Impact of Vitamin A on Maternal Mortality in Ghana
Brief Summary: Main objectives: To evaluate the impact of weekly vitamin A supplementation (VAS) to women of reproductive age (15-45 years) on maternal mortality in rural Ghana, and to compare this with the impact on overall mortality.

Hypotheses:

1. Weekly supplementation with vitamin A (7000 µg retinol equivalent \[RE\]) to reproductive age women will reduce maternal deaths by 33%.
2. This impact will be achieved by reductions in both pregnancy-related and non-pregnancy-related deaths.
3. There will be a reduction in non-maternal deaths, similar in size to that in maternal non-pregnancy related deaths.

Outcome measures: Maternal mortality rate, and overall mortality rate. Deaths will be identified through monthly demographic surveillance, and classified as maternal (pregnancy-related, non-pregnancy-related) or non-maternal using verbal autopsies.


Options:
A: L:M ratio at 1.5 months (1.5 months)
B: Mortality, morbidity (1 year)
C: Pregnancy-related mortality and all cause mortality (Continuous)
D: Thymus size measured by ultrasound (through 15 wk of age); peripheral blood naive T-helper lymphocyte concentration (through 15 wk of age); T-cell receptor excision circle (TREC) level in peripheral blood mononuclear cells (PBMC) (through 15 wk of age); T-cell response to BCG (Bacillus Calmette-Guérin; to protect against tuberculosis) and oral polio virus (OPV) immunization (through 15 wk of age); Antibody response to oral polio virus (OPV) immunization (through 15 wk of age); T-cell and antibody response to tetanus toxoid (TT) and hepatitis B virus (HBV) vaccinations given at 6, 10 and 14 wk of age (through 15 wk of age); bacterial translocation to blood (through 15 wk of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised Double-blind Placebo-controlled Trial to Evaluate the Impact of Vitamin A on Maternal Mortality in Ghana
Brief Summary: Main objectives: To evaluate the impact of weekly vitamin A supplementation (VAS) to women of reproductive age (15-45 years) on maternal mortality in rural Ghana, and to compare this with the impact on overall mortality.

Hypotheses:

1. Weekly supplementation with vitamin A (7000 µg retinol equivalent \[RE\]) to reproductive age women will reduce maternal deaths by 33%.
2. This impact will be achieved by reductions in both pregnancy-related and non-pregnancy-related deaths.
3. There will be a reduction in non-maternal deaths, similar in size to that in maternal non-pregnancy related deaths.

Outcome measures: Maternal mortality rate, and overall mortality rate. Deaths will be identified through monthly demographic surveillance, and classified as maternal (pregnancy-related, non-pregnancy-related) or non-maternal using verbal autopsies.


Options:
A: Mortality; Morbidity
B: Pregnancy-related mortality and all cause mortality (Continuous)
C: Mortality; Hospitalisations
D: Thymus size measured by ultrasound (through 15 wk of age); peripheral blood naive T-helper lymphocyte concentration (through 15 wk of age); T-cell receptor excision circle (TREC) level in peripheral blood mononuclear cells (PBMC) (through 15 wk of age); T-cell response to BCG (Bacillus Calmette-Guérin; to protect against tuberculosis) and oral polio virus (OPV) immunization (through 15 wk of age); Antibody response to oral polio virus (OPV) immunization (through 15 wk of age); T-cell and antibody response to tetanus toxoid (TT) and hepatitis B virus (HBV) vaccinations given at 6, 10 and 14 wk of age (through 15 wk of age); bacterial translocation to blood (through 15 wk of age)

Answer: B