TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2, Open Label, Randomized Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or ICSI.
Brief Summary: The primary objective of this trial is to investigate the dose -response relationship of a single injection of Org 38286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.


Options:
A: Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)); Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Alternate Analysis (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year)); Number of Mothers With Adverse Events (AEs) During Follow-up (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)); Number of Mothers With Serious AEs (SAEs) During Follow-up (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year)); Number of Infants With AEs During Follow-up (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study); Number of Infants With SAEs During Follow-up (From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study)
B: Number of cumulus-oocyte-complexes retrieved (1 cycle)
C: Percentage of Participants With an Ongoing Pregnancy (Cumulative Ongoing Pregnancy Rate) (Up to 1 year after embryo transfer in base trial P05787 (NCT00696800), and FTET cycles in follow up trial)
D: Number of Expectant Mothers Experiencing Adverse Events (AEs) (Up to 1 Year); Number of Expectant Mothers Experiencing Serious AEs (SAEs) (Up to 1 Year); Number of Infants Experiencing AEs (Up to 1 Year); Number of Infants Experiencing SAEs (Up to 1 Year); Take-Home Baby Rate (Birth of a one or more live babies (Up to 1 year))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: AFX01-11: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Correction of Anemia in Patients With Chronic Renal Failure (CRF) Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.


Options:
A: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline to Weeks 29-36)
B: Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36))
C: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 25-36)
D: Local pain due to s.c. injection (by VAS). (After each injection)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: AFX01-11: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Correction of Anemia in Patients With Chronic Renal Failure (CRF) Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.


Options:
A: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 25-36)
B: Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36))
C: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 25-36)
D: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 29-36)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Single Center, Open-label Study to Assess Immunogenicity and Safety of 6 Doses of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®)in Smokers
Brief Summary: Prior clinical trials examined several schedules of a nicotine vaccine (NicVAX) for anti-nicotine antibody responses, and their impact on helping smokers quit. The best schedule so far has been one with doses at weeks 0, 4, 8, 16 and 26. This new study tests whether changing the schedule to weeks 0, 4, 8, 12 and 16 is an improvement for stimulating antibodies to nicotine. Routine vaccine safety information is also collected. Amendment 1 adds a 6th dose at week 26, and extends follow-up through week 52.


Options:
A: Anti-nicotine antibody concentration (12 time points between screening and week 20)
B: Continuous smoking abstinence (8 week interval (Weeks 19 to 26, inclusive, following the first vaccination))
C: Abstinence from smoking defined as self-reported abstinence and confirmed by measurement of carbon monoxide in exhaled air less than 10ppm (Monthly up to month 6, and during follow-up at months 9 and 12); Immunogenicity of the vaccine, by measuring specific anti-nicotine IgG antibodies by ELISA (Baseline, monthly up to month 6, and months 9 and 12); Safety and tolerability by recording adverse events, injection site examinations, vital signs, standard clinical laboratory (serum chemistry, hematology) (Baseline, and at various times up to month 12)
D: Evaluate NicVAX as an aid to smoking cessation for long term abstinence. (one year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: AFX01-13: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Correction of Anemia in Patients With Chronic Renal Failure (CRF) Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.


Options:
A: The Percentage of Participants Maintaining Average Haemoglobin (Hb) Concentration During the Efficacy Evaluation Period (EEP) Within the Target Range (Weeks 16-28)
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: Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53))
D: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 25-36)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: AFX01-13: A Phase 3, Randomized, Active-controlled, Open-label, Multi-center Study of the Safety and Efficacy of Peginesatide for the Correction of Anemia in Patients With Chronic Renal Failure (CRF) Not on Dialysis and Not on Erythropoiesis Stimulating Agent (ESA) Treatment
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease, who are not on dialysis and not on erythropoiesis stimulating agent (ESA) treatment.


Options:
A: Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period (Baseline, Week 29 to Week 36)
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: Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period (Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53))
D: Mean Change in Hemoglobin Between Baseline and the Evaluation Period (Baseline and Weeks 25-36)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: An Exploratory Phase III, Randomised, Double-blind, Therapeutic Single Dose-related Effect, Parallel Group Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on Skin Lesions in Patients With Chronic Urticaria (CU)
Brief Summary: The purpose of this study is to compare urticaria lesions (size, kinetics) by thermography, volumetry and digital time lapse photography in CU patients treated with desloratadine 5 mg or desloratadine 20 mg. Hypothesis: Updosing of desloratadine (20mg) is more efficient in the treatment of urticarial lesions as compared to standard dosing (5 mg desloratadine).


Options:
A: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) (Baseline, 14 days); Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7) (7 days); Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) (14 days)
B: Change From Baseline in the Weekly Itch Severity Score at Week 12 (Baseline, Week 12)
C: Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by thermography. (5 hours)
D: Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR) (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval (Baseline, 14 days); Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) (Baseline, 14 days); Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 3 (Day 7) (7 days); Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) (14 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness for Postoperative Pain After Laparoscopic Cholecystectomy of 0,5% Bupivacaine-Soaked Tabotamp Placed in the Gallbladder Bed
Brief Summary: Evaluate the efficacy on postoperative pain of the positioning of a 0,5% bupivacaine soaked-tabotamp in gallbladder bed after videolaparoscopic cholecystectomy.


Options:
A: Pain at 6 and 24 hours after surgery measured using the Visual Analogue Scale [VAS] [score 0 to 10, 0 = no pain, 10 = unbearable pain], (6 and 24 hours after surgery)
B: VAS pain score (1, 4, 8 hours after operation and at discharge)
C: Postoperative pain measuring using Visual analogue scale at postoperative 2hour (Post op 2 hour)
D: VAS pain score

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Open-Label Extension to the Double-Blind SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease
Brief Summary: The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease


Options:
A: Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (six years)
B: Falls rate (6 months post intervention)
C: Adjusted Mean Change in Total Unified Parkinson Disease Rating Scale (UPDRS) Score (Baseline to 36 months of treatment); Adjusted Mean Change in Adjusted UPDRS Score (Baseline to 36 months of treatment)
D: Change in Static Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 1-3) (Baseline, 16 weeks); Change in Ambulatory Balance Measured by Instrumented Timed up and go (iTUG) Turn Duration (Baseline and 16 weeks); Change in Strength as Recorded by Measuring Knee Flexion Using Biodex (Total Work) (Baseline, 16 weeks); Change in Dynamic Balance as Recorded Using Dynamic Posturography With the Sensory Organization Test (SOT 4-6) (Baseline, 16 weeks); Change in Strength as Recorded by Measuring Knee Extension Using Biodex (Total Work) (Baseline, 16 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Information Technology in the Nursing Home
Brief Summary: The magnitude and intensity of medication use among our nation's 1.6 million nursing home residents matches or exceeds that of hospitalized patients. The residents of nursing homes are among the most frail patients in the population; the challenges of using medications in this setting are great, not only because of the physiologic declines and pharmacologic changes that occur with aging, but also because of the special clinical and social circumstances that often characterize nursing home care. In our previous research, we have determined that medication errors resulting in adverse drug events occur most often at the ordering and monitoring stages of pharmaceutical care. Clinical decision-support systems are clinical consultation systems that combine individual patient information with population statistics and scientific evidence to offer real-time information to health care providers. These systems have been found to improve the quality of medication prescribing in the hospital setting. In this study, we intend to determine the extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring for residents in the long-term care setting through a randomized trial. We will track the costs associated with this system and the system's impact on the productivity of providers. We will also assess the culture of U.S. nursing homes and the organization of the nursing home setting with respect to readiness to incorporate computerized provider order-entry with computer-based clinical decision support. Our project addresses specific areas that are of particular interest to AHRQ with special relevance to the delivery of high-quality care to a priority population--the frail elderly patient population residing in nursing homes. The project will assess the economic implications of health information technology in the nursing home environment that will be of interest to key stakeholders, including physicians, pharmacists, nurses, payers, policymakers, the nursing home industry, and pharmaceutical vendors to long-term care institutions.


Options:
A: Mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD) Score (24 weeks)
B: extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring (two years)
C: Rate of appropriate thromboprophylaxis (During hospital stay (expected average duration of 1 week))
D: Medication Appropriateness Index (MAI)-Score (6 months from baseline)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Information Technology in the Nursing Home
Brief Summary: The magnitude and intensity of medication use among our nation's 1.6 million nursing home residents matches or exceeds that of hospitalized patients. The residents of nursing homes are among the most frail patients in the population; the challenges of using medications in this setting are great, not only because of the physiologic declines and pharmacologic changes that occur with aging, but also because of the special clinical and social circumstances that often characterize nursing home care. In our previous research, we have determined that medication errors resulting in adverse drug events occur most often at the ordering and monitoring stages of pharmaceutical care. Clinical decision-support systems are clinical consultation systems that combine individual patient information with population statistics and scientific evidence to offer real-time information to health care providers. These systems have been found to improve the quality of medication prescribing in the hospital setting. In this study, we intend to determine the extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring for residents in the long-term care setting through a randomized trial. We will track the costs associated with this system and the system's impact on the productivity of providers. We will also assess the culture of U.S. nursing homes and the organization of the nursing home setting with respect to readiness to incorporate computerized provider order-entry with computer-based clinical decision support. Our project addresses specific areas that are of particular interest to AHRQ with special relevance to the delivery of high-quality care to a priority population--the frail elderly patient population residing in nursing homes. The project will assess the economic implications of health information technology in the nursing home environment that will be of interest to key stakeholders, including physicians, pharmacists, nurses, payers, policymakers, the nursing home industry, and pharmaceutical vendors to long-term care institutions.


Options:
A: Intervention acceptance (6 months (May 2010-Nov2010))
B: Changes in decisional conflict (baseline and 3 month post intervention)
C: Proportion of clinical failure by day 7 compared among the 3 study arms. (10 months)
D: extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring (two years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Health Information Technology in the Nursing Home
Brief Summary: The magnitude and intensity of medication use among our nation's 1.6 million nursing home residents matches or exceeds that of hospitalized patients. The residents of nursing homes are among the most frail patients in the population; the challenges of using medications in this setting are great, not only because of the physiologic declines and pharmacologic changes that occur with aging, but also because of the special clinical and social circumstances that often characterize nursing home care. In our previous research, we have determined that medication errors resulting in adverse drug events occur most often at the ordering and monitoring stages of pharmaceutical care. Clinical decision-support systems are clinical consultation systems that combine individual patient information with population statistics and scientific evidence to offer real-time information to health care providers. These systems have been found to improve the quality of medication prescribing in the hospital setting. In this study, we intend to determine the extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring for residents in the long-term care setting through a randomized trial. We will track the costs associated with this system and the system's impact on the productivity of providers. We will also assess the culture of U.S. nursing homes and the organization of the nursing home setting with respect to readiness to incorporate computerized provider order-entry with computer-based clinical decision support. Our project addresses specific areas that are of particular interest to AHRQ with special relevance to the delivery of high-quality care to a priority population--the frail elderly patient population residing in nursing homes. The project will assess the economic implications of health information technology in the nursing home environment that will be of interest to key stakeholders, including physicians, pharmacists, nurses, payers, policymakers, the nursing home industry, and pharmaceutical vendors to long-term care institutions.


Options:
A: Age standardized mortality rates in those aged <60 years. (4 years)
B: extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring (two years)
C: Median "Laboratory turn-around-time" (TAT) (Days from the date a culture or drug susceptibility test (DST) result is obtained to the date when the result is obtained at health center); Percent laboratory errors, by type of error for health establishments in the intervention versus the control group. (2.5 years)
D: Adherence to ART and HIV RNA suppression (6,12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Probiotics and Effects on Illness-Related Symptoms for Pre-School Age Children
Brief Summary: The aim of the present prospective study is to investigate whether the consumption of certain probiotic strains over a six-month winter/spring season would be able to affect the incidence and duration of upper respiratory tract infections, in otherwise healthy children as well as determining whether a combination of two strains would perform differently from a single strain version.


Options:
A: To examine if the consumption of two different probiotic strains added to milk at the point of consumption could reduce the "flu-like" symptoms and other symptoms of illness of preschool-age children in day care centers. (Daily for six months)
B: Gastrointestinal transit time (Weeks 4, 10, 16, 22)
C: days with diarrhoea (January 2011 to June 2011)
D: Severity of cold symptoms (3 months)

Answer: A