TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes
Brief Summary: Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone.


Options:
A: Change From Baseline in A1C at Week 24 (Weeks 0-24)
B: Change from baseline in HbA1c after 24 weeks
C: Change from baseline in HbA1c at 24 weeks
D: Change from baseline in HbA1c after 24 weeks

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes
Brief Summary: The purpose of this study is to assess the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.


Options:
A: Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 52 (Baseline and Week 52); Adjusted Percent Change From Baseline in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) at Week 76+10 Days (Baseline and Week 76+10 days); Adjusted Percent Change in Femoral Neck (FN) Bone Mineral Density (BMD) Via Dual-energy X-ray Absorptiometry (DXA) From Week 52 +10 Days to Week 76+10 Days (Week 52+10 days and Week 76+10 days)
B: N/A
C: 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)
D: Change from baseline in HbA1c at 24 weeks

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes
Brief Summary: The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Options:
A: Novel cardiovascular risk factors modification (2 years)
B: Change from baseline in HbA1c at 24 weeks
C: ß-cell Response Measured by Hyperglycemic Clamp (3-months after medication washout (Month 15)); Insulin Sensitivity, M/I (3-months after a medication washout)
D: Change from baseline in HbA1c at 24 weeks

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes
Brief Summary: The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Options:
A: Change from baseline in HbA1c at 24 weeks
B: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 (Baseline and week 24)
C: Change from baseline in HbA1c at 24 weeks
D: Change from baseline in HbA1c at 24 weeks

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Brief Summary: Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone.


Options:
A: Time to the Composite of All Cause Mortality, Non-Fatal Myocardial Infarction, Stroke, Acute Coronary Syndrome, Major Leg Amputation, Cardiac Intervention, Bypass Surgery or Leg Revascularization. (At First Occurrence)
B: Change from baseline in HbA1c at 24 weeks
C: Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in overall study population (Baseline and every study visit up to 24 weeks); Change from baseline in glycosylated hemoglobin (HbA1c) at study endpoint, assessed in Chinese study population (Baseline and every study visit up to 24 weeks)
D: Primary Major Macrovascular Events (Post baseline time to the first major macrovascular event up to 82 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes
Brief Summary: Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone.


Options:
A: Change from baseline in HbA1c at 24 weeks
B: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 (Baseline and week 24)
C: Change from baseline in HbA1c at 52 weeks
D: Change from baseline in HbA1c after 24 weeks

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Dose Response to Cranberry of Women With Recurrent UTIs
Brief Summary: The purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (UTIs).


Options:
A: Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs (end of study); Whether the degree of UTI prophylaxis is related to the dose of cranberry-containing product (dose response curve) (end of study); Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis (end of study)
B: Length (in days) of the latent period; Neonatal infection; Respiratory distress; Admission to NICU (in days); Neonatal complications rate (NEC, IVH etc); Maternal infections (uterus, UTI)
C: Time to onset of a first UTI within one year of treatment. (one year)
D: Number of symptomatic urinary tract infections per patient per month during in-patient post acute rehabilitation (At end of study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Strategies to Reduce Transmission of Antimicrobial Resistant Bacteria in Intensive Care Units (STAR*ICU) Trial
Brief Summary: Primary Outcome Measures:Incidence density of colonization with MRSA or VRE (number of new colonization events per 1000 patient days at risk) during the intervention phase. Secondary Outcome Measures:The effect of the 2 strategies on the incidence density of colonization with MRSA and VRE individually will be determined and compared descriptively. The effect of the strategies on the cumulative incidence of bacteremia caused by MRSA and VRE will be determined to assess the clinical relevance of the strategy in preventing infection. The trial will evaluate the frequency of hand hygiene and the use of gloves and gowns by healthcare workers to substantiate whether the effect of the intensive control strategy is mediated, as expected, by an increase in the use of gloves and gowns due to an increase in the number of patients cared for using Contact Precautions.


Options:
A: Bacterial colony counts and the frequency with which methicillin-resistant Staphylococcus aureus was found over time (8 hours)
B: N/A
C: 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)
D: Colonization with MRSA, VRE and ESBL (On admission); Colonization with MRSA, VRE and ESBL (During ICU stay)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis
Brief Summary: The intake of high doses of corticosteroids is known to play an important role in the weakening of the bones and is thus an increasing fracture risk. Zoledronic acid (Aclasta) is a drug known for its protective effect in some bone diseases (tumors, paget). This study will test the safety and efficacy of zoledronic acid in the prevention and treatment of corticosteroid induced osteoporosis in male and female patients.


Options:
A: Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.
B: Number of Participants With New Vertebral Fractures (36 months)
C: Number of Participants With Adverse Events (AEs) (84 months); Number of Participants With Laboratory Toxicities of Grade ≥ 3 (84 months); Number of Participants With Antibodies to Denosumab (Every 12 months through Month 84)
D: Incidence of hip fxs; Incidence of new vertebral fxs

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis
Brief Summary: The intake of high doses of corticosteroids is known to play an important role in the weakening of the bones and is thus an increasing fracture risk. Zoledronic acid (Aclasta) is a drug known for its protective effect in some bone diseases (tumors, paget). This study will test the safety and efficacy of zoledronic acid in the prevention and treatment of corticosteroid induced osteoporosis in male and female patients.


Options:
A: Number of Participants With Adverse Events (AEs) (84 months); Number of Participants With Laboratory Toxicities of Grade ≥ 3 (84 months); Number of Participants With Antibodies to Denosumab (Every 12 months through Month 84)
B: Incidence of hip fxs; Incidence of new vertebral fxs
C: Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.
D: Number of Participants With New Vertebral Fractures (36 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of High Dose Olanzapine in a Controlled Fixed Dose-Response Trial for the Treatment of Schizophrenia and Schizoaffective Disorder
Brief Summary: The purposes of this study are to assess the efficacy, safety, and side effects among doses approved by the Food and Drug Administration and higher (not FDA approved) doses of olanzapine in patients with schizophrenia or schizoaffective disorder.


Options:
A: Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine.; The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.
B: Comparison of weight change from baseline to Week 16 in patients with schizophrenia or schizoaffective disorder treated with aripiprazole or olanzapine
C: The primary objective of this study is to assess the fixed dose response relationship for efficacy between standard and higher doses of olanzapine (10, 20, and 40 mg/day) in patients with schizophrenia or schizoaffective disorder.
D: The change in total Positive and Negative Syndrome Scale (PANSS) score from baseline at week 14 of Phase 2.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of High Dose Olanzapine in a Controlled Fixed Dose-Response Trial for the Treatment of Schizophrenia and Schizoaffective Disorder
Brief Summary: The purposes of this study are to assess the efficacy, safety, and side effects among doses approved by the Food and Drug Administration and higher (not FDA approved) doses of olanzapine in patients with schizophrenia or schizoaffective disorder.


Options:
A: The primary efficacy criteria for this study is the time from randomization to the first recurrence event during the double-blind recurrence prevention period (After 68 relapse events)
B: relapse (at least one year)
C: Determine comparative efficacy in patients with schizophrenia of non-inferiority of IM olanzapine depot high and low doses versus oral olanzapine based on exacerbation rates after 6 months of maintenance treatment; Determine comparative efficacy in patients with schizophrenia of superiority of IM olanzapine depot low, med and high doses versus very low dose based on time to exacerbation of symptoms of schizophrenia
D: The primary objective of this study is to assess the fixed dose response relationship for efficacy between standard and higher doses of olanzapine (10, 20, and 40 mg/day) in patients with schizophrenia or schizoaffective disorder.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%
Brief Summary: This study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range.


Options:
A: Novel cardiovascular risk factors modification (2 years)
B: N/A
C: Change from baseline in HbA1c at 24 weeks
D: Change from baseline in HbA1c at 12 weeks

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia
Brief Summary: This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.


Options:
A: Change from baseline in HbA1c after 24 weeks
B: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 (Baseline and week 24)
C: Change from baseline in HbA1c at 52 weeks
D: Change from baseline in HbA1c after 24 weeks

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Drug Naive Patients With Type 2 Diabetes
Brief Summary: Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of the combination of vildagliptin, an unapproved drug, and pioglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Options:
A: Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 52 weeks)
B: Change from baseline in HbA1c at 52 weeks
C: Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) (Baseline, 26 weeks)
D: Change from baseline in HbA1c at 24 weeks

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Drug Naive Patients With Type 2 Diabetes
Brief Summary: Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of the combination of vildagliptin, an unapproved drug, and pioglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.


Options:
A: Change from baseline in HbA1c at 24 weeks
B: Change from baseline in HbA1c at 24 weeks
C: Change from baseline in HbA1c at 24 weeks
D: Change from baseline in HbA1c at 24 weeks

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Aripiprazole in Adolescents With Schizophrenia
Brief Summary: The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.


Options:
A: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score (Week 8)
B: Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score (Week 8)
C: Change in Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline and Day 42)
D: Percentage of Patients Relapsing by Week 16 (From end of Phase 1 (Date of randomization) to Week 16 of Phase 2 and end of treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Aripiprazole in Adolescents With Schizophrenia
Brief Summary: The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.


Options:
A: Change in Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline and Day 42)
B: Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI - I, CGI - S, CDSS, GAF and QoL scale
C: Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint
D: Assess the efficacy of a flexible dose of olanzapine compared to placebo in the treatment of adolescents (ages 13 - 17) with schizophrenia using the BPRS-C

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy
Brief Summary: The purpose of this study is to evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by the platelet response. This study will also evaluate changes in Patient Reported Outcomes and Health Resource Utilization due to treatment with AMG 531.


Options:
A: To evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by durable platelet response during the last 8 weeks of treatment and other platelet response parameters (Last 8 weeks of treatments)
B: Number of Participants With Adverse Events (From first dose of study drug through 8 weeks (Part A) or 6 weeks (Part B) after last dose of study drug; 78 days); Number of Participants With Anti-romiplostim or Anti-endogenous Thrombopoietin Neutralizing Antibodies (Assessed on day 29 (Part A only), day 43 (Part B only), and day 78)
C: The changes from baseline in bone marrow morphology by subject (Entire duration of the study)
D: To evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by durable platelet response during the last 8 weeks of treatment and other platelet response parameters (Last 8 weeks of treatment)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy
Brief Summary: The purpose of this study is to evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by the platelet response. This study will also evaluate changes in Patient Reported Outcomes and Health Resource Utilization due to treatment with AMG 531.


Options:
A: To evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by durable platelet response during the last 8 weeks of treatment and other platelet response parameters (Last 8 weeks of treatments)
B: Percentage of Responders (Baseline; each on-therapy treatment day; Weeks 10, 14, 18, 22, and 26; and Weeks 1, 2, and 4 post-treatment)
C: The changes from baseline in bone marrow morphology by subject (Entire duration of the study)
D: Number of Participants With Splenectomy During 52-Week Treatment Period (52 weeks); Number of Participants With Treatment Failure During 52-Week Treatment Period (52 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Effects of an Internet-Based to an Established Dyspnea Self-Management Program on Dyspnea, Exercise Behavior, and Pulmonary Exacerbations in Patients With COPD
Brief Summary: The overall goal of this study is to compare the impact of a new Internet Dyspnea Self-Management Program (eDSMP) with an established face-to-face Dyspnea Self-Management Program (DSMP) in patients with COPD. The primary aim of the study is to test the following two hypotheses: 1. The eDSMP and the DSMP will have comparable improvements in the primary outcomes of shortness of breath (dyspnea) with activities of daily living (ADL), exercise adherence and performance, and pulmonary exacerbations (frequency and duration) at 3 and 6 months. 2. The eDSMP and the DSMP will have comparable improvements in the secondary outcomes of perception of support, self-efficacy for exercise and managing dyspnea, and health resource utilization at 3 and 6 months. This study is a randomized, longitudinal, repeated measures design with measurement times at 0, 3, and 6 months.


Options:
A: Hemoglobin A1c (HbA1c) at 6 Months Post Randomization (6 months post randomization)
B: Mean # Participants Who Had Hospitalizations or ED Visits Compared to Usual Care in a High Risk Group of Adults ≥ 60 Years of Age With Mixed Chronic Disease. (12 months)
C: Dyspnea; Exercise adherence and performance; Pulmonary exacerbations
D: change of infarct size between baseline and day 6 (day 6)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparing the Effects of an Internet-Based to an Established Dyspnea Self-Management Program on Dyspnea, Exercise Behavior, and Pulmonary Exacerbations in Patients With COPD
Brief Summary: The overall goal of this study is to compare the impact of a new Internet Dyspnea Self-Management Program (eDSMP) with an established face-to-face Dyspnea Self-Management Program (DSMP) in patients with COPD. The primary aim of the study is to test the following two hypotheses: 1. The eDSMP and the DSMP will have comparable improvements in the primary outcomes of shortness of breath (dyspnea) with activities of daily living (ADL), exercise adherence and performance, and pulmonary exacerbations (frequency and duration) at 3 and 6 months. 2. The eDSMP and the DSMP will have comparable improvements in the secondary outcomes of perception of support, self-efficacy for exercise and managing dyspnea, and health resource utilization at 3 and 6 months. This study is a randomized, longitudinal, repeated measures design with measurement times at 0, 3, and 6 months.


Options:
A: Dyspnea; Exercise adherence and performance; Pulmonary exacerbations
B: Hospitalization or Emergency Department Visit for COPD (1 yr); Hospitalization or ED Visit for COPD (Mean Cumulative Frequency) (1 yr)
C: QUAL-E - Preparation Sub-scale (Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 56, 64)); QUAL-E Life Completion Sub-scale (Baseline (n=75, 74, 72), 5 weeks (n=61, 59, 60) and 7 weeks (n=64, 55, 64))
D: Change in the strength of the quadriceps over the 6-week electrostimulation program. (6 to 8 weeks)

Answer: A