TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Citrate Versus Heparin Anticoagulation in Continuous Venovenous Hemofiltration in Critically Ill Patients With Acute Renal Failure: A Randomized Clinical Trial
Brief Summary: The purpose of this study is to compare citrate regional anticoagulation with systemic heparinization in continuous venovenous hemofiltration. The investigators' hypothesis is, that regional citrate anticoagulation with replacement solution containing trisodium citrate, will be associated with lower mortality and less bleeding complications compared to heparin, with also a better filter survival.


Options:
A: Time to Occurrence of Selected Prismaflex® System Alarms/Conditions (Up to 120 hours post CRRT treatment initiation)
B: The primary outcome measure for this study is noradrenaline free time in the first week after randomization (24 months)
C: Mortality (Day 28 after ICU admission)
D: bleeding complications (during administration of study anticoagulant); transfusion requirement (during administration of study anticoagulant); filter survival (during hemofiltration)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Citrate Versus Heparin Anticoagulation in Continuous Venovenous Hemofiltration in Critically Ill Patients With Acute Renal Failure: A Randomized Clinical Trial
Brief Summary: The purpose of this study is to compare citrate regional anticoagulation with systemic heparinization in continuous venovenous hemofiltration. The investigators' hypothesis is, that regional citrate anticoagulation with replacement solution containing trisodium citrate, will be associated with lower mortality and less bleeding complications compared to heparin, with also a better filter survival.


Options:
A: CRRT-filter life span in hours (during continuous renal replacement therapy up to 1 year); Overall survival in a 90day follow-up period (90 days)
B: Number of filters used per hour (24 months)
C: Mortality (Day 28 after ICU admission)
D: bleeding complications (during administration of study anticoagulant); transfusion requirement (during administration of study anticoagulant); filter survival (during hemofiltration)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Citrate Versus Heparin Anticoagulation in Continuous Venovenous Hemofiltration in Critically Ill Patients With Acute Renal Failure: A Randomized Clinical Trial
Brief Summary: The purpose of this study is to compare citrate regional anticoagulation with systemic heparinization in continuous venovenous hemofiltration. The investigators' hypothesis is, that regional citrate anticoagulation with replacement solution containing trisodium citrate, will be associated with lower mortality and less bleeding complications compared to heparin, with also a better filter survival.


Options:
A: Mean running time of a maximum of two consecutive haemodialysis circuits (seven days starting at time of HIT suspicion)
B: Functions of inflammatory cells (24 hours); Regulation of inflammatory reactions and and opsonization in microorganisms (24 hours); Activity of acute phase protein during acute inflammation (24 hours)
C: Duration of event-free survival of the first non-tunneled hemodialysis catheter (defined at the time in days from catheter insertion to withdrawal whatever the reason) (up to 28 days)
D: Mortality (Day 28 after ICU admission)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Center, Randomized, Placebo Controlled, Double Blind Trial of Metformin in Obese Adolescents.
Brief Summary: This study will determine if the drug metformin, coupled with diet and exercise counseling, will help obese adolescents lose weight.


Options:
A: Girls with LOC eating will be randomly assigned to IPT-WG or HE to examine their expected BMI change based upon CDC BMI growth chart data versus their actual in BMI over the course of two years. (1 year)
B: Compare the percent loss of total body fat to the percent loss of visceral fat with leptin alone, caffeine and ephedrine and the combination of leptin,caffeine and ephedrine. (28 weeks)
C: Baseline Adjusted Hemoglobin A1c Over Time (Baseline, 3mo, 6mo, and 9 months)
D: The primary outcome measure that will be used to test the study hypothesis is change in Body Mass Index (BMI). The mean change from baseline in individual BMIs between the two groups will be compared at two time-points; at week 52 and week 100.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intermittent Preventive Treatment (IPTp) With Sulfadoxine-Pyrimethamine Plus Insecticide Treated Nets, Delivered Through Antenatal Clinics for the Prevention of Malaria in Mozambican Pregnant Women
Brief Summary: We aim to evaluate whether IPT in pregnancy provides any additional benefit to the protection afforded by ITNs.


Options:
A: To test the hypothesis that co-trimoxazole prophylaxis is not inferior to SP intermittent preventive treatment in preventing placental malaria. (Pregnancy)
B: Evaluate whether two doses of intermittent treatment with SP delivered through antenatal clinics provides additional benefit to the protection afforded by ITNs on low birth weight
C: Maternal malaria at delivery (Delivery)
D: Level of malaria parasitemia in HIV positive women at delivery after administration of Mefloquine or sulphadoxine-pyrimethamine as prophylaxis for malaria in pregnancy (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intermittent Preventive Treatment (IPTp) With Sulfadoxine-Pyrimethamine Plus Insecticide Treated Nets, Delivered Through Antenatal Clinics for the Prevention of Malaria in Mozambican Pregnant Women
Brief Summary: We aim to evaluate whether IPT in pregnancy provides any additional benefit to the protection afforded by ITNs.


Options:
A: proportion of infants with low birthweight (<2,500 grams)
B: Treatment Failure (PCR adjusted) (Day 63); Safety profiles including significant changes in relevant laboratory values (Until delivery)
C: Evaluate whether two doses of intermittent treatment with SP delivered through antenatal clinics provides additional benefit to the protection afforded by ITNs on low birth weight
D: Trial 1 (IPTp MQ vs IPTp SP): Low birth weight. (day 0, birth); Trial 2 (CTX+IPTp MQ vs. CTX+IPTp placebo): Peripheral parasitaemia. (day 0, delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intermittent Preventive Treatment (IPTp) With Sulfadoxine-Pyrimethamine Plus Insecticide Treated Nets, Delivered Through Antenatal Clinics for the Prevention of Malaria in Mozambican Pregnant Women
Brief Summary: We aim to evaluate whether IPT in pregnancy provides any additional benefit to the protection afforded by ITNs.


Options:
A: proportion of infants with low birthweight (<2,500 grams)
B: Treatment Failure (PCR adjusted) (Day 63); Safety profiles including significant changes in relevant laboratory values (Until delivery)
C: Trial 1 (IPTp MQ vs IPTp SP): Low birth weight. (day 0, birth); Trial 2 (CTX+IPTp MQ vs. CTX+IPTp placebo): Peripheral parasitaemia. (day 0, delivery)
D: Evaluate whether two doses of intermittent treatment with SP delivered through antenatal clinics provides additional benefit to the protection afforded by ITNs on low birth weight

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Intermittent Preventive Treatment (IPTp) With Sulfadoxine-Pyrimethamine Plus Insecticide Treated Nets, Delivered Through Antenatal Clinics for the Prevention of Malaria in Mozambican Pregnant Women
Brief Summary: We aim to evaluate whether IPT in pregnancy provides any additional benefit to the protection afforded by ITNs.


Options:
A: Proportion of preterm births (once, after delivery); Number of serious adverse events (Cumulative during pregnancy and neonatal period)
B: Evaluate whether two doses of intermittent treatment with SP delivered through antenatal clinics provides additional benefit to the protection afforded by ITNs on low birth weight
C: HB at delivery (with inseven 7days of delivery)
D: proportion of infants with low birthweight (<2,500 grams)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: This is a randimized clinical trial comparing the effect of supervised Nordic walking versus unsupervised Nordic walking versus advice to stay active


Options:
A: Five Times Sit-to-stand (5XSTS) (Change from Baseline sit-to-stand at 3 and 6 months)
B: Sickness absence days (Low back (LB) specific, other than LB, total) (6, 12, 24, 36, 48 months); Low back pain (VAS) (0, 3, 6, 12, 24 months); Disability (Roland Morris 18) (0, 3, 6, 12, 24 months); Quality of Life (15-D) (0, 3, 6, 12, 24 months)
C: Change in pain Intensity (Baseline and 6 weeks after beginning treatment.); Change in functional disability (Baseline and 6 weeks after beginning treatment.)
D: N/A

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Protocol for the Treatment of Adults Aged </= 60 Years With De Novo Acute Myeloblastic Leukaemia or Secondary AML or RAEB-T (AML 01/99 Trial)
Brief Summary: This randomized phase II/III trial investigates the antileukemic activity and toxicity of the FLAG-Ida regimen as a second induction course in patients with acute myeloid leukaemia and bad response to the first induction cycle and/or with a high risk karyotype and compares the antileukemic activity and toxicity of high dose cytarabine/daunorubicin vs. autologous peripheral blood stem cell transplantation as late consolidation therapy in standard risk patients.


Options:
A: overall survival; relapse-free survival
B: Event free survival (after 5 years)
C: To compare idarubicin versus daunorubicin: the duration of the event-free survival (EFS) to compare IL2 versus abstention : the relapse rate assessed during the first year following the start of maintenance treatment with interleukin
D: Efficacy and toxicity of FLAG-Ida as second induction course in high risk patients.; Efficacy and toxicity of high-dose cytarabin/daunorubicin (HD-Ara-C/DNR) based late consolidation therapy vs. autologous peripheral blood stem cell transplantation in standard risk patients.

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Surgical Resection With or Without Axillary Lymph Node Excision in Treating Menopausal Women With Infiltrative Breast Cancer Smaller Than 10 mm
Brief Summary: This randomized phase III trial is studying surgery and axillary lymph node dissection to evaluate if systematic axillary node clearance can be avoided in locoregional treatment for operable breast cancer smaller than 10 mm among menopausal women older than 50


Options:
A: Overall Survival (5 years)
B: Morbidity - Number of Participants With Residual Shoulder Abduction Deficit (Before and after surgery (within 30 days of randomization)); Morbidity - Number of Participants With Residual Arm Volume Difference (before and after surgery (within 30 days of randomization)); Morbidity - Number of Participants With Residual Arm Numbness (before and after surgery (within 30 days of randomization)); Morbidity - Number of Participants With Residual Arm Tingling (before and after surgery (within 30 days of randomization)); Overall Survival (8 years); Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event. (8 years)
C: Axillary recurrence rate (from randomization)
D: 5-year Disease-Free Survival (5-year estimate reported after a median follow-up of 60 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects With Refractory Partial Seizures (Protocol 333369-EPY-2003 [Double-blind] and Protocol 333369-EPY-2006 [Open-label Extension])
Brief Summary: The purpose of this study is to evaluate the effectiveness and safety of the novel compound RWJ-333369 in reducing the frequency of seizures in patients with epilepsy.


Options:
A: N/A
B: Adverse events (Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor); Clinical laboratory test values (Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor); 12-lead ECG recordings (Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor); Vital sign measurements (Up to 1 year or until carisbamate is available by prescription or the study is terminated by the sponsor)
C: The primary outcome is the change in seizure frequency of all simple partial motor, complex partial, or secondarily generalized seizures from the pretreatment baseline phase compared with the double-blind treatment phase.
D: The primary outcome is the change in seizure frequency of all simple partial motor, complex partial, or secondarily generalized seizures from the pretreatment baseline phase compared with the double-blind treatment phase.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Placebo-Controlled, Double-Blind, Randomized, Parallel-Group Study of the Efficacy and Safety of Dapoxetine in the Treatment of Men With Premature 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, between last 2 visits during the treatment period
B: 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
C: Average Intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse at the end of the treatment period (Week 12)
D: Average Intravaginal ejaculatory latency time (IELT), as measured by stopwatch, during sexual intercourse, at the end of the treatment period (week 24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel Group, Comparative Study of Flexibly Dosed Paliperidone Palmitate (25, 50, 75, or 100 mg eq.) Administered Every 4 Weeks and Flexibly Dosed RISPERDAL CONSTA (25, 37.5, or 50 mg) Administered Every 2 Weeks in Subjects With Schizophrenia
Brief Summary: The purpose of this study is to compare the effectiveness and safety over 1 year of treatment of intramuscular injections of paliperidone palmitate and long-acting risperidone in patients with schizophrenia.


Options:
A: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia (Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks))
B: Likelihood of accepting a recommendation of long-acting atypical antipsychotic medication; Compare the time until the first episode of antipsychotic nonadherence as defined by 2 or more weeks of continuous and intentional cessation of all prescribed antipsychotic medication; Compare the total amount of outpatient days spent adherent to antipsychotic medication as a proportion of outpatient days in the study; Compare patient and family attitudes and satisfaction with antipsychotic medication given by long-acting route vs. oral route of drug delivery; 5. Modify and adapt psychoeducational material designed for multiple episode patients to better fit the needs of recently diagnosed patients with schizophrenia.
C: The change in the total score of the Positive and Negative Syndrome Scale (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.
D: to evaluate the safety and tolerability of two dose ranges (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel Group, Comparative Study of Flexibly Dosed Paliperidone Palmitate (25, 50, 75, or 100 mg eq.) Administered Every 4 Weeks and Flexibly Dosed RISPERDAL CONSTA (25, 37.5, or 50 mg) Administered Every 2 Weeks in Subjects With Schizophrenia
Brief Summary: The purpose of this study is to compare the effectiveness and safety over 1 year of treatment of intramuscular injections of paliperidone palmitate and long-acting risperidone in patients with schizophrenia.


Options:
A: The change in the total score of the Positive and Negative Syndrome Scale (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.
B: N/A
C: To determine if a mGlu2/3 agonist (LY2140023) dosed for 28 days is superior to placebo in the treatment of patients with schizophrenia as measured by the Positive and Negative Symptom Scales (PANSS) total score (28 days)
D: Time to Relapse or Impending Relapse (Up to 26 weeks post-randomization)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind Trial Comparing the Efficacy, Tolerability and Safety of Monotherapy Topiramate Versus Phenytoin in Subjects With Seizures Indicative of New Onset Epilepsy
Brief Summary: The purpose of this study is to compare the effectiveness and safety of two treatment regimens, topiramate as compared to phenytoin, in preventing seizures in patients with new-onset epilepsy who require rapid initiation of antiepileptic drug therapy. Reasons for requiring rapid initiation of treatment, rather than slowly increasing an antiepileptic drug to an effective dose, may include severe or frequent seizures, or high risk to the patient of recurrent seizures.


Options:
A: Assessment and comparative analysis of initial and follow-up Neuropsychological evaluation in both treated groups. (Levetiracetam and Carbamazepine) (52 weeks)
B: N/A
C: The primary outcome parameter is the time to first seizure during the double blind phase of the study. The statistical evaluation will analyze if there is a significant difference in the proportion of patients being seizure free between both medications.
D: Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety (Visit 1 to End of Study (approximately 52 weeks))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind Trial Comparing the Efficacy, Tolerability and Safety of Monotherapy Topiramate Versus Phenytoin in Subjects With Seizures Indicative of New Onset Epilepsy
Brief Summary: The purpose of this study is to compare the effectiveness and safety of two treatment regimens, topiramate as compared to phenytoin, in preventing seizures in patients with new-onset epilepsy who require rapid initiation of antiepileptic drug therapy. Reasons for requiring rapid initiation of treatment, rather than slowly increasing an antiepileptic drug to an effective dose, may include severe or frequent seizures, or high risk to the patient of recurrent seizures.


Options:
A: The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) (From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23))
B: The primary outcome parameter is the time to first seizure during the double blind phase of the study. The statistical evaluation will analyze if there is a significant difference in the proportion of patients being seizure free between both medications.
C: Rate of seizure-free patients (in the first 6 weeks of the trial)
D: Time to withdrawal from study medication (starting at V1) as a measure of combined efficacy and safety (Visit 1 to End of Study (approximately 52 weeks))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind Trial Comparing the Efficacy, Tolerability and Safety of Monotherapy Topiramate Versus Phenytoin in Subjects With Seizures Indicative of New Onset Epilepsy
Brief Summary: The purpose of this study is to compare the effectiveness and safety of two treatment regimens, topiramate as compared to phenytoin, in preventing seizures in patients with new-onset epilepsy who require rapid initiation of antiepileptic drug therapy. Reasons for requiring rapid initiation of treatment, rather than slowly increasing an antiepileptic drug to an effective dose, may include severe or frequent seizures, or high risk to the patient of recurrent seizures.


Options:
A: The primary outcome parameter is the time to first seizure during the double blind phase of the study. The statistical evaluation will analyze if there is a significant difference in the proportion of patients being seizure free between both medications.
B: The Percentage of Participants in the 300 mg/Day Dose Group Who Prematurely Discontinued the Study Between Study Visit 5 (Approximately Week 7) and Visit 9 (End of the Treatment Phase) (From Study Visit 5 through Visit 9 of the Treatment Phase (approximately Week 7 through Week 23))
C: Rate of seizure-free patients (in the first 6 weeks of the trial)
D: The primary efficacy variable will be the proportion of subjects in the PP set who are seizure free for the entire 26-week Evaluation Period at the last received dose level. (26 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Study to Assess the Safety and Efficacy of Topiramate in the Treatment of Alcohol Dependence
Brief Summary: The purpose of this study is to evaluate the safety and effectiveness of topiramate compared to placebo in patients with alcohol dependence.


Options:
A: The change in percentage of heavy drinking days (5 or more standard drinking units per day for men and 4 or more standard drinking units per day for women) from baseline at 12 weeks or final visit.
B: Percent days abstinent; Time to relapse to heavy drinking
C: Comparison alcohol free "surviving "(heavy alcohol relapse) between experimental therapy (Keppra®) and a group of placebos (During and after treatment)
D: Standard Alcoholic Drinks Per Treatment Period (During each 14 day treatment period)

Answer: A
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 (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: To assess the efficacy of a 7 day course of oral amoxycillin when administered at Home in comparison to administration of oral amoxycillin for first 48 hours in the hospital (Day of enrollment to Day 7)
C: Treatment Failure at 48 Hours (Two Full Days After Enrollment) (48 hours)
D: Adverse Events (Analysis of AEs assessed during the first 3 days of IV therapy and while on IV, a median of 7 days)

Answer: A