TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Antiseptic Skin Preparation for Preventing Surgical Site Infection at Cesarean Delivery: a Randomized Comparative Effectiveness Trial
Brief Summary: The investigators propose a randomized controlled clinical trial to determine the comparative effectiveness of chlorhexidine-alcohol and iodine-alcohol preoperative skin preparation for preventing surgical site infections at cesarean section. While estimates vary, surgical site infections complicate up to 5 - 10% of all cesarean sections and result in significant human suffering and excess health care costs. Interventions such as preoperative antibiotic prophylaxis reduce surgical site infections by 60%, but the rate of infection remains high. There is therefore a great need to identify and test other potential interventions to further reduce these infections.

The skin is a major source of pathogens that cause surgical site infection. Therefore, optimizing preoperative skin antisepsis has the potential to decrease postoperative surgical site infections. There is paucity of evidence to guide the choice of antiseptic for skin preparation at cesarean section. To date, only two underpowered trials have been published comparing two methods of preoperative skin preparation at cesarean section. A recent randomized trial in adults undergoing clean-contaminated mostly general surgical procedures demonstrated a 41% reduction in surgical site infection with the use of chlorhexidine-alcohol when compared to the more commonly used povidone-iodine. While it is plausible that findings from trials in other clean-contaminated surgical procedures may apply to cesarean sections, physiological changes in pregnancy, the peculiar dual microbial source for cesarean-related infections and the hormone-mediated immune-modulation in pregnancy make the validity of such extrapolation uncertain.

The study has the following specific aims:

Primary Aim: To test the hypothesis that preoperative chlorhexidine-alcohol skin preparation at cesarean section significantly reduces surgical site infections compared to iodine-alcohol.

Secondary Aim 1: To test the hypothesis that preoperative chlorhexidine-alcohol skin preparation at cesarean section significantly reduces bacterial contamination at the surgical site compared to iodine-alcohol.

Secondary Aim 2: To determine clinical outcomes and medical costs associated with cesarean-related infections and quantify potential cost savings attributable to use of chlorhexidine-alcohol for preoperative skin preparation at cesarean section.


Options:
A: Number of Patients With Surgical Site Infection (4 weeks after cesarean delivery)
B: Cesarean Surgical Site Infection (42 days after delivery)
C: Postoperative wound infection (0-14 days postpartum)
D: Number of Participants With Surgical Site Infection (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised, Double-blind, Placebo-controlled Study of the Effect of LIraglutide on Left VEntricular Function in Chronic Heart Failure Patients With and Without Type 2 Diabetes (The LIVE-study)
Brief Summary: Type 2 diabetes (T2D) is a major risk factor of chronic heart failure (CHF). Glycemic control in patients with the combination of T2D and CHF is complicated and the currently available treatments have proven to be inadequate in clinical trials.

Objectives To investigate the effect of Liraglutide compared to placebo on left ventricular ejection fraction (LVEF) in CHF patients with and without T2D.

Multicenter, randomized, double blind study of 240 patients with documented systolic CHF (50% with T2DM) will be randomised. The effect of Liraglutide on left ventricular systolic and diastolic function will be evaluated by advanced echocardiography

Primary outcome parameter is change in LVEF from visit 1 to week 24.


Options:
A: Progression of Albuminuria (Up to 3 years)
B: Change in Left ventricular function from visit 1 to week 24, measured by Ecco (24 weeks)
C: Change in HbA1c (Week 0, week 30)
D: Development of diabetes (Up to 5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-blind, Placebo- and Active-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder
Brief Summary: The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.


Options:
A: Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Baseline (the end of the SSRI/SNRI treatment period), at completion of administration)
B: Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Baseline to Week 4)
C: Longitudinal depressive symptom severity (52 weeks); Difference in time to all-cause treatment discontinuation (12 months)
D: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10 (Baseline to Week 10)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Avoiding Diabetes Thru Action Plan Targeting (ADAPT): A Pilot Randomized Control Trial of an Electronic Medical Record Embedded Prediabetes Shared Goal Setting Tool in Primary Care
Brief Summary: The goal of this randomized control trial is to study the impact of an electronic health record embedded tool's ability to facilitate shared provider-patient goal setting to promote lifestyle behavior change and prevent diabetes in primary care.


Options:
A: Adherence to the decision to use or not to use statins
B: N/A
C: Decision to Receive an ICD (1 week post intervention)
D: Physical Activity (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial
Brief Summary: The purpose of this multi-site randomized controlled trial is to determine if the Caring Letters intervention is effective in preventing suicide and suicidal behaviors among U.S. Service Members and Veterans. The primary aim of this project is determine whether caring communications following inpatient psychiatric treatment reduce suicide and self-inflicted injuries among U.S. military personnel and Veterans. The investigators will also explore treatment utilization by comparing the frequency of treatment visits after enrollment into the study. The following specific hypotheses will be tested:

Hypothesis 1: During a two year follow-up after the index hospital discharge, the frequency of suicide will be lower among participants in the Caring Letters group compared to those in the Usual Care group.

Hypothesis 2: The frequency of medically admitted self-inflicted injuries will also be lower in the Caring Letters group compared to the Usual Care group.

Hypothesis 3: The time to suicidal act, among those who do subsequently exhibit one, will be longer among participants in the Caring Letters group compared to the Usual Care group.


Options:
A: Suicide Mortality Rates (Study Completion (2 years))
B: Number of days with hospital admission (Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively)
C: Reduced Self-harm (3 months)
D: Change in scores on Beck Scale for Suicidal Ideation (Baseline, post-therapy, 6 months and 12 months after therapy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial
Brief Summary: The purpose of this multi-site randomized controlled trial is to determine if the Caring Letters intervention is effective in preventing suicide and suicidal behaviors among U.S. Service Members and Veterans. The primary aim of this project is determine whether caring communications following inpatient psychiatric treatment reduce suicide and self-inflicted injuries among U.S. military personnel and Veterans. The investigators will also explore treatment utilization by comparing the frequency of treatment visits after enrollment into the study. The following specific hypotheses will be tested:

Hypothesis 1: During a two year follow-up after the index hospital discharge, the frequency of suicide will be lower among participants in the Caring Letters group compared to those in the Usual Care group.

Hypothesis 2: The frequency of medically admitted self-inflicted injuries will also be lower in the Caring Letters group compared to the Usual Care group.

Hypothesis 3: The time to suicidal act, among those who do subsequently exhibit one, will be longer among participants in the Caring Letters group compared to the Usual Care group.


Options:
A: Patient Satisfaction Questionnaire ((baseline) Assessment taking place immediately after completion of intervention)
B: Suicide Mortality Rates (Study Completion (2 years))
C: Self-harm as measured by the self-harm sub scale of the Risk-taking and Self-harm Inventory for Adolescents (Vrouva et al, 2010) (12 weeks); Self-harm and related hospital use as reported in National Health Service patient records (12 weeks)
D: Change in BHS Scores (Baseline, 6 weeks, and 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Caring Letters for Military Suicide Prevention: A Randomized Controlled Trial
Brief Summary: The purpose of this multi-site randomized controlled trial is to determine if the Caring Letters intervention is effective in preventing suicide and suicidal behaviors among U.S. Service Members and Veterans. The primary aim of this project is determine whether caring communications following inpatient psychiatric treatment reduce suicide and self-inflicted injuries among U.S. military personnel and Veterans. The investigators will also explore treatment utilization by comparing the frequency of treatment visits after enrollment into the study. The following specific hypotheses will be tested:

Hypothesis 1: During a two year follow-up after the index hospital discharge, the frequency of suicide will be lower among participants in the Caring Letters group compared to those in the Usual Care group.

Hypothesis 2: The frequency of medically admitted self-inflicted injuries will also be lower in the Caring Letters group compared to the Usual Care group.

Hypothesis 3: The time to suicidal act, among those who do subsequently exhibit one, will be longer among participants in the Caring Letters group compared to the Usual Care group.


Options:
A: Frequency of non-suicidal self-injurious thoughts and behaviors (Daily (up to 126 days))
B: Time to Suicide Attempt (Up to 18 months)
C: Suicide Mortality Rates (Study Completion (2 years))
D: PTSD Symptom Scale - Interview (Pre-treatment, 4-, 8-, 12-, and 15-months); Suicide Attempt Self-Injury Interview (Pre-treatment, 4-, 8-, 12-, and 15-months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Online Early Resilience Intervention for Combat-Related PTSD in Military Primary Healthcare Settings: A Randomized Trial of "DESTRESS-PC"
Brief Summary: This study will compare a cognitive-behavioral online self-management intervention designed for primary care treatment of war-related PTSD to a control intervention, "optimized usual primary care PTSD treatment". Patients with PTSD will be trained to use the online PTSD treatment website and asked to do so three times per week for six weeks. They will have phone and email access to a nurse trained to assist them in their treatment program. Three scheduled phone check-ins during the six week treatment period will provide ongoing contact with patients during treatment. The investigators will assess PTSD symptoms, depression, anxiety and somatic symptoms, physical health status and occupational functioning on three occasions: before the intervention, at the end of the treatment period, and six weeks after the end of treatment.


Options:
A: concerns about falling (baseline, 5 months and 12 months); avoidance of activities due concerns about falling (baseline, 5 months and 12 months)
B: Fear of falling (2 months (primary)); Activity avoidance (2 months (primary))
C: PTSD Checklist (PCL) (Baseline and 6 weeks, 12 weeks, and 18 weeks post randomization)
D: Change in PTSD Checklist (PCL-5) (Baseline, Post-treatment (8-12 weeks after baseline), 3-months post-treatment, 6-months post-treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Implementation Strategy for a Breastfeeding Guideline in Primary Care: Cluster Randomised Trial
Brief Summary: The purpose of this study is to determine whether an implementation strategy for a breastfeeding guide is more effective than the usual practice (simple circulation of the guide) in terms of increasing the percentage of children receiving exclusive or preferential breastfeeding at 6 months age.


Options:
A: Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery (3 years)
B: Exclusive breastfeeding (6 months postpartum)
C: Newborn survival (to 28 days) (July 2010 to June 2013)
D: proportion of patients with breastfeeding completed at 6 months (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Implementation Strategy for a Breastfeeding Guideline in Primary Care: Cluster Randomised Trial
Brief Summary: The purpose of this study is to determine whether an implementation strategy for a breastfeeding guide is more effective than the usual practice (simple circulation of the guide) in terms of increasing the percentage of children receiving exclusive or preferential breastfeeding at 6 months age.


Options:
A: Exclusive Breastfeeding Rate (3 months postpartum)
B: Perception of Milk Supply (8 weeks postpartum)
C: Number of Participants Exclusively Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely (3 months)
D: proportion of patients with breastfeeding completed at 6 months (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Implementation Strategy for a Breastfeeding Guideline in Primary Care: Cluster Randomised Trial
Brief Summary: The purpose of this study is to determine whether an implementation strategy for a breastfeeding guide is more effective than the usual practice (simple circulation of the guide) in terms of increasing the percentage of children receiving exclusive or preferential breastfeeding at 6 months age.


Options:
A: Early initiation of breastfeeding (Within 1 hour of birth); Exclusive breastfeeding rate (up to 6 months after birth)
B: Percent of infants sleeping 5 consecutive hours at night at 2 months of age (2.5 years)
C: proportion of patients with breastfeeding completed at 6 months (6 months)
D: Newborn survival (to 28 days) (July 2010 to June 2013)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Non Comparative Phase II Trial With Bevacizumab and Fotemustine in the Treatment of Recurrent Glioblastoma
Brief Summary: This randomized, non-comparative study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with fotemustine serves as a calibration arm and no formal efficacy comparison will be made between the two treatment arms. The anticipated time of study treatment is until disease progression or unacceptable toxicity.


Options:
A: The primary end point was 6-month progression-free survival rate (PFS-6) (6 months)
B: Adult Study: Overall Survival (OS) (From the date of randomization up to the date of participant's death; participants who completed treatment were to be assessed every 12 weeks, up to 28 months.); Adult Study: Progression-Free Survival (PFS) (Measured every 8 weeks from date of randomization until the date of first objective progression or subject's death, whichever occurred first, up to 2 years); Pediatric Study: Percentage of Participants With Adverse Events From the First Visit Until 49 Days After the Last Dose of Study Drug (From participant's first visit until 49 days after the participant's last dose of study drug, up to 63 weeks); Pediatric Study: Maximum Observed Serum Concentration (Cmax) of ABT-414 (Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose); Pediatric Study: Maximum Observed Plasma Concentration (Cmax) of Cys-mcMMAF (Samples collected Cycle 1 Days 1, 2, 3, 5, 8); Pediatric Study: Half-life (t1/2) Observed for ABT-414 (Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose); Pediatric Study: Half-life (t1/2) Observed for Cys-mcMMAF (Samples collected Cycle 1 Days 1, 2, 3, 5, 8); Pediatric Study: Area Under the Concentration-time Curve (AUC) Observed for ABT-414 (Samples collected Cycle 1 Days 1, 2,3,5,8,15; Cycle 2 Day 1; Cycle 3 Day 1; Cycle 5 Day 1; Day 1 of every two cycles starting with Cycle 5; and 35 days after the last dose); Pediatric Study: Area Under the Concentration-time-curve (AUC) Observed for Unconjugated Cys-mcMMAF (Samples collected Cycle 1 Days 1, 2, 3, 5, 8)
C: Percentage of Participants Alive 6 Months After Start of Treatment (6 months); Overall Survival (OS) (Baseline until death (up to 691 days))
D: Progression free survival (PFS) at 12 months (1 year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Non Comparative Phase II Trial With Bevacizumab and Fotemustine in the Treatment of Recurrent Glioblastoma
Brief Summary: This randomized, non-comparative study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with fotemustine serves as a calibration arm and no formal efficacy comparison will be made between the two treatment arms. The anticipated time of study treatment is until disease progression or unacceptable toxicity.


Options:
A: Percentage of Participants Alive 6 Months After Start of Treatment (6 months); Overall Survival (OS) (Baseline until death (up to 691 days))
B: Overall Survival (OS) (From randomization to date of death or last follow-up. Analysis occurs after all 390 deaths have been reported.); Progression-free Survival (PFS) (From randomization to date of progression, death, or last follow-up for progression-free survival. Analysis occurs after all 390 deaths have been reported.)
C: Percentage of Participants Achieving Progression-Free Survival (PFS) Without Disease Progression or Death at 6 Months (6 months)
D: Overall Survival (OS) Time (Time from randomization to death or last day known to be alive, reported between day of first participant randomized, that is, Sep 2008 until cut-off date, (19 Nov 2012))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Non Comparative Phase II Trial With Bevacizumab and Fotemustine in the Treatment of Recurrent Glioblastoma
Brief Summary: This randomized, non-comparative study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with fotemustine serves as a calibration arm and no formal efficacy comparison will be made between the two treatment arms. The anticipated time of study treatment is until disease progression or unacceptable toxicity.


Options:
A: Percentage of Participants Alive 6 Months After Start of Treatment (6 months); Overall Survival (OS) (Baseline until death (up to 691 days))
B: Median Overall Survival (OS) (OS calculated from the date of surgery until death or up to 36 months.)
C: Co-Primary: Progression-free Survival (PFS) as Assessed by Investigator (Randomization until PFS Event [Until data cutoff= 31 March 2012 (up to 31.4 months)); Co-Primary: Overall Survival (OS) (Randomization until OS Event (Until data cutoff= 28 February 2013 [up to 42.2 months]))
D: 1. Percentage of patients with a histologically confirmed malignant glioma (grade III or IV -WHO) without definite residual contrast agent-accumulating tumour in the early post-operative control MRI (within 72 hours of the operation). (Within 72 hours after surgery); 2. Progression-free survival 6 months after primary surgical treatment of a malignant gli-oma in patients with histologically confirmed malignant glioma (grade III or IV -WHO). (Within 6 month after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-centre, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over, Exploratory Biomarker and Safety and Tolerability Study of a Single Dose of RO5028442 in Adult Male High-functioning Autistic Patients
Brief Summary: This multi-center, randomized, double-blind study will evaluate exploratory biomarkers and the safety and tolerability of a single dose of RO5028442 in adult male high-functioning autistic patients. In a cross-over design, patients will be randomized to receive either a single dose of RO5028442 or matching placebo with a washout period of 7-14 days. Anticipated time on study is up to approximately 9 weeks.


Options:
A: Clinical Global Impression-Improvement (Change from baseline to end of week 12); Aberrant Behavior Checklist- Irritability (Change between baseline and end of each phase)
B: Efficacy: Behavior assessments (up to 24 hours post-dose); Safety: Incidence of adverse events (up to 24 hours post-dose)
C: Mean Change From Baseline in the Aberrant Behavior Checklist Japanese Version (ABC-J) Irritability Subscale Score (baseline, 8 weeks after dosing)
D: To evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children 2-6 years measuring the change from baseline in ADOS (Autism Diagnostic Observation Schedule) Composite Total scores compared to placebo at 6 months. (Baseline 1, Week 24)

Answer: B