TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Pilot Study)
Brief Summary: Bacteria resistant to antibiotic therapy are a major public health problem. The evolution of multi-drug resistant pathogens may be encouraged by provider prescribing behavior. Inappropriate use of antibiotics for nonbacterial infections and overuse of broad spectrum antibiotics can lead to the development of resistant strains. Though providers are adequately trained to know when antibiotics are and are not comparatively effective, this has not been sufficient to affect critical provider practices.

The intent of this study is to apply behavioral economic theory to reduce the rate of antibiotic prescriptions for acute respiratory diagnoses for which guidelines do not call for antibiotics. Specifically targeted are infections that are likely to be viral.

The objective of this study is to improve provider decisions around treatment of acute respiratory infections.

The participants are practicing attending physicians or advanced practice nurses (i.e. providers) at participating clinics who see acute respiratory infection patients. A maximum of 550 participants will be recruited for this study.

Providers consenting to participate will fill out a baseline questionnaire online. Subsequent to baseline data collection and enrollment, participating clinic sites will be randomized to the study arms, as described below.

There will be a control arm, with clinic sites randomized in a multifactorial design to up to three interventions that leverage the electronic medical record: Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives); Accountable Justification (AJ) triggered by discordant prescriptions that populate the note with provider's rationale for guideline exceptions ; and performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).

The outcomes of interest are antibiotic prescribing patterns, including prescribing rates and changes in prescribing rates over time.

The intervention period will be over one year, with a one-year follow up period to measure persistence of the effect after EHR features are returned to the original state and providers no longer receive email alerts.


Options:
A: Antibiotic Prescribing Rate for 5 Specific Acute Respiratory Infection Diagnoses (2 years)
B: Impact on rates of medication errors (1 year)
C: Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) (12-months)
D: Change in screening and assessment of childhood obesity at the point of care, including BMI, blood pressure, and laboratory screening, and provision of nutrition and physical activity counseling (Baseline and 1 Year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Behavioral Economics to Improve Treatment of Acute Respiratory Infections (Pilot Study)
Brief Summary: Bacteria resistant to antibiotic therapy are a major public health problem. The evolution of multi-drug resistant pathogens may be encouraged by provider prescribing behavior. Inappropriate use of antibiotics for nonbacterial infections and overuse of broad spectrum antibiotics can lead to the development of resistant strains. Though providers are adequately trained to know when antibiotics are and are not comparatively effective, this has not been sufficient to affect critical provider practices.

The intent of this study is to apply behavioral economic theory to reduce the rate of antibiotic prescriptions for acute respiratory diagnoses for which guidelines do not call for antibiotics. Specifically targeted are infections that are likely to be viral.

The objective of this study is to improve provider decisions around treatment of acute respiratory infections.

The participants are practicing attending physicians or advanced practice nurses (i.e. providers) at participating clinics who see acute respiratory infection patients. A maximum of 550 participants will be recruited for this study.

Providers consenting to participate will fill out a baseline questionnaire online. Subsequent to baseline data collection and enrollment, participating clinic sites will be randomized to the study arms, as described below.

There will be a control arm, with clinic sites randomized in a multifactorial design to up to three interventions that leverage the electronic medical record: Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives); Accountable Justification (AJ) triggered by discordant prescriptions that populate the note with provider's rationale for guideline exceptions ; and performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).

The outcomes of interest are antibiotic prescribing patterns, including prescribing rates and changes in prescribing rates over time.

The intervention period will be over one year, with a one-year follow up period to measure persistence of the effect after EHR features are returned to the original state and providers no longer receive email alerts.


Options:
A: Symptomatic venous thromboembolic events and severe haemorrhage (3 months)
B: Cardiac Medication Use (3 and 12 months)
C: Number of LTC residents on vitamin D (16 months)
D: Antibiotic Prescribing Rate for 5 Specific Acute Respiratory Infection Diagnoses (2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Open-Label, Multiple-Dose, Dose Escalation Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Coadministration of BMS-650032, BMS-790052, and BMS-791325 When Administered for 24 or 12 Weeks in Treatment-Naïve Subjects Infected With Hepatitis C Virus Genotype 1
Brief Summary: The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA \< LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 \& Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin


Options:
A: Percentage of Participants With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) (Post-treatment Week 24); Percentage of Participants Who Experienced Adverse Events (Baseline (Day 1) to post-treatment Day 30)
B: Sustained virologic response (SVR) at 12 weeks post-treatment (SVR12) (12 weeks post-treatment)
C: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned (Week 72)
D: Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) (24 weeks after the last planned dose of study treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Study Of Pregabalin In The Treatment Of Subjects With Painful Diabetic Peripheral Neuropathy With Background Treatment Of Nsaid For Other Pain Conditions
Brief Summary: This study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. The suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.


Options:
A: Mean Pain Score at Endpoint as Measured by Daily Pain Rating Scale (DPRS) (Up to Week 12)
B: Duration Adjusted Average Change (DAAC) of Mean Pain Score (Baseline, Week 16)
C: Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period) (End of Period (includes both Visits 5 and 9))
D: Baseline Mean Pain Score (Baseline); Change From Baseline in Mean Pain Score at Endpoint (Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: An 8-week Randomized, Double Blind, Multi-center, Placebo-controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin ( 300mg/Day ) Using A Fixed Dosing Schedule In The Treatment Of Subjects With Postherpetic Neuralgia ( Phn )
Brief Summary: To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).


Options:
A: Number of Participants With Loss of Therapeutic Response. (13 Weeks)
B: A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary (Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study))
C: Baseline Mean Pain Score (Baseline); Change From Baseline in Mean Pain Score at Endpoint (Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint))
D: Change From Baseline for Numerical Rating Scale (NRS) Pain Scores at Endpoint-LOCF (Last Observation Carried Forward) Relative to Baseline (Baseline, Week 14)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Feasibility of Rotational Thromboelastrometry During Cardiopulmonary Bypass Using a Heparinase Modified ROTEM® Assay
Brief Summary: Coagulopathy with transfusion requirements is frequent during cardiac surgery with cardiopulmonary Bypass. Rotational thromboelastrometry (ROTEM®) is a viscoelastic whole blood point of care test used to assess the patient's coagulation status.

The purpose of this study is to evaluate the feasibility of ROTEM® analysis in the presence of very high heparin concentrations as seen during cardiopulmonary bypass.


Options:
A: amount of transfused red blood cell concentrates (24 h after begin of surgical intervention)
B: Graft patency at 3 months (3 months)
C: Total amount of transfused red cell concentrate (24 hours after start of surgery)
D: Change from baseline ROTEM® measurements after the administration of heparin

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Preventing Linear Growth Faltering and Reversal of Stunting Among Low Birth Weight Infants in Bangladesh: a Community-based Cluster Randomized Control Trial
Brief Summary: Low birth weight (LBW) infants are particularly vulnerable to frequent infections and consequent morbidity resulting in sub-optimal breastfeeding, limited ingestion of complementary foods and ultimately micronutrient deficiencies that result in post-natal linear growth faltering. The objective of this study is to facilitate improved feeding practices through the early reduction of infections using the innovative tools of water-based hand sanitizer (beginning at birth) and an improved micronutrient powder (I-MNP) (beginning at 6 months of age). A community-based cluster randomized controlled trial will be carried out in Bangladesh using a 2x2 factorial design. LBW infants (n=480) will be recruited at birth and allocated to either HS or No HS from 0 to 6 months. From 6 to 12 months, half of the children in each group will be randomized to receive I-MNP. All groups will receive nutrition and hygiene education from birth to 12 months. Recumbent length is the primary outcome; morbidity, dietary intake and hemoglobin will be assessed as secondary outcomes. By working with BRAC, the largest implementation agency in Bangladesh, there is the opportunity to translate the results directly and quickly into child health programs in Bangladesh.


Options:
A: Anthropometry - Recumbent Length (Change from baseline in length over 12 months); Anthropometry - Weight (Change from baseline in weight over 12 months)
B: child nutritional status (Burundi: 2 years; Guatemala: at pregnancy, 1 mo, 4 mo, 6 mo, 9 mo, 12 mo, 18 mo, 24 mo)
C: incidence of clinical malaria (if fever recorded a blood sample will be taken to determine parasite species and count) (5 months)
D: gut microbiota composition (Fecal sample after 2 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Programme of Diabetes Education in the City of Corrientes (PRODIACOR): Clinical, Metabolic and Economic Outcomes of a Prospective-randomized Trial Based on Different Patient-centered Educational Strategies for People With Type 2 Diabetes
Brief Summary: Objective: To evaluate the effect of system interventions (data recording procedures and complete coverage of medications and supplies) with or without physician and/or patient education, upon the psychological, clinical, metabolic and therapeutic indicators and the costs of care of people with type 2 diabetes.

Design: Randomized 2x2 design; sample size was determined considering the change in haemoglobin A1c (primary outcome variable) using a two-sided test at the 5% level of significance, and 80% power using a paired t-test. Sample size was increased by 25% to account for non-independence and patient drop-out.

Setting: Primary care level in the city of Corrientes, Argentina with involvement of all three Argentinean health subsectors (public health, social security and the private, prepaid system).

Participants: 36 general practitioners and 468 adults (62-71% women, mean age 62 years) with type 2 diabetes. Patients of the participating physicians (nine in each group), were randomly selected and assigned to one of four groups (117 patients each): control, provider education, patient education, and provider/patient education.

Intervention: Structured group education programmes were delivered to provider and/or people with type 2 diabetes by trained professionals; identical system interventions were applied to all four groups.

Main outcome measures: Body mass index, blood pressure, fasting glucose, haemoglobin A1c levels, lipid profile, drug consumption, resource use, and patient well being (WHO-5 questionnaire and Lowe score), at baseline and up to 42 months at every 6 months intervals.


Options:
A: HbA1c (42 months)
B: change in hemoglobin A1c (6 and 12 months)
C: Glycemic relapse: increase in HbA1c by 1% over baseline and >8%
D: Glycated hemoglobin level before and after intervention (1 year after start of the intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Brief Summary: This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).


Options:
A: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)
B: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
C: Rate of 7-day Point Prevalence Abstinence at the End of the Relapse Prevention Phase (Study Week 53) in the Extended Duration Pharmacotherapy Group vs. the Placebo Group (76 weeks)
D: Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936. (Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Brief Summary: This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).


Options:
A: Smoking Abstinence (12 months)
B: Biochemically confirmed continuous 30-day abstinence from smoking (12 weeks post-Target Quit Day (TQD))
C: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)
D: tobacco related knowledge post program (at the end of the program (+ 1 DAY POST THE PROGRAM)); tobacco cessation related skills difference between the 2 groups (at the end of the program (+ 1 DAY AFTER THE PROGRAM))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Brief Summary: This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).


Options:
A: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)
B: 7-day Prevalence of Abstinence From Cigarette Smoking at 12 Weeks (12 weeks); 7 Day Prevalence of Abstinence From Cigarette Smoking at 24 Weeks (24 weeks)
C: Number of Participants With Salivary Cotinine-verified Smoking Abstinence at 6 Months (6 months)
D: Time-to-lapse (Week 2 pre quit day); Smoking Withdrawal (Week 2 pre quit day)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Brief Summary: This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
B: Percentage of Participants Who Abstained From Smoking at 10 and 30 Weeks Post Quit Day (End of treatment (10 weeks post quit day) and 30-week follow-up)
C: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)
D: Prolonged Abstinence (Weeks 7-10)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Brief Summary: This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).


Options:
A: Continuous 4-week Abstinence From Smoking Between Weeks 8-11 After the Quit Date (Through the End of Treatment) (weeks 8-11 after quit date)
B: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)
C: The primary outcome variable for the study was biochemically verified 7-day point prevalence smoking cessation at 6 months, defined as having smoked no cigarettes - not even a puff - for the previous 7 days. (6 months)
D: Smoking Abstinence (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Brief Summary: This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).


Options:
A: The daily number of intakes during the first three weeks recorded with an electronic device fixed on the spray unit (microswitch-actuated metered-dose inhaler chronology, MDILog™, model MDC-511, Medtrac, Denver, Colorado). (first 3 weeks)
B: Percentage of Participants With 30-day Abstinence (6-months post enrollment)
C: Continuous and complete smoking abstinence of the pregnant women from the first administration of nicotine/placebo patch until delivery. (from the first administration of nicotine/placebo patch until delivery)
D: Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.); Estimated NPS AE Rate (%), by Cohort (Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.)

Answer: D