TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Multilevel Tobacco Intervention in Community Clinics for Underserved Families
Brief Summary: The purpose of this randomized controlled trial is to develop and test the efficacy of a multilevel, multimodal intervention designed to modify maternal smoking behavior to reduce children's exposure to secondhand tobacco smoke (primary outcome) and promote their smoking cessation (secondary outcome). Low-income mothers who smoke will be enrolled. Mothers will be recruited from the supplemental nutrition program, Women, Infants and Children (WIC) clinics. All mothers visiting WIC clinics will receive a clinic-level intervention, which consists of nutrition counselors following an "ask, advise, and refer" protocol to identify if their children are exposed to secondhand tobacco smoke, advise mothers who smoke about the harms of such exposure and the benefits of reducing exposure, and referring mothers to the trial. Screened eligible mothers will be consented and randomized to an attention control condition focused on nutrition (CTL) or to an experimental (EXP) multimodal behavioral intervention that integrates telebased counseling to promote the reduction of child secondhand smoke exposure (SHSE) and maternal smoking with an adjunct smoking cessation mobile app and nicotine replacement therapy use. The investigators will test the primary hypothesis that relative to children in the CTL condition, those in the EXP condition will have lower exposure SHSE as measured by mothers' reports and child cotinine levels. The investigators will also test the secondary hypothesis that relative to mothers in the CTL condition, those in the EXP condition will have higher bioverified 7-day point prevalence quit rates. In addition, the study will: (a) evaluate if specific psychosocial and behavioral factors-- social support, urge coping skills, self-efficacy, and SHSe protective behaviors--mediate the effects of the EXP intervention on outcomes and (b) explore whether other residential smokers, level of nicotine dependence, depressive/anxious symptoms, weight concerns, intervention dosage, and pregnancy status predict outcomes and moderate treatment effects.


Options:
A: Quit smoking status (1, 3, and 6 month follow up)
B: Child Urine Cotinine (3 months and 12 months); Cigarettes/Day (3 months and 12 months)
C: Self-reported 7-day Point Prevalence Abstinence From Smoking That Was Sustained at 60 Days After the Quit Date (60 days after quit date)
D: The primary outcome will be self-reported and biologically verified continuous smoking abstinence. (Six month)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Prone Position Effects on Work of Breathing and Intrinsic PEEP in Children With Severe Acute Viral Bronchiolitis
Brief Summary: Acute viral bronchiolitis is the first cause of respiratory distress in infant. Airway inflammation increases the respiratory system resistances and dynamic hyperinflation. This leads to an increase in the work of breathing. In Chronic obstructive pulmonary disease patients as in neonates, prone position (PP) improves lung function and decreases the end expiratory lung volume. The investigators hypothesized that in infants with severe bronchiolitis, prone position reduces the intrinsic Positive End Expiratory Pressure (PEEPi) and the work of breathing (WOB). The investigator designed a prospective randomized crossover study with 16 infants younger than six months who need ventilatory support by nasal continuous positive airway pressure (nCPAP) for severe acute viral bronchiolitis. Work of breathing (product time pressure) and PEEPi will be estimated using an esophageal pressure probe in prone and supine position.


Options:
A: Incidence of ventilator-associated pneumonia (14 days of mechanical ventilation)
B: Incidence of pre-extubation atelectasis (postoperative 10 minutes)
C: Area under ROC curve of the variation in continuous cardiac output during Trendelenburg position, to detect preload dependence (1 minute after Trendelenburg position onset.)
D: Work of breathing (60 min)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects Who Are Virologically Suppressed
Brief Summary: The primary objective of this study is to evaluate the efficacy of switching from a regimen of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1) infected adults.


Options:
A: Loss-to-follow-up (delivery, six weeks, 12 and 24 weeks postpartum); Virological suppression (delivery, 12 and 24 months postpartum)
B: Measure the number of infants who have HBV infection at the age of 28 weeks (From the date of birth to age of 28 weeks); Assessment of the safety and tolerability of TDF, measure the number of participants and paired infants with adverse events (From the date of randomization until 28 weeks of postpartum.)
C: Percentage of Participants With Virologic Failure (HIV-1 RNA ≥ 50 Copies/mL) as Defined by the Modified US FDA-defined Snapshot Algorithm (Week 48)
D: HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study (At Month 6); Frequency and Severity of Adverse Reactions Among Participating Infants (6 weeks through 18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Web-based Implementation for the Science of Enhancing Resilience Study
Brief Summary: Resilience means a healthcare provider's ability to cope, recover, and learn from stressful events, as well as their access to resources that promote health and well-being. Neonatal intensive care unit (NICU) health professionals' need to have particularly good resilience, because their work is extremely stressful and their patients, fragile preterm infants, require their undivided attention. The investigators propose a feasible and engaging intervention to enhance resilience among NICU health professionals promoting their ability to provide safe care.


Options:
A: Significant score reduction at the Perceived Stress Scale (T0 inclusion); Significant score reduction at the Perceived Stress Scale (T1 (3-month follow-up)); Significant score reduction at the Perceived Stress Scale (T1 (up to 8 weeks treatment)); Significant score reduction at the Perceived Stress Scale (T2 (6-month follow-up))
B: NICU health professional resilience (10 days, 1 month, 6 months, 12 months)
C: Average daily mood (7 days); Patient Health Questionnaire-9 (PHQ-9) (4 months)
D: Professional Quality of Life Scale-IV (ProQoL), "change" is being assessed. (Change from Baseline up to 1 year); Perceived Stress Scale, "change" is being assessed. (Change from Baseline up to 1 year); Resilience Scale for Adults, "change" is being assessed. (Change from Baseline up to 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Web-based Implementation for the Science of Enhancing Resilience Study
Brief Summary: Resilience means a healthcare provider's ability to cope, recover, and learn from stressful events, as well as their access to resources that promote health and well-being. Neonatal intensive care unit (NICU) health professionals' need to have particularly good resilience, because their work is extremely stressful and their patients, fragile preterm infants, require their undivided attention. The investigators propose a feasible and engaging intervention to enhance resilience among NICU health professionals promoting their ability to provide safe care.


Options:
A: Resilience - Brief Resilience Scale (BRS) (20 weeks); General Health - General Health Questionnaire (GHQ-12). (20 weeks)
B: Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks (Baseline and after 4, 8 weeks later)
C: Change in Stress (baseline, 8wks (post-intervention),12-month follow-up)
D: NICU health professional resilience (10 days, 1 month, 6 months, 12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Web-based Implementation for the Science of Enhancing Resilience Study
Brief Summary: Resilience means a healthcare provider's ability to cope, recover, and learn from stressful events, as well as their access to resources that promote health and well-being. Neonatal intensive care unit (NICU) health professionals' need to have particularly good resilience, because their work is extremely stressful and their patients, fragile preterm infants, require their undivided attention. The investigators propose a feasible and engaging intervention to enhance resilience among NICU health professionals promoting their ability to provide safe care.


Options:
A: Changes in scores on Beck's Scale for Suicide Ideation (BSSI) (From baseline to 6 and 12 months after patient is included in the study)
B: Change on the severity of borderline personality disorder measured by Borderline Personality Symptom List (BSL-23). (Baseline and up to 12 months after inclusion.)
C: NICU health professional resilience (10 days, 1 month, 6 months, 12 months)
D: Outcome Questionnaire -45.2 (Lambert et al., 2004) (3 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Web-based Implementation for the Science of Enhancing Resilience Study
Brief Summary: Resilience means a healthcare provider's ability to cope, recover, and learn from stressful events, as well as their access to resources that promote health and well-being. Neonatal intensive care unit (NICU) health professionals' need to have particularly good resilience, because their work is extremely stressful and their patients, fragile preterm infants, require their undivided attention. The investigators propose a feasible and engaging intervention to enhance resilience among NICU health professionals promoting their ability to provide safe care.


Options:
A: Rate of participant recruitment (1 year); Rate of retention (1 year); Completeness of data entry (1 year); Cost of interventions (1 year); Unexpected costs (1 year)
B: NICU health professional resilience (10 days, 1 month, 6 months, 12 months)
C: Blindly-rated depression and anxiety severity: Hospital Anxiety and Depression Scale (HADS) (26 weeks)
D: Professional Quality of Life Scale-IV (ProQoL), "change" is being assessed. (Change from Baseline up to 1 year); Perceived Stress Scale, "change" is being assessed. (Change from Baseline up to 1 year); Resilience Scale for Adults, "change" is being assessed. (Change from Baseline up to 1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A 26-week, Randomized, Double Blind, Parallel-group Multicenter Study to Assess the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD
Brief Summary: This study will evaluate the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPD


Options:
A: Adjusted Rate of Moderate or Severe Exacerbations (52-week treatment period)
B: FEV1 AUC0-4 (at Week 24); Change From Baseline in Morning Pre-dose Trough FEV1 (at Week 24)
C: Moderate and severe COPD exacerbation rate over 52 weeks of treatment (1 year)
D: Mean Change From Baseline in Post-dose Trough FEV1 (Baseline, 26 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Lifestyle Interventions to Control Weight After Bariatric Surgery
Brief Summary: This randomized controlled trial is designed to test the feasibility and efficacy of a novel 10-week mindfulness-based intervention (MBI) on weight maintenance as well as behavioral and psychosocial outcomes in patients who have undergone bariatric surgery.

Primary hypothesis:

Bariatric patients who have stopped losing weight (\< 5 lbs weight loss in past month) 1-5 years post-surgery will be willing to participate in this 10-week intervention. The investigators expect a high adherence rate (\>70%) and no issues with meeting recruitment goals.

Secondary hypotheses:

Patients assigned to the MBI will show greater improvement in a) weight control (defined by differences in body weight between baseline and follow-up); b) eating behaviors (binge eating, emotional eating); and c) psychosocial measures (quality of life, depression, perceived stress, eating self-efficacy, coping ability) than a standard lifestyle intervention (1 hr lifestyle counseling).

Patients assigned to the MBI intervention will show greater improvement in biomarkers of stress and inflammation \[salivary cortisol, high sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha)\] as compared with a standard lifestyle intervention.

Food-related attentional bias as measured by the food-related Stroop task will be differentially affected among patients assigned to the MBI as compared with the intensive lifestyle intervention and standard lifestyle intervention.


Options:
A: Change in impulsive eating (TFEQ-R18 "uncontrolled eating" subscale) (From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.)
B: Changes in weight self-stigma (9 months (from Baseline to 6-months follow-up)); Changes in eating behaviours (9 months (from Baseline to 6-months follow-up)); Changes in obesity-related quality-of-life (9 months (from Baseline to 6-months follow-up))
C: Change in Weight From Baseline to 18 Months (18 months)
D: Success meeting recruitment goals (20 patients within 3-4 months) (4-month recruitment window); Willingness to participate in study (>10% of eligible) (4-month recuitment window); Adherence rate (≥70% attendance, 7 of 10 classes) (12-weeks); Retention (≤25% drop-out) (6-months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-center, Double-blind, Double-dummy, Randomized, Placebo- and Active-reference, Parallel Group, Phase 2, Dose-finding Study With ACT-132577 in Subjects With Essential Hypertension (Grade 1 and 2).
Brief Summary: The main objective will be to evaluate the dose-response of ACT-132577 (aprocitentan) on diastolic blood pressure (DBP) in participants with grade 1 or 2 essential hypertension.

Secondary objectives will be to evaluate the dose-response of ACT-132577 on: systolic blood pressure (SBP); control and response rate of blood pressure; 24-hour ambulatory blood pressure monitoring (ABPM) and to evaluate the safety and tolerability of a once daily oral regimen of 4 doses of ACT-132577.


Options:
A: 6 minute walk distance change from baseline to Week 16 (16 weeks)
B: Change From Baseline to Week 16 in Pulmonary Vascular Resistance (PVR) at Rest. (From baseline to Week 16)
C: Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough (Baseline (Day 1) and end of double-blind treatment (Day 56))
D: Digital Micro-vascular Flow (Baseline and 12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Ontario Appropriate Prescribing Demonstration Project: Pragmatic, Cluster-Randomized Clinical Trial to Reduce Antipsychotic Medication Prescribing in Long-Term Care Homes
Brief Summary: Two arm, pragmatic, cluster-randomized trial, with nursing homes allocated to the full, active intervention (featuring educational outreach offered to each prescriber and team members in the home) or standard quality improvement supports (including online audit and feedback reports for each prescriber in the home). The 'standard' quality improvement supports represent 'usual care' as these are to be launched province-wide; a concurrent control arm with no exposure to a quality improvement intervention is not feasible.


Options:
A: Agitation Behavior Mapping Instrument (ABMI) (10 days of intervention vs. 10 days of baseline)
B: Antipsychotic Efficacy (Day 43)
C: Proportion of residents receiving at least one antipsychotic medication after 12 months (12 months)
D: Antipsychotic dispensing (6 months post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Ontario Appropriate Prescribing Demonstration Project: Pragmatic, Cluster-Randomized Clinical Trial to Reduce Antipsychotic Medication Prescribing in Long-Term Care Homes
Brief Summary: Two arm, pragmatic, cluster-randomized trial, with nursing homes allocated to the full, active intervention (featuring educational outreach offered to each prescriber and team members in the home) or standard quality improvement supports (including online audit and feedback reports for each prescriber in the home). The 'standard' quality improvement supports represent 'usual care' as these are to be launched province-wide; a concurrent control arm with no exposure to a quality improvement intervention is not feasible.


Options:
A: Medication adherence (One month after patients receive intervention materials)
B: Failure to persist with medication regimen (6 months)
C: Composite of readmission to hospital or death. (30 days after hospital discharge)
D: Antipsychotic dispensing (6 months post-intervention)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Product Evaluation for the Effectiveness of the ClearGuard™ HD End Cap
Brief Summary: To assess positive blood cultures (PBCs) in hemodialysis central venous catheter (CVC) patients using two FDA cleared devices: ClearGuard HD end caps compared to conventional end caps.


Options:
A: Positive Blood Cultures (PBCs) Per 1,000 Central Venous Catheter (CVC)-Days (Up to 12 months)
B: The catheters dysfunction rate (as partial or complete occlusion or infection associated with dialysis catheter)
C: Success Rate (90 days)
D: infection free survival (45 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Forced-dose Titration, Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
Brief Summary: The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and 37.5 mg) given to participants daily in the morning compared to placebo in the treatment of adults aged 18 to 55 years diagnosed with ADHD.


Options:
A: Last Three Weeks of Cocaine Abstinence Based on Urine Toxicology Results and Self Reported Use (weekly for 14 weeks of trial or for length of participation); ADHD Symptoms Based on ADHD Rating Scale (measured once per week for 14 weeks or length of study participation)
B: Clinician-administered ADHD-rating scale (ADHD-RS) performed using adult DSM-IV prompts (weekly over a period of 4 weeks)
C: N/A
D: Change From Baseline in the Adult Attention-deficit/Hyperactivity Disorder Rating Scale-4 (ADHD-RS) With Prompts Total Score at Visit 6 (Week 4) (Baseline, Visit 6 (Week 4))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study
Brief Summary: A study in adolescents and adults with eosinophilic esophagitis (EoE) to measure the histologic response and determine if any reduction in dysphagia is achieved.


Options:
A: Percentage of Participants Who Attained Remission. (3 months)
B: Number of Participants With Histologic Response at the Final Treatment Period Evaluation (Week 16) (Week 16); Number of Participants With Dysphagia Symptom Response at the Final Treatment Period Evaluation (Week 16) (Week 16)
C: Peak Esophageal Eosinophil Count (2 months)
D: To measure change in eosinophil infiltration and degranulation at 8 weeks in response to treatment of allergy versus treatment for GER in EE patients (8 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Trial of Antimicrobials Versus Placebo in Addition to Fecal Microbiota Therapy in for the Induction of Remission in Active Ulcerative Colitis
Brief Summary: The investigators will test the hypothesis that giving antibiotics prior to fecal transplant therapy for active UC increases the proportion of patients in remission at the end of treatment. The investigators will randomize patients aged 18 or over with active UC to antibiotics (metronidazole 500mg, doxycycline 100mg, Terbinafine 250 mg, all twice daily for two weeks); or identical placebo. At the end of two weeks the investigators will give all patients fecal transplant therapy twice per week for eight weeks from an anonymous donor stool.). Patients will complete a validated UC questionnaire, have a flexible sigmoidoscopy to assess the degree of inflammation in the colon and complete general and disease specific quality of life questionnaire as well as a questionnaire on anxiety and depression. Patients will complete the same questionnaires again at the end of treatment at week 9 when they will also have a repeat flexible sigmoidoscopy. The main outcome that will be assessed is the proportion of patients in remission from their UC at the end of treatment.


Options:
A: Incidence of treatment-emergent adverse events (3 months)
B: The primary outcome of the randomized trial is remission of UC defined as a Mayo score < 3 with an endoscopic Mayo score = 0 at the end of the trial Transplant Therapy in Ulcerative Colitis (9 weeks)
C: Clinical Cure (8 weeks)
D: durability of clinical remission (One year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Financial Incentive for Smoking Cessation in Pregnancy
Brief Summary: Maternal smoking during pregnancy (MSDP) increases the risk of adverse pregnancy and birth outcomes and may have long-lasting effects in the offspring.Financial incentives may increase smoking abstinence rate in pregnancy and therefore reduce MSDP related negative health effects. This is a randomized open label study comparing financial incentives for smoking abstinence with no financial incentives for smoking abstinence.Research objectives

1. To test the efficacy of financial incentives on smoking abstinence rate among pregnant smokers;
2. To explore the heterogeneity of efficacy according to individual characteristics: socioeconomic status, social background, smoking characteristics, personality traits, time and risk preferences to determine profiles of women which could benefit best from this kind of intervention;
3. To provide a cost-benefit analysis based on the cost of newborn and children disease due to maternal smoking during pregnancy.


Options:
A: Continuous smoking abstinence since target quit date until last visit before delivery. (Last 6 months of pregnancy)
B: Stimulant drug use as measured by urine analysis (Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
C: Abstinence from smoking (Measured 6 months after births at follow-up assessment)
D: Salivary cotinine or anabasine testing (metabolites of nicotine) (at 6 months following the patient selected target quit date.)

Answer: A