TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Safety and Efficacy of Probiotics in Bangladeshi Infants
Brief Summary: Here the investigators propose to preliminarily investigate the safety and effects of probiotics in infants in Bangladesh through a pilot randomized clinical trial. The investigators hypothesize that two probiotics are safe for infants in Bangladesh and may have an effect on biomarkers of gut health and immunity. The specific aims of this pilot are: i) to confirm the safety of administering probiotic strains to infants in low-income countries, ii) to determine the effects of dosing frequency on colonization and persistence of probiotics in the GI tract, iii) to measure markers of intestinal and immune function and microbiota structure.


Options:
A: Presence of probiotic in the stool (weeks 0-12); Adverse events (duration of study - through study completion)
B: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)
C: Reduction of the onset of gaseous colic, regurgitation and of constipation. (one year)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Mental Health E-screening in Pregnant and Postpartum Women
Brief Summary: To compare e-screening versus usual screening on: 1) women's and healthcare providers' views on feasibility and acceptability; 2) rates of detection of prenatal and postpartum depression and anxiety; 3) perceived risk and benefit of disclosure; 4) cost-effectiveness; 5) psychometric properties. We also aim to identify factors associated with feasibility of e-screening.Compared to usual screening:1) e-screening is as feasible; 2) e-screening yields similar rates of prenatal and postpartum depression and anxiety; 3) the mean score for risk of disclosure is significantly lower and benefit of disclosure is significantly higher in the e-screening group; 4) e-screening is as or more cost effective in detecting prenatal and postpartum depression and anxiety; 5) features of e-screening are significantly associated with feasibility and acceptability, whereas demographic factors are not; and 6) reliability and validity indices of ALPHA and EPDS are strongly correlated for both administration modes.


Options:
A: Symptom burden and quality of life 2-4 weeks post treatment (3 years)
B: The primary outcome is feasibility/acceptability of the process of e-screening (vs 'usual' screening). (10 months)
C: Alcohol Use Disorders Identification Test - Consumption scale (AUDIT-C scale) (6 weeks)
D: Differences in Hamilton Depression Rating Scale (HAM-D17) score and Young Mania Rating Scale (YMRS) score during the entire 6 months study period. (Measured on all participants included one time a month for six months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Open Label, 3 Crossover, Balanced Incomplete Block Study To Evaluate The Pharmacokinetics Of Umeclidinium Bromide and Vilanterol Trifenatate as Monotherapies and Concurrently in Healthy Chinese Subjects.
Brief Summary: This study is to assess the pharmacokinetics (PK), safety and tolerability of UMEC (62.5µg and 125µg) and VI (25µg) as monotherapies and combinations in healthy Chinese subjects.


Options:
A: Cmax (5 months); tmax (5 months); tlast (5 months); AUC0-t (5 months); t1/2 (5 months); CL/F (5 months); Vd/F (5 months); AUC0-inf (5 months); AUC0-t' (5 months); C τ (5 months); AUC0-τ (5 months); Ro (5 months); RCmax (5 months); DF (5 months)
B: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Baseline (BL) and Day 85)
C: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)
D: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) (Baseline and Day 169)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: DB2116960: A Randomized, Double-Dummy, Parallel Group, Multicenter Trial Comparing the Efficacy and Safety of UMEC/VI (a Fixed Combination of Umeclidinium and Vilanterol) With Tiotropium In Subjects With COPD Who Continue To Have Symptoms on Tiotropium
Brief Summary: The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg) once-daily with tiotropium (18 mcg) once-daily over 12 weeks for the treatment of subjects with COPD who have received tiotropium and continue to have symptoms while on tiotropium.


Options:
A: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Visit 8) (Baseline (BL) and Day 85)
B: Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period. (From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days)
C: Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo (Baseline and 6 weeks)
D: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at Day 85 (12 Weeks) (1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Day 85); Trough FEV1 Response at Day 85 (12 Weeks) (1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h and - 10 mins prior to study drug at Day 85.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: DB2116960: A Randomized, Double-Dummy, Parallel Group, Multicenter Trial Comparing the Efficacy and Safety of UMEC/VI (a Fixed Combination of Umeclidinium and Vilanterol) With Tiotropium In Subjects With COPD Who Continue To Have Symptoms on Tiotropium
Brief Summary: The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg) once-daily with tiotropium (18 mcg) once-daily over 12 weeks for the treatment of subjects with COPD who have received tiotropium and continue to have symptoms while on tiotropium.


Options:
A: Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1) (Day 7 and Day 8 of each treatment period (up to Study Day 50)); Final Dose-response Model for Trough FEV1 for ED50 (Potency) Parameter (Day 7 and Day 8 of each treatment period (up to Study Day 50)); Final Dose-response Model Parameter β-FEV1MB-S0 for Trough FEV1 (Day 7 and Day 8 of each treatment period (up to Study Day 50)); Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 8 of Each Treatment Period (Baseline and Day 8 of each treatment period (up to Study Day 50))
B: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 (Visit 8) (Baseline (BL) and Day 85)
C: Identifying new patient subtypes and endpoints for COPD (3 years)
D: Composite of Pharmacokinetic (PK) Parameters as a measure of systemic exposure. (PK Blood samples will be collected at Predose, 3, 5, 7, 10, 15, 12, 15, 30, 45 minutes, 1hour, 1.5, 2, 4, 6, 8, 12, 24 hours post dose on Day 1 of each treatment period); Systemic exposure of FF and UMEC and VI following single inhaled doses (four inhalations) of FF/UMEC/VI 100mcg /62.5mcg /25mcg compared with FF/VI 100mcg /25mcg and UMEC/VI 62.5mcg /25mcg (PK Blood samples will be collected at Day 1 Predose, 3, 5, 7, 10, 15, 12, 15, 30, 45 minutes, 1hour, 1.5, 2, 4, 6, 8, 12, 24 hours post dose.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Same-Day HIV Testing and Treatment Initiation to Improve Retention in Care
Brief Summary: The purpose of this study is to determine if same-day HIV testing and antiretroviral therapy (ART) initiation improves retention in care (as measured by the proportion of participants who are alive and in-care with an undetectable viral load 12 months after HIV testing), compared with standard of care (three visits prior to ART initiation). Secondary outcomes include survival, ART initiation, retention in care with viral load \< 200 and \< 1000 copies/ml, 6-month viral load, and adherence as measured by self-report and pharmacy refill records. Enrollment for the main study was completed in October 2015.

In June 2015, enrollment was started for a new sub-study. This sub-study, funded by MAC AIDS, includes patients with WHO stage 1 or 2 disease and CD4 count \>500 cells/mm3. The purpose of the sub-study is to compare 6-month retention for patients who receive same-day ART vs. standard pre-ART care. Secondary outcomes include adherence to INH and Bactrim, and cost-effectiveness between the two groups. Enrollment for the sub-study is ongoing.


Options:
A: Treatment initiation (28 days after study enrollment); Treatment initiation and retention (8 months after study enrollment)
B: Proportion non-pregnant subjects virally suppressed at routine six-month viral load (10 months after study enrollment); Proportion of pregnant subjects who adhere to ART or the prior PMTCT regimen until delivery (Up to 9 months after study enrollment)
C: Receipt of post-test results and counseling following testing completeness (30 days)
D: Retention in care with undetectable viral load (12 months after HIV testing)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effects of Isolated Strengthening and Functional Training on Strength, Running Mechanics, Postural Control and Injury Prevention in Novice Runners
Brief Summary: The purpose of this study is to understand the effects of muscle strengthening and balance exercise interventions on muscle strength, running mechanics and postural control in novice recreational runners. Participants will be assessed before and after they engage in an 8-week exercise intervention program.


Options:
A: Knee Extension Strength (Baseline, 8-weeks, 16-weeks and 24-weeks); Participation Rate (Duration of the 8-week intervention for both study groups (week 1 to 8 for intervention group, week 9 to 16 for control group.)
B: Running-related injury (First-time) (6 months)
C: Change in Strength (Week 0, Week 8); Change in Running Mechanics (Week 0, Week 8); Change in Postural Control (Week 0, Week 8)
D: Pain (6 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Health Worker Support to Help Patients Control Chronic Disease
Brief Summary: The purpose of this proposal is to compare the effectiveness of community health worker (CHW) support vs. usual primary care for helping chronically-ill, low-SES patients to improve control of chronic conditions. Upon enrollment each patient will select one of their multiple chronic conditions as a focus for the trial and work with his/her PCP to set a chronic disease management goal. Patients are then randomized to receive usual primary care vs. CHW support for moving towards that goal.


Options:
A: Medication Adherence (12 months)
B: Proportion of Participants that Receive Annual Eye Exam (Baseline; Change from Baseline at 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years (number of follow-up exams depends on number of years enrolled in the study))
C: Change in standardized score (Six months after enrollment)
D: Changes of glycosilated haemoglobin (HbA1c) (At least 12 weeks from baseline (visit 3))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Community Health Worker Support to Help Patients Control Chronic Disease
Brief Summary: The purpose of this proposal is to compare the effectiveness of community health worker (CHW) support vs. usual primary care for helping chronically-ill, low-SES patients to improve control of chronic conditions. Upon enrollment each patient will select one of their multiple chronic conditions as a focus for the trial and work with his/her PCP to set a chronic disease management goal. Patients are then randomized to receive usual primary care vs. CHW support for moving towards that goal.


Options:
A: SF-36 Physical Health Summary Scale (Baseline, 6, 18, and 32 months); SF-36 Mental Health Summary Scale (Baseline, 6, 18, and 32 months); Health Services Utilization (Baseline, 8, 20, and 32 months)
B: Health Related Quality of Life according to EuroQoL (5 questions, 3 levels) (12 months)
C: Change in standardized score (Six months after enrollment)
D: All-cause mortality (within 5 years of enrollment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Niños Sanos, Familia Sana (Healthy Children/Healthy Family): A Multi-Intervention Program to Prevent Childhood Obesity in Mexican-Heritage Children in Rural California
Brief Summary: Obesity and overweight are health problems resulting from the interaction of predisposing genes with environmental, economic and social stimuli, in conjunction with excess caloric intake throughout growth from childhood to adulthood. Evidence suggests that a major barrier in controlling overweight/obesity is the complex interrelation of these factors, making single-approach interventions less likely to succeed than integrated, multi-faceted approaches. The proposed project aims to deliver a multi-faceted behavioral intervention developed over the past 18 months by a university-community /school-based collaborative. This project aims to provide new knowledge about the effectiveness of interventions designed specifically to achieve successful weight management among Mexican-origin children ages 3-8, and identify associated mediating factors. Deliverables will include community-based, collaborative and sustainable tools to support weight-management goals in this demographic. UC Davis and UC Cooperative Extension (UCCE) faculty form the investigator team, collaborating on key decision points with the project community in California's Central Valley. The investigators hypothesize that the identified mediating factors will increase fruit and vegetable consumption. The investigators also hypothesize an increase in the intensity and frequency of physical activity among children in the intervention group.


Options:
A: At set time points the following will be measured: Recovery from depression Patient quality of life 1 year before and after: Clinic depression treatment utilization and costs
B: Change in uptake of shared decision-making from the patients' perspective (All clinics: baseline, 8 months, 16 months, 24 months)
C: Reach (Entire 6 month early or delayed implementation phase); Effectiveness - Ask (6 month early implementation phase); Effectiveness - Goal Setting (6 month early implementation phase); Effectiveness - Assistance (6 month early implementation phase); Effectiveness - Referred (6 month early implementation phase)
D: Child BMI (3 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Hospital-based Risk Reduction to Impede Vascular Events After Stroke
Brief Summary: The purpose of this study is to determine whether a culturally-sensitive multipronged post-discharge intervention can significantly reduce blood pressure, enhance achievement of guideline recommended targets for risk factor control, and lower recurrent vascular events in a low-income and middle-income (LMIC). The study will have 2 Phases - a qualitative phase (Phase 1) lasting less than one year involving development of the intervention through focus group methodologies and structured interviews, and a clinical trial phase (Phase 2)lasting 3 years involving a randomized trial testing the efficacy of the intervention.


Options:
A: Reduction in systolic blood pressure (1 year)
B: Blood Pressure (6 months post enrollment into trial); LDL Cholesterol (6 months post enrollment into trial); Use of Anti-thrombotic Medication (6 months post enrollment into trial)
C: Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction (Up to 5 years)
D: Recruitment rates (9 months); Patient Satisfaction Scales (9 months); Clinic based Blood Pressure (9 months); Retention rates (9 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Tailored Hospital-based Risk Reduction to Impede Vascular Events After Stroke
Brief Summary: The purpose of this study is to determine whether a culturally-sensitive multipronged post-discharge intervention can significantly reduce blood pressure, enhance achievement of guideline recommended targets for risk factor control, and lower recurrent vascular events in a low-income and middle-income (LMIC). The study will have 2 Phases - a qualitative phase (Phase 1) lasting less than one year involving development of the intervention through focus group methodologies and structured interviews, and a clinical trial phase (Phase 2)lasting 3 years involving a randomized trial testing the efficacy of the intervention.


Options:
A: Duration and Intensity of Physical Activity (1 month, 3 months and 12 months after discharge)
B: Systolic Blood Pressure (12 weeks)
C: medication adherence (one month)
D: Reduction in systolic blood pressure (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating the Impact of Community Led Total Sanitation in Mali. A Randomized Controlled Trial
Brief Summary: Behavioral change is a key ingredient for successful adoption of better sanitation practices in rural Africa. Sanitation programs have, for some time now, incorporated the need to raise awareness and emphasize the benefits of toilet usage. These endeavors, often combined with subsidies linked to toilet construction by households, seek to create a demand for sanitation goods. Yet, progress in securing the desired outcomes from sanitation programs has been slow. Moreover, benefits of sanitation largely take the form of externalities, which individuals do not take into account when making their own decisions about investments. This makes sanitation promotion at the household level particularly challenging.

A new approach to sanitation entails a shift away from the provision of subsidies for toilets to individual households and a promotion of behavioral change at individual-level towards emphasizing collective decision-making in order to produce 'open defecation-free' villages. The objective of the intervention is to reduce the incidence of diseases related to poor sanitation and manage public risks posed by the failure to safely confine the excreta of some community members. The way to achieve this objective is by empowering communities motivated to take collective action. Local governments and other agencies perform a facilitating role. There is a growing recognition that this approach, referred to as Community-Led Total Sanitation (CLTS), may help with the reduction of open defecation practices. However, no rigorous impact evaluation of CLTS has been conducted so far. This randomized controlled trial will study the effect of CLTS in rural Mali. As a result, sound evidence will become available to see to what extent CLTS improves health outcomes and what is driving collective action in order to increase sanitation coverage.

The direct recipients of the intervention are members of rural communities in Mali who aspire to live in a cleaner environment. The donor community, international organizations, and governments in developing countries will benefit from having simple and clear evidence on the effectiveness of an innovative program for improving sanitation in rural areas. They will learn whether the program has worked or failed to achieve its objective of eradicating open defecation, and about key factors explaining success and failure.


Options:
A: Diarrhea prevalence of children under five years old (Measured 24 months after the baseline survey (12 months after intervention complete))
B: Infant length at 18 months (18 months of age. Protocol and Statistical Analysis Plan are available at https://osf.io/w93hy.); Infant hemoglobin at 18 months (18 months)
C: Diarrhoea (<5s) (21 months)
D: Diarrhea in Children Under 5 (one year after the intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT): Intervening Early to Improve Maternal and Family Well-being.
Brief Summary: We hypothesize that the intervention will: (1) offer a feasible approach for providing mental healthcare to pregnant women and have a high level of acceptability by pregnant women and healthcare providers; (2) reduce symptoms of depression, stress, anxiety, and parenting stress; improve parenting competence, coping, and relationship adjustment compared to usual care; and (3) reduce the risk of poor maternal-infant attachment. As such, this early intervention holds promise for reducing maternal mental health morbidity and its negative influences on infants, children, and families.


Options:
A: The primary outcome of this study is the feasibility/acceptability of integrated psychosocial care and its components. (6 weeks post randomization)
B: Drug abstinence
C: Reduction of risk behaviors:; Active smoking; Environmental Tobacco Smoke Exposure; Depression; Intimate Partner Violence
D: PTSD symptom severity (Measured at Month 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Smoking Cessation and Cognitive Processing Therapy for PTSD
Brief Summary: Posttraumatic stress disorder (PTSD) and cigarette smoking are both associated with significant impairment in Veterans and cost to the Veterans' Affairs (VA) system. Though research suggests smoking is linked with PTSD symptoms, existing smoking cessation treatments targeting PTSD smokers do not include PTSD treatment. The purpose of this study is to examine a treatment that combines evidence based treatment for PTSD (cognitive processing therapy, or CPT) with smoking cessation treatment for PTSD and a mobile text messaging program. The study objectives are to evaluate feasibility of the treatment and to examine effectiveness of CPT and smoking cessation treatment combined compared to smoking cessation treatment without CPT. Fifty Veteran smokers with PTSD will participate in fourteen study sessions, ending with the final follow-up session six months after the scheduled quit date.


Options:
A: 4 week Continuous Quit Rate ( 4 week CQR ) for weeks 9 -12
B: Number of Participants Who Self-report 7-day Point Prevalence Smoking Abstinence at 6-month Follow-up. (6-month follow-up); Number of Participants Who Self-reported 7-day Point Prevalence Smoking Abstinence as Bioverified by Breath Carbon Monoxide < 4 Parts Per Million. (6-month follow-up)
C: 7-day Point Prevalence Quit Rate at End-of-Treatment (EOT) (Week 11)
D: The Number of Participants Reporting 7 Day Point Prevalence Abstinence (12-months); Change in Perceived Stress Scores (Baseline, 4 weeks); Change in Depressive Symptoms Scores (Baseline, 4 weeks)

Answer: B