TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Comparative Effectiveness Trial Of Financial Incentives Versus Usual Care For Smokers Hospitalized In The Veterans Affairs Hospital System
Brief Summary: The investigators plan to compare the impact of two approaches for smoking cessation on smoking abstinence, use of evidenced-based therapy, and quality of life among a diverse population of patients at the Manhattan campus of the VA New York Harbor Healthcare System, which serves a critical safety-net role for urban veterans. During hospitalization, all smokers will receive usual care. Patients will be randomized to one of two arms: financial incentives plus usual care vs. usual care alone, which includes referral to the state Quitline. All patients enrolled in the study will be offered nicotine replacement therapy. The investigators will conduct follow-up assessments at 2 weeks, 2 months, 6 months and 12 months after discharge. The primary study outcome is smoking abstinence at 6-month follow-up, verified by salivary/urinary cotinine.


Options:
A: smoking, self-report (6 months follow-up)
B: Quitting success rates at the end of the 1st, 3rd and 6th month (6 months)
C: Smoking abstinence assessed by self-reported and biochemically verified by salivary cotinine (6 months)
D: Continuous abstinence Weeks 13 -24.

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Very Intensive Variable Repetitive AmbulatioN Training
Brief Summary: The overall objective of this subproject is to evaluate the individual and paired contributions of intensity and variability of stepping training on lower extremity (LE) function, health and community participation in patients with chronic hemiparesis post-stroke.


Options:
A: Change in 10 meter walk test (Pre Test, 4 weeks, 8 weeks, 3 month follow up)
B: Fugl-Meyer Assessment (before and after intervention)
C: Change in peak walking speed (At baseline, following 8 weeks of training and a 2 month follow-up)
D: Fugl-Meyer Assessment (upper extremity subscale) (0-, 4- week)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Very Intensive Variable Repetitive AmbulatioN Training
Brief Summary: The overall objective of this subproject is to evaluate the individual and paired contributions of intensity and variability of stepping training on lower extremity (LE) function, health and community participation in patients with chronic hemiparesis post-stroke.


Options:
A: The change in Tinetti Performance Oriented Mobility Assessment (week 0, week 5, and week 9)
B: Change in peak walking speed (At baseline, following 8 weeks of training and a 2 month follow-up)
C: Improvement of postural control measured with the trunc control test (TCT) on day 9 after admission to the hospital (Day 1-9 after admission to hospital (+/- 1))
D: Functional motor recovery assessed by a composite endpoint (one for upper limbs and one for lower limbs) (After one year of treatment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 2b Randomized, Double-blind Study to Evaluate the Efficacy of MEDI7510 for the Prevention of Acute Respiratory Syncytial Virus-associated Respiratory Illness in Older Adults
Brief Summary: This study will be the first assessment of the efficacy of MEDI7510 for the prevention of respiratory syncytial virus (RSV) disease. It will also provide estimates of vaccine efficacy and of endpoint incidence in the placebo arm. It will also assess the safety and immunogenicity of concurrent dosing of MEDI7510 and IIV to expand on the observations made in the Phase 1b study of MEDI7510. It will also expand the safety database of participants dosed with MEDI7510. The study will also assess the immune response to MEDI7510 in Season 1 and Season 2.


Options:
A: Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm (At the end of the entire study period (16 months)); Cumulative Number of Reported Episodes of Infectious Disease in the Arm Over the Total Number of Follow-up Weeks in the Arm (At the end of the study period (16 months))
B: Percentage of Participants Who Had a First Episode of Acute Respiratory Syncytial Virus-Associated Respiratory Illness (ARA-RI) During Respiratory Syncytial Virus (RSV) Surveillance Period in Season 1 (Day 14 after dosing through end of surveillance period (approximately 7 months))
C: Frequency of vaccine-related reaction events and other adverse events in each cohort (Throughout study); Amount of vaccine virus shed by each participant (Throughout study); Amount of serum antibody and mucosal antibody induced by the vaccine in each participant (Throughout study)
D: Number of Subjects With Solicited Local Symptoms (During the 7-day (Days 0-6) post-vaccination period); Number of Subjects With Solicited General Symptoms (During the 7-day (Days 0-6) post-vaccination period); Number of Subjects With Unsolicited Adverse Events (AEs) (During the 30-Day (Days 0-29) post-vaccination period); Number of Subjects With Serious Adverse Events (SAEs) (From vaccination at Day 0, up to Day 30 post-vaccination); Titres of RSV-A Neutralizing Antibodies (At Day 0 pre-vaccination); Titres of RSV-A Neutralizing Antibodies (At Day 30 post-vaccination)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The POP-study: Effect of Probiotics on Weight, Microbiota and Glucose Tolerance in Obese Pregnant Women and Their Newborn - a Randomized, Double-blind Placebo Controlled Trial With Vivomixx®
Brief Summary: The purpose of the study is to investigate if the probiotics Vivomixx® can affect gestational weight gain, microbiota and pregnancy complications in pregnant obese women and birth weight body composition of their infants.


Options:
A: Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts (Weekly during the first 6 months after birth)
B: Gestational weight gain (week 36-37 of pregnancy); Change in glucose levels (Oral glucose tolerance test) (baseline (week 14-20) and 27-30 of pregnancy)
C: 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)
D: Changes in Body Toxin Levels (Before and after the 25 day intervention period.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The POP-study: Effect of Probiotics on Weight, Microbiota and Glucose Tolerance in Obese Pregnant Women and Their Newborn - a Randomized, Double-blind Placebo Controlled Trial With Vivomixx®
Brief Summary: The purpose of the study is to investigate if the probiotics Vivomixx® can affect gestational weight gain, microbiota and pregnancy complications in pregnant obese women and birth weight body composition of their infants.


Options:
A: 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)
B: The rate of women who will require pharmacotherapy for glycemic control. (During the length of pregnancy (up to 9 months)); Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products. (2 weeks)
C: Gestational weight gain (week 36-37 of pregnancy); Change in glucose levels (Oral glucose tolerance test) (baseline (week 14-20) and 27-30 of pregnancy)
D: Prevalence of gestational diabetes mellitus, GDM (Assessed at gestational weeks 24-28); Fasting glucose levels (assessed at the third trimester of pregnancy); Prevalence of allergy in child (assessed at 12 and 24 months of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vitamin D3 for Autism Spectrum Disorder: a Randomized, Double-blind, Placebo-controlled Trial.
Brief Summary: To build on a recent case study and open label trial, the investigators want to find out if vitamin D supplementation can influence behavioural and core symptoms of autism.


Options:
A: Serum interleukin-6 (At trial entry and 7 days after daily vitamin D supplementation therapy); Serum tumor necrosis-alpha (At trial entry and 7 days after daily vitamin D supplementation therapy)
B: Change from baseline in stereotypic behaviour from the aberrant behaviour checklist (Day 1 and day 140)
C: Vitamin D Status (7 days)
D: Serum 25-hydroxy vitamin D [25(OH)D] Levels (1 year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: WEB-Based Physiotherapy for People With Multiple Sclerosis
Brief Summary: The study will be a pragmatic, single blind, randomised, controlled feasibility study, comparing 6 months of web-based physiotherapy plus usual care with usual care alone in pwMS. The study will recruit 90 pwMS from three UK Centres (30 from each centre); NHS Ayrshire and Arran, NHS Lothian, and Plymouth Hospitals NHS Trust.

The aim of this study is to assess the feasibility of a randomised controlled trial examining the effectiveness of a six-month web-based physiotherapy programme and usual care compared to usual care alone, in people moderately affected by MS and to gather essential information for the planning of a definitive trial, which would evaluate both clinical and cost effectiveness of the intervention.


Options:
A: Quality of life (At inclusion (baseline), change from baseline at 3, 6 and 12 months)
B: Composite of COPD Hospital Readmission/Death Within 6 Month of Discharge (6 months post-discharge from hospitalization following COPD exacerbation)
C: Change from baseline peak VO2 (ml/kg/min) at 12 week (Baseline, 12 week); Change from baseline MLHFQ at 12 week (Baseline,12 week)
D: Compliance to the exercise programme (9 months); Two Minute Walk Test (9 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Text Messages to Increase Attendance to Follow-up Cervical Cancer Screening Appointments Among HPV Positive Tanzanian Women (Connected2Care)
Brief Summary: This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance rate to cervical cancer screening follow-up appointments.


Options:
A: Effect of SMS intervention on attendance rate to follow-up screening appointment (up to 14 months)
B: Proportion of women who received a Pap smear within 6 months from the date when the study randomization began. (6 months after randomization of study)
C: contraceptive continuation (6 months)
D: Number of eligible participants who consent and complete study intervention (1-4 days postpartum)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Text Messages to Increase Attendance to Follow-up Cervical Cancer Screening Appointments Among HPV Positive Tanzanian Women (Connected2Care)
Brief Summary: This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance rate to cervical cancer screening follow-up appointments.


Options:
A: Effect of SMS intervention on attendance rate to follow-up screening appointment (up to 14 months)
B: Uptake of the timed appointment provided by the screening service (Usually within a month (Individual timed appointment is provided by the screening service))
C: Patient retention in care (12 months)
D: Confirmed HBV and HCV test uptake (enrollment - 4 weeks after enrollment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Text Messages to Increase Attendance to Follow-up Cervical Cancer Screening Appointments Among HPV Positive Tanzanian Women (Connected2Care)
Brief Summary: This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance rate to cervical cancer screening follow-up appointments.


Options:
A: Recent HIV Testing (past 6 months); Condom Use with Clients (Past 1 month); Condom Use with boyfriend/husband/romantic partner (Past 1 month); Contraceptive Prevalence Rate (Past 1 month); Abortion Rate (Past 6 months); Workplace Alcohol Consumption (Past 6 months); Gender-Based harassment rate (Past 6 months); Gender-based violence rate (Past 6 months); STI Screening (Past six months)
B: Effect of SMS intervention on attendance rate to follow-up screening appointment (up to 14 months)
C: Exclusive breastfeeding duration (Six months)
D: Full on time early vaccination coverage (OPV0 and BCG) (First month of life)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Text Messages to Increase Attendance to Follow-up Cervical Cancer Screening Appointments Among HPV Positive Tanzanian Women (Connected2Care)
Brief Summary: This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance rate to cervical cancer screening follow-up appointments.


Options:
A: The rate of the Exclusive Breastfeeding (from birth of baby to 6 months post birth)
B: MV Coverage at 12 months of age (12 months of age)
C: Effect of SMS intervention on attendance rate to follow-up screening appointment (up to 14 months)
D: HIV-1 Viral Load (log10 Transformed) (Past 90 days); Self-reported Medication Adherence (Past 30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Crowd Funding and Social Networks as a Novel Mechanism to Promote Sustainable Physical Growth and Positive Psychosocial and Neurodevelopmental Outcomes in Severely Stunted Guatemalan Children
Brief Summary: This study seeks to evaluate the impact of an intensive home-based education intervention targeting severely stunted Guatemalan children for catch up growth and improved development. Half of the children in the study will receive standard of care, which includes micronutrient supplementation and a food ration. The other half of children in the study will receive, in addition to the above, home-based dietary assessment and individualized parental nutrition education.


Options:
A: Change in Height/Length for Age Z Score (Baseline, 6 months)
B: Weight-for-Length Percentile (Weight and length were measured at both pre-treatment (when infant was 3 months of age) and post-treatment (when infant was 9 months of age).); Appetite Regulation (The BEBQ was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).); Fruit and Vegetable Variety (The Block Food Frequency Questionnaire was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).)
C: Change in the prevalence of stunting (<-2 SD of the WHO, 2006 growth reference standards) (6-8, 12-16, 20-24 (main outcome time point), 36 months, 7-10 years)
D: Percent of infants sleeping 5 consecutive hours at night at 2 months of age (2.5 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health "(NiPPeR)"
Brief Summary: The study aims to assess whether a nutritional drink taken before conception and continuing through pregnancy, assists in the maintenance of healthy glucose metabolism in the mother and promotes offspring health.


Options:
A: Number of Participants With Composite Neonatal Morbidity (Delivery through discharge of infant from hospital up to 120 days); Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex (Age 5-10 years)
B: Glucose tolerance during pregnancy (Pregnancy Oral Glucose Tolerance Test (OGTT) measurement at 24 - 32 weeks gestation)
C: Prevalence of gestational diabetes mellitus, GDM (Assessed at gestational weeks 24-28); Fasting glucose levels (assessed at the third trimester of pregnancy); Prevalence of allergy in child (assessed at 12 and 24 months of age)
D: The rate of women who will require pharmacotherapy for glycemic control. (During the length of pregnancy (up to 9 months)); Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products. (2 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing Tobacco Use Disparities in Rural Older Adults Through an Innovative Mobile Phone Intervention: Testing the Feasibility of the Textto4gotobacco Intervention
Brief Summary: The purpose of this study is to evaluate the feasibility, acceptability and preliminary efficacy of a Scheduled Gradual Reduction (SGR) intervention via SMS (short message service) text messaging plus SMS Support Messages in decreasing smoking in an older adult rural population. The SGR group (n=20) will receive a four-week SGR program delivered via SMS text messages plus SMS support messages. The control group (n=20) will receive SMS support messages to aid in quitting.


Options:
A: smoking cessation (52 weeks)
B: Tobacco cessation, defined as quit rate at 30 days, as measured by self-reported abstinence from tobacco use (30-days)
C: Change from baseline in number of smoked cigarettes/day at 6, 17 and 29 weeks (6, 17 and 29 weeks); Change from baseline in percentage of carbon monoxide in exhalation air at 6, 17 and 29 weeks (6, 17 and 29 weeks)
D: Number of Participants With Prolonged Abstinence Through 6 Months Verified by Carbon Monoxide Measurement (6 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention
Brief Summary: The purpose of this study is to test the effects of a group smoking cessation program. The study will also examine individual differences in response to the intervention program.


Options:
A: Prolonged Abstinence Rates (6-month)
B: 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)
C: Self-reported prolonged abstinence and cotinine-validated point-prevalence abstinence at 1 year follow-up (1 year)
D: smoking cessation (6-months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention
Brief Summary: The purpose of this study is to test the effects of a group smoking cessation program. The study will also examine individual differences in response to the intervention program.


Options:
A: 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)
B: 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)
C: Three month point-prevalence abstinence from cigarettes (3 months post-intervention)
D: Emotional Reactivity By Pharmacotherapy (Baseline to 1 month); Emotional Reactivity By Pharmacotherapy Moderated by DRD2 A1 Allele (Baseline to 1 month)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Randomized, Controlled, Double-Arm, Open-Label, Multi-center Study of VB-111 Combined With Bevacizumab vs. Bevacizumab Monotherapy in Patients With Recurrent Glioblastoma
Brief Summary: The purpose of this pivotal, phase 3, randomized, multicenter study is to compare VB-111 plus bevacizumab to bevacizumab in adult patients with recurrent Glioblastoma.


Options:
A: Objective response, as determined by the independent review facility (IRF) (Complete response or partial response, determined on two consecutive assessments ≥4 weeks apart); Progression-free survival, as determined by the IRF (6 months)
B: Overall survival (From date of study entry until the date of death from any cause (up to 10 years))
C: Progression Free Survival (PFS) (Baseline at 6 weeks and then every 6 weeks to discontinuation)
D: Overall Survival (at 12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Introducing Child Menus in Restaurants to Improve Access to Healthier Foods
Brief Summary: This study will introduce healthy child menu items into 8 independent full service restaurants in San Diego County. The restaurants will be assigned either to receive new, healthy kids' menu items or to receive the new menu items in addition to marketing materials and staff trainings to support promotion of these new menu items. The primary outcome for the study is sales of kids' menu items. Additional customer observation and interview data will be collected, as well as manager interviews and restaurant environment assessments. Process evaluation measures will also evaluate the implementation of the intervention.


Options:
A: Rate Support of a Label on a 1 (not at all) to 7 (a great deal) Scale. (Immediately following the presentation of the labels.)
B: Change from Baseline in Kilocalories of Sugar-Sweetened Beverages at 6 months (baseline, 6-months)
C: Overweight (one school year)
D: Sales ($) of kids' menu items (weekly throughout study period (4 wk baseline, 8 wk Ix phase, 4 week post-ix))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Clinical Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy: One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy
Brief Summary: The aim of this study is to investigate a new pancreaticojejunal (PJ) anastomosis procedure named "One-layer duct-to-mucosa pancreaticojejunostomy" in pancreatoduodenectomy, which could provide a feasible option to pancreatic surgeons for patients with pancreaticoduodenectomy.


Options:
A: the postoperative pancreatic fistula(POPF) rate (30 days)
B: The primary endpoint will be the pancreatic fistula rate. (1 year)
C: The frequency of pancreatic fistula including ISGPF grade B and C (Ninety days after operation)
D: postoperative pancreatic fistula(POPF) rate (30 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Study of a Tele-pharmacy Intervention for Chronic Diseases to Improve Treatment Adherence (STIC2IT)
Brief Summary: The purpose of this cluster randomized controlled trial is to evaluate whether a novel tele-pharmacist-based intervention for patients with hyperlipidemia, hypertension, and diabetes improves medication adherence, disease control, and patients' understanding of their treatment.


Options:
A: The comparison of change in vascular monitoring process total score (proportion of process targets met in group) between intervention and control groups. (6 months to 1 year)
B: Medication Adherence (12 months)
C: Cardiovascular mortality (Sept 2010); MI (non fatal) (Sept 2010); Stroke (non fatal) (Sept 2010); Revascularisation (operating procedures) (Sept 2010); Amputations, non traumatic (Sept 2010)
D: Hemoglobin A1c (1 year after date of discharge)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Study of a Tele-pharmacy Intervention for Chronic Diseases to Improve Treatment Adherence (STIC2IT)
Brief Summary: The purpose of this cluster randomized controlled trial is to evaluate whether a novel tele-pharmacist-based intervention for patients with hyperlipidemia, hypertension, and diabetes improves medication adherence, disease control, and patients' understanding of their treatment.


Options:
A: Combined adherence endpoint (at Visit 2 (follow-up visit after 3 months of intervention period))
B: Blood Pressure Control (blood pressure (SBP/DBP) <140/90 mmHg)) (At 1 year from the time of initiation of the intervention); Mean HbA1c (At 1 year from the time of initiation of the intervention)
C: Medication Adherence (12 months)
D: Systolic blood pressure (12-months)

Answer: C