TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Patient-Centered Risk Stratification Method for Improving Primary Care for Back Pain
Brief Summary: Back pain is one of the most common, controversial and costly problems in healthcare. Despite numerous studies, care for back pain has deteriorated over time and become much more expensive. The risk stratification approach developed in England and found effective in National Health Service general practices in the UK provides a very promising strategy for improving care for back pain in the U.S.

The MATCH trial will use a cluster randomization design involving 6 primary care clinics at Group Health. Of these 6 clinics, 3 will be randomized to receive Group Health's standard training in the use of Group Health back pain guidelines and 3 clinics will receive this standard training plus supplemental training. Primary care clinicians and physical therapists in the intervention group will receive training in the use of the STarTBack risk stratification strategy for matching the most appropriate evidence-based treatments to the needs of patients in each risk level. We will evaluate the effect of this supplemental training on patient outcomes, clinician and physical therapist knowledge and comfort treating patients with back pain, and utilization of services for back pain.


Options:
A: Back pain related dysfunction (6 month); Back Pain Symptom Bothersomeness (6 month)
B: Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 18 months (Measured at baseline, 6, 12 and 18 months after randomisation)
C: Adjuvant Endocrine Therapy (AET) Medication Adherence (Up to Month 12)
D: Quality Of Life In Epilepsy (QOLIE)-31 global score (Month 18); Adverse Events Profiles (AEP) score (Month 18)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Informed Decisions About Lung Cancer Screening: Randomized Trial
Brief Summary: Educational research study where goal is to test educational materials that help people make informed decisions about lung cancer screening.


Options:
A: Mean Value: Preparation for Decision Making© Scale (Assessment at 1-week follow-up.); Mean Value: Informed Subscale of the Decisional Conflict Scale© (Assessment at 1-week follow-up.); Mean Value: Values Clarity Subscale of the Decisional Conflict Scale© (Assessment at 1-week follow-up.)
B: Change in Depressive symptoms (3, 6 and 12 months.)
C: Trial feasibility measured with number of patients recruited for study who have consented and participate for the duration of the study. (1 year)
D: Number of participants compliant with endocrine therapy as assessed by Morisky Green Levine (MGL) scale (12 months after the onset of endocrine therapy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: An Evaluation of the Immune Response to Pentavalent Rotavirus Vaccine After a Supplemental Dose Given at 9 Months of Age With Local EPI Vaccines in Mali
Brief Summary: This study is an evaluation of the immune response to pentavalent rotavirus vaccine (PRV) after an additional fourth dose is given at 9 months of age with local World Health Organization (WHO) Expanded Programme on Immunization (EPI) vaccines in Mali.


Options:
A: Occurrence of severe RV GE caused by the wild RV strains from 2 weeks after Dose 2 until two years of age. Occurrence of definite IS cases within 31 days (Day 0 -Day 30) after each HRV vaccination dose.
B: Number/Percentage of Subjects With Seroconversion for Anti-measles Immunoglobulin G (IgG) Antibody (28 days post-vaccination); Number/Percentage of Subjects With Seroresponses for Yellow Fever Neutralizing Antibody (28 days post-vaccination)
C: Safety of Rotavin-M1 vaccine in healthy adult volunteers (3 months)
D: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain (From 2 weeks after the last vaccine or placebo dose up to 1 year of age)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Eating vs Skipping Breakfast on Postprandial Hyperglycemia After Subsequent Isocaloric Lunch and Dinner in Type 2 Diabetic Patients
Brief Summary: Background: Skipping breakfast and/or overeating at evening, has been associated in type 2 diabetic (T2D) individuals, with higher BMI, visceral adiposity, hyperlipidemia, increased overall postprandial glycemia (PPHG) and higher HbA1c. The absence of breakfast is also associated with increased plasma free fatty acids (FFA) along the morning until lunch. High plasma FFA in turn are triggering factor of insulin resistance, by inhibiting insulin mediated glucose uptake in obese and T2D subjects The investigators therefore hypothesize that compared to eating breakfast the prolonged overnight fasting caused by the breakfast omission will result in increased postprandial glycemic response after subsequent isocaloric lunch and dinner in T2D individuals.

Objectives: With this aim will study T2D patients in randomized crossover design to consume in two separate days, either 3 standard isocaloric meals: Yes Breakfast condition (YesB) or omit breakfast: no breakfast condition (NoB) and consume only lunch and dinner with the same caloric content.

Methods and Study Design: The YesB intervention will consist on three identical meals coating 700 Kcal each: breakfast at 8:00, lunch at 13:00 and dinner at 19:00. The NoB intervention the breakfast will be omitted and the subject continue fasting until lunch. Then the participants will consume identical 700 kcal Lunch at 13:00 and 700 Kcal dinners at 19:00. The investigators will assess plasma glucose, insulin, C-peptide, GLP-1 and FFA with blood samples collected every 30 min up to 180 min after breakfast, lunch and dinner and at the same time point the blood samples will be collected after 8:00 when the breakfast will be omitted.

Expected results: The investigators expect that compared to NoB condition, in the YesB condition the postprandial response after lunch and dinner will be reduced for glucose and for FFA, while plasma insulin, C-peptide and GLP-1 postprandial response after lunch and dinner will be enhanced


Options:
A: Measure of plasma glucose (5 weeks)
B: Revised QUICKI (RQUICKI) (Baseline); RQUICKI (day 29); RQUICKI (day 31)
C: Body weight (Change from baseline to week 24)
D: Body Weight (Baseline to month 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)
Brief Summary: Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is usually mild, but can cause serious illness or death. The purpose of this study is to test the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune immunoglobulin or IVIG) in people who are hospitalized for severe flu.


Options:
A: Number of Patients in Each of 6 Clinical Status Categories on Day 7 (Assessed on Day 7)
B: Clinical Status at Day 7 (Day 7)
C: Mortality (From date of randomization until the date of death from any cause during hospitalization, assessed up to 6 months)
D: Time to Normalization of Respiratory Status (Primary Efficacy Population) (Measured from Day 0 through Day 28)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)
Brief Summary: Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is usually mild, but can cause serious illness or death. The purpose of this study is to test the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune immunoglobulin or IVIG) in people who are hospitalized for severe flu.


Options:
A: Number of Patients in Each of 6 Clinical Status Categories on Day 7 (Assessed on Day 7)
B: Time to Normalization of Respiratory Status (Primary Efficacy Population) (Measured from Day 0 through Day 28)
C: Death versus survival of treated patients (Up to 8 weeks)
D: Development of severe respiratory disease defined as a respiratory rate (RR)>30 and/or an O2 sat<93% (From 12 hours post infusion to day 15 post infusion)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)
Brief Summary: Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is usually mild, but can cause serious illness or death. The purpose of this study is to test the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune immunoglobulin or IVIG) in people who are hospitalized for severe flu.


Options:
A: death (within 7 days)
B: N/A
C: Mortality (From date of randomization until the date of death from any cause during hospitalization, assessed up to 6 months)
D: Number of Patients in Each of 6 Clinical Status Categories on Day 7 (Assessed on Day 7)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the DIABEO System in Poorly Controlled DM1 or DM2 Patients Treated With a Basal-bolus Insulin Regimen
Brief Summary: The aim of the TELESAGE study is to demonstrate

1. the superiority of follow up with the DIABEO system (software alone) versus usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a basal-bolus insulin regimen.
2. the superiority of follow up with the DIABEO system (software + telemonitoring) compared to usual follow up in terms of improvement in HbA1c after 1 year in DM1 or DM2 patients treated with a basal-bolus insulin regimen.

The DIABEO software alone is an electronic diary system incorporating an immediate automatic aid to calculating the insulin dose according to the prescription given by the doctor, and a data processing, automated analysis message and secure internet data transfer system.

The DIABEO software added by paramedical telemonitoring is the electronic diary combined with remote paramedical monitoring of data (telemeonitoring)


Options:
A: Specialist referral rate per 100 patients seen (to medical specialties available through eConsult) (24 months)
B: Efficacy data: change in HbA1c, measured at 1 year minus the value baseline (one year)
C: Relative dose intensity (Assessed every 30 days from randomization up to 6 months)
D: Changes in mean SBP (From baseline (T1) to 12 months (T3))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparative Effectiveness and Cost-effectiveness of a Fall Prevention Intervention: Tai Ji Quan: Moving for Better Balance
Brief Summary: Objective: To conduct a comparative efficacy and cost-effectiveness study of an evidence-based fall prevention program-Tai Ji Quan: Moving for Better Balance (TJQMBB).


Options:
A: Falls rate (6 months post intervention)
B: Change in the number of falls (Baseline, 6 Months)
C: Fall incidence, which is measured by monthly fall registration cards
D: Cognitive Performance of Executive Function (12 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A EUROPEAN, MULTICENTRE, PHASE II/III RANDOMISED DOUBLE-BLIND, PLACEBO CONTROLLED STUDY EVALUATING LANREOTIDE AS MAINTENANCE THERAPY IN PATIENTS WITH NON-RESECTABLE DUODENO-PANCREATIC NEUROENDOCRINE TUMOURS AFTER FIRST-LINE TREATMENT
Brief Summary: This European, prospective, multicentre, double-blind randomised study will evaluate the effect of lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours.


Options:
A: Change of standardized uptake value of 68Ga-DOTA-TATE before and after the treatment in metastatic neuroendocrine tumors (1 year); the safety of 3.7GBq of 177Lu-DOTA-EB-TATE with and without amino acid infusion. (1 year)
B: Change From Baseline in the Number of Bowel Movements (BMs) Per Day Averaged Over 12 Weeks (Baseline and 12 Weeks); Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Treatment Period (First dose of study drug to within 30 days of last dose of study drug in the Double-Blind Treatment Period (Up to 17.6 Weeks)); Number of Participants With TEAEs in the Open-Label Extension Period (First dose of study drug to within 30 days of last dose of study drug in the Open-Label Extension Period (Up to 54.3 Weeks))
C: Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review (Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010)
D: Proportion of Patients Alive and Progression-free at 6 Months (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Novel Long Lasting Insecticidal Net and Indoor Residual Spray Product, Separately and Together, Against Malaria Transmitted by Pyrethroid Resistant Mosquitoes.
Brief Summary: The proposed study is a four-arm randomized control trial (RCT) in 48 villages in the Lakes region in Tanzania comparing the relative effectiveness of 4 vector control interventions for reducing malaria transmission and controlling vector populations in an area where An gambiae s.s is pyrethroid and carbamate resistant: 1/ a standard long lasting insecticidal net (LLIN), 2/ a LLIN which incorporates a piperonyl butoxide (PBO) synergist, 3/ a long lasting indoor residual spray (IRS) formulation used in conjunction with standard pyrethroid LLIN or 4/ the long lasting indoor residual spray (IRS) formulation used in conjunction with the LLIN which incorporates a PBO synergist.

The trial will provide epidemiological, entomological, economic and social evidence of impact, as the investigators shall be measuring the reductions in malaria prevalence and malaria transmission rates EIR, and changes in the frequency of resistance, mosquito species ratios and economic cost effectiveness. The proposed trial will demonstrate whether the novel LLIN and long lasting IRS formulation will be more effective for controlling An.gambiae s.s. and reducing malaria prevalence than current practice with the conventional LLIN. There is great interest in conducting this trial. Alternative vector control products are limited and most new insecticides are not suitable for use on LLINs or as IRS.


Options:
A: Difference in prevalence of malaria infection in children 0.5-14 years between intervention arms (up to 36 months); Difference in Entomological Inoculation Rate (up to 36 months)
B: Malaria Incidence (3 years)
C: Prevalence of malarial infection in children 6 months to 10 years (9 months post randomisation)
D: Cost per case averted in children five years of age and under at health facility level by adding Actellic-IRS (24 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Novel Long Lasting Insecticidal Net and Indoor Residual Spray Product, Separately and Together, Against Malaria Transmitted by Pyrethroid Resistant Mosquitoes.
Brief Summary: The proposed study is a four-arm randomized control trial (RCT) in 48 villages in the Lakes region in Tanzania comparing the relative effectiveness of 4 vector control interventions for reducing malaria transmission and controlling vector populations in an area where An gambiae s.s is pyrethroid and carbamate resistant: 1/ a standard long lasting insecticidal net (LLIN), 2/ a LLIN which incorporates a piperonyl butoxide (PBO) synergist, 3/ a long lasting indoor residual spray (IRS) formulation used in conjunction with standard pyrethroid LLIN or 4/ the long lasting indoor residual spray (IRS) formulation used in conjunction with the LLIN which incorporates a PBO synergist.

The trial will provide epidemiological, entomological, economic and social evidence of impact, as the investigators shall be measuring the reductions in malaria prevalence and malaria transmission rates EIR, and changes in the frequency of resistance, mosquito species ratios and economic cost effectiveness. The proposed trial will demonstrate whether the novel LLIN and long lasting IRS formulation will be more effective for controlling An.gambiae s.s. and reducing malaria prevalence than current practice with the conventional LLIN. There is great interest in conducting this trial. Alternative vector control products are limited and most new insecticides are not suitable for use on LLINs or as IRS.


Options:
A: Annual clinical malaria incidence rate (Clinical malaria will be monitored for up to 60 months)
B: Difference in prevalence of malaria infection in children 0.5-14 years between intervention arms (up to 36 months); Difference in Entomological Inoculation Rate (up to 36 months)
C: Decrease in Parasite prevalence according to RDT (6 months); Decrease in Parasite prevalence according to PCR (6 months); Total and confirmed outpatient (OPD) malaria case incidence and inpatient (IPD) malaria case incidence among all ages (12 months)
D: Malaria Incidence (3 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Negative Pressure Wound Therapy in High Risk Patients Undergoing Cesarean
Brief Summary: The investigators propose a prospective, randomized trial evaluating the use of negative pressure wound therapy (NPWT) with high risk obstetrical patients. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators aim to look at all wound complications such as infection and disruption and will be using Prevena incision management system for our NPWT device .


Options:
A: Early Complications of Vascular Zone (2 weeks)
B: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)
C: Incisional Dehiscence (last post operative visit, up to 2 years); Post operative infection (last post operative visit, up to 2 years)
D: Number of Participants With Wound Complication (Day of surgery to 30 days postoperative); Number of Participants With Classification of Wound Morbidity (Day of Surgery to 30 days postoperative)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Negative Pressure Wound Therapy in High Risk Patients Undergoing Cesarean
Brief Summary: The investigators propose a prospective, randomized trial evaluating the use of negative pressure wound therapy (NPWT) with high risk obstetrical patients. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators aim to look at all wound complications such as infection and disruption and will be using Prevena incision management system for our NPWT device .


Options:
A: Number of Participants With Wound Complication (Day of surgery to 30 days postoperative); Number of Participants With Classification of Wound Morbidity (Day of Surgery to 30 days postoperative)
B: Number of Participants With Wound Complications (Four weeks after cesarean section)
C: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)
D: Early Complications of Vascular Zone (2 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Negative Pressure Wound Therapy in High Risk Patients Undergoing Cesarean
Brief Summary: The investigators propose a prospective, randomized trial evaluating the use of negative pressure wound therapy (NPWT) with high risk obstetrical patients. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators aim to look at all wound complications such as infection and disruption and will be using Prevena incision management system for our NPWT device .


Options:
A: Surgical Site Infection (30 days)
B: Number of Participants With Wound Complication (Day of surgery to 30 days postoperative); Number of Participants With Classification of Wound Morbidity (Day of Surgery to 30 days postoperative)
C: Groin Wound Complication (30 days)
D: Change from baseline ASEPSIS score of wound healing at 6 weeks. (Baseline and 6 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Negative Pressure Wound Therapy in High Risk Patients Undergoing Cesarean
Brief Summary: The investigators propose a prospective, randomized trial evaluating the use of negative pressure wound therapy (NPWT) with high risk obstetrical patients. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators aim to look at all wound complications such as infection and disruption and will be using Prevena incision management system for our NPWT device .


Options:
A: Surgical Site Infection (30 days)
B: Number of Participants With Wound Complication (Day of surgery to 30 days postoperative); Number of Participants With Classification of Wound Morbidity (Day of Surgery to 30 days postoperative)
C: Incisional Dehiscence (last post operative visit, up to 2 years); Post operative infection (last post operative visit, up to 2 years)
D: Wound infection rate (Wounds will be checked at 3 month follow-up)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of a Self-Management Group-Intervention on Participation in Post-Stroke Patients.
Brief Summary: Stroke is defined as a sudden vascular accident that causes brain damage and neurological impairment. Literature shows that a stroke has a negative effect on participation. Self-Management (SM) is defined as health promotion and education programs used mostly for people with chronic diseases, which aim at helping patients to maintain a feeling of wellness. The primary aim of this study is to assess the effectiveness of a group-based SM program for post-stroke patients in a community setting, and its contribution to improving participation, compared to standard care.


Options:
A: Frontal Assessment Battery (3 months)
B: Patient Participation (12 and 36 weeks)
C: Change from baseline in the Montreal Cognitive Assessment (Baseline, End (4-6 weeks) and 8-weeks follow-up)
D: Change scores of Montreal Cognitive Assessment (MoCA) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Memory Scale - Third Edition (WMS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Useful Field of View (UFOV) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop Color-Word test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))

Answer: B