TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Targeted Screening of At-Risk Adults for Acute HIV-1 Infection
Brief Summary: In this research, the investigators want to see if early detection of HIV infection can be improved by testing young adults who seek urgent health care from pharmacies and healthcare facilities with symptoms similar to those people get with recent HIV infection.

Specific objectives:

1. What proportion of people presenting with these symptoms are HIV positive at the point of seeking urgent health care?
2. What proportion of those who test negative or where the result is unclear (one rapid test positive and one negative) at first rapid HIV testing, will test positive two weeks later?
3. What is the best way (SMS, phone call or home visit) to remind people to come for the second test after two weeks?
4. Will young adults who seek urgent health care for fever, body pains, diarrhoea or an STD from pharmacies or health facilities find it acceptable to be invited for an HIV-1 test at the time of health care seeking?

Hypotheses

1. Targeted screening for AHI among patients seeking health care for symptoms compatible with AHI or sexually transmitted disease (STD) will identify AHI cases in more than 1% of those screened.
2. Intense follow-up of patients evaluated for AHI will improve rates of repeat HIV-1 testing 2-4 weeks after initial health-care seeking, relative to standard practice (i.e., recommendation to return for testing on a given date).


Options:
A: Biometrically confirmed abstinence (3-6 months); Quitline call rates (1-6 months); Knowledge as measured by survey items (1-6 months)
B: Adherence to ART and HIV RNA suppression (6,12 months)
C: Prevalence of Influenza Vaccination of those who do receive text message reminders compared to those who do not. (Up to 5 months)
D: Difference in Number and proportion of adults responding to standard appointment versus intense follow up. (2 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Should we Associate Dexamethasone and Ondansetron to Closed-loop Anesthesia to Reduce the Incidence of Postoperative Nausea and Vomiting After Bariatric Surgery?
Brief Summary: The investigators want to test if it is indicated to associate dexamethasone and ondansetron in obese patients having bariatric surgery under total intra-venous closed-loop anesthesia.


Options:
A: incidence and severity of postoperative nausea and vomiting (upto 2 days after surgery)
B: Postoperative nausea or vomiting (24 hours)
C: Effect of Granisetron and Ondansetron on QTc interval Prolongation at various time intervals after administration (0 mins (before injection of study drug), 2 mins, 5 mins, 15mins, 1 hour and 2 hours)
D: Incidence of akathisia (1 day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2 Study of MK-3475 in Patients With Microsatellite Unstable (MSI) Tumors
Brief Summary: This study will be looking at whether MK-3475 (an antibody that blocks negative signals to T cells) is effective (anti-tumor activity) and safe in three different patient populations. These include: 1. patients with MSI positive colon cancer, 2. patients with MSI negative colon cancer and 3. patients with other MSI positive cancers.


Options:
A: Recurrence-free survival: loco-regional, adrenal, kidney and distant-metastases were the events considered for event-free survival.
B: Progression-free Survival (Randomization until progression (up to 2 years))
C: Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2 (20 weeks); Immune-related Objective Response Rate in MSI Positive and Negative Colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2 (28 months); Immune-related Progression Free Survival (irPFS) at 20 Weeks in MSI Positive Non-colorectal Adenocarcinoma Participants Using Immune Related Response Criteria (irRC) During Stages 1 and 2 (20 weeks); Objective Response Rate in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (28 months); Progression Free Survival (PFS) at 20 Weeks in MSI Positive Solid Tumor Malignancies Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (20 weeks)
D: Progression-Free Survival (PFS): Independent-Assessment (Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of an Electronic Alert Into the Primary Care Medical Health Record to Increase Participation in a Population Colorectal Cancer Screening Program.
Brief Summary: The implementation of screening programs for colorectal cancer by screening for fecal occult blood has proven effective in reducing the incidence and mortality from this type of neoplasms. However, to ensure the efficiency of the programs require population participation rates of at least 50%. Experiences in our country show that the population participation is far from this recommended minimum number.

Interventions to promote preventive activities in primary care are well received by the population; in the case of colorectal cancer, direct recommendation of primary care professionals to carry out the screening is one of the factors with greatest impact on increasing population participation in such programs. Care overload, circuit design for screening without the direct intervention of primary care professionals and the multiplicity of tasks that they must face, are elements that influence the low recommendation for screening in the target population who consults for any other reason.

The introduction of specific reminders in electronic medical record (in widespread use in primary care), as a tool to facilitate and encourage direct referral by physicians and nurse practitioners to perform colorectal cancer screening will mean an increase of at least 10% in participation of the target population, increasing the efficiency of screening programs. The introduction of this new software tool will have good acceptance and increase compliance with recommendations from health professionals.


Options:
A: Adherence to ART and HIV RNA suppression (6,12 months)
B: Patient's status participation to colorectal cancer screening program (one year)
C: Median "Laboratory turn-around-time" (TAT) (Days from the date a culture or drug susceptibility test (DST) result is obtained to the date when the result is obtained at health center); Percent laboratory errors, by type of error for health establishments in the intervention versus the control group. (2.5 years)
D: extent to which a computer-based clinical decision-support system (accompanying computerized provider order-entry) can improve the quality of medication ordering and monitoring (two years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Wearable Pulsed Electromagnetic Fields Device in Knee Osteoarthritis Patients: a Double Blinded, Randomized Clinical Trial
Brief Summary: The aim of the study is to evaluate the efficacy of a wearable device using pulse electromagnetic fields on pain intensity reduction, measured by visual analogue score (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in patients affected by osteoarthritis Secondary aim is the evaluate the effect on knee effusion reduction, when present and to evaluate pain intensity changes corrected by pain threshold measured by pressure algometry.


Options:
A: Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4 (baseline and 4 weeks); Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4 (baseline and 4 weeks)
B: Numerical rating scale of pain (NRS) : (collected at baseline up to 3 months after therapy)
C: Pain evaluation (1 year follow up)
D: Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (Change from baseline at 9 weeks, 1 year and 2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physiologic Comparison Between Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) and Pressure Support (PS) in Preterm Infants
Brief Summary: Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a nasal cannula, in premature infants postextubation. Patients will undergo a 30-min crossover trial of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and airway pressure (Paw) are recorded to derive neural and mechanical respiratory rate and timing, inspiratory trigger delays time of synchrony between diaphragm contraction and ventilator assistance, and the asynchrony index (AI).


Options:
A: Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support. (At 7 days after non-invasive respiratorynsupport.)
B: Extubation failure (apnea rate and respiratory failure.)
C: Trigger Delay (last 5-min of each 15-min trial)
D: combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. (corrected age of 18 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Physiologic Comparison Between Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) and Pressure Support (PS) in Preterm Infants
Brief Summary: Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a nasal cannula, in premature infants postextubation. Patients will undergo a 30-min crossover trial of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and airway pressure (Paw) are recorded to derive neural and mechanical respiratory rate and timing, inspiratory trigger delays time of synchrony between diaphragm contraction and ventilator assistance, and the asynchrony index (AI).


Options:
A: Trigger Delay (last 5-min of each 15-min trial)
B: Efficacy of nasal intermittent mandatory ventilation (IMV) and nasal continuous positive airway pressure (CPAP) in early rescue surfactant treatment in preterm infants (3 months)
C: Need for Endotracheal Ventilation in the First 72 hs of Life (first 72 hs of life); Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) (first 3 days of life(72hours))
D: Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support. (At 7 days after non-invasive respiratorynsupport.)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Physiologic Comparison Between Noninvasive Neurally Adjusted Ventilatory Assist (NAVA) and Pressure Support (PS) in Preterm Infants
Brief Summary: Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a nasal cannula, in premature infants postextubation. Patients will undergo a 30-min crossover trial of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and airway pressure (Paw) are recorded to derive neural and mechanical respiratory rate and timing, inspiratory trigger delays time of synchrony between diaphragm contraction and ventilator assistance, and the asynchrony index (AI).


Options:
A: Trigger Delay (last 5-min of each 15-min trial)
B: Need for Endotracheal Ventilation in the First 72 hs of Life (first 72 hs of life); Mechanical Ventilation Within the First 72h of Life in the Two Study Groups.(NIPPV vs NCPAP) (first 3 days of life(72hours))
C: Composite of survival to 36 weeks gestational age, free of moderate-severe bronchopulmonary dysplasia (36 weeks gestational age)
D: The rate of successful extubation with either mode of NCPAP (Day 7 post primary extubation)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Rivaroxaban With Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects With Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure
Brief Summary: The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.


Options:
A: Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke (Randomization up to 12 months); Participants With Any Major Bleeding Event (First dosing up to 12 months)
B: Yearly Event Rate for Composite Endpoint of Stroke/SEE (36 months)
C: Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (From start of study treatment until follow-up (up to 390 days))
D: Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke (Up to Global treatment end date (approximately 54 months)); Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability (Up to 227 Weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Rivaroxaban With Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects With Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure
Brief Summary: The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.


Options:
A: Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke (Up to Global treatment end date (approximately 54 months)); Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability (Up to 227 Weeks)
B: Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days (Up to Day 35 + 6 days); Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days (Up to Day 10 + 5 days)
C: acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke (30 months intake; 12-42 months follow-up)
D: Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death (From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in adolescent outpatients (12-17) with major depressive disorder.


Options:
A: The primary objective is to compare the antidepressant efficacy, safety, and tolerability of DVS-SR in subjects receiving daily doses of 50 mg or 100 mg of DVS SR versus subjects receiving placebo.
B: Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106) (Baseline and Week 8)
C: Alcohol Use Behaviors (Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase.); Depressive Symptoms (Average score as measured by participant's report on the Beck Depression Inventory (BDI).)
D: Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score (From Baseline to week 8)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya
Brief Summary: The project goal is to conduct a randomized controlled trial (RCT) to test whether mobile phone short message system (SMS) reminders, either with or without mobile-phone based travel subsidies will improve timeliness, coverage, and drop-out rates of routine EPI vaccines in rural western Kenya.


Options:
A: Percent of children immunized (Up to 12 months of age)
B: Neurodevelopment as measured by the Protocol for Child Monitoring - Infant and Toddler version assessment (12 months of age)
C: prevalence of participants with at least one of the following four complications: pregnancy-induced hypertension, gestational diabetes mellitus, caesarean section, large-for-gestational age baby (at the time of delivery 2nd pregnancy (max pregnancy duration 44 weeks))
D: Number of Timely Vaccinations Received (Up to 6 months after birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya
Brief Summary: The project goal is to conduct a randomized controlled trial (RCT) to test whether mobile phone short message system (SMS) reminders, either with or without mobile-phone based travel subsidies will improve timeliness, coverage, and drop-out rates of routine EPI vaccines in rural western Kenya.


Options:
A: Immunization Rate (12 months)
B: Percent of children immunized (Up to 12 months of age)
C: Completion of vaccine primary series (12 months of age)
D: Neonatal death (28 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya
Brief Summary: The project goal is to conduct a randomized controlled trial (RCT) to test whether mobile phone short message system (SMS) reminders, either with or without mobile-phone based travel subsidies will improve timeliness, coverage, and drop-out rates of routine EPI vaccines in rural western Kenya.


Options:
A: Percent of children immunized (Up to 12 months of age)
B: Measles vaccination coverage (10 months)
C: The rate of the Exclusive Breastfeeding (from birth of baby to 6 months post birth)
D: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized Controlled Trial of the Impact of Mobile Phone Delivered Reminders and Travel Subsidies to Improve Childhood Immunization Coverage Rates and Timeliness in Western Kenya
Brief Summary: The project goal is to conduct a randomized controlled trial (RCT) to test whether mobile phone short message system (SMS) reminders, either with or without mobile-phone based travel subsidies will improve timeliness, coverage, and drop-out rates of routine EPI vaccines in rural western Kenya.


Options:
A: Full on time early vaccination coverage (OPV0 and BCG) (First month of life)
B: Cumulative adverse event (AE) rate (moderate or severe) (≤ Day 14 for each participant with analysis completed in year 1.); Mean number of in-person visits (Before 42 day visit for each participant with analysis completed in year 1.); 2wT costs (The costing data collection will be completed by April 2018 at the completion of all study participant follow-up. Analysis will conclude in year 1); 2WT acceptability (The acceptability activities will be completed by April 2018 at the completion of all study participant follow-up with analysis to commence after that point. Analysis will conclude in year 1.); 2WT feasibility (The feasibility activities be completed by April 2018 at the completion of all study participant follow-up with analysis to commence after that point. Analysis will conclude in year 1.)
C: Immunization coverage (12 months); Timeliness of receipt of scheduled immunization (12 months)
D: Percent of children immunized (Up to 12 months of age)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase I Randomised Trial to Evaluate the Safety and Immunogenicity of MVA85A-IMX313 Compared to MVA85A in Bacille Calmette-Guérin (BCG) Vaccinated Adults
Brief Summary: This is a Phase I trial to evaluate the safety and immunogenicity of MVA85A-IMX313 vaccination compared to MVA85A vaccination, in BCG vaccinated adults.


Options:
A: Culture and RT-PCR quantification of BCG in challenge site biopsy (10 weeks post biopsy)
B: To assess the safety of a new tuberculosis vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime, to healthy volunteers, who have previously been vaccinated with BCG (3 months)
C: Safety (1 year)
D: Safety evaluation through actively and passively collected data on adverse events (Up to 24 weeks)

Answer: D