TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, 24-Week Treatment, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids
Brief Summary: Primary Objective:

To evaluate the efficacy of dupilumab 300 milligram (mg) every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyposis (NP). In addition for Japan participants, reduction in computed tomography (CT) scan opacification of the sinuses was a coprimary objective.

Secondary Objectives:

* To evaluate the efficacy of dupilumab in improving total symptoms score (TSS).
* To evaluate the efficacy of dupilumab in improving sense of smell.
* To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (primary objective for Japan).
* To evaluate ability of dupilumab in reducing proportion of participants requiring treatment with systemic corticosteroids or NP surgery.
* To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life outcome by sinonasal outcome test-22 (SNOT-22).
* To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and co-morbid asthma (including non-steroid antiinflammatory drug \[NSAID\] exacerbated respiratory disease \[ERD\]).
* To evaluate residual effect in follow up.
* To evaluate the safety of dupilumab in participants with bilateral NP.
* To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment-emergent anti-drug antibodies.


Options:
A: Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score (Baseline, Week 24); Change From Baseline at Week 24 in Nasal Polyp Score (Baseline, Week 24)
B: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Week 52); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Week 52)
C: Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population (Baseline to Week 52); Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population (Baseline, Week 12)
D: Change in Nasal Polyp Score (Week 5 and Week 25)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, 24-Week Treatment, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids
Brief Summary: Primary Objective:

To evaluate the efficacy of dupilumab 300 milligram (mg) every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyposis (NP). In addition for Japan participants, reduction in computed tomography (CT) scan opacification of the sinuses was a coprimary objective.

Secondary Objectives:

* To evaluate the efficacy of dupilumab in improving total symptoms score (TSS).
* To evaluate the efficacy of dupilumab in improving sense of smell.
* To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (primary objective for Japan).
* To evaluate ability of dupilumab in reducing proportion of participants requiring treatment with systemic corticosteroids or NP surgery.
* To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life outcome by sinonasal outcome test-22 (SNOT-22).
* To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and co-morbid asthma (including non-steroid antiinflammatory drug \[NSAID\] exacerbated respiratory disease \[ERD\]).
* To evaluate residual effect in follow up.
* To evaluate the safety of dupilumab in participants with bilateral NP.
* To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment-emergent anti-drug antibodies.


Options:
A: Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score (Baseline, Week 24); Change From Baseline at Week 24 in Nasal Polyp Score (Baseline, Week 24)
B: Mucosal thickness on CT scan (after 6 months of treatment)
C: Frequency of Clinical Asthma Exacerbations (CAEs) During 12 Months of Treatment (Day 1 to Month 12); Frequency of Each of the Two Criteria for Clinical Asthma Exacerbations (CAEs) (Day 1 to Month 12)
D: Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population (Baseline, Week 12); Absolute Change From Baseline in FEV1 at Week 12: ITT Population (Baseline, Week 12)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Compensatory Movements in Stroke Therapy Through the Use of Robotic Devices and Augmented Feedback, 3rd Phase
Brief Summary: The project targets stroke survivors to investigate the effect of augmented feedback (using robotic force cues and visual feedback) and rewards (game scores), on their upper limb reaching patterns and trunk compensatory movements


Options:
A: Recruitment (Through study completion, an average of 1.5 months.); Retention (Through study completion, an average of 1.5 months.); Participation (Through study completion, an average of 1.5 months.); Adherence (Through study completion, an average of 1.5 months.); Acceptability and enjoyment (Through study completion, an average of 1.5 months.); Safety and Adverse events (Through study completion, an average of 1.5 months.); Device development or modifications (Through study completion, an average of 1.5 months.); Fatigue (Through study completion, an average of 1.5 months.); Patient Global Impression of Change (Through study completion, an average of 1.5 months.)
B: Change in Anterior Trunk Displacement (Baseline, 1 hour (after completing 1st feedback condition) and 2 hours (after completing 2nd feedback condition))
C: MIP (maximal inspiratory pressure) (At the beginning and the end of program respectively, up to 6 weeks.); MEP (maximal expiratory pressure) (At the beginning and the end of program respectively, up to 6 weeks.)
D: Timed get up and go (eight weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomized Open-label Multi-center Study of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation
Brief Summary: Assess the efficacy and safety of ruxolitinib compared to Best Available Therapy (BAT) in patients with corticosteroid-refractory acute graft vs. host disease (aGvHD) after allogeneic stem cell transplantation.


Options:
A: Percentage of Participants With Grade II-IV Acute GVHD Between the 2 Groups (180 days after HCT)
B: Incidence of acute GVHD, and chronic GVHD (2 years)
C: Primary: Early treatment failure defined by the occurrence of severe acute GvHD (°III-°IV) or early mortality within 100 days post transplantation. (100 days)
D: Overall Response Rate (ORR) at Day 28 (Day 28)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: RE-SPECT CVT: a Randomised, Open-label, Exploratory Trial With Blinded Endpoint Adjudication (PROBE), Comparing Efficacy and Safety of Oral Dabigatran Etexilate Versus Oral Warfarin in Patients With Cerebral Venous and Dural Sinus Thrombosis Over a 24-week Period
Brief Summary: This is a multi-center, prospective, international, randomized (1:1), open-label study with two parallel groups. This phase III study is planned to investigate the efficacy and safety of dabigatran etexilate versus dose-adjusted warfarin on a net clinical benefit endpoint of major bleeding (ISTH criteria) and new venous thrombotic event (VTE) (primary endpoint) with blinded endpoint adjudication.


Options:
A: Percentage of Participants With Composite of Venous Thrombotic Event (VTE) or Major Bleeding Event (MBE) According to International Society on Thrombosis and Haemostasis (ISTH) Criteria in Full Observation Period. (From first administration of trial medication until 6 days after last administration of trial medication, up to 25 weeks.)
B: Safety of nadroparine or heparin (DAY 3,7,30,90); Efficacy of nadroparine or heparin (DAY 3,7, 30, 90)
C: Rate of symptomatic hemorrhagic transformation (within 5 weeks of treatment initiation)
D: Number of Participants With a Composite Endpoint of Fatal Stroke, Recurrent Ischemic Stroke, or TIA (180 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: MHealth Interventions to Improve Access and Coverage of Uninsured People With High Cardiovascular Risk in Argentina.
Brief Summary: Cardiovascular disease (CVD) accounts for approximately one-third of Argentina's deaths. Despite the availability of management and treatment for CVD which is offered to the uninsured population at government primary care clinics (PCCs), the rates at which those at risk are screened, identified and referred to the clinics are very low. This study will determine if providing CHWs with an mHealth application using an integrated, inexpensive and validated screening tool on cell phones for screening in the community which is linked with the PCC scheduling system wirelessly allowing the CHWs to make appointments at the time they identify high-risk individuals, will increase the number of referral and follow-up visits that patients attend at the PCCs.


Options:
A: Change in Mean Systolic Blood Pressure (12 months)
B: Adherence to ART and HIV RNA suppression (6,12 months)
C: Impact of mHealth app on rate of uninsured persons who are at risk and attend a first visit with a health professional at a local government primary care clinic. (6 weeks)
D: Change in Physical Activity (PA) as Measured by the Study-provided Monitoring Device (Change from Baseline in objectively monitored physical activity at one year after randomization)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Exercise and Intensive Vascular Risk Reduction in Preventing Dementia
Brief Summary: Physical inactivity, high blood pressure and dyslipidemia are risk factors for Alzheimer's disease (AD) and vascular dementia. Importantly, these risk factors are modifiable with lifestyle changes, pharmacological treatment, or both. The rrAD study will determine effects of aerobic exercise training and intensive vascular risk reduction on cognitive performance in older adults who have high risk for AD.


Options:
A: Mobility - Measured by Change in Gait Speed (Change from baseline to 36 months)
B: Change in global neurocognitive function (2 Years)
C: The primary study outcomes are composite of non-fatal stroke, non-fatal myocardial infarction and cardiovascular death. (3-4 years)
D: ONTARGET. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months); ONTARGET. 3-fold Composite Endpoint of Doubling of Serum Creatinine, Progression to End Stage Renal Disease (ESRD) and All-cause Mortality in Diabetic Nephropathy Patients (56 months); TRANSCEND. Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke and Hospitalization for Congestive Heart Failure (56 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Recent studies showed the benefits of early initiation and advancement enteral feeds with daily increments in preterm infants on decreasing invasive infections and early achievement of full enteral feedings. But the data on enteral feeds of extremely low birthweight infants are limited. Preterm infants especially those \<1250 gr birthweight are at increased risk of developing feeding intolerance and necrotizing enterocolitis (NEC) and so the initiation and the rate of increments of enteral feeds are usually uncertain issues for neonatologists.


Options:
A: Time to reach full feeds (First 40 days after birth)
B: Postnatal day when enteral feeding exceeded at 100ml/kg/day (From birth untill the date of enteral feeding first exceeded at 100ml/kg/day or date of death from any cause, whichever came first, assesed up to 27 days after birth)
C: incidence of feeding intolerance (28 days); time to reach full enteral feedings sustained for 72 hours. (72 hours)
D: the incidence of combined death and necrotizing enterocolitis (at 36 weeks correct gestational age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mass Drug Administration of Monthly DHA-PQP to Accelerate Towards Malaria Elimination in Magude District, Southern Mozambique
Brief Summary: In line with the global and regional efforts towards malaria elimination, a five year program was established to assist the NMCP in adopting targeted evidence-based elimination plans through a 'learn by doing' strategy. The project aims to generate knowledge as data is generated to inform the programmatic aspects of the elimination plan, most importantly how to clear malaria parasites from the asymptomatic reservoir.


Options:
A: Parasite prevalence during the high transmission season among children <6 years old (excluding neonates <1 month) (For up to 12 months); P.falciparum infection incidence rate among individuals ≥3 months (For up to 12 months)
B: Cumulative notified malaria incidence in the MDA and control Shehias (6 months after second round of MDA)
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 morbidity by active and passive case detection. (during the entire study period); asexual parasite prevalence and density by microscopy, rapid diagnostic test and molecular QT-NASBA (monthly during the entire study period); gametocyte prevalence and density by QT-NASBA and microscopy (monthly during the entire study period); transmission intensity quantified by entomologic inoculation rate (continuously during the study period); human infectious reservoir (prior to the intervention and several months after the intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Mass Drug Administration of Monthly DHA-PQP to Accelerate Towards Malaria Elimination in Magude District, Southern Mozambique
Brief Summary: In line with the global and regional efforts towards malaria elimination, a five year program was established to assist the NMCP in adopting targeted evidence-based elimination plans through a 'learn by doing' strategy. The project aims to generate knowledge as data is generated to inform the programmatic aspects of the elimination plan, most importantly how to clear malaria parasites from the asymptomatic reservoir.


Options:
A: 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)
B: Cost per case averted in children five years of age and under at health facility level by adding Actellic-IRS (24 months)
C: Prevalence of malarial infection in children 6 months to 10 years (9 months post randomisation)
D: Incidence (Up to 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Immunogenicity and Safety Study of Two Formulations of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks
Brief Summary: The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study.


Options:
A: Occurrence of RV GE
B: To assess immunogenicity of a new rotavirus vaccine Rotavin-M1 in terms of anti-rotavirus IgA antibody seroconversion 1 month after complete the vaccination schedule (up to 7 months)
C: Rotavirus vaccine lots Immunogenicity (Four weeks after the third dose of vaccination); Immunogenicity of UIP vaccines (Four weeks after the third dose of vaccination)
D: Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations in the Human Rotavirus (HRV) Liquid Formulation Groups (Liq_A, Liq_B and Liq_C) (At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)); Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to Cut-off Value in Porcine Circovirus (PCV) -Free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Control Group (At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)); Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to 20 U/mL in Porcine Circovirus (PCV)-Free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group (At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)); Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Lyophilised Control Group (At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)); Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group (At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Women's Heart Attack Research Program: Stress Ancillary Study; Telephone-Based Stress Management for Women With Myocardial Infarction
Brief Summary: The Women's HARP study is a multi-center study focusing on women with clinical presentation of myocardial infarction (MI). Women will complete stress questionnaires following presentation to the medical center with elevated cardiac enzymes and abnormal electrocardiograms (ECGs). 2 months following MI, participants will be screened for the Stress Ancillary Study and enrolled if an elevated level of perceived stress is reported. After completing baseline assessments, participants will be randomized to Enhanced Usual Care (EUC) or stress management for 8 weeks. Participants will be followed for 6 months.


Options:
A: Progression of albuminuria (1,2,3,4 and 5 year)
B: Change in Weight (Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3)); Change in Psychological Well-Being (Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3)); Change in Psychological Treatment (Baseline, after 4 weeks (Time 1), after 6 months (Time 2), after 1 year (Time 3))
C: Perceived Stress Scale (PSS-10) scores (6 months)
D: composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke (every six months for an average of 5.4 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Imaginator: a Pilot of a Brief Functional Imagery Training Intervention for Self-harm in Young People, Supported by a Smart-phone 'App'
Brief Summary: Self-harm has substantial personal impacts as well as costs on the National Health Service (NHS). Around 13-17% of young people report experiences of self-harm. In Cambridgeshire, this is a significant issue with the number of admissions to hospital for self-harm in young people being higher than the United Kingdom (UK) average. Treating underlying mental illness can lead to a reduction in self-harm, but these are long interventions for complex disorders and many people who self-harm are not under treatment for mental illness. Moreover, young people struggle to access traditional mental health services where these therapies are delivered. No short interventions specifically tailored for young people have been developed so far.

The Imaginator project aims to address the urgent need for an effective and innovative short-term therapy for self-harm in young people. The investigators will pilot a new imagery-based psychological intervention for young people aged 16-25 who experience repetitive self-harm. Mental imagery (the experience of "seeing through the mind's eye") can carry intense emotions (positive and negative), and imagining something can facilitate behaviour. Imagery-based therapies have proven useful (i) for problems that feature intense, hard to manage emotions such as those associated with self-harm, and (ii) for promoting healthy behaviour. Our new intervention called Functional Imagery Training will support young people to imagine more adaptive behaviours to cope with the emotional distress that triggers self-harm, and motivate them to reduce self-harm. Imaginator will comprise of just two sessions followed by phone support over three months.

Moreover, the investigators will address the challenge of young people accessing and staying in therapy by using a smartphone app to support the therapy, as apps are widely used and favoured by this age group. The app will enable participants to continue with the strategies they have learnt in therapy by themselves, thus ensuring a potential longer-term benefit and self-empowerment.


Options:
A: Suicidal thoughts or attempts (Measured at Year 2)
B: Suicide Attempts (Assessed bimonthly)
C: N/A
D: Reduced Self-harm (3 months)

Answer: D