TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Double-Masked, Randomized Study of the Efficacy and Safety of Intravitreal Aflibercept Injection in Patients With Moderately Severe to Severe Nonproliferative Diabetic Retinopathy
Brief Summary: The primary objective of the study is to assess the efficacy of intravitreal (IVT) aflibercept compared to sham treatment in the improvement of moderately severe to severe nonproliferative diabetic retinopathy (NPDR).

The secondary objectives of the study are:

* To characterize the safety of IVT aflibercept in patients with moderately severe to severe NPDR
* To determine if IVT aflibercept will prevent the worsening of diabetic retinopathy and reduce the incidence of DME
* To determine the anatomic effects of IVT aflibercept in patients with moderately severe to severe NPDR


Options:
A: Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy (Measured at Year 4)
B: Mean Change in Visual Acuity From Baseline (2-years)
C: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. (4.9 years); First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial. (4.7 years); First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial. (4.7 years)
D: Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 Groups (At Week 24); Percentage of Participants With a ≥ 2-step Change at Week 52 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline (At Week 52)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis
Brief Summary: The main purpose of this study is to evaluate the efficacy and safety of the study drug ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.


Options:
A: Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)); PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device (Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration))
B: Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on endothelial function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on vascular function in psoriasis (12 weeks); Comparison of effect (improvement or deterioration) of treatment with biological vs. non biological agents on cardiac function in psoriasis (12 weeks)
C: Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1) (Week 12)
D: Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1) (Week 12); Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Part 1) (Week 12); Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1) (Up to Week 12); Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1) (Up to Week 12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis
Brief Summary: The main purpose of this study is to evaluate the efficacy and safety of the study drug ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.


Options:
A: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 (Baseline, Week 4)
B: Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1) (Week 12)
C: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 (Week 16)
D: Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis
Brief Summary: The main purpose of this study is to evaluate the efficacy and safety of the study drug ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.


Options:
A: Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest (From Day 169 to Day 729); Short-term Period: Number of Participants With ACR 20 Response at Day 169 (At Day 169 from Baseline)
B: Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1) (Week 12)
C: Percentage of Participants Who Achieve a PASI75 Response at Week 16 Compared With Baseline (Week 0) (Week 0 and Week 16)
D: Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16 (Week 16)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis
Brief Summary: The main purpose of this study is to evaluate the efficacy and safety of the study drug ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.


Options:
A: Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75 at Week 12 (0-12 weeks); Percentage of Participants With Static Physician Global Assessment (sPGA) Score Success (Score of 0 or 1) at Week 12 (0 - 12 Weeks)
B: Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) (Week 12 (or end of trial if prior to Week 12)); Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Base Study) (Baseline and Week 12 (or end of trial if prior to Week 12)); Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study) (Up to 12 weeks); Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study) (Up to 12 weeks)
C: Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16); Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear or Almost Clear at Week 16 in Participants Who Received Risankizumab Compared With Placebo (Part A) (Week 16)
D: Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1) (Week 12)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective Randomized Controlled Trial to Evaluate the Effect of Infant Formula on the Resolution of Cow's Milk Allergy of Infancy
Brief Summary: Primary Endpoint

-The percentage of subjects who develop tolerance to cow's milk protein by 12 months post randomization to study formula.

Secondary Endpoints

* Tolerance

  * The transcriptional profile of milk-specific T cells by clinical outcome.
  * Growth and Weight Velocity
  * Stool Consistency and Frequency
  * The estimated frequency of milk-specific T cells by clinical outcome.
  * The TCR diversity of milk-specific T cells by clinical outcome.
  * The milk allergen component-specific IgE, IgG4 and IgA by clinical outcome.
* Safety

  * The rate of reported adverse events by treatment group.


Options:
A: Weight (14 days of age to 112 days of age)
B: Study to assess the allergic symptoms, using a questionnaire. (5 months)
C: The percentage of subjects who develop tolerance to cow's milk protein by 12 months post randomization to study formula. (12 months post randomization)
D: Weight (Study Day (SD) 1, 28 and 84)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Triggered Palliative Care for Advanced Dementia
Brief Summary: The objective of this study is to generate preliminary data for a large multi-site randomized clinical trial of a model of palliative care consultation for patients with advanced dementia, and for their family caregivers.


Options:
A: Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days) (From time of hospital discharge up to 60 days)
B: Post Traumatic Stress Disorder (90 days after baseline)
C: Aim 1: feasibility and acceptability of learning Motivational Interviewing techniques by palliative care clinicians (Through study completion, an average of 1 year.)
D: Mean Patient-centered Communication in Advanced Cancer Score (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Triggered Palliative Care for Advanced Dementia
Brief Summary: The objective of this study is to generate preliminary data for a large multi-site randomized clinical trial of a model of palliative care consultation for patients with advanced dementia, and for their family caregivers.


Options:
A: Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF) (Baseline to week 24); Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF) (Week 24)
B: Hospital / Emergency Visits Per 60 Days (no. of Events/Follow-up Days) (From time of hospital discharge up to 60 days)
C: Hospital Transfer Rate in Target Cohort (12-month observation period)
D: Decisional Conflict Scale (3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Reducing Hazardous Alcohol Use & Human Immunodeficiency Virus (HIV) Viral Load: A Randomized Controlled Trial (RCT) in Antiretroviral Therapy (ART) Clinics in Vietnam
Brief Summary: The purpose of this study is to compare the effectiveness of two interventions \[a Brief Intervention (BI) and a Motivational Enhancement Therapy+Cognitive Behavioral Therapy (MET+CBT) Intervention\], against each other and with an assessment-only control, in improving both alcohol- and HIV-related outcomes, among hazardous and heavy drinking HIV-infected antiretroviral therapy (ART) clinic clients in Thai Nguyen, Vietnam.


Options:
A: Alcohol use and STI/HIV infection (up to 12 months)
B: Post-intervention ASSIST screening score. (3 months)
C: Alcohol use (12 months); HIV viral load (12 months)
D: Number of Participants With and Without Non-hazardous Drinking, as Determined by Self-report and the Biomarker Phosphatidylethanol, at 3- and 6-months. (Both 3 months and 6 months (composite measure)); Number of Participants With >90% Isoniazid (INH) Adherence During Prescribed Course of INH (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Determinants of Olfactory Dysfunction in Chronic Rhinosinusitis
Brief Summary: Olfactory dysfunction is a cardinal symptom of chronic rhinosinusitis, a disease which affects 12.5% of the adult population across all racial and ethnic groups. Previous research has documented olfactory deficit in 68% of patients with chronic rhinosinusitis and 20% with complete anosmia, suggesting that olfactory dysfunction affects over 25 million individuals in the United States with chronic rhinosinusitis. This proposed investigation will be used to predict olfactory outcomes following treatments for chronic rhinosinusitis and gain insights into mechanisms of olfactory dysfunction in this population.


Options:
A: Smell sensation improvement (4 weeks)
B: Symptom Reduction (28 days)
C: improvement of olfaction (3 weeks)
D: Sniffin' Stick olfactory testing (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Determinants of Olfactory Dysfunction in Chronic Rhinosinusitis
Brief Summary: Olfactory dysfunction is a cardinal symptom of chronic rhinosinusitis, a disease which affects 12.5% of the adult population across all racial and ethnic groups. Previous research has documented olfactory deficit in 68% of patients with chronic rhinosinusitis and 20% with complete anosmia, suggesting that olfactory dysfunction affects over 25 million individuals in the United States with chronic rhinosinusitis. This proposed investigation will be used to predict olfactory outcomes following treatments for chronic rhinosinusitis and gain insights into mechanisms of olfactory dysfunction in this population.


Options:
A: Change in Brief Smell Identification Test (BSIT) (Week 0 and Week 6); Change in Brief Smell Identification Test (BSIT) in Participants With Severe Olfactory Dysfunction (Week 0 and Week 6); Change in Brief Smell Identification Test (BSIT) in Participants With Laboratory-Confirmed COVID-19 and Severe Olfactory Dysfunction (Week 0 and Week 6); Change in Brief Smell Identification Test (BSIT) in Participants With Laboratory-Confirmed COVID-19 (Week 0 and Week 6)
B: Sniffin' Stick olfactory testing (6 months)
C: Patient with more than 2 points on the ODORATEST (30 days)
D: improvement of olfaction (3 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Determinants of Olfactory Dysfunction in Chronic Rhinosinusitis
Brief Summary: Olfactory dysfunction is a cardinal symptom of chronic rhinosinusitis, a disease which affects 12.5% of the adult population across all racial and ethnic groups. Previous research has documented olfactory deficit in 68% of patients with chronic rhinosinusitis and 20% with complete anosmia, suggesting that olfactory dysfunction affects over 25 million individuals in the United States with chronic rhinosinusitis. This proposed investigation will be used to predict olfactory outcomes following treatments for chronic rhinosinusitis and gain insights into mechanisms of olfactory dysfunction in this population.


Options:
A: Patient with more than 2 points on the ODORATEST (30 days)
B: Recovery of smell (T1 (30 days), T2 (60 days), T3 (90 days))
C: Sniffin' Stick olfactory testing (6 months)
D: Recovery rate of anosmia and shorten recovery time (30 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Determinants of Olfactory Dysfunction in Chronic Rhinosinusitis
Brief Summary: Olfactory dysfunction is a cardinal symptom of chronic rhinosinusitis, a disease which affects 12.5% of the adult population across all racial and ethnic groups. Previous research has documented olfactory deficit in 68% of patients with chronic rhinosinusitis and 20% with complete anosmia, suggesting that olfactory dysfunction affects over 25 million individuals in the United States with chronic rhinosinusitis. This proposed investigation will be used to predict olfactory outcomes following treatments for chronic rhinosinusitis and gain insights into mechanisms of olfactory dysfunction in this population.


Options:
A: Patient with more than 2 points on the ODORATEST (30 days)
B: improvement of olfaction (3 weeks)
C: Smell sensation improvement (4 weeks)
D: Sniffin' Stick olfactory testing (6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness Meditation Using a Smart-phone Application for Women With Chronic Pelvic Pain
Brief Summary: Chronic pelvic pain (CPP) in women is common, painful and disabling and puts much strain on women's lives and the (National Health Service) NHS.

CPP may be related to internal organs, the nervous system or psychological factors and is often difficult to treat. Surgery and drugs have risks and side effects, are expensive and do not help all patients.

Psychological treatments have potential to improve CPP but are not consistently available. Mindfulness meditation teaches people to accept their sensations and emotions in the present moment. This can help to accept pain better, which enables patients to focus on daily activities and improve their quality of life. It has been shown to help in headache, back pain and depression. Usually mindfulness meditation is taught by attending courses for 8 weeks.

The investigators want to find out in a full-scale trial if mindfulness meditation, taught by using a smartphone app, can help CPP patients.

In preparation for this full-scale study the investigators will conduct the MEMPHIS study to answer the following questions:

* How many patients are willing to participate?
* How often they use the app?
* Reasons for not wanting to participate/not using the app -

  - Which health questionnaires are the most useful ones?
* How many patients will be required for the full-scale trial?

Patients will receive the usual treatment and be divided into three groups

* using a 60-day mindfulness meditation app,

  -- using comparison app with progressive muscle relaxation but no meditation
* no app

Patients will complete health questionnaires, may be asked to comment in a focus group and record pain, medication changes, surgery and emergency medical visits


Options:
A: Health Distress Scale at six months and one year; Activities Limitation Scale at six months and one year; Self Efficacy for Management of Arthritis Scale at six months and one year; Stretching and strengthening exercise at six months and one year; Visits of Physicians at six months and one year
B: Duration of recruitment (6 months); Patient adherence to app use (first 8 weeks post-randomisation)
C: Change over time in Catastrophizing (Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU); Change over time in (Dis)ability/ pain screening (Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU); Change over time in Work ability (Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU); Change over time in Functioning (Pre-post treatment (meaning Baseline and week 7), 3- and 6-month FU)
D: Change in catastrophizing cognitions (T1: At the start of in-house rehabilitation T2: At the end of in-house rehabilitation - begin situational feedback intervention T3: End of situational feedback intervention T4: 6 month after T1 T5: 12 months after T1)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Measuring and Understanding the Effects of a Performance Based Financing Scheme Applied to Nutrition Services in Burundi
Brief Summary: The government of Burundi is implementing a new financing scheme in health centres. The objective is to provide additional financial compensations to health centres on the basis of their performance in nutrition activities: it consists in the introduction of criteria focusing on malnutrition prevention and care activities in the existing performance based financing (PBF) system.

The general objective of this study is to assess the effects of this new financing scheme, to document its impact and to study the chains through which it occurred. This study will provide key evidence for countries with an existing PBF scheme and confronted with malnutrition problems on the appropriateness to extend the strategy to nutrition services. If this impact evaluation brings positive results, this may have implications for the global fight against malnutrition.


Options:
A: Change in recovery rate of acute malnutrition in children below five years old over two years (26 months from baseline; endline survey in December 2016); Difference in prevalence of acute malnutrition among children aged 6-23 months between Dec 2014 and Dec 2016 (Two years from baseline; endline survey in December 2016)
B: Number of Participants Who Present Children for HIV Testing (2 months); Number of Days Participants Take to Bring Children for HIV Testing (2 months)
C: In-hospital case-fatality
D: Proportion of children under 5 years of age who are treated with antimalarials following a negative malaria test (At one year post-intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Mass Drug Administration (MDA) for Reducing Seasonal Malaria Transmission Towards Its Elimination in Hotspot Areas in Zanzibar - a Cluster-randomised Controlled Trial
Brief Summary: The overall aim of this study is to determine the effectiveness of two rounds of mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHAp) + single low dose (SLD) primaquine for reducing seasonal malaria transmission in Shehias considered hotspots on Unguja Island, Zanzibar.


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: Cumulative notified malaria incidence in the MDA and control Shehias (6 months after second round of MDA)
C: 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)
D: prevalence of falciparum malaria measured by qPCR (quantitative real time polymerase chain reaction), 12 months after the first administration of treatment with dihydroartemisinin-piperaquine and primaquine. (1017-13 and 23-15) (12 months); prevalence of falciparum malaria measured by qPCR (quantitative real time polymerase chain reaction), 12 months after the first administration of targeted malaria elimination (1015-13) (12 months); prevalence of falciparum malaria measured by qPCR (quantitative real time polymerase chain reaction), 4 months after the first administration of target malaria-elimination (23-15) (4 months)

Answer: B