TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Multi-institutional, Randomized Controlled Trial Assessing Opioid Use and Analgesic Requirements After Endoscopic Sinus Surgery
Brief Summary: Given the ongoing national opioid epidemic, an increased interest has developed in optimizing opioid prescribing practices of physicians, including otolaryngologists. Endoscopic sinus surgery (ESS) is one of the most commonly performed surgeries by otolaryngologists with over 250,000 ESS's performed annually in the U.S. Multiple studies have shown that, compared to the amount patients actually consume, otolaryngologists prescribe a high quantity of opioids to patients recovering from ESS). It has been shown that these excess opioid medications contribute to prolonged use or abuse by the patient, family members, or friends. The purpose of this study is to better understand the pain management requirements of patients who undergo ESS for recurrent acute rhinosinusitis (RARS) or chronic rhinosinusitis (CRS).

This prospective, randomized, multi-institutional controlled trial will aim to determine the degree to which pain following ESS can be adequately controlled by non-opioid medications. It will also determine whether post-ESS narcotic use can be avoided entirely, or at least significantly limited. Patients will be randomized into two groups, each of which will receive a stepwise analgesic regimen consisting of acetaminophen and oxycodone or acetaminophen and ibuprofen. Pain will be assessed daily using visual analog scales (VAS) and the Brief Pain Inventory (BPI).

The results of this study will help to develop a standardized approach to pain management in the post-ESS setting and help to elucidate the role of non-opioid pain medications. The ultimate goal would be to positively affect opioid prescribing patterns among surgeons who perform ESS in order to significantly reduce the quantity of opioids prescribed to patients while continuing to adequately manage patients' pain.


Options:
A: 11-point Visual Analog Scale for Pain (1-2 weeks)
B: Pain Severity (Average pain score will be collected for preoperative visit (the day before surgery)); Pain Severity (Average pain score was collected for postoperative day 1); Pain Severity (Average pain score will be collected for postoperative day 2); Pain Severity (Average pain score will be collected for postoperative day 3); Pain Severity (Average pain score will be collected for postoperative day 4); Pain Severity (Average pain score will be collected for postoperative day 5); Pain Severity (Average pain score will be collected for postoperative day 6); Pain Severity (Average pain score will be collected for postoperative day 7); Medication Log (Postoperative day 1 to 7)
C: Time-weighted Sum of Pain Relief (PAR) and Pain Intensity Difference (PID) From 0 to 8 Hours (SPRID0-8h) (0 to 8 hours)
D: Safety (1.5 years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Mindfulness-Based Resilience Training for Aggression, Health, and Stress Among Law Enforcement Officers
Brief Summary: Law enforcement officers (LEOs) are exposed to significant stressors, elevating their risk for aggression and excessive use of force, as well as mental health consequences, including post-traumatic stress disorder, burnout, alcohol misuse, depression, and suicide. The proposed study will identify, optimize and refine best clinical and research practices across two sites to ensure success in a future multisite efficacy trial assessing preventative effects of Mindfulness-Based Resilience Training on physiological, behavioral, and psychological outcomes.


Options:
A: Change in Aggression (baseline, post-intervention (week 8), 3-month followup, 6-month followup)
B: level of depression (Baseline to 3 months)
C: Pre-/post-intervention changes in mRNA transcript abundance across the entire transcriptome of circulating immune cells in the intervention group relative to the control group. (6 weeks); Pre-/post-intervention changes in IL-6 (6 weeks); Pre-/post-intervention changes in IL-8 (6 weeks); Pre-/post-intervention changes in IL-10 (6 weeks); Pre-/post-intervention changes in TNF-α (6 weeks); Pre-/post-intervention changes in IFN-γ (6 weeks); Pre-/post-intervention changes in peripheral blood mononuclear cell (PBMC) telomerase activity (6 weeks)
D: Changes in PTSD symptoms(PCL) (Pre-treatment(baseline), after first deployment, 10 days after combat, 4 months after combat); Probable PTSD diagnosis(CAPS) (Four months after combat)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Non-interventional Cross-sectional Study to Capture the Prevalence of Cardiovascular Disease in Patients With Type 2 Diabetes in Selected Countries in Europe
Brief Summary: The purpose of the study is to register the occurrence of cardiovascular disease among type 2 diabetes (T2DM) patients across five selected countries in Europe. Participants will be asked to give information about their health. Participants will continue their normal way of life and will not get any medication other than what has been prescribed to them by their doctor. Participants' participation will be one day/one visit at study doctor. The study will last for about 3 months in total.


Options:
A: HbA1c, LDL-cholesterol, Systolic Blood Pressure (Visit 1; Visit 2 (after approximately 4 months after visit 1); Visit 3 (after approximately 8 months after visit 1); Visit 4 (after approximately 12 months after visit 1))
B: Change from baseline in blood glucose level (Baseline and 12 months); Change from baseline in blood pressure (Baseline and 12 months); Change from baseline in body mass index (Baseline and 12 months)
C: The difference in change in estimated cardiovascular risk between advanced care and usual care groups (3 months)
D: Diagnosed with cerebrovascular disease: Ischaemic stroke, haemorrhagic stroke, stroke (unspecified) and/or transient ischaemic attack (Day 1); Diagnosed with CVD: Myocardial infarction, stable coronary artery disease (SCAD) also referred as angina (pectoris), other ischaemic heart disease and/or past revascularisation procedures (Day 1); Diagnosed with symptomatic heart failure: New York Heart Association Functional Classification (NYHA) (group IIIV) and/or left ventricular ejection fraction (LVEF) greater than or equal to 50 percent, LVEF 40-49 percent and LVEF less than 40 percent) (Day 1); Diagnosed with asymptomatic heart failure (Day 1); Hospitalisation for heart failure (Day 1); Diagnosed with cardiac arrhythmia: Atrial fibrillation or flutter, ventricular tachycardia and/or ventricular fibrillation (Day 1); Diagnosed with aortic diseases: Aortic dissection, aortic aneurysms and/or thromboembolic aortic disease (Day 1); Diagnosed with peripheral artery disease: Asymptomatic peripheral arterial disease (PAD) defined as Low Ankle-Brachial Index (less than 0.90) or pulse abolition, claudication, limb ischemia and/or non-traumatic amputation (Day 1); Diagnosed with carotid artery disease (Day 1)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Use of an Innovative Device for Therapeutic Adherence in Pediatric Asthma
Brief Summary: The management of chronic diseases requires a constant monitoring of treatment adherence, in order to obtain an optimal disease control. However, this is often difficult to achieve, especially in pediatric age.

In this sense, for asthmatic patients treated by Symbicort Turbohaler, "AstraZeneca" developed the "Turbo+", an electronic device attached to the Turbohaler, which allows to feel whether the patient does the inhalation, and to register it on a specific application.

The present randomized trial aims to compare the treatment adherence between asthmatic children/adolescents aged 6-17 years treated with Symbicort Turbohaler plus Turbo+ or Symbicort Turbohaler without Turbo+.


Options:
A: Change in asthma control from baseline at 3 months (3 months); Change in asthma control from baseline at 6 months (6 months); Change in asthma control from baseline at 9 months (9 months); Change in asthma control from baseline at 12 months (12 months)
B: Change in Asthma Control Test Scores (Baseline and Six months)
C: Proportion of Participants With Severe Asthma Exacerbations (from baseline to week 26)
D: Medication Adherence Rating Scale (MARS) (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Facilitating Weight Loss and Reversing Type 2 Diabetes (T2D) by Means of a Collaborative eHealth Lifestyle Coaching Intervention in Primary Care - A 2-year Randomised Controlled Trial
Brief Summary: Background: Systematic reviews conclude that Internet and mobile interventions can significantly change lifestyle in a short time span. The applicant has developed a collaborative eHealth tool (LIVA) that has led to a significant and clinically relevant weight loss of 5.4 to 7.0 kg over 12 to 20 months in primary care settings. The objective of this study is to develop and evaluate a model targeting long-term effects using eHealth coaching assisted by machine learning-generated advice intervention for overweight patients at risk of developing diabetes as well as current type 2 diabetes (T2D) patients in a primary care setting.

Methods and analysis: Randomized controlled trial with 1-year intervention and 1-year maintenance. The primary outcome is weight loss and the secondary outcome is reduced HbA1c level. The study will comprise 340 overweight patients of which 170 will have T2D. Individual data will be obtained from clinical measurements, questionnaire data, registered from the collaborative eHealth tool, as well as other registry data at baseline and at 6, 12 and 24 months. The core of the intervention is the establishment of an empathic relationship and ongoing real-life coaching using the LIVA app (working together with native iOS and Android) and Internet for patients combined with an effective coaching module supported by machine learning methods. The intervention will be compared with usual care.


Options:
A: Change in Body Weight (Baseline to 12 months); Physical Activity-Active Minutes/Day (12 months); Physical Activity-Steps/Day (12 months); Food Frequency Questionnaire (FFQ) (12 months); Healthy Eating Index (HEI) (12 months)
B: Weight (Baseline to 6-Months)
C: Weight change (Baseline, 6, 12, and 24 months)
D: Weight loss (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Hydroxyurea Optimization Through Precision Study (HOPS): A Prospective, Multi-center, Randomized Trial of Personalized, Pharmacokinetics-guided Dosing of Hydroxyurea Versus Standard Weight-based Dosing for Children With Sickle Cell Anemia.
Brief Summary: Hydroxyurea Optimization through Precision Study (HOPS) is a prospective, multi-center, randomized trial that will directly compare a novel, individualized dosing strategy of hydroxyurea to standard weight-based dosing for children with SCA. The primary objective of the study is to evaluate whether a pharmacokinetics-based starting hydroxyurea dose thieves superior fetal hemoglobin response to to standard weight-based initial dosing. Patients will be recruited from the pediatric sickle cell clinic at Cincinnati Children's Hospital Medical Center and from additional pediatric sickle cell centers within the United States.


Options:
A: Change in Soluble Vascular Cell Adhesion Molecule-1 (sVCAM) (baseline to eight weeks)
B: Distribution of the Density of Hemoglobin SC Red Cells (measured 2 months after initiation of treatment)
C: Occurrence of an Adjudicated Secondary Stroke During the 30-month Treatment Period (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months)); Liver Iron Content (LIC) Change-from-baseline (Because the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 30 Months))
D: Fetal Hemoglobin (HbF) Response Following Six Months of Hydroxyurea Therapy (6 months after starting daily hydroxyurea therapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Study of Some Pharmacological and Biochemical Effects of Gum Arabic Supplementation to Hemodilaysis Patients
Brief Summary: Gum Arabic is a naturally produced gummy exudate from Acacia Senegal tree. It's a complex polysaccharide with proven prebiotic properties. Through its effect on intestinal bacteria, it's expected to reduce systemic levels of toxic bacterial metabolites and reduce inflammatory markers.By increasing fecal bacteria mass it's also expected to reduce blood urea level. These changes are potentially beneficial to hemodialysis patients who suffer from disturbed intestinal flora and a chronic inflammatory status. The investigators hypothesize that supplementing the diet of hemodialysis patients with Gum Arabic for four weeks would reduce inflammatory markers, increase total anti-oxidant capacity and reduce blood urea concentration.


Options:
A: Highly sensitive C-reactive protein (hs CRP) level (4 weeks); Total anti-oxidant capacity (4 weeks); Blood urea level (4 weeks)
B: Uremic toxicity evaluated by serum and urinary levels of p-cresyl sulfate and indoxyl sulfate (12 weeks)
C: inflammatory adipokine- Progranulin (PGRN) (8 week); cytokine receptor -soluble tumor necrosis factor receptor 1 (sTNFR1), (8 week); serum levels of Neutrophil gelatinase-associated lipocalin (NGAL) (8 week); cystatin C (Cys- C) (8 week)
D: Change from Baseline Triglyceride/HDL cholesterol ratio at 3 months, 6 months and 3 months after the trial (baseline,3 months, 6 months and 3 months after the trial)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of a Mobile Preconception Lifestyle Programme in Couples Undergoing in Vitro Fertilisation: a Multicentre Randomized Controlled Trial (PreLiFe-RCT)
Brief Summary: The aim of the PreLiFe RCT is to assess the effects of a new mobile preconception lifestyle programme (PreLiFE-programme) for couples undergoing IVF. Couples about to start IVF will be randomized between an attention control programme or the PreLiFe-programme for 12 months or until an ongoing pregnancy is confirmed by ultrasound.This study will examine whether the PreLiFe-programme results in a higher cumulative ongoing pregnancy rate within 12 months as compared to an attention control programme. Secondary outcomes include changes in diet, physical activity, personal wellbeing, body mass index, waist circumference, quality of life and other reproductive outcomes including clinical pregnancy and time to pregnancy. Additionally, the partners' support and the feasibility of the PreLiFe-programme will be evaluated.


Options:
A: Live birth (Approximately 10-16 months after randomization, depending on study group.)
B: Cumulative ongoing pregnancy rate (COPR) within 12 months after randomisation (12 months)
C: Reduction in body weight (From baseline to 6 weeks postpartum)
D: Clinical pregnancy will be obtained from evidence of gestational sac on ultrasound exam at 6 weeks of amenorrhea either after the first ART attempts (3 to 12 months after the initial visit)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial on the Effectiveness and Adherence of Modified Alternate-day Calorie Restriction (MACR) in Improving Activity of Non-Alcoholic Fatty Liver Disease
Brief Summary: There is no effective therapy for non-alcoholic fatty liver disease (NAFLD), although intensive calorie restriction is typically recommended but dietary adherence is an issue. Currently, there are no studies had been focusing the effect of Modified Alternate Day Calorie Restriction in NAFLD patient focusing on changes in liver steatosis and fibrosis.


Options:
A: Change in Total Body Weight (in kg) at 3 months compared to baseline (Baseline to 3 months)
B: Change from baseline shear wave elastography (SWE) at 8 weeks (Change from baseline at 8-week); Change from baseline liver steatosis at 8 weeks (Change from baseline at 8-week); Concentration of high-density lipoprotein (HDL) (Change from baseline at 8-week); Concentration of low-density lipoprotein (LDL) (Change from baseline at 8-week); Concentration of triglycerides (TG) (Change from baseline at 8-week); Concentration of total cholesterol (TC) (Change from baseline at 8-week); Concentration of fasting blood sugar (FBS) (Change from baseline at 8-week); Concentration of alanine aminotransferase (ALT) (Change from baseline at 8-week); Concentration of aspartate aminotransferase (AST) (Change from baseline at 8-week)
C: Change From Baseline in Fasting Body Weight (Week 0, Week 56); Proportion of Subjects Losing at Least 5% of Baseline Fasting Body Weight. (At Week 56); Proportion of Subjects Losing More Than 10% of Baseline Fasting Body Weight (At 56 weeks); Proportion of Subjects With Onset of Type 2 Diabetes (At 160 weeks)
D: Incretin effect (24 weeks); Cognitive function (18 months); Insulin resistance (12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pilot Cluster Randomised Controlled Trial, of an Implicit Learning Approach (ILA) Versus Standard Care, on Recovery of Mobility Following Stroke
Brief Summary: This trial will compare an Implicit Learning Approach (ILA) to usual care, during the rehabilitation of mobility post stroke.

It is a multicentre, assessor blind, cluster randomised controlled pilot trial, with embedded feasibility study. It also includes a nested qualitative evaluation, designed to explore the views of participants and therapists.


Options:
A: Safety of the intervention as assessed by frequency of adverse events (2 weeks)
B: Disability (three months)
C: change in motor function before/after tDCS (Baseline (>6 months after stroke), immediately after intervention (30min of tDCS), 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks)
D: Change in Modified Rivermead Mobility Index Score (12 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Time-Restricted Feeding(TRF) on Overweight/Obese Women with Polycystic Ovarian Syndrome(PCOS): a Randomized Controlled Trial
Brief Summary: The aims of the present study is to examine whether Time-Restricted Feeding (TRF) is a safe and effective regimen to improve insulin resistance and decrease body weight in overweight/obese Polycystic ovary syndrome (PCOS) patients over 16 weeks compared to reduced energy restriction.


Options:
A: Total fat oxidation in response to eTRF (Week 1 or Week 5); Total fat oxidation in response to mTRF (Week 1 or Week 5); Insulin sensitivity in response to eTRF (Week 1 or Week 5); Insulin sensitivity in response to mTRF (Week 1 or Week 5); Glucose control in response to eTRF (Week 1 or Week 5); Glucose control in response to mTRF (Week 1 or Week 5)
B: Body weight (Change from baseline to week 24)
C: Changes in body weight (Kilograms) (Baseline and 16 weeks); Change in insulin resistance (Baseline and 16 weeks)
D: Change in HSCRP ( high sensitivity C-reactive protein) at 6 and 12 months (Every 6 months- baseline, 6 month and 12 month)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial on the Effect of 400 vs. 800 IU of Vitamin D on T Regulatory Cells in Preterm Infants
Brief Summary: This study evaluate the effect of two different doses of vitamin D on T-regulatory cells in preterm infants. Half of the subjects receives 400 IU vitamin D and the other half receives 800 IU vitamin D.


Options:
A: Change in Serum Hepcidin With Vitamin D Intervention for Children With Chronic Kidney Disease (change from baseline to up to three months)
B: Change from baseline in stereotypic behaviour from the aberrant behaviour checklist (Day 1 and day 140)
C: Equivalency of isoforms (3 months)
D: Percent Change in The Number of T Regulatory Cells (At 1 week (compared to baseline)); Percent Change in The Number of T Regulatory Cells (At 4 weeks (compared to baseline))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Use of Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis: A Randomised Trial
Brief Summary: The study is planned as a randomised control trial to study the adjuvant use of antibiotics (ceftriaxone and metronidazole) to achieve a clinical response in hospitalised patients with acute severe ulcerative colitis


Options:
A: Total PUCAI (Pediatric Ulcerative Colitis Activity Index) score (at day 5 after treatment (compared between the two treatment groups).)
B: Response rate at 8 weeks defined as a drop in PCDAI (Pediatric Crohn's Disease Activity Index ) of at least 12.5 points (or remission without steroids, intention to treat principle) (8 weeks)
C: Clinical response as defined by the Oxford's criteria (48 hours)
D: Safety and Tolerability of SER-287 (Day 246); Composition of the Intestinal Microbiome (Baseline and 8 weeks); Engraftment of SER-287 Bacteria in All Treatment Arms (Baseline and 8 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors
Brief Summary: The study will conduct a randomized comparative effectiveness trial of peer-facilitated, online, 6-week group Motivational Interviewing (MI) vs. Motivational Interviewing (MI) with a trauma-informed Sexual and Gender Minority (SGM) affirmative care approach.


Options:
A: Change in Number of Health Risks (Two months); Change in Number of Health Risks (Four months)
B: Change in Pittsburgh Sleep Quality Index total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU); Change in Modified PTSD Symptom Scale - Self Report total score (Pre-Treatment; Post-Treatment 1 (5 weeks after pre-treatment); Post-Treatment 2 (20 weeks after pre-treatment); 3-month FU; 6-month FU; 12-month FU)
C: Number of Participants Who Engage in Mental Health Treatment (Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.); Center for Epidemiological Studies Depression Scale (Baseline (pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.)
D: Good end-state functioning: Beck Depression Inventory-II and Posttraumatic Distress Scale Scores (2 weeks post-treatment)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Peer Online Motivational Interviewing for Sexual and Gender Minority Male Survivors
Brief Summary: The study will conduct a randomized comparative effectiveness trial of peer-facilitated, online, 6-week group Motivational Interviewing (MI) vs. Motivational Interviewing (MI) with a trauma-informed Sexual and Gender Minority (SGM) affirmative care approach.


Options:
A: Alcohol Use Interview (Past month); Alcohol Use Self-Report (Past month); Posttraumatic Stress Disorder Severity (PTSD) Interview (Past two weeks); Posttraumatic Stress Disorder Severity (PTSD) Self-Report (Past two weeks)
B: Change in PTSD Checklist (PCL-M) score from baseline to end of treatment (approximately 2 weeks)
C: Severity of mental health symptoms (previous 4 weeks)
D: Number of Participants Who Engage in Mental Health Treatment (Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.); Center for Epidemiological Studies Depression Scale (Baseline (pre-intervention), Post-intervention (immediately following last online group), 60-day follow-up, and 120-day follow-up.)

Answer: D