TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Phase 2, Placebo Controlled, 2 Arm Study To Evaluate Dupilumab In Patients With Bilateral Nasal Polyposis And Chronic Symptoms Of Sinusitis
Brief Summary: Primary Objective:

To evaluate the efficacy of dupilumab (SAR231893/REGN668) in the treatment of bilateral Nasal Polyposis (NP) by assessment of the endoscopic nasal polyp score (NPS) in comparison to placebo.

Secondary Objectives:

To evaluate effect of dupilumab with regards to:

* symptoms of sinusitis,
* sinus computed tomography (CT) scan,
* NPS in the sub-group of participants with co-morbid asthma,
* Safety and tolerability.


Options:
A: Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16 (Baseline, Week 16)
B: 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)
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 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Phase 2, Placebo Controlled, 2 Arm Study To Evaluate Dupilumab In Patients With Bilateral Nasal Polyposis And Chronic Symptoms Of Sinusitis
Brief Summary: Primary Objective:

To evaluate the efficacy of dupilumab (SAR231893/REGN668) in the treatment of bilateral Nasal Polyposis (NP) by assessment of the endoscopic nasal polyp score (NPS) in comparison to placebo.

Secondary Objectives:

To evaluate effect of dupilumab with regards to:

* symptoms of sinusitis,
* sinus computed tomography (CT) scan,
* NPS in the sub-group of participants with co-morbid asthma,
* Safety and tolerability.


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: Change From Baseline in Bilateral Endoscopic Nasal Polyp Score (NPS) at Week 16 (Baseline, Week 16)
D: 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)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Improving Care in Chronic Obstructive Lung Disease Study: CAROL Improving Processes of Care and Quality of Life of COPD Patients in Primary Care: A Cluster Randomized Trial
Brief Summary: Background The Swiss health ministry launched a national quality program "QualiCCare" in 2011 to improve healthcare for patients with COPD.

The aim of this study is to determine whether participation in the COPD quality initiative ("QualiCCare") improves adherence to recommended clinical processes and shows impact on patients COPD care and on quality of life in patients with COPD.


Options:
A: "Quality of care process" (one year)
B: Changes in the use of NIV (At baseline and 18 months after baseline); Sustainability (36 months after training is completed); Acceptability and feasibility of the educational training (At 18 months after baseline); Penenetration of training (18 months after training is completed); Changes in Respiratory Therapist Job Autonomy (Pre-training (baseline), 12 months after training, 36 months after training); Changes in team functionality (Pre-training (baseline), 12 months after training, 36 months after training)
C: Disease-specific health related quality of life assessed with the Chronic Respiratory Questionnaire (CRQ-SR) (At baseline, after one year follow-up, and after two years follow-up)
D: Changes in COPD-patients self reported-health, their evaluation of the health system and in the distribution of health resources. (14 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Improving Care in Chronic Obstructive Lung Disease Study: CAROL Improving Processes of Care and Quality of Life of COPD Patients in Primary Care: A Cluster Randomized Trial
Brief Summary: Background The Swiss health ministry launched a national quality program "QualiCCare" in 2011 to improve healthcare for patients with COPD.

The aim of this study is to determine whether participation in the COPD quality initiative ("QualiCCare") improves adherence to recommended clinical processes and shows impact on patients COPD care and on quality of life in patients with COPD.


Options:
A: Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score (9 months); Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF) (9 months)
B: "Quality of care process" (one year)
C: COPD hospitalization rates (1 year (study inclusion - 12 months of follow-up))
D: The two primary outcomes are disease-specific quality of life assessed with the St. George's Respiratory Questionnaire (SGRQ) and the total number of exacerbations

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Improving Care in Chronic Obstructive Lung Disease Study: CAROL Improving Processes of Care and Quality of Life of COPD Patients in Primary Care: A Cluster Randomized Trial
Brief Summary: Background The Swiss health ministry launched a national quality program "QualiCCare" in 2011 to improve healthcare for patients with COPD.

The aim of this study is to determine whether participation in the COPD quality initiative ("QualiCCare") improves adherence to recommended clinical processes and shows impact on patients COPD care and on quality of life in patients with COPD.


Options:
A: "Quality of care process" (one year)
B: The primary measure of results will be the differences in smoking cessation rates between intervention and control groups (12 months after been conducted the intervention)
C: 30 day readmission rate (30 days)
D: sustained smoking abstinence (during the study)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Nutrition and Physical Activity in Child Care Centers
Brief Summary: The study is an evaluation of a nutrition and physical activity intervention in child care centers in NC, CA, and CT.


Options:
A: Change in Nutrition and Physical Activity Policies (Baseline, Year 1, Year 2)
B: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)
C: Change in Child BMI-z score (Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2) rather than 4 years as planned); Modified change in BMI z-score (Collected at the beginning and end of each academic year (i.e., fall, spring) for 3 years (BL, Y1, Y2))
D: Caloric intake in the Eating in the Absence of Hunger (EAH) paradigm (week 4)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Nutrition and Physical Activity in Child Care Centers
Brief Summary: The study is an evaluation of a nutrition and physical activity intervention in child care centers in NC, CA, and CT.


Options:
A: Change of BMI Z-score for preschoolers (Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up)
B: Change in Nutrition and Physical Activity Policies (Baseline, Year 1, Year 2)
C: Body height and weight (Sept 2006- May 2009); Healthy Start Knowledge Quiz (Sept 2006- May 2009); 24-hour diet observation and recall (Sept 2006- May 2009); Physical activity (Sept 2006- May 2009); Television viewing (child outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Score on short Acculturation Scale (parent outcome, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009); Nutrition and exercise knowledge (Sept 2006- May 2009); Self-efficacy for eating and exercise behaviors (Sept 2006- May 2009); Score on Nutrition Attitudes Scale (Sept 2006- May 2009); Support and role modeling for healthy eating (teacher outcomes, measured immediately after the study and at a 1-year follow-up visit) (Sept 2006- May 2009)
D: BMI and aerobic fitness (1 schoolyear)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Nutrition and Physical Activity in Child Care Centers
Brief Summary: The study is an evaluation of a nutrition and physical activity intervention in child care centers in NC, CA, and CT.


Options:
A: Body Mass Index (BMI)-for-age percentile (one year)
B: Body fat percentage (One year (interim analysis))
C: Change in Nutrition and Physical Activity Policies (Baseline, Year 1, Year 2)
D: School-time and total daily MVPA (5 months and 1.5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Nutrition and Physical Activity in Child Care Centers
Brief Summary: The study is an evaluation of a nutrition and physical activity intervention in child care centers in NC, CA, and CT.


Options:
A: Increase MVPA (6 months)
B: Change in The Environment and Policy Assessment and Observation tool (EPAO) score (3 years)
C: Body Mass Index Z-Score (Fall 2005, Spring 2006, Fall 2006, Spring 2007, Fall 2007, Spring 2008)
D: Change in Nutrition and Physical Activity Policies (Baseline, Year 1, Year 2)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Promoting Nutrition and Physical Activity in Child Care Centers
Brief Summary: The study is an evaluation of a nutrition and physical activity intervention in child care centers in NC, CA, and CT.


Options:
A: Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (Baseline, 24 months); Change in Waist Circumference (Baseline, 78 months); Prevalence of Acanthosis Nigricans (Baseline, 24 months); Change in Prevalence of Overweight and Obesity Using Body Mass Index Percentile for Age and Sex (Baseline, 78 months); Change in Waist Circumference (Baseline, 24 months); Prevalence of Acanthosis Nigricans (Baseline, 78 months)
B: BMI and aerobic fitness (1 schoolyear)
C: To evaluate and compare in overweight children the effectiveness of the following interventions: a parent-centered dietary modification program; a physical activity skill development program; and a parent-centered dietary modification + physical activity skill development program.
D: Change in Nutrition and Physical Activity Policies (Baseline, Year 1, Year 2)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Competence Network - Dementia (BMBF) "Pharmacological and Psychosocial Treatment" (Modul E.2) Part II: The Efficacy of a Combination Regimen in Patients With Mild to Moderate Probable Alzheimer's Disease
Brief Summary: This is a national multicenter, double-blind, randomized, parallel-group trial of 12 months in duration. Following a 4 week wash-out period, subjects will be randomized to one of 2 treatment groups: (1) galantamine CR 24 mg/day with dose-titration over twelve weeks\[maintenance phase from week 9\], (2) a combination of galantamine CR 24 mg/day plus memantine 10 mg b.i.d. with a dose titration of sixteen weeks (12 weeks for galantamine \[maintenance phase from week 9\], additional 4 weeks for memantine).


Options:
A: Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Mini-Mental State Examination Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Neuropsychiatric Inventory Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline); Caregiver Activity Survey Change From Baseline (6, 12, 18, 24, 30, 36, 42 and 48 months minus baseline)
B: ADAScog/11 (change from Baseline to 12 months of treatment)
C: Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain. (6 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Anticholinergics on Cognitive Function in the Elderly: a Randomized Controlled Trial
Brief Summary: Anticholinergic medication is used to treat overactive bladder (OAB). A known side effect of this medication is cognitive dysfunction. OAB is more prevalent in the elderly population - a group that also has a higher baseline risk of cognitive dysfunction. Our objective is to evaluate the effect of an anticholinergic medication on cognitive function in elderly women.


Options:
A: Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 (Study Baseline, Week 12); Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1 (Study Baseline, Week 12)
B: Hopkins Verbal Learning Test - Revised (Week 4); Hopkins Verbal Learning Test - Revised (Week 4)
C: Base Study/Part 1: Change From Baseline in Average Daily Micturitions at Week 8 (Baseline and Week 8); Base Study/Part 1 + Part 2: Number of Participants Who Experienced an Adverse Event (AE) (Part 1: up to 8 weeks; Part 2: up to 4 weeks. The time frame was an additional 2 weeks for participants not continuing to the Extension Study.); Base Study/Part 1 + Part 2: Number of Participants Who Had Study Medication Withdrawn Due to an AE (Part 1: up to 8 weeks; Part 2: up to 4 weeks); Extension Study: Number of Participants Who Experienced an Adverse Event (AE) (Extension: up to 54 weeks (including 2-week follow-up)); Extension Study: Number of Participants Who Had Study Medication Withdrawn Due to an AE (Extension: up to 52 weeks)
D: Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12 (Baseline, Week 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Flexible Dosing of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Brief Summary: To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with agitation associated with dementia of the Alzheimer's type


Options:
A: Antipsychotic Efficacy (Day 43)
B: N/A
C: Change From Baseline to Week 12/Early Termination in the Cohen-Mansfield Agitation Inventory (CMAI) Total Score (From screening to week 12/early termination)
D: N/A

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Clinical Research on the Efficacy and Safety of East-West Collaborative Treatment Using NSAIDs and BV on Chronic Cervical Pain; A Randomized, Controlled, Parallel, Pilot Study
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of east-west collaborative treatment using bee venom acupuncture and NSAIDs on pain intensity, functional status and quality of life of patients with chronic cervicalgia


Options:
A: Subjective Pain scored by Visual Analogue Scale (VAS.Participants were followed for the duration of the intervention, an average of 6 weeks) (pretreatment, postreatment and follow-up(15 days))
B: Visual Analogue Scale for bothersomeness (Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up)
C: muscle contractility (30 minutes)
D: Pain Scores on the Visual Analogue Scale(VAS) (7 week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Adductor Canal Blockade vs Femoral Nerve Blockade on Muscle Strength, Mobility and Pain in Patients With Severe Pain After Total Knee Arthroplasty
Brief Summary: The purpose of the study is to compare the effect of a Adductor Canal Blockade (ACB) vs a Femoral Nerve Blockade (FNB), on muscle strength, mobility and pain in patients with severe pain (VAS pain score \> 60) after Total Knee Arthroplasty (TKA.


Options:
A: Change i muscle strength of the quadriceps muscle, after the blockade (0 and 120 minutes)
B: Changes in Visual pain scale (Changes from the baseline visual pain scale to 1 week after surgery)
C: Total morphine consumption (0-24 hours postoperative)
D: Morphine Equivalents (12 hours postoperatively and 20 hours after placement of catheter)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Efficacy of Concomitant Therapy for Eradication of Helicobacter Pylori
Brief Summary: If we compare eradication rate of Helicobacter pylori divided to 4 groups: amoxicillin, rabeprazole, clarithromycin(AOC), amoxicillin, rabeprazole, metronidazole(AOM), treated with amoxicillin, rabeprazole for 5 day, followed by clarithromycin, metronidazole, rabeprazole for 5 days(sequential), amoxicillin, clarithromycin, metronidazole, rabeprazole(concomitant), then the eradication rate of concomitant group will be the highest.


Options:
A: H pylori eradication rate (at least 4 weeks up to 24 weeks after finishing course of antibiotics)
B: Number of Participants With Complete Eradication of Helicobacter Pylori (at the 6th week after the end of anti- H. pylori therapy)
C: Evaluation of the efficacy of concomitant therapy for eradication of Helicobacter pylori (6 months (Feb 2014))
D: Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis (6 weeks after eradication therapy)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Placebo-controlled Intervention Study for Maternal and Child Health
Brief Summary: A randomized double-blind placebo controlled intervention study with pregnant obese women (n=440) will be conducted. The intervention will involve consumption of fish oil and/or probiotic capsules from early pregnancy until 6 months after delivery.

The aim of the study is firstly to investigate the effects of the supplements on the risk of gestational diabetes mellitus and obesity in the women and secondly to modify the risk markers of allergy and obesity in children of the women. Also the underlying metabolic mechanisms will be investigated.

Follow up visits at child's age of 5 to 6 years will be conducted to evalute long-term effects on maternal and child health. The aim is to investigate the impact of dietary intervention, diet, maternal overweight/obesity and gestational diabetes status as well as gut microbiota and metabolism during pregnancy on maternal and child's health, allergy and child neuropsychological development.


Options:
A: Gestational weight gain (week 36-37 of pregnancy); Change in glucose levels (Oral glucose tolerance test) (baseline (week 14-20) and 27-30 of pregnancy)
B: The rate of women who will require pharmacotherapy for glycemic control. (During the length of pregnancy (up to 9 months)); Mean value of the mean daily glucose charts after 2 weeks of treatment with the study products. (2 weeks)
C: Prevalence of gestational diabetes mellitus, GDM (Assessed at gestational weeks 24-28); Fasting glucose levels (assessed at the third trimester of pregnancy); Prevalence of allergy in child (assessed at 12 and 24 months of age)
D: Number of participants with allergic disease (Up to 13 years); Weight gain (Up to 13 years); Number of patients with chronic inflammatory disease (Up to 13 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Study Investigating Optimal Duration of Indwelling Urinary Catheter Following Infraperitoneal Colorectal Surgery and Role of Postoperative Alpha Blockade
Brief Summary: There is no general agreement about the optimal duration of postoperative urinary drainage, with relevant literature reporting durations ranging from 1 to 10 days. The available research supporting the routine use of prolonged catheterization is limited and studies investigating early removal following infraperitoneal colorectal surgery have largely been underpowered to form valid practice conclusions. The aim of the investigators study is to determine whether a postoperative colorectal patient can safely have an indwelling catheter removed on postoperative day one (24 hours following surgery) with the addition of a study medication (prazosin), without a statistically significant difference in the incidence of urinary retention compared to the standard, accepted approach of delayed removal (72 hours postoperatively). Patients undergoing laparoscopic and open pelvic colorectal surgery below the peritoneal reflection for both benign and malignant conditions will be randomized into two groups: group one will have the catheter removed on postoperative day 3 (72 hours postoperatively) Group 2 will have a dose of the alpha-blocker prazosin given 6 hours prior to catheter removal and will have the urinary catheter removed on postoperative day 1 (24 hours postoperatively).


Options:
A: Number of Participants With Acute Urinary Retention (Postoperative day 1 or postpoperative 3 depending on group randomization)
B: Need for insertion of catheter after Foley removed. (participants will be followed for the duration of hospital stay, an expected average of 5 weeks)
C: time to return of normal bladder function (5 days)
D: The incidence of acute urinary retention (within the 30 days after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomized,Double-blind Trial Comparing the Effects of a Rivaroxaban Regimen During the First 30 Days,Versus Aspirin for the Acute Treatment of TIA or Minor Stroke
Brief Summary: Transient ischemic attack (TIA) or minor ischemic stroke has a high risk of early recurrent stroke. As the golden standard, aspirin effect modestly on acute ischemic stroke, and slightly increase the risk of intracerebral hemorrhage. Recently, rivaroxaban, a new oral anticoagulant, is proved to be as effective as traditional anticoagulants, while carrying significantly less risk of intracranial hemorrhage.

The TRACE trial is a randomized, double-blind, multicenter, controlled clinical trial in China. The investigators will assess the hypothesis that a 30-days rivaroxaban regimen is superior to aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event.


Options:
A: New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death (every 4 months)
B: Number of Participants With Intracranial Bleeding and/or Recurrent Ischemic Lesion as Confirmed by MRI Imaging (1 month after randomization)
C: percentage of patients with new stroke (ischemic or hemorrhage) (90 days)
D: Adjudicated Recurrent Stroke (From randomisation until full follow up period, approximately 43 months.); First Major Bleed (Adjudicated) (Between the first trial medication intake up to 6 days after the last trial medication intake, approximately 42 months.)

Answer: C