TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Adjustment Post Stroke and Aphasia: Supporting Psychological Wellbeing Through Peer Befriending
Brief Summary: Aims: This exploratory trial will:

1. Explore the feasibility of a definitive/phase III RCT on clinical and cost-effectiveness of peer-befriending for people with aphasia post-stroke.
2. Investigate psychological and social wellbeing outcomes of participants, significant others, and peer befrienders.
3. Explore the feasibility of a full economic evaluation of usual care + peer befriending versus usual care control.

Design: Single blind, mixed methods, parallel group phase II RCT comparing usual care + peer-befriending vs. usual care, starting at discharge from hospital. The study will deliver on four work packages: development phase; RCT; qualitative study; economic evaluation. Participants (n=60) will be assessed three times up to 10 months post-randomisation.

Outcome measures: Feasibility: feasibility of recruitment to definitive trial (proportion screened who meet criteria; proportion who consent; rate of consent); participant, significant other, peer befriender views on acceptability of procedures (qualitative study); number of missing/incomplete data on outcome measures; attrition rate at follow-up; potential value of conducting main trial using value of information analysis (economic evaluation); description of usual care; treatment fidelity of peer-befriending. Patient-reported outcomes will include mood, wellbeing, communication and social participation.

Benefits: Peer befriending may help avert some of the serious psychological consequences of stroke, and prevent the need for more complex and costly psychological therapies.


Options:
A: Feasibility of recruitment (ability to recruit dyads) (Baseline); Feasibility of intervention delivery (ability to deliver intervention to dyads) (Feasibility of program delivery will be measured at 6 weeks); Credibility and expectancy questionnaire (Baseline); Client Satisfaction Questionnaire (post intervention (6 weeks after baseline))
B: General Health Questionnaire-12 (GHQ-12) continuous total score (4 months post randomisation); Depression Intensity Scale Circles (DISCS) continuous total score (4 months post randomisation); General Health Questionnaire-12 (GHQ-12) continuous total score (10 months post randomisation); Depression Intensity Scale Circles (DISCS) continuous total score (10 months post randomisation)
C: Reduction in depression (Hamilton Depression Rating Scale)at 12 months following stroke. (12 months following stroke)
D: response rate (baseline, 2nd and 4th week); remission rate (baseline, 2nd and 4th week)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Sugar Sweetened Beverage Labeling Support
Brief Summary: This is an online survey assessing consumer support for different labeling policies related to sugar sweetened beverages. The investigators will present consumers with three labels that are being considered for sugar sweetened beverages: a calorie label, a text warning label that says "Warning drinking beverages with added sugar(s) can lead to health problems like obesity, diabetes and tooth decay" and a graphic warning label that includes graphic images to correspond with each of the health problems listed with the text warning. The investigators will ask participants their support for each label. The investigators will also see if support for the labels change after learning of the effectiveness of these labels. The investigators will share the results of a recent field study that suggested calorie and textual warning labels had no influence on the purchasing of sugar sweetened beverages while the graphic label decreased purchasing by 11 percent.


Options:
A: Rate Support of a Label on a 1 (not at all) to 7 (a great deal) Scale. (Immediately following the presentation of the labels.)
B: Body Weight (kg) (Six months); MR spectroscopy (Six months); Magnetic resonance imaging (Six months); Dual-energy X-ray absorptiometry (DEXA) scan (Six months)
C: Sales ($) of kids' menu items (weekly throughout study period (4 wk baseline, 8 wk Ix phase, 4 week post-ix))
D: Visual Analogue Scale (Four hours)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Enhancing mHealth Technology in the PCMH Environment to Activate Chronic Care Patients
Brief Summary: Multi-site feasibility study designed to assist type-2 diabetes patients in self-care activities. The study includes Bluetooth-enabled medical devices (i.e. scales, blood pressure cuffs, glucometers, and activity monitors) for both intervention and control groups. Those in the intervention group will have the devices linked too a mobile health care environment that provides key benefits that include: device data trending, reinforcing tailored behavioral messages, and enhanced communication with the clinic.


Options:
A: Change in Hemoglobin A1c (3 months, 6 months, 12 months)
B: Change in Glycosylated hemoglobin (HbA1c) (Baseline and 12 months)
C: Primary Process Outcome: A composite score counting the number of appropriate processes achieved for patients within appropriate time-frames, including laboratory testing, blood pressure measurements and active prescriptions (24 months); Primary Disease-Related Outcomes: mean BP and mean LDL level. (24 months)
D: Patient Activation Measure (PAM) (Every 3 months during the 12-month trial)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Single Arm Study of ALXN1210 in Complement Inhibitor Treatment-naïve Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
Brief Summary: The purpose of the study is to assess the safety and efficacy of ravulizumab to control disease activity in adolescent and adult participants with aHUS who had not previously used a complement inhibitor.


Options:
A: Percentage Of Participants With Complete Thrombotic Microangiopathy (TMA) Response at Week 26 (Week 26)
B: Percentage of Patients With TMA Event-free Status (Through 26 weeks); Percentage of Patients With Hematologic Normalization (Through 26 weeks); Percentage of Patients With Complete TMA Response (Through 26 weeks)
C: TMA complication-free survival (5 Years)
D: Assess the Safety and Tolerability of Multiple-dose Administration of OMS721 in Participants With TMA (Day 1 to 37 days after end of treatment, approximately up to 31 weeks.); Number of Participants With HSCT-TMA Who Respond to OMS721 (Day 1 to up to 2 years following the first dose of OMS721)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Saline Hypertonic in Preschoolers With Cystic Fibrosis and Lung Structure as Measured by Computed Tomography (CT)
Brief Summary: The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice daily for 48 weeks reduces structural lung disease as assessed by computed tomography (CT) in comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 6) with cystic fibrosis.


Options:
A: The change in LCI from baseline to end of treatment in rhDnase treated patients versus patients receiving placebo (The duration of the patient's involvement in the study (approximately 3 months))
B: Chest CT (48 weeks)
C: Computed Tomography Evidence of Less Sinus Disease (baseline and 1 year); Improvement in Appearance of Nasal Passages/Sinuses (baseline and 1 year)
D: Change in FEV1 Percentage Predicted From Baseline (14 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, Multi-center, Randomized, 2-arm Parallel, Double-blind, Active-comparator (Darbepoetin Alfa) Conversion Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia
Brief Summary: The objective of this study is to evaluate the safety and efficacy of ASP1517 compared to darbepoetin alfa in hemodialysis chronic kidney disease patients with anemia.


Options:
A: Part 1 (ESA Naïve): Percentage of Participants who Achieved Hb ≥110 g/L in the First 20 Weeks (Weeks 1 to 20); Part 1 (ESA Treated): Percentage of Participants who Achieved Mean Hb ≥100 g/L Averaged Over Weeks 17 to 21 Visits (Weeks 17 to 21); Part 2: Mean Hb Value Averaged Over Weeks 33 to 37 Visits (Weeks 33 to 37)
B: Rate of rise in Hb (Hemoglobin) level (g/dL/week) (Up to 8 weeks); Responder rate: proportion of responders among the subjects (Week 21 to 24)
C: Change From Baseline (BL) to the Average Hemoglobin (Hb) in Weeks 28-36 Without Rescue Therapy [EU (EMA)] (Baseline and weeks 28 to 36); Change From BL to the Average Hb in Weeks 28 to 52 Regardless of Rescue Therapy [US (FDA)] (Baseline and weeks 28 to 52)
D: Change from baseline in the average hemoglobin (Hb) (Baseline and Weeks 18 to 24)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sequential Versus Concurrent Use of Vaginal Misoprostol Plus Foley Catheter for Induction of Labor
Brief Summary: to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter for induction of labor


Options:
A: Time From Induction of Labor Until Delivery (Time from induction to delivery (average 14.2 hours))
B: The Time Interval From Induction to Delivery: All Participants (Day 1); Time (Hours) From Induction to Delivery: Nulliparous (Day 1); Time (Hours) From Induction to Delivery: Multiparous (Day 1); Time From Induction to Delivery: VD (Day 1); Time From Induction to Delivery: CD (Day 1); Per Treatment Protocol: Time (Hours) From Induction to Delivery (day 1)
C: Time to Delivery (Hours between start of induction to delivery); Length of Stay (Days between admit to hospital and discharge); Severe RDS (enrollment through neonatal discharge)
D: induction delivery interval (time from starting induction to delivery) (48hours)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Sequential Versus Concurrent Use of Vaginal Misoprostol Plus Foley Catheter for Induction of Labor
Brief Summary: to compare between sequential and concurrent use of vaginal misopristol plus foleys catheter for induction of labor


Options:
A: Attainment of vaginal delivery within 24 hours. (24 hours)
B: induction delivery interval (time from starting induction to delivery) (48hours)
C: Time from treatment start to delivery (At delivery)
D: Caesarean section rate for non-reassuring fetal status. (Up to 2 days after cervical ripening)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Glycopyrronium and Indacaterol, as Monotherapy and in Combination, on the Methacholine Dose-response Curve
Brief Summary: The study will assess the effects of two drugs, glycopyrronium and indacaterol, taken either as monotherapy or in combination, on the methacholine dose-response curve. This will allow for further elucidation of the mechanisms of each drug in human participants.


Options:
A: Change from baseline methacholine bronchoprotection at 1 hour (baseline versus 1 hour post-treatment)
B: Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments. (7 assessments within 12 month treatment period)
C: Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period (Baseline and Week 24); Change From Baseline in Weighted Mean Serial FEV1 Over 0-24 Hours Post-dose at Week 24 (Baseline and Week 24)
D: Pre-dose FEV1 (Forced Expiratory Volume in the first second) (Week 26); Reduction of moderate and severe asthma exacerbations rate (Week 0 to Week 52)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients
Brief Summary: With the availability of well-studied once-daily formulations of tacrolimus, the ability to achieve a true once-daily immunosuppressant regimen along with everolimus and steroids may finally be achievable and have the potential to optimize immunosuppression safety and efficacy in kidney transplantation.


Options:
A: The primary end-point was the influence of pharmaceutical intervention in tacrolimus intra-subject variability during the first 3 months after kidney transplant. variability during the first 3 months after transplantation. (3 months)
B: Medication Adherence Change from Baseline to 6 Months (6 months); Medication Adherence Change from 6 Months to 12 Months (12 months); Medication Adherence Change from Baseline to 12 Months (12)
C: Self-reported Medication Adherence From Baseline to 6 Months. (6 months post conversion)
D: 12-week immunosuppression medication adherence (12 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention Of Delirium in Elderly With Obstructive Sleep Apnea (PODESA)
Brief Summary: Delirium is a common complication in elderly patients following surgery. Patients who develop delirium after surgery are at increased risk for serious complications, and even death.This multi-centre randomized controlled trial will enroll elderly patients scheduled for elective hip/knee replacement surgery.The objective of this trial is to identify obstructive sleep apnea using ApneaLink Air and to determine whether auto-titrating CPAP treatment of obstructive sleep apnea will decrease the incidence of post-operative delirium in elderly patients undergoing elective hip and knee replacement surgery.


Options:
A: Instrumental and Physical Functionality (Assessed at T0 (time of hospital admission), at T1 (3 months after discharge) and T2 (12 months after discharge)); Re-Admission to Hospital (Assessed 3 months and 12 months after the time of hospital discharge (T1, T2).); Institutionalisation (Assessed 12 months after the time of hospital discharge (T2).)
B: Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death (60 days after randomization)
C: postoperative delirium (2 MONTHS)
D: Changes in functional status after the intervention (Barthel Index) (Baseline (Hospital Admiission), 1 and 3 months later); Changes in functional status after the intervention (Mini Mental State Evaluation, GDS Yesavage, Trail Making Test) (Baseline (Hospital Admiission) and 1 and 3 months later)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention Of Delirium in Elderly With Obstructive Sleep Apnea (PODESA)
Brief Summary: Delirium is a common complication in elderly patients following surgery. Patients who develop delirium after surgery are at increased risk for serious complications, and even death.This multi-centre randomized controlled trial will enroll elderly patients scheduled for elective hip/knee replacement surgery.The objective of this trial is to identify obstructive sleep apnea using ApneaLink Air and to determine whether auto-titrating CPAP treatment of obstructive sleep apnea will decrease the incidence of post-operative delirium in elderly patients undergoing elective hip and knee replacement surgery.


Options:
A: We will use a composite endpoint by these two instruments: Clinical Dementia Rating Scale (CDR), and the 10 words memory task from the Consortium to Establish a Registry for Alzheimer's Disease battery (CERAD) (4 and 12 months)
B: Delirium (5 days); Subsyndromal delirium (5 days)
C: Return to Baseline Physical Function Based on the Barthel Index (Change From 2 Weeks Prior to Admission and Changes at Admission, Discharge, and 2 and 6 Months Post-discharge). (Change from 2 weeks prior to admission to changes at admission, discharge, and 2 and 6 months post-discharge); Caregiver Preparedness (Discharge and 2 and 6 months post-discharge)
D: postoperative delirium (2 MONTHS)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of Moment of Systemic Metronidazole and Amoxicillin Administration in the Treatment of Chronic Periodontitis: a Randomized Clinical Trial.
Brief Summary: The aim of this multicenter randomized clinical trial is to compare the clinical, microbiological and immunological effects of the adjunctive use of systemic metronidazole plus amoxicillin administered in different phases of the treatment of generalized chronic periodontitis.


Options:
A: Change in Mean Clinical Attachment Level. (Baseline, 3, 6 and 12 months)
B: Periodontal Attachment Level (5 years post-treatment)
C: Probing Depth (six months period (two measurements))
D: Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Influence of Moment of Systemic Metronidazole and Amoxicillin Administration in the Treatment of Chronic Periodontitis: a Randomized Clinical Trial.
Brief Summary: The aim of this multicenter randomized clinical trial is to compare the clinical, microbiological and immunological effects of the adjunctive use of systemic metronidazole plus amoxicillin administered in different phases of the treatment of generalized chronic periodontitis.


Options:
A: Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months (12 months)
B: Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months (12 months)
C: Clinical Attachment Level (6 months)
D: Probing Depth (six months period (two measurements))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Video-Based Task Oriented Activity Training on Activity Performance and Participation in Patients With Juvenile Idiopathic Arthritis
Brief Summary: Juvenile idiopathic arthritis (JIA) is most common chronic rheumatic disease in childhood. The upper extremity involvement in JIA causes muscle imbalance, joint destruction, pain, stiffness and limitations on daily living activities (DLA) in varying degrees. However, the information about prevalence of symptoms, disorders, DLA limitations, participation restriction and options of treatments for upper extremity involvement in JIA are limited. It has been reported that improvements of upper extremity functions were achieved by video-based games (VBG) in various disease groups. However, in the literature, no study has been found about effectiveness of WBG in children with arthritis. The aim of the study was to investigate effects of task-oriented activity training (TOAT) with VBG versus activity training in real life on activity performance and participation in children with arthritis. Participants with upper limb involvement in JIA were randomly assigned to the activity training in real life group (group I) and TOAT with VBG in real life group (group II). The actual materials and rehabilitation kits will be used for activity training in group 1, the DLA that expected to gain independence will be trained with VBG in group 2. Upper extremity muscle strength and grip, range of motion, upper limb functions, activity, participation and quality of life will be evaluated. The hypothesis of this study is that TOAT with VBG improves the activity performance and physical functions and increases the participation, via being stimulative and interactive in order to provide feedback and to increase interest and motivation.


Options:
A: Number of recurrences during the follow-up period. (2 1/2 year)
B: walking economy at completion of the exercise program; PEAK power, muscular endurance, and subjective function at completion of the exercise program
C: Childhood Health Assessment Questionaire (CHAQ) (8 weeks); Canadian Occupational Performance Measure (COPM) (8 weeks)
D: PATIENT-RATED LOW BACK PAIN (3 and 12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Comparison Between Recorded Mother's and Stranger's Voice on the Emergence of General Anesthesia on Pediatric Patients
Brief Summary: Mother spend a large amount of time with their children. It is assumed that mother contributes to their neurological development not only with visual stimuli, but also with auditory stimuli. A recent study revealed that prefrontal cortex can be activated in response to the self-name being spoken by the mother than by a stranger. Therefore, investigators suppose that recorded maternal voice can stimulate the pediatric patients and thereby fasten the emergence from general anesthesia.


Options:
A: Infant Behavioural Pain Score (up to 1 minute post-vaccinations)
B: Pain Sensitivity (Baseline); Genetic variations in COMT (Baseline)
C: Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP) (before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection)
D: initial PAED score (During 1 minutes after PACU admission)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Combined Atropine With Orthokeratology in Childhood Myopia Control (AOK) -A Randomized Controlled Trial
Brief Summary: This study aims to compare effects in retardation of myopia progression of combined ortho-k and 0.01% atropine therapy with those of ortho-k alone.Myopia control methods mainly focus on optical and pharmaceutical interventions . Currently, overnight-wear orthokeratology (ortho-k), is used extensively in Hong Kong with approximately 50% retardation effect. Pharmaceutical methods have focused on the use of atropine eye drops to slow myopic progression.The use of 1% atropine was limited by the manifestation of side effects and rebound effect.However, both side effect and rebound effect was minimal with 0.01% atropine.It was suggested that 0.01% was the optimum concentration for controlling myopia.The mechanisms of neither ortho-k nor atropine in myopia control are fully understood.It is believed that ortho-k and atropine act via different mechanisms.It is possible that by combining these two methods, additional retardation of myopia progression could be achieved.


Options:
A: Axial length (every 6 monthly in 2 years)
B: Changes in uncorrected visual acuity (Baseline, Month 6, Month 12)
C: Change in Refractive Error Relative to Baseline (12 months); Change in Refractive Error Relative to Baseline (24 months); Change in Refractive Error Relative to Baseline (36 months); Change in Axial Length Relative to Baseline (12 months); Change in Axial Length Relative to Baseline (24 months); Change in Axial Length Relative to Baseline (36 months)
D: Changes in axial length in 2 years (Every 6 months for a period of 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Cannabinoids for Behavioral Problems in Autism Spectrum Disorder: A Double Blind, Randomized, Placebo-controlled Trial With Crossover.
Brief Summary: This study aims to assess the safety, tolerability and efficacy of cannabinoids mix \[cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio, BOL Pharma, Israel\] for behavioral problems in children and youth with ASD.


Options:
A: Change From Baseline in Parent Rated Social Responsiveness Scale, 2nd Edition (SRS-2) T-Score After Treatment. (Baseline; Week 4)
B: N/A
C: Clinical Global Improvement (Week 12)
D: Change from baseline Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD) score, at three months. Within subject difference between the placebo condition and the whole plant extract condition. (At onset of each treatment period, at 1 month, 2 months and 3 months (end of treatment period)); Clinical Global Impression-Improvement scores (CGI-I ) at three months. Within subject difference between the placebo condition and the whole plant extract condition. (At 3 months (end of treatment period))

Answer: D