TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness and Subsequent Healthcare Use Associated With Early Physical Therapy Access Compared With a Stepped Usual Care Approach for Treatment of Low Back Pain.
Brief Summary: The primary purpose of this study is to compare the effectiveness of two management strategies for patients with a recent onset of low back pain (LBP). One is based on usual care and the other is based on early access to physical therapy following a pragmatic treatment-based classification approach. The secondary purposes are to compare the subsequent healthcare utilization associated with two management strategies as well as to evaluate the importance of psychosocial factors on outcomes within both groups of treatment. The overall hypothesis guiding the study is that the additional initial treatment expense incurred by early implementation will result in superior short-term clinical effectiveness, and will be more cost-effective in the long-term due to reduced healthcare utilization. We will also explore the importance of psychosocial factors on outcomes within both treatment groups, which may provide insights for further improving treatment strategies.


Options:
A: Pain of the neck and shoulders (At week 0 (baseline) and week 20 (follow-up)); Pain in the arm/hand (At week 0 (baseline) and week 20 (follow-up))
B: Sick leave (2 years)
C: Modified Oswestry Disability Index (12 months)
D: Change in functional limitations and symptoms measured with the Oswestry Disability Index (ODI) version 2.1 (Change from baseline at 1-week, 1-month, 3-month and 6-month follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: CLLM1-Protocol of the German CLL-Study Group (GCLLSG) A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for High-risk Patients With Chronic Lymphocytic Leukemia Following First-line Therapy
Brief Summary: CLLM1 is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study that compares the efficacy and safety of oral lenalidomide maintenance therapy to that of placebo maintenance therapy in high-risk subjects with Chronic Lymphocytic Leukemia (CLL) who have achieved at least a partial response (PR) and either:

* MRD levels of ≥ 10-2 or
* MRD levels of ≥ 10-4 - \< 10-2 combined with at least one of the following factors:

  * an unmutated IGHV-status
  * 17p-deletion or
  * TP53 mutation after first line therapy with FCR, FR, BR or FC (in case of of contraindications to receive Rituximab).


Options:
A: Progression-free Survival (PFS) Rate at 3 Years (Assessed every 3 months until progression up to 4 years and 8 months)
B: Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B (IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months.)
C: Progression-free survival (PFS) based on independent review committee (up to 6 years)
D: Lenalidomide Maximum Tolerated Dose (Dose escalation stage)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized Controlled Trial of Short Message Service by Cellular Phone for Professional Drivers With Pre-diabetes
Brief Summary: The purpose of this study is to prevent the professional drivers from pre-diabetes to diabetes.


Options:
A: incidence rate of DM (Follow-up in 12 months)
B: Development of diabetes (Up to 5 years)
C: Reduction in incidence of diabetes at 3 years (3 years from entry into the study)
D: Diabetes incidence (During the intervention period + after the intervention has been stopped)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea. A 32 Week Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre and Multinational Trial
Brief Summary: This trial is conducted in North America. The aim of the trial is to investigate the effect of liraglutide in obese subjects with sleep apnoea.


Options:
A: 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)
B: Change in ambulatory blood pressure (50 days)
C: Percent Weight Change at End of Treatment, Week 108. (From baseline to end of treatment); Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108. (Baseline to End of Treatment)
D: Change From Baseline in Apnoea-hypopnoea Index (AHI) (Week 0, Week 32)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea. A 32 Week Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre and Multinational Trial
Brief Summary: This trial is conducted in North America. The aim of the trial is to investigate the effect of liraglutide in obese subjects with sleep apnoea.


Options:
A: Mean Percentage Change in Fasting Body Weight From Baseline (Week 0, week 56); Percentage of Subjects Who Maintained Their run-in Fasting Weight Loss From Week 0 (Week 0, week 56); Percentage of Subjects Who Lost More Than or Equal to 5% of Fasting Body Weight From Week 0 (Week 0, week 56)
B: Glucose tolerance (Baseline - 16 weeks)
C: Change From Baseline in Apnoea-hypopnoea Index (AHI) (Week 0, Week 32)
D: Participants With Any Event From the Composite of Cardiovascular Death (CV Death), Non-fatal Myocardial Infarction (MI), or Non-fatal Ischaemic Stroke (Randomization (day 0) up to 2.9 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Intake of vegetables and fruits in preschool children is less than recommended amounts. Although offering a variety of foods has been shown to increase intake, this effect has not been well studied for low-energy-dense foods. The purpose of this study was to test whether increasing the variety of vegetables and fruits served to preschool children affected the amount eaten. The hypotheses were that increasing the variety of vegetables and fruits would increase both the amount selected and the amount eaten.


Options:
A: Intake of vegetables and fruit (One month)
B: sugar-sweetened beverages (one time point (baseline only))
C: Breastfeeding Initiation (first month after birth of child)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Intake of vegetables and fruits in preschool children is less than recommended amounts. Although offering a variety of foods has been shown to increase intake, this effect has not been well studied for low-energy-dense foods. The purpose of this study was to test whether increasing the variety of vegetables and fruits served to preschool children affected the amount eaten. The hypotheses were that increasing the variety of vegetables and fruits would increase both the amount selected and the amount eaten.


Options:
A: Change from baseline in energy dense food consumption at 12 months (12 months); Change from baseline in nutrient dense food consumption at 12 months (12 months)
B: Intake of vegetables and fruit (One month)
C: BMI z score (24 months (end of intervention)); BMI z score (60 months of age (followup at 5 years of age)); BMI z score (Follow-up at 11 years of age)
D: Infant weight for height (One year after study entry)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Intake of vegetables and fruits in preschool children is less than recommended amounts. Although offering a variety of foods has been shown to increase intake, this effect has not been well studied for low-energy-dense foods. The purpose of this study was to test whether increasing the variety of vegetables and fruits served to preschool children affected the amount eaten. The hypotheses were that increasing the variety of vegetables and fruits would increase both the amount selected and the amount eaten.


Options:
A: Intake of vegetables and fruit (One month)
B: Change in child adiposity from baseline measured via BMI z-score (Enrollment, 6 months, 12 months, 18 months, 24 months); Change in adult adiposity from baseline measured via BMI (Enrollment, 12 months, 24 months)
C: Group differences in percentage of mothers who meet breastfeeding and complementary feeding recommendations and percentage of mothers who introduce sugar sweetened beverages over time as assessed by the Child Feeding Assessment. (2 weeks - 24 months postpartum); Group differences in mean scores for infant feeding style subscales assessed using the Infant Feeding Behavior Questionnaire. (2 months-12 months postpartum); Group differences in in mean scores for toddler feeding style subscales assessed using the Toddler Feeding Behavior Questionnaire (TFBQ). (24 months postpartum); Group differences in children's fruit and vegetable intake, sugar sweetened beverage (SSB) consumption, snacks, and desserts over time. (6 and 24 months postpartum); Group differences in children's physical activity levels as assessed by accelerometry. (18 months-24 months postpartum); Group differences in children's reported physical activity, screen time and other sedentary activities over time as assessed by the Child Physical Activity Assessment. (2 weeks-24 months postpartum); Group differences in children's mean BMI z-scores over time as assessed through child weight and length measurements over time. (2 weeks-24 months postpartum)
D: Vegetable Flavor Acceptance [Infants' Intake] (6- to 10-month-old weaned infants (3 separate test days )); Taste Liking Ratings of Vegetable Flavors [Mothers]. (Monthly, 0.5 to 4.5 months); Vegetable Flavor Acceptance (Infants' Rate of Feeding) (6- to 10-month-old weaned infants (3 separate test days))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Intake of vegetables and fruits in preschool children is less than recommended amounts. Although offering a variety of foods has been shown to increase intake, this effect has not been well studied for low-energy-dense foods. The purpose of this study was to test whether increasing the variety of vegetables and fruits served to preschool children affected the amount eaten. The hypotheses were that increasing the variety of vegetables and fruits would increase both the amount selected and the amount eaten.


Options:
A: Number of parents engaging with the HENRY programme measured using Centre level process data (12 month post randomisation (allowing 3 months for Optimisation intervention implementation and collecting data from 1- 2 HENRY courses per site).)
B: Growth trajectories (using BMI, waist circumference), body composition (3 months)
C: 1 Year change in insulin resistance via HOMA-IR (Change during first year); 2 year change in insulin resistance via HOMA-IR (Change during 2 years)
D: Intake of vegetables and fruit (One month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Intake of vegetables and fruits in preschool children is less than recommended amounts. Although offering a variety of foods has been shown to increase intake, this effect has not been well studied for low-energy-dense foods. The purpose of this study was to test whether increasing the variety of vegetables and fruits served to preschool children affected the amount eaten. The hypotheses were that increasing the variety of vegetables and fruits would increase both the amount selected and the amount eaten.


Options:
A: Intake of vegetables and fruit (One month)
B: Energy density of the diet (Weeks 0 and 13)
C: Overweight and obesity according to IOTF references (0-1-2 years)
D: Change in physical activity (Participants' physical activity will be measure over the course of 5 consecutive school days pre-intervention and 5 consecutive school days post-intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Intake of vegetables and fruits in preschool children is less than recommended amounts. Although offering a variety of foods has been shown to increase intake, this effect has not been well studied for low-energy-dense foods. The purpose of this study was to test whether increasing the variety of vegetables and fruits served to preschool children affected the amount eaten. The hypotheses were that increasing the variety of vegetables and fruits would increase both the amount selected and the amount eaten.


Options:
A: Overweight and obesity according to IOTF references (0-1-2 years)
B: Number of Targeted Products Selected Relative to Others (up to 8 months)
C: Energy density of the diet (Weeks 0 and 13)
D: Intake of vegetables and fruit (One month)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Intake of vegetables and fruits in preschool children is less than recommended amounts. Although offering a variety of foods has been shown to increase intake, this effect has not been well studied for low-energy-dense foods. The purpose of this study was to test whether increasing the variety of vegetables and fruits served to preschool children affected the amount eaten. The hypotheses were that increasing the variety of vegetables and fruits would increase both the amount selected and the amount eaten.


Options:
A: Vegetable Flavor Acceptance [Infants' Intake] (6- to 10-month-old weaned infants (3 separate test days )); Taste Liking Ratings of Vegetable Flavors [Mothers]. (Monthly, 0.5 to 4.5 months); Vegetable Flavor Acceptance (Infants' Rate of Feeding) (6- to 10-month-old weaned infants (3 separate test days))
B: Satisfaction and Exit Survey Composite Scale Score -- ONLY CAREGIVERS COMPLETED THIS MEASURE (6 weeks)
C: Intake of vegetables and fruit (One month)
D: Child percent body fat after the 8-month intervention period, controlling for baseline percent body fat. Percent body fat will be calculated using Dezenberg's equation which takes into account child height, weight, gender, race, and tricep skinfolds. (baseline, 8 months and 14 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI)
Brief Summary: The objectives of this trial are to determine whether, in critically ill patients with severe acute kidney injury (AKI), randomization to accelerated initiation of renal replacement therapy (RRT), compared with standard initiation, is:

1. Feasible, in terms of adherence to the protocol (primary outcome), recruitment rates, and achievement of follow-up; and
2. Safe, from the perspective of potential adverse events associated with earlier initiation of RRT


Options:
A: overall mortality (90 days)
B: Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (24 hours)
C: Feasibility of protocol adherence (14 days)
D: We will study the feasibility of recruiting ther target population, administering the study therapies according to pre-defined protocols and following patients for clinical endpoints. (60 days)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI)
Brief Summary: The objectives of this trial are to determine whether, in critically ill patients with severe acute kidney injury (AKI), randomization to accelerated initiation of renal replacement therapy (RRT), compared with standard initiation, is:

1. Feasible, in terms of adherence to the protocol (primary outcome), recruitment rates, and achievement of follow-up; and
2. Safe, from the perspective of potential adverse events associated with earlier initiation of RRT


Options:
A: Death (90 days)
B: Accumulation of anti-Xa activity in plasma and removal of anti-Xa activity by filtration. (24 hours)
C: We will study the feasibility of recruiting ther target population, administering the study therapies according to pre-defined protocols and following patients for clinical endpoints. (60 days)
D: Feasibility of protocol adherence (14 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Center for Research in Implementation Science and Prevention (CRISP): Project 1: Comparative Effectiveness Trial of Two Reminder/Recall Methods to Increase Immunization Rates in Young Children
Brief Summary: The purpose of this study is to determine if a collaborative centralized population-based reminder/recall intervention is more effective than a traditional practice-based reminder/recall intervention at increasing immunizations among young children.


Options:
A: To assess the ability of direct communication and education to patients using modern technology (cellular text messaging) to enhance vaccine uptake. (at participant post-partum visit)
B: 1 Dose Coverage of the HPV vaccine series at End of Study Period (12 months); 3 Dose Coverage of the HPV vaccine series at End of Study Period (12 months)
C: new immunization doses (within 60 days of reminder notification)
D: 1) Change in up-to-date rates for 19- to 35-month-olds (who needed an immunization at baseline) in collaborative population-based counties compared to practice-based intervention counties (every 6 months for 2 years); 2) Change in percent of children (who needed an immunization at baseline) who received any additional vaccines in each type of intervention county. (every 6 months for two years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet Treatment for Social Phobia in Romania: A Randomized Controlled Trial
Brief Summary: The main aim of this study is to investigate the effectiveness of an Internet-delivered intervention for social phobia by comparing it to a waitlist control group. The second aim of the study is to track the potential changes in participants' thinking patterns. Because this is among the first guided Internet-delivered interventions conducted in Romania, the treatment credibility will also be investigated. Finally, the predictive power of anxiety sensitivity for both SAD symptoms and the treatment effectiveness will be investigated.


Options:
A: The Generalised Anxiety Disorder 7-item (GAD-7) (Change from baseline at: [1] day 24 and [2] day 48 into the 10-week treatment period; [3] 0-1 week after the treatment period; follow-ups at [4] month 12 and [5] month 36 after the treatment period.)
B: Panic Disorder Severity Scale (PDSS) (Two weeks pre treatment, two weeks post treatment, six months and 12 months post treatment)
C: Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) (pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)); Social Phobia Inventory (SPIN) (pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37))
D: Measure of social anxiety and avoidance - Liebowitz Social Anxiety Scale (LSAS) (5-year follow-up)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Internet Treatment for Social Phobia in Romania: A Randomized Controlled Trial
Brief Summary: The main aim of this study is to investigate the effectiveness of an Internet-delivered intervention for social phobia by comparing it to a waitlist control group. The second aim of the study is to track the potential changes in participants' thinking patterns. Because this is among the first guided Internet-delivered interventions conducted in Romania, the treatment credibility will also be investigated. Finally, the predictive power of anxiety sensitivity for both SAD symptoms and the treatment effectiveness will be investigated.


Options:
A: Leibowitz Social Anxiety Scale - Self Report (LSAS-SR) (pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37)); Social Phobia Inventory (SPIN) (pretreatment (week 0), post treatment (week 11), 6 month follow-up (week 37))
B: Change from baseline in Clinical Outcome in Routine Evaluation - Outcome Measure (CORE-OM) (Two weeks pre treatment (baseline), two weeks post treatment, and 12 months post treatment)
C: Panic Disorder Severity Scale (PDSS) (Pre, post at 6-month follow-up)
D: Health Anxiety Inventory (3 days before treatment start); Health Anxiety Inventory (12 weeks after pre asessment); Health Anxiety Inventory (6 months after post assessment); Health Anxiety Inventory (12 months after post assessment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Follicular Flushing on Cycle Outcomes in Poor Responders
Brief Summary: Patients with infertility often undergo in vitro fertilization (IVF) to achieve a pregnancy, which involves ovarian stimulation, monitoring of follicular growth, oocyte retrieval, sperm insemination, embryo culture and embryo transfer.

The oocytes are removed during surgery by aspirating the follicles using a single lumen needle with an ultrasound to guide the procedure. There is some data that flushing the follicles with embryo culture media before aspiration using a double lumen needle increases the number of oocytes retrieved, particularly among poor responding patients for whom each additional oocyte recovered may substantially alter the outcome of that IVF cycle.

The objective of the research is to evaluate the effect of follicular flushing in poor responders on IVF cycle outcomes.


Options:
A: Frequency of Ovarian Hyperstimulation Syndrome (OHSS) (3 years)
B: FOLLICULAR FLUSHING ON CYCLE OUTCOMES IN POOR RESPONDERS (2 weeks)
C: Number of retrieved oocytes per procedure (through study completion, 9 months)
D: Proportion of mature oocytes retrieved (day of intervention)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Drug Eluting Balloon in peripherAl inTErvention For Below The Knee Angioplasty Evaluation: the DEBATE-BTK Study
Brief Summary: Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK) vessels.


Options:
A: Event-free Survival (6 months)
B: Safety: Major adverse event rate (MAE), defined as all cause death, major amputation of target extremity, target lesion thrombosis, target lesion revascularisation (TLR)and target vessel revascularization (TVR) at 30 days. (30 days); Performance: Target lesion primary patency rate at 6 months assessed by quantitative vascular angiogram (QVA). (6 months)
C: Angiographic Binary Restenosis (6 months)
D: angiographic binary restenosis (12 months)

Answer: D