TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Pre-EDIT: A Randomised, Feasibility Trial of Elastance-Directed Intra-pleural Catheter or Talc Pleurodesis (EDIT) in the Management of Symptomatic Malignant Pleural Effusion Without Obvious Non-expansile Lung
Brief Summary: Malignant Pleural Effusion (MPE) is a collection of fluid inside the chest caused by cancer. It is a common medical problem and often causes severe breathlessness. Patients with this condition generally have a very poor survival and so it is extremely important that they are given effective treatment as soon as possible to minimise the amount of time they have to spend in hospital.

Standard treatment for MPE involves an admission to hospital to drain the fluid and then attempt to prevent the fluid from returning by sticking the lung to the inside of the rib cage with medical talc powder which acts like glue. This is called talc pleurodesis (TP) but unfortunately it fails in about 30% of patients. This is usually because the lung has not fully re-expanded and has not made contact with the inside of the ribs. When this happens, the fluid can be effectively treated with a different type of drainage tube called an indwelling pleural catheter (IPC) which tunnels under the skin and is drained at home by the district nurses.

It is thought that pressure measurements taken from the fluid as it is drained may be able to show doctors whether or not the lung will re-expand before patients are committed to either TP or an IPC. In this research we wish to test if these measurements can be used to choose which is the best first treatment option (TP or IPC) for patients with MPE. We have called this 'EDIT management'. Since it is uncertain whether this new approach will work, patients will be randomised to have either standard treatment or EDIT management. We will compare the two groups to assess whether the patients who had EDIT management had to have fewer repeat procedures over the following 3 months.


Options:
A: Radiological lung expansion after talc pleurodesis and clinical outcome (6 months)
B: To measure the standard deviation of Visual Analogue Scale scores for breathlessness (Daily from randomisation to 12 months)
C: Recurrence of pleural effusion (2 months following intervention)
D: Feasibility of recruiting 30 patients within 12 months and randomising them to either EDIT Management or Standard Care (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective Randomized Multicenter Study to Demonstrate the Benefits of Hemodialysis Without Acetate (With Citrate): ABC-treat Study
Brief Summary: Prospective randomized cross-over multicenter study to demonstrate the benefits of hemodialysis without acetate dialysate, with citrate.

32 weeks duration, in two phases. In the first, half of the patients started with citrate dialysate for 16 weeks and the other half with acetate dialysate, and then patients cross.

The primary objective is to analyze the effect of citrate dialysate on acid base balance decreasing chronic metabolic acidosis and avoiding / reducing post-dialytic alkalosis.


Options:
A: Assess the safety of the factor Xa inhibitor apixaban versus a vitamin-K antagonist phenprocoumon in patients with NVAF and ESKD on hemodialysis. (1-60 months)
B: therapy interruption event (through study completion, from start to four hours)
C: Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma kallikrein. (Blood samples are taken before hemodialysis treatment start and 5minutes (min), 15min, 30min, 90min and 240min after hemodialysis treatment start.); Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIa. (Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.); Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIIa. (Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.)
D: Effect of citrate dialysate on acid base status in hemodialysis patients measured by pH, BEecf and Bicarbonate at the end of HD session. (32 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Can Commercial Mobile Apps for Weight Management be Used in Interventions? Bridging the Gap Between Usability, Theoretical Adherence, and User Experience - Part II - WaznApp Trial
Brief Summary: WaznApp study is a 12-week randomized controlled trial aimed to evaluate the feasibility and preliminary efficacy of a self-directed behavioral weight-loss intervention targeting employees of an academic institution, using two popular consumer mobile applications for weight loss. The hypothesis is that individuals assigned to the app that provides interactive feedback and proactively motivates engagement in healthy behaviors (eating healthily and being more active) will be significantly better than those who receive the comparison condition (a simple calorie tracking app).


Options:
A: Weight change (kg) (Baseline, 4, 8, 12 weeks); Waist circumference change (cm) (Baseline, 12 weeks); BMI change (kg/m^2) (Baseline, 4, 8, 12 weeks); Physical activity change (self-reported - IPAQ-SF, MET-hours/week) (Baseline, 12 weeks); Physical activity change (automatically tracked - steps/week) (Baseline, 4, 8, 12 weeks); Dietary caloric intake change (Baseline, 12 weeks)
B: Weight loss (3 months, 6 months, 12 months)
C: the amount of weight loss (kg) (12 weeks)
D: 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)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomized, Observer-blind, Multicenter, Phase 3 Study to Evaluate the Lot Consistency, Immunogenicity, and Safety of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Healthy Adults 18-49 Years of Age
Brief Summary: This Phase 3 study is intended to assess the clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three consecutively manufactured lots of the Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine, during the 2016-2017 influenza season, in healthy adults 18-49 years of age. A single dose of one of three consecutive lots of Quadrivalent VLP Influenza Vaccine (30 µg/strain) will be administered to 1,200 participants.


Options:
A: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain (Day 21 (post-vaccination))
B: Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 28 (Week 4) (Day 28)
C: Percentage of Participants in Sustained Remission at Week 52 (Tocilizumab + 26 Weeks Prednisone Taper Versus Placebo + 26 Weeks Prednisone Taper) (Week 52)
D: Time to exhaustion during exercise (Up to 20 minutes); Change from baseline in peak power output (Up to 20 minutes)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Vacuum Myofascial Therapy Device for Non-specific Neck Pain. A Single Blind Randomized Clinical Trial
Brief Summary: This study aim to investigate the effects of physium therapy for improving pressure pain thresholds (PPTs), range of motion,Neck Disability Index, the multidimensional health related quality of life (SF-12) and the multidimensional health related quality of life and pain in patients with mechanical neck pain (NP).


Options:
A: The intensity of cervical pain (Baseline)
B: Visual Analogue Scale (5 months)
C: Numeric pain rating scale (NPRS) (Baseline); Numeric pain rating scale (NPRS) (post 3 weeks); Pain pressure threshold (baseline); Pain pressure threshold (post 3 weeks); Thoracic ROM (Baseline); Thoracic ROM (post 3 weeks)
D: Pain intensity (week 8)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Role of Whole Body Vibration and Pelvic Floor Muscle Exercises in Treating Urinary Incontinence Following Prostate Cancer Surgery: A Comparative Randomized Controlled Trial
Brief Summary: Stress urinary incontinence is common in men following prostate cancer surgery. Rehabilitative interventions incorporate pelvic floor muscle training, biofeedback, electrical stimulation, lifestyle changes, or a combination of these strategies. However, little is known about the physiological impact of whole-body vibration for stress urinary incontinence following radical prostatectomy. Participants: Sixty-one patients with mild Stress urinary incontinence after radical prostatectomy.

Intervention: patients were randomly assigned into two groups: group 1 included 30 patients who received pelvic floor muscle training and whole-body vibration training with a frequency and amplitude of 20 Hz/ 2 mm for the first 2 sessions and 40 Hz/ 4 mm for the rest of intervention; while group 2 included 31 patients who performed only pelvic floor muscle training. The intervention in both groups was performed three times per week for 4 weeks.


Options:
A: Incontinence Visual Analogue Scale (I-VAS) (7 months)
B: Percent Change in Incontinence Episodes on Bladder Diary (2 months); Percent Change in Incontinence Episodes Per Week on Bladder Diary (1 year)
C: Recovery of urinary continence (postoperative 1 month)
D: improves muscle strength of the pelvic floor at 3 months (baseline and 3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke
Brief Summary: This study evaluates the effectiveness of Guttmann NeuroPersonalTrainer (GNPT), a tele-rehabilitation platform developed as a tool for the cognitive rehabilitation of chronic stroke patients. All patients will receive this treatment but in different order: half will receive GNPT and the other half will receive sham cognitive training; after a washout period of three months, crossover will occur and participants from the GNPT condition will receive sham cognitive training, while participants originally from the control intervention will receive GNPT.


Options:
A: Change scores of Montreal Cognitive Assessment (MoCA) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Memory Scale - Third Edition (WMS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Wechsler Adult Intelligence Scale - Third Edition (WAIS-III) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Useful Field of View (UFOV) (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Stroop Color-Word test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)); Change scores of Dual-task test (Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months))
B: Conners Continuous Performance Test (CPT-II) (1 day); Rey Auditory Verbal Learning Test (RAVLT) (1 day); Spanish phonemic fluency test- PMR (1 day); Digit Span forward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III) (1 day); Digit Span backward Subtest from the Wechsler Adult Intelligence Scale (WAIS-III) (1 day); Letter-Number Sequencing Subtest from the Wechsler Adult Intelligence Scale (WAIS-III) (1 day); Rating Scale for Attentional Behavior (RSAB) (1 week); Prospective and Retrospective Memory Questionnaire (PRMQ) (1 week); Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) (1 week)
C: Number of participants with treatment emergent serious adverse events (At 12 weeks visit (post-intervention)); Adherence to a 12-week combined exercise and cognitive training protocol versus a sham group (At 12 weeks visit (post-intervention))
D: Barthel Index (Change from Baseline to 2, 4, 12 and 22 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Ultrasound Guided Versus Landmark Guided Arterial Line Placement by Emergency Medicine Interns
Brief Summary: Critically ill patients in the emergency department commonly require arterial line placement for continuous direct blood pressure monitoring, frequent arterial blood gas sampling, and frequent blood sampling. Trans-radial catheterization has been shown to reduce access site complications and increase patient comfort compared to trans-femoral access. Radial artery access on the first attempt is optimal; attempts at reentry delay care and increase the risk of vascular spasm, hematoma, infection, neurovascular injury, and pain. The traditional pulse palpation method of radial artery cannulation can be challenging, especially in patients with weak pulses (i.e. morbidly obese or hypotensive individuals).

A review of literature suggests that ultrasound guided trans-radial catheterization compared to standard pulse palpation reduces access time and increases rate of first-entry success when performed by physicians trained in ultrasound. Thus, complications ascribed to reentry are prevented and timely care is provided.

To the investigator's knowledge, only one other prospective study has been conducted to assess the utility of ultrasound guided radial artery cannulation in the emergency department. Due to the paucity of literature to support the use of ultrasound guided trans-radial catheterization in critically ill patients, the study will aim to provide further data on the topic. Both techniques are considered standard of care.


Options:
A: Successful rate without extra vascular damage (Through study completion, an average of 1 year.)
B: First Pass Success When Attempting Arterial Catheterization. (Immediate, upon study entry)
C: Superiority of Method of arterial line placement (1 day)
D: Is only one puncture attempt necessary to attain the radial artery? yes/no (maximum two hours)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Engaging Rural Men With Mobile Technologies for Weight Loss: A Randomized Controlled Trial.
Brief Summary: Overweight and obese men in rural Northeast Nebraska are an unrepresented, at-risk group exhibiting rising rates of cardiovascular disease, poor access to preventive care, and a rural milieu that contributes to their sedentary physical activity and unhealthy diet. This study proposes to use a pragmatic randomized controlled trial and community engaged research approaches to 1) determine the feasibility and acceptability of a commercially available, smart phone self-monitoring app (premium-version) plus text-based coaching and daily weighing via Wi-Fi scale intervention for achieving weight loss, 2) determine preliminary efficacy of this intervention group to a comparison group receiving only a self-monitoring app (basic-version) in achieving the outcomes of weight loss (kilogram) and improved dietary and physical activity behaviors (secondary) at 6 months post-baseline, and 3) determine quantitative and qualitative indicators of community capacity to support a contextually relevant weight loss intervention. Eighty men (ages 40-69) with body mass index of 28 or higher, randomly assigned (1:1 ratio) to intervention group or comparison group. Men will complete baseline assessments (weight, % body fat, body mass index height, blood pressure, health history, dietary intake, physical activity frequency/intensity) and receive orientation to the mobile technologies (app features, text messaging, Wi-Fi scale). Men will track their dietary intake, physical activity, and weight on the app for 12 weeks. After the 3-month intervention, post-measure assessments (weight, % body fat, BMI, dietary intake, PA frequency/intensity, technology usability surveys) will be collected at 3 and 6 months post-baseline. At 6 months post-baseline, two groups (n=8 each) of intervention completers will be purposively selected to share their perceptions of the intervention efficacy in an evaluative focus group. A community advisory board comprising local leaders within the men's social network, together with investigators and rural student nurses will guide community outreach efforts for study recruitment, implementation and evaluation. Study findings will be evaluated with the community to inform local dissemination, future intervention revision, and determination of community capacity for support of a larger clinical trial.


Options:
A: Weight (6 months post randomization)
B: weight reduction (at 6 months)
C: Mean Change in Weight by Randomized Group (Observed means from baseline weight and at 6 months)
D: Weekly Moderate-Vigorous Physical Activity Minutes, Accelerometry (Phase II baseline to 1 month, 2 months and 4 months (end of treatment)); Delay Discounting (Adjusting Amount Task) (Phase II baseline to 1 month, 2 months and 4 months (end of treatment)); Delay Discounting (Monetary Choice Questionnaire) (Phase II baseline to 2 months and 4 months (end of treatment))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III, Open-label, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
Brief Summary: For Non-dialysis subjects with anemia associated with chronic kidney disease, demonstrate non-inferiority of MT-6548 compared to darbepoetin alfa using Hb value and evaluate long-term safety of MT-6548.

For subjects not currently receiving ESAs, evaluate Hb correction and maintenance effect of MT-6548 and for subjects currently receiving ESAs, evaluate Hb conversion and maintenance effect of MT-6548


Options:
A: Mean Hb Level of Week 20 and Week 24 (Up to Week 24)
B: Hemoglobin level (24 weeks)
C: Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36) (Baseline; Weeks 24 to 36); Median Time to First Major Adverse Cardiovascular Event (MACE) (Up to Week 208)
D: Mean Hb Level of Week 20 and Week 24 (Up to Week 24)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Bladder Training and Pelvic Floor Muscle Training on the Symptomatology of Overactive Bladder Syndrome - a Randomized Controlled Clinical Trial
Brief Summary: The question is whether vesical training and TMAP can be used in isolation without treatment of overactive bladder syndrome? ALSO will be evaluated in urinary symptoms, a function of the MAP, a quality of life and a satisfaction of the women with the treatment offered.


Options:
A: Evaluation of subjective cure (At the end of 3 months of supervised treatment)
B: Overactive bladder-validated 8-questions (4 weeks)
C: Urogenital Distress Inventory (UDI-6) (baseline to 6 or 8 weeks); Incontinence Impact Questionnaire (IIQ-7) (baseline to 6 or 8 weeks)
D: urgencyepisodes (after 2 month (end of study)); urgeincontinence (after 2 month (studyend)); VAS score from ICI_OAB_Q (after 2 month (studyend))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Bladder Training and Pelvic Floor Muscle Training on the Symptomatology of Overactive Bladder Syndrome - a Randomized Controlled Clinical Trial
Brief Summary: The question is whether vesical training and TMAP can be used in isolation without treatment of overactive bladder syndrome? ALSO will be evaluated in urinary symptoms, a function of the MAP, a quality of life and a satisfaction of the women with the treatment offered.


Options:
A: Proportion of Women Who Meet Definition of Success (8 months)
B: Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward) (From Baseline to 6 Weeks); Change in Frequency of Urination From 6 Weeks to 12 Weeks (Last Observation Carried Forward) (Change from 6 weeks to 12 weeks); Change in Frequency of Urination From Baseline to 12 Weeks (Last Observation Carried Forward) (Baseline to 12 weeks)
C: Evaluation of subjective cure (At the end of 3 months of supervised treatment)
D: Percentage of Change From Baseline in 72-hour Incontinence Episode Frequency (IEF) Over Weeks 1-12 (baseline, weeks 1-12)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Novel Approach to Improving Lactation Support Using Mobile Health Technology
Brief Summary: This is a randomized trial of use of a mobile health tool (EpxBreastfeeding) aimed at improving breastfeeding adherence and duration among recent mothers who self identify as motivated to breastfeed. As a result of text communication and expedited coaching through common breastfeeding challenges, the investigators expect more mothers in the study arm will continue breastfeeding through the first 6 months after giving birth.


Options:
A: Initiation of highly effective contraception, as defined by the World Health Organization. (3 months after initial enrollment)
B: Confirmed HBV and HCV test uptake (enrollment - 4 weeks after enrollment)
C: Measles - 2 Completion (When the participants reach 2 years of age)
D: Exclusive breastfeeding duration (Six months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Novel Approach to Improving Lactation Support Using Mobile Health Technology
Brief Summary: This is a randomized trial of use of a mobile health tool (EpxBreastfeeding) aimed at improving breastfeeding adherence and duration among recent mothers who self identify as motivated to breastfeed. As a result of text communication and expedited coaching through common breastfeeding challenges, the investigators expect more mothers in the study arm will continue breastfeeding through the first 6 months after giving birth.


Options:
A: Smoking Abstinence (3 months)
B: The rate of the Exclusive Breastfeeding (from birth of baby to 6 months post birth)
C: Exclusive breastfeeding duration (Six months)
D: Mammogram receipt (1 week)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Novel Approach to Improving Lactation Support Using Mobile Health Technology
Brief Summary: This is a randomized trial of use of a mobile health tool (EpxBreastfeeding) aimed at improving breastfeeding adherence and duration among recent mothers who self identify as motivated to breastfeed. As a result of text communication and expedited coaching through common breastfeeding challenges, the investigators expect more mothers in the study arm will continue breastfeeding through the first 6 months after giving birth.


Options:
A: Highly-effective contraceptive use (6 months postpartum)
B: Smoking Abstinence (3 months)
C: Exclusive breastfeeding duration (Six months)
D: Exclusive breastfeeding (0-6 months following delivery); Immediate breastfeeding (1 hour following delivery)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Novel Approach to Improving Lactation Support Using Mobile Health Technology
Brief Summary: This is a randomized trial of use of a mobile health tool (EpxBreastfeeding) aimed at improving breastfeeding adherence and duration among recent mothers who self identify as motivated to breastfeed. As a result of text communication and expedited coaching through common breastfeeding challenges, the investigators expect more mothers in the study arm will continue breastfeeding through the first 6 months after giving birth.


Options:
A: Immunization Rates at 14 weeks (14 Weeks)
B: Exclusive breastfeeding duration (Six months)
C: Vaccines received (Electronic Health Record) (up to a year of follow up)
D: Proportion of Children Under 5 Years in Vulnerable Households That Have a Birth Certificate (1 year); Proportion of Children Under 5 Years in Vulnerable Households That Have Up-to-date Vaccinations (1 year); Proportion of Children Aged 6-12 Years That Attended Primary School 80% of Days in the Last Month (1 year)

Answer: B