TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Implementation of Uterine Fibroid Option Grid Patient Decision Aids Across Five Organizational Settings: a Randomized Stepped-wedge Study
Brief Summary: UPFRONT is a study that aims to use two implementation frameworks - the Consolidated Framework for Implementation Research and the Normalization Process Theory - to guide the implementation of a uterine fibroid patient decision aid, known as Option Grid, at five diverse gynecology settings across the United States. Option Grid provides evidence-based information on the various treatment options to help women across socioeconomic strata with symptomatic uterine fibroids make a preference-sensitive decision.


Options:
A: Prostate Specific Antigen (PSA) Screening Rates (Up to Month 3); Patient Knowledge Survey Score (Day 1); Decision Quality Score (Day 1); Percentage of Participants Who Make Informed Choice (Day 1)
B: The number of eligible patients that can be identified who receive the uterine fibroid Option Grid patient decision aid. (Month 1-14)
C: Decision Self Efficacy (post intervention)
D: Number of Participants Who Used Dual Contraception or Safer Conception Method (Month 12)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Thermal Therapy in Combination With Exercises to Relieve Acute Low Back Pain
Brief Summary: Low back pain (LBP) ranks among the first diseases in term of years lived with disability. The latest Clinical Guideline from the American College of Physicians for acute LBP recommends to select "nonpharmacologic treatment with superficial heat, massage, acupuncture or spinal manipulation". The application of superficial heat ("thermal therapy") may provide enough pain relief in the acute phase to remain active, which is recommended to prevent the development of chronicity. However, no studies have tested if the combination of heat and exercises provide additional benefit on short, middle and long-term follow-up in people with acute LBP.

Hence, the main objective of this study is to determine the immediate, short-, middle- and long-term effect of continuous low-level thermal therapy in combination or not with exercises on pain, disability, and physical activity level in people with acute LBP.

Project hypothesis : The Thermal care + Exercises group will show greater improvement in pain, disability and physical activity level than both Thermal care and Control groups for immediate, short-, middle- and long-term follow-ups.

Sixty individuals with acute LBP will be recruited. This study will include six assessments over 6 months. At the baseline evaluation, participants will complete questionnaires on symptoms, disability, pain-related fear and self-efficacy. Afterwards, participants will be randomly assigned to one of three intervention programs: 1) Thermal care group, 2) Exercises + Thermal care group, and 3) Control group. They will immediately meet a physical therapist to review and perform their assigned program.

Participants will then take part in their assigned 7-day intervention program, during which they will wear a fitness wristband to track physical activity level. Finally, the same outcomes will be reassessed to determine the effect of intervention at 1 week, 1 month, 3 months and 6 months after baseline.


Options:
A: Change from baseline on the Modified Oswestry Disability Index (ODI) (Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months); Change from baseline on the Numeric Pain Rating Scale (NPRS) (Baseline, 2 weeks, end of intervention (discharge; an average of 6 weeks), 6 month and 12 months)
B: 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))
C: Sick leave (2 years)
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: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pharmacist Intervention for Monitoring and Treating Hypertension Using Bidirectional Texting
Brief Summary: Bidirectional texting is an effective way to collect home blood pressure (BP) measurements from subjects, but collecting BP measurements and sending them to physicians does not necessarily lead to decreased BP. Pharmacist interventions have been successful in decreasing subject BP. However, pharmacists are expensive, and in successful interventions, spent a substantial amount of time collecting home BP measurements. In this study, a proven pharmacist intervention will be added to a bidirectional texting program to determine if a combined pharmacist-bidirectional texting intervention is successful at decreasing subject BP and increasing subject BP treatment intensification in a cost-effective manner. This study will be a cluster-randomized, controlled trial of a new intervention.


Options:
A: Estimated Percentage of Participants in Blood Pressure Control at Baseline (Baseline); Estimated Percentage of Participants in Blood Pressure Control at 6 Months (6month); Estimated Percentage of Participants in Blood Pressure Control at 12 Months (12 month); Estimated Percentage of Participants in Blood Pressure Control at 18 Months (18 month); Blood Pressure Averages Systolic & Diastolic (Baseline); Blood Pressure Averages Systolic & Diastolic (12-month)
B: Medication Adherence (12 months)
C: Difference in Change in Systolic Blood Pressure- 12 Months (12 months)
D: Changes in mean SBP (From baseline (T1) to 12 months (T3))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Music Therapy on Newborns
Brief Summary: The clinical study is evaluating the impact of music therapy on neonates, specifically infants with neonatal opioid withdrawal syndrome (NOWS). The goal is to study the effect of music therapy on an infant's behavioral (i.e feeding patterns, sleep patterns, severity of withdrawal) and physiological systems (i.e. heart rate, respiratory rate). The investigators are also studying the impact of music therapy on the infant's utilization of resources (i.e. total opioid usage and total length of stay).


Options:
A: Length of Treatment (Patients will be followed for the duration of hospital stay, an expected average of 5 weeks.)
B: Hospital length of stay (Up to hospital discharge, an anticipated average of 4 weeks)
C: Length of Treatment With Opioid Medication (Up to 12 months)
D: Change in Heart Rate (Change in average heart rate over the 20 minute sessions (both control and music therapy)); Change in Heart Rate Variability (Change in average heart rate variability over the 20 minute sessions (both control and music therapy)); Change in Sleeping Patterns (Change in phase of sleep over the 20 minute sessions (both control and music therapy)); Change in Feeding Patterns (Time from feeding to onset of sleep over the 20 minute session (both control and music therapy)); Morphine Utilization (From day of birth through day of discharge, up to 6 months); Total Length of Stay (From day of birth through day of discharge, up to 6 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Music Therapy on Newborns
Brief Summary: The clinical study is evaluating the impact of music therapy on neonates, specifically infants with neonatal opioid withdrawal syndrome (NOWS). The goal is to study the effect of music therapy on an infant's behavioral (i.e feeding patterns, sleep patterns, severity of withdrawal) and physiological systems (i.e. heart rate, respiratory rate). The investigators are also studying the impact of music therapy on the infant's utilization of resources (i.e. total opioid usage and total length of stay).


Options:
A: Change in Heart Rate (Change in average heart rate over the 20 minute sessions (both control and music therapy)); Change in Heart Rate Variability (Change in average heart rate variability over the 20 minute sessions (both control and music therapy)); Change in Sleeping Patterns (Change in phase of sleep over the 20 minute sessions (both control and music therapy)); Change in Feeding Patterns (Time from feeding to onset of sleep over the 20 minute session (both control and music therapy)); Morphine Utilization (From day of birth through day of discharge, up to 6 months); Total Length of Stay (From day of birth through day of discharge, up to 6 months)
B: Duration of treatment (0 to 42 days)
C: Heart Rate (up to 2 weeks); Respiratory Rate (up to 2 weeks); O2 sats (up to 2 weeks); Activity level (up to 2 weeks); Sleep category (up to 2 weeks); Feeding (sucking and absorption) category (up to 2 weeks); Neonatal Abstinence Scoring (NAS) (up to 2 weeks)
D: Methadone and EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine) blood concentration (Participants will be followed for the duration of the hospital stay (an expected average of 4 weeks).)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Music Therapy on Newborns
Brief Summary: The clinical study is evaluating the impact of music therapy on neonates, specifically infants with neonatal opioid withdrawal syndrome (NOWS). The goal is to study the effect of music therapy on an infant's behavioral (i.e feeding patterns, sleep patterns, severity of withdrawal) and physiological systems (i.e. heart rate, respiratory rate). The investigators are also studying the impact of music therapy on the infant's utilization of resources (i.e. total opioid usage and total length of stay).


Options:
A: Length of Hospitalization (Up to 4 months)
B: Cortical oxy-haemoglobin increase (During the procedure)
C: Change in Heart Rate (Change in average heart rate over the 20 minute sessions (both control and music therapy)); Change in Heart Rate Variability (Change in average heart rate variability over the 20 minute sessions (both control and music therapy)); Change in Sleeping Patterns (Change in phase of sleep over the 20 minute sessions (both control and music therapy)); Change in Feeding Patterns (Time from feeding to onset of sleep over the 20 minute session (both control and music therapy)); Morphine Utilization (From day of birth through day of discharge, up to 6 months); Total Length of Stay (From day of birth through day of discharge, up to 6 months)
D: Heart Rate (up to 2 weeks); Respiratory Rate (up to 2 weeks); O2 sats (up to 2 weeks); Activity level (up to 2 weeks); Sleep category (up to 2 weeks); Feeding (sucking and absorption) category (up to 2 weeks); Neonatal Abstinence Scoring (NAS) (up to 2 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Outcome Following Truncation of Asparaginase in the NOPHO ALL2008 Protocol
Brief Summary: This study aimed to investigate the outcome of patients who had their asparaginase treatment truncated in the NOPHO ALL2008 protocol.


Options:
A: Efficacy of dexamethasone vs prednisone during the induction phase (5 years); Event-free survival (EFS) and overall survival after initial remission in intermediate-risk and high-risk patients (5 years); Safety and efficacy of treatment reduction during reintensification in standard-risk patients (5 years); EFS after second delayed reintensification in intermediate-risk patients (5 years); Outcome after extended reintensification therapy in high-risk patients (5 years)
B: Number of Participants With Asparaginase-Related Toxicity (30-week post-induction asparaginase treatment period. Toxicities assessed on an ongoing basis (at least 1 per month) while participant is on study, an average of 2 years.); Induction and Post-Induction Nadir Serum Asparaginase Activity Level (Samples for nadir serum asparaginase activity levels were assayed at 4,11,18,and 25 days after 1st dose, and then prior to asparaginase dose given during post-induction, at Week 7, 13, 19, and 25.)
C: Risk of relapse (5 years)
D: Asparaginase-Related Toxicity Rate (30-week post-induction asparaginase treatment period)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Vaginal Micronized Progesterone or Levonorgestrel-releasing Intrauterine System (LNG-IUS) for Treatment of Non-atypical Endometrial Hyperplasia: A Prospective Randomized Trial
Brief Summary: The purpose of this study is to compare the efficacy of the vaginal micronized progesterone and Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial hyperplasia in premenopausal women.


Options:
A: Regression and remission rate of endometrial hyperplasia (3 month)
B: Pathological response rate (From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months); Pathological response time (From date of randomization until the date of CR or date of hysterectomy, whichever came first, assessed up to 12 months)
C: Regression of hyperplasia related to treatment arm after 6 months of therapy (Six months)
D: Pathologic Response (6-12 months); Pregnancy Rate (7-144 months); Live Birth Rate (16-144 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation
Brief Summary: The population of older Veterans with non-traumatic lower limb amputation is growing. Following lower limb amputation, asymmetrical movements persist during walking and likely contribute to disabling sequelae including secondary pain conditions, poor gait efficiency, impaired physical function, and compromised skin integrity of the residual limb. This study seeks to address chronic gait asymmetry by evaluating the efficacy of two error-manipulation gait training programs to improve gait symmetry for Veterans with non-traumatic lower limb amputation. Additional this study will evaluate the potential of error-manipulation training programs to improve secondary measures of disability and residual limb skin health. Ultimately, this study aims to improve conventional prosthetic rehabilitation for Veterans with non-traumatic amputation through gait training programs based in motor learning principles, resulting in improved gait symmetry and lower incidence of long-term disability after non-traumatic lower limb amputation.


Options:
A: Change from baseline of the phantom limb pain using a VAS (4 weeks)
B: Timed Up & Go Test (TUG) (6 weeks)
C: Step Length Symmetry (Change from baseline (pre-intervention) to intervention end, persisting at 12 weeks after intervention end.)
D: Timed Up-and-Go Test (Baseline, 12-weeks, and 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Ultrasound vs Palpation for Radial Artery Cannulation in Patients Undergoing Bariatic Surgery
Brief Summary: The primary purpose of this study is to compare the palpation technique with ultrasound guidance for radial artery cannulation for bariatic surgery.


Options:
A: Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100) (1 year); Thumb and Forefinger Pinch Strength Test (1 year); Hand Grip Strength Test (1 month)
B: success rate of radial artery cathertrization (postoperate 72 hours)
C: First pass success rate (1 year); Final/ultimate success rate of an intervention (1 year)
D: Success rate (at first attempt, as average 5 min)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Ultrasound vs Palpation for Radial Artery Cannulation in Patients Undergoing Bariatic Surgery
Brief Summary: The primary purpose of this study is to compare the palpation technique with ultrasound guidance for radial artery cannulation for bariatic surgery.


Options:
A: Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100) (1 year); Thumb and Forefinger Pinch Strength Test (1 year); Hand Grip Strength Test (1 month)
B: Duration of Use of Arterial Cannula (During Procedure)
C: Success rate of the radial artery cannulation at first attempt (intraoperative)
D: Success rate (at first attempt, as average 5 min)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Ultrasound vs Palpation for Radial Artery Cannulation in Patients Undergoing Bariatic Surgery
Brief Summary: The primary purpose of this study is to compare the palpation technique with ultrasound guidance for radial artery cannulation for bariatic surgery.


Options:
A: Arterial catheterization time (Interval between contact of the ultrasound transducer with the skin and confirmation of an arterial waveform on the monitor, an expected average of 200 seconds)
B: Number of Attempts (Immediately during procedure. (up to 30 minutes))
C: Time to Successful Radial Arterial Catheterization (up to 5 minutes)
D: Success rate (at first attempt, as average 5 min)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Efficacy and Effect of Methenamine Hippurate in a Non-antibiotic, Multimodal Approach to UTI Prevention
Brief Summary: Urinary tract infections (UTIs) are the most common bacterial infection and are especially common in postmenopausal women, who often experience recurrent UTIs. Women with recurrent UTIs are commonly treated with antibiotics, but side effects, collateral damage to commensal bacteria, and antimicrobial resistance result from frequent antibiotic use. It is paramount that researchers develop non-antibiotic treatment strategies for UTIs.

Several non-antibiotic strategies may be successful in preventing recurrent UTIs in postmenopausal women, including low-dose vaginal estrogen, d-mannose, and methenamine hippurate. Methenamine hippurate (MH) is interesting as it causes few side effects, kills bacteria by denaturing bacterial proteins, RNA, and DNA, and does not develop resistance. Several studies have demonstrated the efficacy of daily methenamine on the incidence of UTI. However, women often require multiple therapies in order to prevent recurrence. There are currently few guidelines to help clinicians identify optimal treatment regimens for non-antibiotic prevention of UTI.

The purpose of this pilot study is to examine the feasibility of developing a sequential, multiple assignment, randomization trial (SMART); and examine the treatment effect of MH in combination with vaginal estrogen (VET) and D-mannose on prevention of UTI. The investigators plan to examine the efficacy of the addition of MH to low dose VET and d-mannose in the UTI prevention through randomization to MH + VET + D-mannose vs continuing VET + D-mannose alone. The primary outcome will be the proportion of patients who have symptomatic, culture-proven UTI during a 3 month treatment period. The investigators hypothesize that women on low dose VET, d-mannose, and MH will be less likely to have recurrent UTI than those with VET and d-mannose alone.

This study uses a pragmatic, longitudinal approach that mimics patients' clinical experiences and physicians' decision points during management of UTI prophylaxis. Through this randomized, controlled pilot study, this proposal would allow the investigators to examine the feasibility of conducting a larger-scale, adaptive study trial, and estimate the treatment effect of a non-antibiotic regimen augmented with MH in women who continue to develop recurrence.


Options:
A: Frequency of UTIs (6 months)
B: Days (168)
C: UTI Recurrence (Variable for each participant over course of up to one year)
D: Culture proven, symptomatic urinary tract infection (UTI) (3 months); Recruitment rate (Through study recruitment, an average of 1 year); Retention rate (3 months); Adherence (3 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: The Impact of a Home-based Pulmonary Telerehabilitation Program on Muscle Function and Quality of Life Following Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Brief Summary: COPD impacts a significant proportion of the Veteran population. Acute exacerbations, or flare-ups, of COPD are associated with impaired muscle function and worse quality of life. Pulmonary rehabilitation, a formal exercise program for patients with lung disease that includes both endurance and strength training exercises, has been shown to improve muscle function and quality of life after an acute exacerbation of COPD. However, lack of geographically accessible rehabilitation facilities and/or transportation issues are often barriers to pulmonary rehabilitation attendance in the Veteran population. This study will assess the feasibility and impact of an eight-week, three sessions per week, home-based, pulmonary telerehabilitation program in Veterans with COPD following hospitalization for an acute exacerbation of their lung disease. We will measure adherence and satisfaction with the program and muscle strength, physical activity, quality of life, and exercise tolerance pre and post-intervention in Veterans randomized to the pulmonary telerehabilitation arm versus Veterans randomized to the control arm who do not participate in pulmonary rehabilitation.


Options:
A: Quadriceps Muscle Strength Testing Change (measured at baseline and at ten weeks); Six Minute Walk Test (measured at baseline and at ten weeks); Health-related Quality of Life Assessments Change (measured at baseline and ten weeks); Participant Satisfaction Survey (measured at ten weeks (study completion))
B: Six Minute Walk Distance (6 weeks); COPD Assesment Tool (CAT) (6 weeks)
C: Physical activity (Change between baseline (T0) and directly after the intervention, after 4-6 months from baseline (T1)); Physical activity (Change between T1 and T2: 3 months follow up)
D: Change in Adherence of each participant (3 months, 6 months and 12 months); Change in Adherence of each participant (3 months, 6 months and 12 months); Change in Adherence of each participant (3 months, 6 months and 12 months); Change in Adherence of each participant (3 months, 6 months and 12 months)

Answer: A