TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluating Individual and Patient-Selected Family/Friend/or Reciprocal Peer Notifications to Improve Statin Medication Adherence Among Patients With Coronary Artery Disease
Brief Summary: The purpose of this research study is to improve statin medication adherence among Veterans with coronary artery disease with poor adherence to medications. The investigators are testing if newer technology pill bottle devices linked with individual feedback and/or social incentive strategies can improve medication taking behavior.


Options:
A: Recruitment (Baseline); Dropout (24 weeks); Satisfaction with intervention (12 weeks); Number of contacts (24 weeks); Content of contacts (24 weeks); CR attendance (12 weeks); CR attendance (24 weeks); Change in Health-related Quality of Life (Baseline to 24 weeks); Change in Self-efficacy (Baseline to 24 weeks); Change in symptoms of anxiety and depression (Baseline to 24 weeks); Change in dietary quality (Baseline to 24 weeks); Change in physical activity (Baseline to 24 weeks)
B: Adherence (Change in baseline adherence at 3 month and 6 month)
C: Adherence to exercise. (18 months)
D: Mortality or readmission (one year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Different Routes of Misoprostol for Same-day Cervical Preparation Prior to First Trimester Surgical Abortion: a Randomized Controlled Trial
Brief Summary: A randomized clinical trial to assess the effectiveness of same-day cervical preparation with oral, buccal or vaginal Misoprostol, given 2-4 hours prior first trimester curettage.


Options:
A: Preoperative cervical width in centimeters (intraoperative)
B: doxycycline side effects (24 hours)
C: Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection (7 days)
D: Complete abortion without recourse to surgical intervention (follow up visit 7 days after initial treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Identification of People at Risk for Sick-leave Due to Work-related Stress - A Randomized Controlled Study of People With Mental Disorders and Physical Complaints Consulting Primary Health Care
Brief Summary: A vital question for society in general and primary health care in particular is early identification of persons at risk of sickness absence due to work-related stress. Even though both the individual and society can gain a lot from the prevention of absence, not the least since return to work is costly once a person is sick-listed. There is, surprisingly enough, no established method to do this. This project is a randomized controlled study of people with mental disorders and physical complaints consulting primary care. The purpose is to evaluate if a systematic use of early identification of work-related stress, combined with feedback at consultation, at the primary health care centers can prevent sickness absence among employed women and men with common mental disorders and subjective physical health complaints.


Options:
A: Trial feasibility measured with number of patients recruited for study who have consented and participate for the duration of the study. (1 year)
B: Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up (baseline and 3 month follow up)
C: Post-discharge Utilization within 30 days after hospital discharge (30 days after hospital discharge)
D: Number of sick-leave days. (12 months after inclusion); Number of periods of sick-leave, full-time or part-time. (12 months after inclusion)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Growth and Tolerance of Cow's Milk-Based Infant Formulas
Brief Summary: This clinical trial will evaluate the growth, tolerance, and iron status of infants who consume an investigational infant formula containing a nutrient-rich whey protein compared to a previously marketed infant formula.


Options:
A: Mean weight gain (6 months)
B: Composite measure of Growth (1 year)
C: Mean rank stool consistency at 14 days of age (14 days of age)
D: Body weight measured at each study visit (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: BRE-WL4AA Moving Forward: A Weight Loss Intervention for African-American Breast Cancer Survivors
Brief Summary: This is a randomized intervention study to examine the effects of the Moving Forward Guided Weigh Loss Intervention compared to a self-guided weight loss program on BMI and behavioral, biological, and psychosocial outcomes in overweight and obese African American women diagnosed with Stage I, II, or III breast cancer.


Options:
A: Change in weight (6 months); change in weight (12 months)
B: Percent interlimb difference, change over 12 months. (Baseline and 12 months)
C: Change from Baseline in Arthralgia Severity (6 months); Change from Baseline in Arthralgia Severity (12 months)
D: Weight loss (2 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome - A Pilot Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine the feasibility of conducting a large trial examining the effect on clinical outcome of a liberal red blood cell (RBC) transfusion strategy compared to a restrictive strategy (usual care) in patients with aneurysmal subarachnoid hemorrhage (SAH).


Options:
A: Randomization Rate (12 months)
B: Occurrence of a composite endpoint (90 days)
C: Enrollment rate (Time Frame: 6 months); Non-adherence (30 days)
D: Number of Participants in Need for Bank Blood Transfusion (At discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome - A Pilot Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine the feasibility of conducting a large trial examining the effect on clinical outcome of a liberal red blood cell (RBC) transfusion strategy compared to a restrictive strategy (usual care) in patients with aneurysmal subarachnoid hemorrhage (SAH).


Options:
A: Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm. (60 days)
B: Randomization Rate (12 months)
C: Occurrence of a composite endpoint (90 days)
D: Mortality (90 day)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome - A Pilot Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine the feasibility of conducting a large trial examining the effect on clinical outcome of a liberal red blood cell (RBC) transfusion strategy compared to a restrictive strategy (usual care) in patients with aneurysmal subarachnoid hemorrhage (SAH).


Options:
A: Hemoglobin Concentration (In-hospital up to 30 days post randomization); Red Blood Cell Transfusion (In-hospital up to 30 days post randomization)
B: Methodology of the pilot study (up to 30 days)
C: Postoperative Functional mobility; Restricting factors for functional mobility
D: Randomization Rate (12 months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Aneurysmal Subarachnoid Hemorrhage: Red Blood Cell Transfusion and Outcome - A Pilot Randomized Controlled Trial
Brief Summary: The purpose of this study is to determine the feasibility of conducting a large trial examining the effect on clinical outcome of a liberal red blood cell (RBC) transfusion strategy compared to a restrictive strategy (usual care) in patients with aneurysmal subarachnoid hemorrhage (SAH).


Options:
A: Randomization Rate (12 months)
B: Total Number of Units Transfused (From randomization until discharge from admission for delivery, an average of 2-3 days)
C: Composite score of any one of the following: (1) all-cause mortality; (2) myocardial infarction; (3) new renal failure requiring dialysis; or (4) new focal neurological deficit (Up to hospital discharge or postoperative day 28 (whichever occurs first))
D: Occurrence of a composite endpoint (90 days)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Tetracaine on Pain Management and Corneal Healing in Patients With Acute Corneal Abrasion
Brief Summary: Corneal abrasions are associated with significant discomfort during a 24-48 hrs healing phase. Current practice guidelines discourage the use of topical anesthetics in treating these patients due to concerns that these medications may prevent proper corneal epithelial healing. These concerns are based primarily on decades old animal based research. However, recent evidence suggests topical anaesthetics are a safe and effective way of managing patient pain in the short term. This study will investigate the effect of topical 0.5% tetracaine on corneal healing and pain management in patients with corneal abrasions in the first 48 hours.

This will be a prospective, double blind, randomized, controlled study of 260 adults with uncomplicated acute corneal injuries presenting to the tertiary acute care settings in Kingston. Patients will be randomly assigned to receive either 0.5% tetracaine or saline in addition to usual care as outpatients. They will be followed through the ophthalmology emergency eye clinic to assess healing at 36-48hrs. after the acute care visit. The primary outcome will be an assessment of pain as measured every 4 hours for 48 hrs. using a 10mm Visual Analogue Scale (VAS). Secondary outcomes will include assessments of corneal healing, use of adjunct pain medications, time lost from work/usual activities, quality of sleep, ability to read and the SF12 quality of life questionnaire.

This study will better inform the safety and effectiveness of short-term tetracaine usage in patients with simple corneal abrasions for optimal treatment of patients in the future.


Options:
A: Overall Visual Analog Scale score (48 hours)
B: pain reduction (continuous)
C: Pain assessed with Visual Analog Scale (Up to 24 months)
D: pain control as measured by visual analogue score (at 12 hours post baseline)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Tetracaine on Pain Management and Corneal Healing in Patients With Acute Corneal Abrasion
Brief Summary: Corneal abrasions are associated with significant discomfort during a 24-48 hrs healing phase. Current practice guidelines discourage the use of topical anesthetics in treating these patients due to concerns that these medications may prevent proper corneal epithelial healing. These concerns are based primarily on decades old animal based research. However, recent evidence suggests topical anaesthetics are a safe and effective way of managing patient pain in the short term. This study will investigate the effect of topical 0.5% tetracaine on corneal healing and pain management in patients with corneal abrasions in the first 48 hours.

This will be a prospective, double blind, randomized, controlled study of 260 adults with uncomplicated acute corneal injuries presenting to the tertiary acute care settings in Kingston. Patients will be randomly assigned to receive either 0.5% tetracaine or saline in addition to usual care as outpatients. They will be followed through the ophthalmology emergency eye clinic to assess healing at 36-48hrs. after the acute care visit. The primary outcome will be an assessment of pain as measured every 4 hours for 48 hrs. using a 10mm Visual Analogue Scale (VAS). Secondary outcomes will include assessments of corneal healing, use of adjunct pain medications, time lost from work/usual activities, quality of sleep, ability to read and the SF12 quality of life questionnaire.

This study will better inform the safety and effectiveness of short-term tetracaine usage in patients with simple corneal abrasions for optimal treatment of patients in the future.


Options:
A: pain reduction (continuous)
B: pain control as measured by visual analogue score (at 12 hours post baseline)
C: Overall Visual Analog Scale score (48 hours)
D: Pain assessed with Visual Analog Scale (Up to 24 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Strengthening the Evidence Base on Effective scHool Based intErventions for pRomoting Adolescent Health (SEHER)
Brief Summary: SEHER- Strengthening Evidence base on scHool-based intErventions for pRomoting adolescent health, seeks to develop and evaluate a school based adolescent health promotion intervention delivered by two different delivery agents viz. teacher-as-SEHER Mitra (TSM) and lay school counsellor called as SEHER Mitra (SM) in government-run secondary schools in Bihar, India. SEHER will implement a three armed clustered randomised trial (CRT) to evaluate the effectiveness and cost-effectiveness of these two models compared with the Tarang-Adolescence Education Programme (usual care) implemented by the State Government of Bihar. The hypothesis is that both interventions, compared to the control arm, will lead to a greater impact on school climate (school connectedness and relationship with teachers and fellow students). In addition, the interventions will increase the knowledge, attitude and awareness, and promoting healthy behaviours in youth on reproductive and sexual health outcomes, mental health and substance use, and gender related attitudes and violence. It is hypothesized that the addition of more resource intensive component (the SM arm) will be associated with the best outcomes.


Options:
A: School Climate (Up to 7 months)
B: children's behavior problems and health (Change from baseline to 6-, 12-, 18-, and 24 month follow up)
C: Medical students' empathy (3 months)
D: Remission (i.e. recovery from depression) and depressive symptoms, assessed by the PHQ-9 (6 months post-child birth)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Gene Therapy, Open-label, Dose-escalation Study of PF-06838435 (SPK-9001) [Adeno-associated Viral Vector With Human Factor IX Gene] in Subjects With Hemophilia B
Brief Summary: A Phase 1/2, Open-Label, Non-Randomized, Dose-Escalation Study of SPK-9001 in Subjects with Hemophilia B.


Options:
A: N/A
B: Number of Participants With Potentially Clinically Significant Laboratory Abnormalities (up to 52 weeks ± 1 week); Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (up to 52 weeks + 30 days ± 1 week); Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs) During the Surgical / Rehabilitation Period (up to 52 weeks + 30 days ± 1 week); Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) During the Surgical / Rehabilitation Period (up to 52 weeks + 30 days ± 1 week); Incidence Rate of FIX Inhibitor Development (up to 52 weeks ± 1 week); Annualized Bleeding Rate (up to 52 weeks ± 1 week (efficacy period as defined in description)); Comparison of Annualized Bleeding Rates (up to 52 weeks ± 1 week (efficacy period as defined in description))
C: Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings (Baseline up to Week 52); Number of Participants With Clinically Significant Change From Baseline in Vital Signs (Baseline up to Week 52); Number of Participants With Clinical Laboratory Abnormalities Reported as TEAE (Baseline up to Week 52); Number of Participants With Drug -Related TEAEs and Serious Adverse Events (SAEs) (Baseline up to Week 52); Number of Participants With Positive Immune Reponses Against Adeno-associated Virus Vector (AAV) Capsid (Baseline up to Week 52); Number of Participants Who Reached > 150% Vector-derived FIX:C Activity Level After SPK-9001 Infusion (Baseline up to Week 52); Number of Participants With FIX Inhibitor (Baseline up to Week 52); Incremental Recovery of FIX Product (Day 0 and Week 52)
D: Annualized Bleeding Rate (ABR) (9 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses
Brief Summary: The aim of this study is to assess the visual performance of multiple optimised prototype soft contact lens designs compared to commercially available contact lenses.


Options:
A: Visual acuity on a LogMAR (logarithm of the minimum angle of resolution) scale (Approximately 1 week after lens fitting)
B: Incidence of Adverse Events (Self-report at 2 Week, 4 Month or 12 Month surveys)
C: Tear film osmolarity (3 months)
D: Number of Participants Developing a Corneal Inflammatory Event (CIE) (up to 1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Personalized Extracorporeal Biofeedback Device for Pelvic Floor Muscle Training on Post-prostatectomy Incontinence
Brief Summary: To evaluate the efficacy of postoperative pelvic floor muscle training using personalized extracorporeal biofeedback device among patients with post-prostatectomy incontinence


Options:
A: Effects of transcutaneous perineal stimulation compared to anal stimulation (Baseline, 6 and 10 weeks)
B: Recovery of urinary continence (postoperative 1 month)
C: Incontinence Visual Analogue Scale (I-VAS) (7 months)
D: improves muscle strength of the pelvic floor at 3 months (baseline and 3 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-Blind, Randomized, Placebo-Controlled Trial of Human Fecal Microbiota Transplantation for the Therapy of Pediatric Ulcerative Colitis and Inflammatory Bowel Disease Unclassified
Brief Summary: The PediFETCh study is a pilot trial designed to assess the feasibility of fecal microbiota transplants for the therapy of pediatric ulcerative colitis (UC) and pediatric inflammatory bowel disease-unclassified (IBD-U). Investigators will test the hypothesis that a protocol of twice-weekly retention enemas delivered over six weeks, using fecal transplant material from a healthy donor, will improve clinical and biological disease markers in patients with pediatric UC or IBD-U.


Options:
A: Feasibility (Composite Measure) (30 weeks)
B: diversity and steady state of the stool (6 months)
C: Safety (up to 6 mo post FMT)
D: Clinical Cure (8 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-Blind, Randomized, Placebo-Controlled Trial of Human Fecal Microbiota Transplantation for the Therapy of Pediatric Ulcerative Colitis and Inflammatory Bowel Disease Unclassified
Brief Summary: The PediFETCh study is a pilot trial designed to assess the feasibility of fecal microbiota transplants for the therapy of pediatric ulcerative colitis (UC) and pediatric inflammatory bowel disease-unclassified (IBD-U). Investigators will test the hypothesis that a protocol of twice-weekly retention enemas delivered over six weeks, using fecal transplant material from a healthy donor, will improve clinical and biological disease markers in patients with pediatric UC or IBD-U.


Options:
A: The primary outcome of the randomized trial will remission of UC with colonic mucosa healing defined as Mayo endoscopy score = 0 at 6 weeks (Subjects will have a sigmoidoscopy, physician assessment and complete a Mayo score and IBDQ questionnaire at baseline, week 3 (no sigmoidoscopy is required), week 6 at exit from the study.)
B: Feasibility (Composite Measure) (30 weeks)
C: The primary outcome of the randomized trial is remission of UC defined as a Mayo score < 3 with an endoscopic Mayo score = 0 at the end of the trial Transplant Therapy in Ulcerative Colitis (9 weeks)
D: durability of clinical remission (One year)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschoolers
Brief Summary: Socioeconomic disparities in early childhood place low-income children at 1.5 to 2 times higher risk for obesity compared to middle- to upper-income children. Obesity interventions have turned toward the promotion of family mealtimes. This study will test the effects of 6 intervention components reflecting differing levels of supports to ultimately reduce childhood obesity prevalence and increase the frequency of healthy family mealtimes and improve dietary quality. The investigators will test 6 intervention components in Phase 1 (Screening Phase), resulting in the implementation and evaluation via a randomized controlled trial of a "final" intervention model in Phase 2 (Confirming Phase). The investigators hypothesize that providing low-income families with effective supports to enhance family capability to plan and implement family mealtimes will lead to improvements in children's adiposity indices, dietary quality and frequency of family meals.


Options:
A: Absolute change in mean accelerometry counts over 6 days (baseline, end of intervention, six months after end of intervention)
B: Change in BMIz (Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).)
C: Change in Body Mass Index (Baseline, 8 months, 21 months)
D: Difference Between Interventions in Vegetable Intake (One meal per week for each intervention (Study weeks 1, 2, 3, and 4))

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschoolers
Brief Summary: Socioeconomic disparities in early childhood place low-income children at 1.5 to 2 times higher risk for obesity compared to middle- to upper-income children. Obesity interventions have turned toward the promotion of family mealtimes. This study will test the effects of 6 intervention components reflecting differing levels of supports to ultimately reduce childhood obesity prevalence and increase the frequency of healthy family mealtimes and improve dietary quality. The investigators will test 6 intervention components in Phase 1 (Screening Phase), resulting in the implementation and evaluation via a randomized controlled trial of a "final" intervention model in Phase 2 (Confirming Phase). The investigators hypothesize that providing low-income families with effective supports to enhance family capability to plan and implement family mealtimes will lead to improvements in children's adiposity indices, dietary quality and frequency of family meals.


Options:
A: Intake of nutrients; Serum lipid and lipoprotein concentrations; Growth and development; Smoking; Physical activity level and fitness; Intima-media thickness of arteries and rate of NO-induced vasodilatation
B: Maintenance of a Child's Body Mass Index as a result of the intervention (up to two years)
C: Change in BMIz (Prior to the implementation of the intervention (Baseline) and immediately post the 12 week intervention period (Post).)
D: 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)

Answer: C