TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Early Salpingectomy (Tubectomy) With Delayed Oophorectomy to Improve Quality of Life as Alternative for Risk Reducing Salpingo-oophorectomy in BRCA1/2 Gene Mutation Carriers
Brief Summary: The purpose of this study is to determine whether an innovative preventive strategy, consisting of early salpingectomy upon completion of childbearing with delayed oophorectomy beyond current guideline age, improves menopause-related quality of life without significantly increasing ovarian cancer incidence in comparison to current standard salpingo-oophorectomy in female BRCA1/2 mutation carriers.


Options:
A: Menopause-related quality of life (Up to 5 years after last surgery)
B: Change from baseline in ovarian function as measured by Anti-Mullerian Hormone (AMH) (AMH blood samples collected prior to surgery at day 1 (the day of the surgery) and at 1 and 3 months after day 1.)
C: Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary (Baseline and 12 months)
D: Count of Treatment Responders in the Intent to Treat (ITT) Cohort (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Direct Improvement of Quality of Life Using a Tailored Pathway With Quality of Life Diagnosis and Therapy: Protocol of a Randomised Clinical Trial in Colorectal Cancer Patients
Brief Summary: The purpose of the study is to determine whether a quality of life pathway with defined diagnostic and therapeutic options improves quality of life in colorectal cancer patients during follow-up.


Options:
A: proportion of patients in both groups with diseased quality of life (<50 points in at least one dimension) (1 year after the date of primary surgery for colorectal cancer)
B: The incidence of postoperative complications, classified by Clavien Scale (Time Frame: 30days or the postoperative hospital stay if longer than 30 days)
C: 6 minute walk test (6MWT) (up to 8 weeks after surgery)
D: Post operative complications (30 days after surgery)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Direct Improvement of Quality of Life Using a Tailored Pathway With Quality of Life Diagnosis and Therapy: Protocol of a Randomised Clinical Trial in Colorectal Cancer Patients
Brief Summary: The purpose of the study is to determine whether a quality of life pathway with defined diagnostic and therapeutic options improves quality of life in colorectal cancer patients during follow-up.


Options:
A: Recovery measured as physical recovery measured in questionnaire (4-6 weeks)
B: 6 minute walk test (6MWT) (up to 8 weeks after surgery)
C: proportion of patients in both groups with diseased quality of life (<50 points in at least one dimension) (1 year after the date of primary surgery for colorectal cancer)
D: Anaerobic threshold prior to liver resection (4 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Direct Improvement of Quality of Life Using a Tailored Pathway With Quality of Life Diagnosis and Therapy: Protocol of a Randomised Clinical Trial in Colorectal Cancer Patients
Brief Summary: The purpose of the study is to determine whether a quality of life pathway with defined diagnostic and therapeutic options improves quality of life in colorectal cancer patients during follow-up.


Options:
A: proportion of patients in both groups with diseased quality of life (<50 points in at least one dimension) (1 year after the date of primary surgery for colorectal cancer)
B: Child Distress - unrelieved symptoms (20 weeks); Trends of PedsQL Total Scores (20 weeks); Trends of MSAS total scores (20 weeks); Trends of MSAS physical scores (20 weeks); Trends of MSAS psychological scores (20 weeks); Trends of PedsQL Physical Subscale Scores (20 weeks); Trends of PedsQL Emotional Subscale Scores (20 weeks)
C: N/A
D: Trial feasibility measured with number of patients recruited for study who have consented and participate for the duration of the study. (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Green Tea Extracts for the Prevention of Colorectal Adenomas and Colorectal Cancer
Brief Summary: Experimental studies have shown the chemopreventive properties of green tea extract (GTE) on colorectal cancer. And colorectal adenomas are precursors to colorectal cancers. The aim of this study is to determine the preventive effect of GTE supplements on metachronous colorectal adenomas by giving GTE tablets of which are equivalent of 9 cup-of-green tea per day (0.9 g/day GTE, 0.6 g/day Epigallocatechin gallate (EGCG).


Options:
A: Recurrence/Number/Size of metachronous colorectal adenoma(s) (1 year)
B: Complete Response - Clearance of Oncogenic Human Papillomavirus (HPV) and Complete Colposcopic, Histologic and Cytologic Clearance of Disease (4 months); Partial Response - Clearance of Oncogenic HPV With Evidence of Low Grade Cervical Intraepithelial Neoplasia (4 months); No Response - Persistent Oncogenic HPV Positivity, With or Without Evidence of Low Grade Cervical Intraepithelial Neoplasia (4 months); Progression - Persistent Oncogenic HPV Positivity, With Evidence of Progression to Worsening Cervical Intraepithelial Neoplasia or Invasive Cancer (4 months)
C: Rate of Progression to Prostate Cancer (PCa) (12 months); Rate of Progression From HGPIN to ASAP or PCa (12 months)
D: Incidence of metachronous colorectal adenomas (tubulovillous, tubular, villous and serrated lesions) at the 3 year follow-up colonoscopy (3 years)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pragmatic Randomized Controlled Trial to Evaluate the Impact of HealthPROMISE Platform on Quality of Care and Quality of Life in Patients With Inflammatory Bowel Disease
Brief Summary: HealthPROMISE is a mobile application (app) for patients that allows regular tracking of symptoms by patients and communicates them to physicians. The purpose of this randomized controlled trial is to determine the impact of the HealthPROMISE application on improving patient outcomes. The trial will look at how much patients use the application, whether physicians change treatment in response to new information from patients, and how the patients quality of life change over the span of the study. The investigators hypothesize that HealthPROMISE will enhance physician-patient communication and improve clinical outcomes.


Options:
A: Improvement in Quality Indicators (adapted from the American Gastroenterological Association (AGA) outpatient IBD quality metrics and other consensus recommendations) (up to 2 years)
B: Changes in the paediatric IBD-specific health-related quality of life (QOL) scores. (6 monthly over 2 years)
C: Outpatient hospital visits (1 year); Satisfaction (1 year)
D: Clinical Remission (6 months); Clinical Remission (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pragmatic Randomized Controlled Trial to Evaluate the Impact of HealthPROMISE Platform on Quality of Care and Quality of Life in Patients With Inflammatory Bowel Disease
Brief Summary: HealthPROMISE is a mobile application (app) for patients that allows regular tracking of symptoms by patients and communicates them to physicians. The purpose of this randomized controlled trial is to determine the impact of the HealthPROMISE application on improving patient outcomes. The trial will look at how much patients use the application, whether physicians change treatment in response to new information from patients, and how the patients quality of life change over the span of the study. The investigators hypothesize that HealthPROMISE will enhance physician-patient communication and improve clinical outcomes.


Options:
A: Improvement in Quality Indicators (adapted from the American Gastroenterological Association (AGA) outpatient IBD quality metrics and other consensus recommendations) (up to 2 years)
B: Overall length of stay (1 year); Percentage of patients undergoing colectomy (1 year)
C: Harvey Bradshaw Index (12 months); Inflammatory Bowel Disease Questionnaire (12 months)
D: Outpatient hospital visits (1 year); Satisfaction (1 year)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Pragmatic Randomized Controlled Trial to Evaluate the Impact of HealthPROMISE Platform on Quality of Care and Quality of Life in Patients With Inflammatory Bowel Disease
Brief Summary: HealthPROMISE is a mobile application (app) for patients that allows regular tracking of symptoms by patients and communicates them to physicians. The purpose of this randomized controlled trial is to determine the impact of the HealthPROMISE application on improving patient outcomes. The trial will look at how much patients use the application, whether physicians change treatment in response to new information from patients, and how the patients quality of life change over the span of the study. The investigators hypothesize that HealthPROMISE will enhance physician-patient communication and improve clinical outcomes.


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 in the Patient Safety Climate Synthetic Index (At pre-intervention and after 12 months follow-up)
C: Improvement in Quality Indicators (adapted from the American Gastroenterological Association (AGA) outpatient IBD quality metrics and other consensus recommendations) (up to 2 years)
D: Mean Value: Preparation for Decision Making© Scale (Assessment at 1-week follow-up.); Mean Value: Informed Subscale of the Decisional Conflict Scale© (Assessment at 1-week follow-up.); Mean Value: Values Clarity Subscale of the Decisional Conflict Scale© (Assessment at 1-week follow-up.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients With Mild to Moderate Persistent Asthma.
Brief Summary: The purpose of this trial is to confirm the safety and clinical benefit of benralizumab administration in asthma patients with mild to moderate persistent asthma in order to gain an understanding of the benefit/risk of benralizumab across the spectrum of asthma disease.


Options:
A: Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108); Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients (Week 56); Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA) (Week 108)
B: Safety and tolerability in healthy volunteers.Assessed using clinical safety assessments and blood and urine analysis (Throughout the study); Safety and tolerability in mild asthmatics.Assessed using clinical safety assessments and blood and urine analysis. (Throughout the study)
C: Change From Baseline in Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (L) at Week 12 (Baseline, Week 4, Week 8 and Week 12)
D: Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline (Baseline (Day 1), Weeks 20-24)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase IIb, Observer-blind, Randomised Controlled Trial to Assess the Immunogenicity and Protective Efficacy of Vi Conjugated (Vi-TCV) and Unconjugated (Vi-PS) Polysaccharide Vaccines in Preventing Typhoid Infection Compared to a Control Vaccine (Meningococcal ACWY), Using a Human Challenge Model of Typhoid Infection
Brief Summary: Using an established model of human typhoid infection, whereby healthy adults are deliberately exposed to typhoid-causing bacteria, the investigators will determine how effective a new typhoid conjugate vaccine (Vi-TCV) is in preventing infection. The new typhoid vaccine will be compared with a control vaccine (meningococcal ACWY). The protective effect of a currently used typhoid polysaccharide vaccine (Vi-PS) will also be studied and compared with the control vaccine using this model of typhoid infection.

A second component of this study will involve vaccinating 15-20 participants with Vi-PS. Serum will be obtained prior to vaccination and 4-6 weeks after vaccination. The post-vaccination serum will be pooled and used to create an anti-Vi IgG serum standard.


Options:
A: Clinically or microbiologically proven typhoid infection (Up to 14 days after typhoid challenge dose administration)
B: Number of Subjects Reporting Any Post Immunization Reactions (During the 7-day period after vaccination); Number of Subjects Reporting Adverse Events (During the 28-day period after vaccination); Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC) (At 28 days after vaccination); Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer (At 28 days after vaccination)
C: Total protection against S. typhi (2 years from zero time)
D: Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer (At 28 days after last vaccination as compared to baseline); Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer (At 6 months after last vaccination as compared to baseline); Anti-Vi ELISA Geometric Mean Concentration (GMC) (At 28 days after last vaccination); Anti-Vi ELISA GMC (At 6 months after last vaccination)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Changes in Cortical Excitability Associated With Upper Limb Motor Recovery - a Study of Neural Strategies Employed in Motor Recovery
Brief Summary: This study is to investigate changes in brain activities in acute stroke patients , and to correlate findings with clinical outcome measures. Another aim of the study is to investigate whether transcranial direct current stimulation (tDCS) could improve motor function in subjects with poor brain activity after stroke. The brain activity will be measured by single and paired pulse TMS (transcranial magnetic stimulation). The study hypothesizes that:

1. The neural mechanisms employed in patients who have different response to TMS stimulation are different. It is hypothesized that patients with no response upon TMS stimulation might have poorer motor function outcome, compared with patients with response upon TMS stimulation.
2. The result of clinical outcome measures is related with TMS measurement.
3. tDCS intervention is beneficial to subjects with poor brain activity. Clinical outcome measures will include a battery of upper limb motor tests such as upper extremity component of the Fugl-Meyer Assessment, Modified Ashworth scale for spasticity, box and block test, and manual muscle testing. Clinical outcome and TMS measurement will be assessed at within 2 weeks, 4-6 weeks and at 6 months post-stroke.


Options:
A: Fugl-Meyer Assessment (upper extremity subscale) (0-, 4- week)
B: Change of TMS (transcranial magnetic stimulation) measurement of cortical excitability (within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke)
C: Fatigue relief (assessed by the Fatigue Severity Scale) (4 months after the stroke)
D: Disability (three months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Changes in Cortical Excitability Associated With Upper Limb Motor Recovery - a Study of Neural Strategies Employed in Motor Recovery
Brief Summary: This study is to investigate changes in brain activities in acute stroke patients , and to correlate findings with clinical outcome measures. Another aim of the study is to investigate whether transcranial direct current stimulation (tDCS) could improve motor function in subjects with poor brain activity after stroke. The brain activity will be measured by single and paired pulse TMS (transcranial magnetic stimulation). The study hypothesizes that:

1. The neural mechanisms employed in patients who have different response to TMS stimulation are different. It is hypothesized that patients with no response upon TMS stimulation might have poorer motor function outcome, compared with patients with response upon TMS stimulation.
2. The result of clinical outcome measures is related with TMS measurement.
3. tDCS intervention is beneficial to subjects with poor brain activity. Clinical outcome measures will include a battery of upper limb motor tests such as upper extremity component of the Fugl-Meyer Assessment, Modified Ashworth scale for spasticity, box and block test, and manual muscle testing. Clinical outcome and TMS measurement will be assessed at within 2 weeks, 4-6 weeks and at 6 months post-stroke.


Options:
A: Change From Baseline in Star Cancellation Test Scores at 1,3, and 6 Months (Baseline, 1,3 and 6 months); Change From Baseline in Line Bisection Test Scores at 1,3, and 6 Months (Baseline, 1,3 and 6 months); Change From Baseline in Picture Identification Task at 1,3, and 6 Months (Baseline, 1,3 and 6 months)
B: Change in Upper Extremity Fugl Meyer Assessment (6 weeks from baseline); Percentage of Sessions With Adverse Events (Post treatment (6 weeks from baseline).)
C: Four Square Step Test (Change from Baseline in Risk of Falls at 3 months)
D: Change of TMS (transcranial magnetic stimulation) measurement of cortical excitability (within 1 month from stroke, 6-8 weeks post-stroke, 6 months post-stroke)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Inspiratory and Respiratory Pressure Threshold Training in Patients With Chronic Obstructive Pulmonary Disease
Brief Summary: The study will investigate the effects of different training types ,including combined inspiratory with expiratory pressure threshold training,inspiratory pressure threshold training on patients with chronic obstructive airway disease and investigate whether expiratory pressure threshold training associated with inspiratory pressure threshold training would be better than inspiratory pressure threshold training alone, with regard to exercise capacity, respiratory muscle strength and endurance.


Options:
A: N/A
B: respiratory muscle strength measurements (baseline and 8 weeks)
C: Recruitment (4 months)
D: N/A

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: UH3 Pragmatic Trial of Population-based Programs to Prevent Suicide Attempt
Brief Summary: This pragmatic clinical trial will evaluate the effectiveness of two population-based outreach programs for preventing suicide attempts among patients identified as at-risk. The study will be conducted at Kaiser Permanente (KP) Washington (the lead site) and at HealthPartners, KP Colorado and KP Northwest. Electronic health records will be used to identify outpatients aged 18 or older who respond to a routinely administered PHQ depression questionnaire by reporting thoughts of death or self-harm "most of the days" or "nearly every day". This trial will be limited to patients receiving care from one of the four participating health systems. Eligible patients will be automatically assigned to continue in usual care (1/3) or to either of the two intervention programs (1/3 each). Those assigned to usual care will not be contacted at all by study staff and will continue to receive usual care from treating primary care and mental health providers. Both intervention programs involve outreach by Epic secure messaging (with optional telephone outreach for those not reading messages). The Care Management intervention includes routine outreach to assess ongoing risk of suicide attempt and care management to monitor and facilitate ongoing engagement in outpatient follow-up. The Care Manager will coordinate care with treatment by primary and behavioral health care providers using Epic Staff Messaging (or telephone contacts if necessary). The Skills Training intervention uses an online skills training program to support patients in developing and using self-management skills for emotion regulation and crisis management. A Coach will monitor each participant's use of the program and send periodic messages (using Epic secure messaging) to encourage and support use of the program and practice of program skills. Each intervention continues for up to one year. In all three groups (Usual Care, Care Management, and Skills Training) virtual data warehouse data will be used to identify likely suicide attempts over 18 months following randomization. Analyses will compare risk of suicide attempt among all those randomized, regardless of response to the initial invitation or level of participation in the intervention programs. Comparison of all those randomized is the only scientifically valid method for assessing the overall impact of either program on population-level risk of suicide attempt.


Options:
A: Changes in Beck Scale for Suicide Ideation (Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline))
B: Time to Fatal or Non-fatal Suicide Attempt or Self-Harm (18 Months after randomization)
C: MHS heavy use (2 years)
D: Suicide Attempt Self-Injury Interview (SASII) (4 months, 8 months and 12 months)

Answer: B