TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: A Randomised Sham-controlled Double-blinded Study of Burst Spinal Cord Stimulation for Chronic Peripheral Neuropathic Pain.
Brief Summary: This study will evaluate the effect of Burst spinal cord stimulation (SCS) in the treatment of painful radiculopathy in lower extremity(ies) with or without lower back pain. It is a multicenter double-blinded "n-of-1" RCT with repeated two-week periods of Burst SCS or sham in randomised order.


Options:
A: Change in regional cerebral blood flow measured with 15O-water Positron Emission. Tomography (PET) (PET is performed at study day 0 (baseline), day 14 and day 35.)
B: Visual Analogue Scales for pain back, pain limb, pain general and paresthesia
C: Usual pain intensity in lower extremity(ies) (Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))
D: Pain intensity measured on a weighted NRS according to Jensen and a PGIC for pain measured on a 7-point Likert scale. (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Prospective, Randomized, Controlled Study to Assess Medication Adherence in Children With Asthma Managed on BreatheSmart and Feedback
Brief Summary: Non-adherence to controller medication is a common problem in children with Asthma, resulting in overuse of reliever medication, increased asthma symptoms, more frequent Asthma attacks, and increased emergency room visits and hospital admissions. Additionally, current absence of a gold standard to measure adherence forces clinicians and researchers to rely on patient-self report, which is notoriously inaccurate, to support clinical decision making. Many young patients suffer from both intentional and non-intentional non-adherence, thus an appropriate intervention must address both types. Current studies using electronic monitoring devices (EMDs) primarily focus on non-intentional non-adherence through reminder systems and thus are limited in their ability to engage patients for long-term behavior change.

This trial addresses an important knowledge gap by evaluating whether EMDs with a combination of reminder system and patient education can prove to be effective in increasing adherence rates and can be used in clinical practice to achieve better asthma control and outcomes through improved patient and clinician engagement.


Options:
A: Asthma Exacerbations (12 months)
B: Asthma control - as measured by the Asthma Control Test (Measured at Year 1)
C: Proportion of Days Covered (PDC) (6 months post start of intervention)
D: Medication Adherence (12 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Inspiratory Muscle Training in Individuals Who Have Cystic Fibrosis
Brief Summary: Cystic fibrosis is a genetic disease that affects some organs of the human body. Among them, the lungs tend to be the most affected due to the accumulation of mucus in the airways, which in addition to avoiding the passage of air, favors pulmonary infections. With the evolution of the condition, secondary complications arise, such as postural changes, decreased respiratory muscle strength, decreased functional capacity and, consequently, quality of life. Therefore, respiratory muscle training may be an intervention that improves the respiratory condition of these individuals, allowing an improvement in the quality of life and may delay the evolution of respiratory symptoms. Thus, this study aims to investigate a home protocol of respiratory muscle training on respiratory muscle strength, lung function, quality of life, posture and functional capacity in adolescents and adults with cystic fibrosis. The researchers believe that the training can cause an improvement in the studied variables, and can be inserted in the usual treatment of these patients.


Options:
A: Change from baseline Posture at 4 weeks (Baseline and after 4 weeks of training); Change from baseline Health-related quality of life at 4 weeks (Baseline and after 4 weeks of training)
B: Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics (Day 0 to Day 84 (end of study))
C: Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline sensory integriation and balance test score in Biodex Balance System SD at 8 weeks (Eight weeks); Change from baseline Forced Vital Capacity (FVC) at 8 weeks (Eight weeks); Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks (Eight weeks); Change from baseline Peak Expiratory Flow (PEF) at 8 weeks (Eight weeks); Change from baseline maximum inspiratory pressure at 8 weeks (Eight weeks); Change from baseline maximum expiratory pressure at 8 weeks (Eight weeks); Change from baseline distance covered in six-minute walk test at 8 weeks (Eight weeks)
D: Hospital Length of Stay (Admission to Discharge)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).
Brief Summary: This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.


Options:
A: Progression Free Survival (PFS) - in non-tBRCA HRD positive patients (Approximately 4 years); Progression Free Survival (PFS) - in all non-tBRCA patients (Approximately 4 years)
B: Progression Free Survival (For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, Up to 5 years)
C: N/A
D: Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (after 6 weeks (2 cycles))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).
Brief Summary: This is a Phase III randomised, double-blind, multi-centre study to evaluate the efficacy and safety of durvalumab in combination with standard of care platinum based chemotherapy and bevacizumab followed by maintenance durvalumab and bevacizumab or durvalumab, bevacizumab and olaparib in patients with newly diagnosed advanced ovarian cancer.


Options:
A: Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1) (From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.); Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1) (From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.); Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1) (From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.)
B: Primary objective: Determination of the progression-free survival (PFS) of patients treated with topotecan and sorafenib versus topotecan and placebo (18 months)
C: progression free survival (6 months from randomization)
D: Progression Free Survival (PFS) - in non-tBRCA HRD positive patients (Approximately 4 years); Progression Free Survival (PFS) - in all non-tBRCA patients (Approximately 4 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Title : SEACOAST 1 SEdAtion With COllAteral Support in Endovascular Therapy for Acute Ischemic Stroke 1: a Randomized Controlled Phase 2B Clinical Trial
Brief Summary: SEACOAST 1 is a prospective, randomized, blinded endpoint trial comparing collateral vigor and clinical outcomes, with different forms of GA in patients with acute ischemic stroke due to anterior circulation large vessel occlusion (LVO) undergoing mechanical thrombectomy. The study compares GA with normocarbia (GAN) versus GA with mild hypercarbia (GAH), with a primary outcome of collateral robustness at measured at catheter angiography and clinical efficacy as secondary outcome. It is anticipated that the SEACOAST 1 will be followed by a larger, pivotal trial, SEACOAST 2, with primary clinical endpoints, in which the best method of GA identified in SEACOAST 1 is compared with the alternative strategy of anesthesia care (MAC) with minimal or no sedation. The current study focuses uppn SEACOAST 1, which is to be conducted in University of California, Los Angeles Ronald Reagan Medical Center and Santa Monica Medical Center. All acute stroke patients who arrive to one of these two stroke centers and are deemed eligible for thrombectomy will be considered for the proposed study. Physician-investigators will determine study eligibility. Informed consent to participate in the study will be obtained from legally authorized representatives or competent patients. For non-competent patients without on-scene legally authorize representatives, the consent process will utilize enrollment in emergency circumstances with exemption of informed consent (EFIC).


Options:
A: modified rankin score（mRS） (post-procedural 90 days)
B: Modified Angiographic collateral circulation assessed by blinded core lab (Immediately prior to revascularization)
C: the score on the modified Rankin Scale assessed at 90±7 days after randomization (at 90±7 days after ET surgery)
D: Neurological outcome in the two different arms (90 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Motivating Survey Compliance: Game Play Study 1
Brief Summary: Self-reports, especially for patients with chronic physical or mental diseases, are critical for disease research and drug development. Historically, it has been very difficult to collect self-reported data for long periods of time as it is an unpleasant and inconvenient task. Paper and digital surveys are the traditional way of collecting self-reports and have been around for a long time, but still suffer from lack of adherence despite the best efforts of researchers to remind and motivate individuals to fill them out.

Mobile games, on the other hand, benefit from an enormous amount of human adherence. These video games can be played on a smartphone and have captured the attention of a wide variety of demographics. The investigators have used established game design principles to develop a mobile game to motivate individuals to fill out a daily survey.

The purpose of this study is to determine which method of survey administration (paper, digital survey, or game- motivated survey) leads to the highest adherence rates for daily surveys.


Options:
A: Knowledge of Consent Information (At baseline (time zero))
B: Proportion of respondents who will complete the 3-month follow-up (Finish all telephone survey by Jan 2018)
C: Overall response rate (Up to 3 months (from February 3 2017 to maxium Maj 5 2017))
D: Adherence Rates to various methods of daily survey administration (35 days)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Lingual, Culturally-Competent Mobile Health Intervention to Reduce Medical Mistrust, Stigma, and Improve Treatment Adherence Among Women Living With HIV/AIDS (WLWH)
Brief Summary: The purpose of this study is:

1. To develop a new mobile health (mHealth) system that will send text messages to remind both pregnant and non-pregnant women with HIV to adhere to their treatment plan (like keeping appointments, fillings prescriptions, and taking their medication) and address individual barriers to HIV care (like stigma, medical mistrust and resilience).
2. The intervention will also include patient navigation and motivational interviewing

2) Investigators also want to see if the mHealth system is feasible, easily accepted and if it will impact patient health in a positive way.


Options:
A: Knowledge of Reproductive Health True/False Quiz of 20 questions (5-6 months after baseline and then again 14-16 months after baseline); Sexual behavior (14-16 months after baseline)
B: Rate of Enrollment (Month 12); Acceptability of the mHealth application (Month 12)
C: Linkage to HIV Care (Indicated by a HIV-related Laboratory Blood Test Within 8 Months) (Recruitment +8 months)
D: Acceptability of at least one method of effective contraception (4 months)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Lingual, Culturally-Competent Mobile Health Intervention to Reduce Medical Mistrust, Stigma, and Improve Treatment Adherence Among Women Living With HIV/AIDS (WLWH)
Brief Summary: The purpose of this study is:

1. To develop a new mobile health (mHealth) system that will send text messages to remind both pregnant and non-pregnant women with HIV to adhere to their treatment plan (like keeping appointments, fillings prescriptions, and taking their medication) and address individual barriers to HIV care (like stigma, medical mistrust and resilience).
2. The intervention will also include patient navigation and motivational interviewing

2) Investigators also want to see if the mHealth system is feasible, easily accepted and if it will impact patient health in a positive way.


Options:
A: Overall MEMS Adherence to Antiretroviral Medication (6 weeks); MEMS Adherence to Antiretroviral Medication Based on Dose Timing (6 weeks)
B: The rate of the Exclusive Breastfeeding (from birth of baby to 6 months post birth)
C: Rate of Enrollment (Month 12); Acceptability of the mHealth application (Month 12)
D: MV Coverage at 12 months of age (12 months of age)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Multi-Lingual, Culturally-Competent Mobile Health Intervention to Reduce Medical Mistrust, Stigma, and Improve Treatment Adherence Among Women Living With HIV/AIDS (WLWH)
Brief Summary: The purpose of this study is:

1. To develop a new mobile health (mHealth) system that will send text messages to remind both pregnant and non-pregnant women with HIV to adhere to their treatment plan (like keeping appointments, fillings prescriptions, and taking their medication) and address individual barriers to HIV care (like stigma, medical mistrust and resilience).
2. The intervention will also include patient navigation and motivational interviewing

2) Investigators also want to see if the mHealth system is feasible, easily accepted and if it will impact patient health in a positive way.


Options:
A: Smoking status by collecting an expired carbon monoxide breath sample (3-Month Follow-Up)
B: Count of Women Who Have Excess Gestational Weight Gain (Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation))
C: Rate of Enrollment (Month 12); Acceptability of the mHealth application (Month 12)
D: Effect of SMS intervention on attendance rate to follow-up screening appointment (up to 14 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy and Safety of Exocrine Pancreatectomy With Neoprene®-Based Glue After High-risk Pancreatoduodenectomy (PD) in Patients With Pancreatic, Papilla, Duodenal, and Distal Choledochus Neoplasm
Brief Summary: The study evaluates the safety and efficacy of Neoprene-based glue in the management of pancreatic stump after pancreatoduodenectomy (PD) in patients at high risk for pancreatic fistula and early neoplastic recurrence, compared with a population of patients at conventional risk.


Options:
A: The rate of pancreatic fistula between groups (postoperative 3rd day)
B: Rate of postoperative complications of grade > II according to Dindo-Clavien classification (90 days); Rate of overall postoperative complications (90 days); Rate of postoperative mortality (90 days)
C: Number of Participants With a Clinically Significant Post-operative Pancreatic Fistula (POPF) (Within 90 days post-operatively)
D: Pancreatic fistula development post distal pancreatectomy (30 days post surgery)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Kids SipSmartER: A Multi-level Behavioral and Health Literacy Intervention to Reduce Sugar-sweetened Beverages Among Appalachian Middle-school Students
Brief Summary: Overall Goal: To determine the effectiveness of Kids SIPsmartER in improving sugar-sweetened beverages behaviors among 7th grade students. Secondary aims are to determine (1) changes in secondary student outcomes (e.g. quality of life, BMI z-score, theory-related variables, health and media literacy), (2) changes in caregiver SSB behaviors and home environment, (3) maintenance of outcomes at 19-months post-baseline, (4) assess the reach and representativeness of Kids SIPsmartER, among students and caregivers, and (5) implementation, adoption, and maintenance among teachers and schools.


Options:
A: Student: SSB Change From Baseline to 7-months (All Participants) (Baseline and 7-months)
B: Body mass index (BMI) >= 85th percentile, adjusted for gender and age (baseline, end of 7th grade, end of study); Fasting glucose (mg/dL) (baseline, end of study); Fasting insulin (mU/mL) (baseline, end of study)
C: MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (Post-2 year intervention); MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET) (Post-3 year intervention)
D: Students' BMI change immediately after the intervention completion (at end of the 8-month intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Kids SipSmartER: A Multi-level Behavioral and Health Literacy Intervention to Reduce Sugar-sweetened Beverages Among Appalachian Middle-school Students
Brief Summary: Overall Goal: To determine the effectiveness of Kids SIPsmartER in improving sugar-sweetened beverages behaviors among 7th grade students. Secondary aims are to determine (1) changes in secondary student outcomes (e.g. quality of life, BMI z-score, theory-related variables, health and media literacy), (2) changes in caregiver SSB behaviors and home environment, (3) maintenance of outcomes at 19-months post-baseline, (4) assess the reach and representativeness of Kids SIPsmartER, among students and caregivers, and (5) implementation, adoption, and maintenance among teachers and schools.


Options:
A: standardized body mass index (zbmi)
B: BMI change at 6 month post assessment (Baseline and 6 month post assessment); BMI change at 1 year post assessment (Baseline to 1 year post assessment)
C: Change in Stress (3 months); Change in Stress (1 month)
D: Student: SSB Change From Baseline to 7-months (All Participants) (Baseline and 7-months)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Neuropathic Pain With Spinal Cord Stimulation and Physiotherapy for More Effective Pain Relief, Increased Physical Activity and Improved Health Related Quality of Life
Brief Summary: The study evaluates the combined effect of optimized pharmacological treatment, spinal cord stimulation and physiotherapy on pain relief, health-related quality of life and physical function in patients with neuropathic pain. All patients will receive optimized pharmacological treatment before start of spinal cord stimulation treatment. Half of the participants will be randomized to physiotherapy before start of spinal cord stimulation treatment while the other half will start physiotherapy after spinal cord stimulation treatment.


Options:
A: Pain intensity according to numeric rating scale (NRS) (3 months after implantation)
B: Duration Adjusted Average Change (DAAC) of Mean Pain Score (Baseline, Week 16)
C: Completion of EQ-5D5L Health questionnaire (1 hour); Numeric Rating Scale (NRS) recording pain severity (1 hour)
D: Composite of Safety and Effectiveness (3 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Neuropathic Pain With Spinal Cord Stimulation and Physiotherapy for More Effective Pain Relief, Increased Physical Activity and Improved Health Related Quality of Life
Brief Summary: The study evaluates the combined effect of optimized pharmacological treatment, spinal cord stimulation and physiotherapy on pain relief, health-related quality of life and physical function in patients with neuropathic pain. All patients will receive optimized pharmacological treatment before start of spinal cord stimulation treatment. Half of the participants will be randomized to physiotherapy before start of spinal cord stimulation treatment while the other half will start physiotherapy after spinal cord stimulation treatment.


Options:
A: Pain intensity according to numeric rating scale (NRS) (3 months after implantation)
B: The Difference in Responders Between Both Groups (6 Months)
C: The primary endpoint is to assesses the pain coverage capability of the RESTORE SCS system.
D: Changes in pain (6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Treatment of Neuropathic Pain With Spinal Cord Stimulation and Physiotherapy for More Effective Pain Relief, Increased Physical Activity and Improved Health Related Quality of Life
Brief Summary: The study evaluates the combined effect of optimized pharmacological treatment, spinal cord stimulation and physiotherapy on pain relief, health-related quality of life and physical function in patients with neuropathic pain. All patients will receive optimized pharmacological treatment before start of spinal cord stimulation treatment. Half of the participants will be randomized to physiotherapy before start of spinal cord stimulation treatment while the other half will start physiotherapy after spinal cord stimulation treatment.


Options:
A: Pain intensity according to numeric rating scale (NRS) (3 months after implantation)
B: Responder rate (1 month post-implant)
C: Change from baseline in disease-specific functional outcome between active burst stimulation and placebo stimulation periods (12 months)
D: Completion of EQ-5D5L Health questionnaire (1 hour); Numeric Rating Scale (NRS) recording pain severity (1 hour)

Answer: A