TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomised, Crossover, Controlled, Feasibility Study to Assess the Efficacy of BurstDR Spinal Cord Stimulation (SCS) as a Treatment for Persistent AbdomiNal RefrActory VisCEral PAin Secondary to Chronic Pancreatitis: PANACEA Trial
Brief Summary: To evaluate the effectiveness of Burst DR stimulation as a treatment for persistent abdominal refractory visceral pain secondary to chronic pancreatitis. Abdominal pain is a main symptom in patients with chronic pancreatitis. Patients have a background constant pain with acute episodes needing admissions. Spinal cord stimulation (SCS) is a recognised treatment for neuropathic pain. This involves placing an electric wire in the spine and the use of electricity to manage the pain. This is a pacemaker for controlling pain. Burst DR stimulation delivers a wave form which mimics the way nerves conduct electrical signals, there are short bursts or spikes of stimulation followed by short periods of rest. The key aims and objectives of this study are to evaluate the efficacy of Burst DR SCS as a treatment for persistent pain secondary to chronic pancreatitis


Options:
A: Difference between treatment groups in responder rates. (3 Months)
B: Change from baseline in disease-specific functional outcome between active burst stimulation and placebo stimulation periods (12 months)
C: Oxford Shoulder Score (6 months post randomisation)
D: Completion of EQ-5D5L Health questionnaire (1 hour); Numeric Rating Scale (NRS) recording pain severity (1 hour)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Prospective, Randomised, Crossover, Controlled, Feasibility Study to Assess the Efficacy of BurstDR Spinal Cord Stimulation (SCS) as a Treatment for Persistent AbdomiNal RefrActory VisCEral PAin Secondary to Chronic Pancreatitis: PANACEA Trial
Brief Summary: To evaluate the effectiveness of Burst DR stimulation as a treatment for persistent abdominal refractory visceral pain secondary to chronic pancreatitis. Abdominal pain is a main symptom in patients with chronic pancreatitis. Patients have a background constant pain with acute episodes needing admissions. Spinal cord stimulation (SCS) is a recognised treatment for neuropathic pain. This involves placing an electric wire in the spine and the use of electricity to manage the pain. This is a pacemaker for controlling pain. Burst DR stimulation delivers a wave form which mimics the way nerves conduct electrical signals, there are short bursts or spikes of stimulation followed by short periods of rest. The key aims and objectives of this study are to evaluate the efficacy of Burst DR SCS as a treatment for persistent pain secondary to chronic pancreatitis


Options:
A: Mean VAS Back Pain (7 Day Subject VAS Pain Diary) (6 months post randomisation)
B: Change in Multidimensional Pain Inventory (MPI)-SCI average activity score (Baseline, 9 months); Motor recovery as measured by EMG (Up to 9 months); Motor recovery as measured by dynamometry (Up to 9 months)
C: Visual Analog Scale (VAS) on Back Pain (12 weeks)
D: Completion of EQ-5D5L Health questionnaire (1 hour); Numeric Rating Scale (NRS) recording pain severity (1 hour)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Healthy Start to Feeding Pilot Trial
Brief Summary: The current study will test the impact of a 3-session obesity prevention program targeting healthy introduction of solid foods in infancy on growth trajectories, appetite regulation, and diet. The investigators will also test the feasibility and family satisfaction with the treatment. Healthy infants with normal and elevated weight-for-length will be enrolled in the study at 3 months of age and complete an initial study visit to assess baseline anthropometrics,demographics, parental feeding practices and beliefs, and infant appetite. Infants will than be randomly assigned to either the treatment condition (n = 20) or control condition (n = 20). Infants in the control condition will receive no intervention or further contact with the study team besides for completion of a final study assessment visit when the child is 9 months old. Infants in the treatment condition will receive a 3 session intervention targeting healthy introduction of solid foods, with study visits occurring when the child is 4 months, 6 months, and 9 months old. All families will complete a final study visit to complete post-treatment period measurements, which will include infant anthropometrics and parent-report of infant appetite, infant diet, and parental feeding practices and beliefs. Outcomes include: weight-for-length percentile, infant satiety responsiveness, infant food responsiveness, and infant fruit and vegetable consumption. Family satisfaction and treatment attendance will also be assessed.


Options:
A: Weight-for-Length Percentile (Weight and length were measured at both pre-treatment (when infant was 3 months of age) and post-treatment (when infant was 9 months of age).); Appetite Regulation (The BEBQ was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).); Fruit and Vegetable Variety (The Block Food Frequency Questionnaire was completed at both pre-treatment (when infant is 3 months of age) and post-treatment (when infant is 9 months of age).)
B: Nutritional status (baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline)); Child development (baseline (before intervention), endline (6 months after intervention), and follow up (2 years after endline))
C: Mean weight-for-length z-score at 15 months of age (15 months of age)
D: Change in Length-for-age Z scores (LAZ) at 3, 6, 12, 18 and 24 months age of children in intervention vs. comparison arms, compared to the baseline LAZ at 7 days of birth. (1, 3, 6, 9, 12, 15, 18, 21 and 24 months of child's age)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Nutritional Supplementation for Extending Time Between Recurrent Urinary Tract Infections in Women: a Randomized Double Blind Cross-over Trial
Brief Summary: The study will test the ability of specially formulated nutritional supplement capsules to extend the time between recurrent urinary tract infections in women. This objective will be completed by enrolling women who have suffered from 3-4 uncomplicated UTIs in the past 12 months into a double blind placebo controlled cross-over trial. Cross-over and study completion are triggered by the next two UTI recurrences. The goal of the study is for the supplement to extend the time to the next UTI for study participants as compared to placebo.


Options:
A: Number of symptomatic urinary tract infections per patient per month during in-patient post acute rehabilitation (At end of study)
B: Number of cases of asymptomatic bacteriuria
C: UTI Recurrence (Variable for each participant over course of up to one year)
D: Time to onset of a first UTI within one year of treatment. (one year)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Nutritional Supplementation for Extending Time Between Recurrent Urinary Tract Infections in Women: a Randomized Double Blind Cross-over Trial
Brief Summary: The study will test the ability of specially formulated nutritional supplement capsules to extend the time between recurrent urinary tract infections in women. This objective will be completed by enrolling women who have suffered from 3-4 uncomplicated UTIs in the past 12 months into a double blind placebo controlled cross-over trial. Cross-over and study completion are triggered by the next two UTI recurrences. The goal of the study is for the supplement to extend the time to the next UTI for study participants as compared to placebo.


Options:
A: UTI Recurrence (Variable for each participant over course of up to one year)
B: Frequency of UTIs (6 months)
C: Days (168)
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: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Single-center, Open Study Evaluating Efficacy and Safety of XLCART001（CD-19） Treatment in Relapsed/Refractory/High-risk B-cell Malignancy Subjects
Brief Summary: The trial is a single arm, single-center, non-randomized clinical trial which is designed to evaluate the efficacy and safety of XLCART001 in treatment of relapsed/refractory/high-risk B-cell malignancy subjects


Options:
A: Treatment-related adverse events (AEs) (2 years); Dose-limiting toxicities of JWCAR029 (28 days after JWCAR029 infusion); Objective response rate (ORR) (2 years)
B: Overall Response Rate (ORR) Per Independent Review Committee in Cohorts 1, 2 and 3 (From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)); Overall Response Rate (ORR) Per Investigator in Cohort 4 (From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)); Overall Response Rate (ORR) Per Investigator in Cohort 5 (From JCAR017 infusion until disease progression, end of study, the start of another anticancer therapy, or hemopoietic stem cell transplant (HSCT) (up to approximately 63 months)); Number of Participants With Adverse Events in Cohort 7 (From leukapheresis to end of study (up to approximately 63 months)); Number of Participants With Serious Adverse Events (SAEs) in Cohort 7 (From leukapheresis to end of study (up to approximately 63 months)); Number of Participants With Increase From Baseline in Select Hematology Parameters - Cohort 7 (At Baseline and Day 29 after JCAR017 infusion); Number of Participants With Increase From Baseline in Select Serum Chemistry Parameters - Cohort 7 (At Baseline and Day 29 after JCAR017 infusion)
C: Overall Response Rate (ORR) Per Independent Review Committee (IRC) in Main Cohort (60 months)
D: Overall response rate (12 weeks); Overall Survival (6 months,1 year, 2 years); Progression-free Survival (12 weeks,6 months,1 year, 2 years); Event-free Survival (12 weeks,6 months,1 year, 2 years)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing the Efficacy of the Teachable Moment Brief Intervention for Suicide Attempt Survivors in an Inpatient Setting: Effects on Psychosocial and Experimental Pain Outcomes
Brief Summary: This study is looking at the helpfulness of a brief treatment targeting suicidality (Teachable Moment Brief Intervention \[TMBI\]) and experimental pain responses in an inpatient population as well as collecting comparison data from the community.


Options:
A: Suicide attempts (measured by the Columbia Suicide Severity Rating Scale) (6-months); Suicidal ideation (measured by the Beck Suicide Scale (BSS)) (6-months)
B: Reduction of dissociative symptoms (End of 3rd week treatment of naltrexon)
C: 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))
D: Days/skill (Daily measurements up to 1 year. (minimum 8 months.))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing the Efficacy of the Teachable Moment Brief Intervention for Suicide Attempt Survivors in an Inpatient Setting: Effects on Psychosocial and Experimental Pain Outcomes
Brief Summary: This study is looking at the helpfulness of a brief treatment targeting suicidality (Teachable Moment Brief Intervention \[TMBI\]) and experimental pain responses in an inpatient population as well as collecting comparison data from the community.


Options:
A: Suicide Attempt Self Injury Interview SASII (up to 12th months)
B: 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))
C: Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm (16 weeks and 68 weeks); Severity of suicidal ideation, level of depressive symptoms (16 weeks and 68 weeks)
D: Completion of follow-up (End of treatment at 12 weeks); The fraction of eligible participants who consent to inclusion and randomization (End of treatment at 12 weeks); Compliance (End of treatment at 12 weeks); Non-suicidal self-injury as explorative primary clinical outcome (End of treatment at 12 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Testing the Efficacy of the Teachable Moment Brief Intervention for Suicide Attempt Survivors in an Inpatient Setting: Effects on Psychosocial and Experimental Pain Outcomes
Brief Summary: This study is looking at the helpfulness of a brief treatment targeting suicidality (Teachable Moment Brief Intervention \[TMBI\]) and experimental pain responses in an inpatient population as well as collecting comparison data from the community.


Options:
A: Suicidal behaviour (3 and 6 months); Suicidal behaviour (3 and 6 months)
B: Client Satisfaction Questionnaire (Immediately following Brief Intervention)
C: Self-stigma related to suicide attempt (2 weeks)
D: 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))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Modified One-layer Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
Brief Summary: The aim of this study is to compare surgical outcomes of modified One-layer duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy


Options:
A: Surgical Site Infection at D30 (30 days after surgical intervention)
B: 60-day ≥ Grade II Complication Rate (60 days)
C: Abdominal Complications (1 month)
D: Rate of clinically relevant postoperative pancreatic fistula (POPF) (Up to 60 days after Surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Modified One-layer Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy
Brief Summary: The aim of this study is to compare surgical outcomes of modified One-layer duct-to-mucosa versus invagination pancreaticojejunostomy after pancreatoduodenectomy


Options:
A: The frequency of pancreatic fistula including ISGPF grade B and C (Ninety days after operation)
B: postoperative pancreatic fistula(POPF) rate (30 days)
C: POPF (up to 30 days)
D: Rate of clinically relevant postoperative pancreatic fistula (POPF) (Up to 60 days after Surgery)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
Brief Summary: This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and ivacaftor (IVA) in participants 1 to less than 2 years of age with cystic fibrosis (CF), homozygous for F508del (F/F).


Options:
A: Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Baseline up to Week 100)
B: Part A: Observed Plasma Concentrations From 3-4 Hours (C3-4hr) of LUM and IVA (Day 1 and Day 15); Part A: Observed Pre-dose Plasma Concentration (Ctrough) of LUM and IVA (Pre-dose at Day 8 and Day 15); Part B : Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 26)
C: Absolute Change From Baseline in Percent-predicted Forced Expiratory Volume in One Second (ppFEV1) at Week 48 (From Baseline to Week 48)
D: Change from baseline in sweat chloride concentration compared to placebo (Between day 1 pre-morning dose and Day 28.)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
Brief Summary: This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and ivacaftor (IVA) in participants 1 to less than 2 years of age with cystic fibrosis (CF), homozygous for F508del (F/F).


Options:
A: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (Day 1 Through Safety Follow-up (up to Day 61 for Part 1, Day 85 for Part 2 and Day 57 for Part 3)); Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) (From Baseline Through Day 29)
B: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Week 24 (Baseline, Week 16 and 24)
C: Part A: Observed Plasma Concentrations From 3-4 Hours (C3-4hr) of LUM and IVA (Day 1 and Day 15); Part A: Observed Pre-dose Plasma Concentration (Ctrough) of LUM and IVA (Pre-dose at Day 8 and Day 15); Part B : Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From Day 1 up to Week 26)
D: change in response to Chloride-free solution and isoproterenol ( reflecting chloride transport) (change from baseline ( visit 1) and placebo to miglustat instillation)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing Safe Outpatient Care for Emergency Department Patients With Acute Pulmonary Embolism: a Pragmatic Trial
Brief Summary: To evaluate the impact of an integrated electronic clinical decision support system to facilitate risk stratification and site-of-care decision-making for patients with acute pulmonary embolism.


Options:
A: Rate of home discharge from the emergency department following treatment for pulmonary embolism (8 months post-implementation compared to 8 months pre-implementation)
B: Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group
C: 90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE (90 Days)
D: -Thromboembolic recurrences; -Bleeding Complications; -Deaths

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Increasing Safe Outpatient Care for Emergency Department Patients With Acute Pulmonary Embolism: a Pragmatic Trial
Brief Summary: To evaluate the impact of an integrated electronic clinical decision support system to facilitate risk stratification and site-of-care decision-making for patients with acute pulmonary embolism.


Options:
A: Mortality rate due to pulmonary embolism or its treatment during a period of ten days in the outpatient group
B: Rate of home discharge from the emergency department following treatment for pulmonary embolism (8 months post-implementation compared to 8 months pre-implementation)
C: 90-day all-cause mortality, recurrent VTE, and Major Bleeding during outpatient treatment of Low-risk PE (90 Days)
D: Recurrent, symptomatic venous thromboembolism (deep vein thrombosis or pulmonary embolism) (within 3 months of randomization)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Optimal Health Program in Improving Self-efficacy in Patients With Diabetes Mellitus in Putrajaya, Malaysia
Brief Summary: Addressing the increasing trend in diabetes and mental illness co-morbidities, Malaysia is currently in need of a self- management program that promotes patient empowerment and overall well-being - beyond education. Committing to the self-care behaviours is highly dependent on the individual's self-efficacy. Self-efficacy has been shown to have a direct positive relationship with self-care behaviours, direct negative relationship with psychological distress and depression. Self-efficacy has also been found to hold a mediating effect on the relationship between emotional distress and self-care behaviours.

The objective of this study is to assess the effectiveness of a self-management program for patients with diabetes, the Optimal Health Program (OHP) in improving self-efficacy, depression, anxiety, diabetes distress, well-being and self-care. This study is a randomized controlled trial study of patients with diabetes attending the four diabetes health clinics within the Putrajaya District. Eligible patients will be randomly allocated to either treatment as usual (TAU) or OHP and treatment as usual (OHP + TAU). The treatment as usual group (TAU) participants will be invited to participate in the OHP at the end of the study. The participants in the OHP + TAU will attend 5 weekly 1.5 hour sessions and a booster session at 3 months. Following ethics approval, recruitment and training will commence in September, data collection expected to be until April 2020.

It is hypothesized that the OHP + TAU group will have higher self-efficacy, well-being and self-care scores and reduced depression, anxiety, diabetes related-distress and HbA1c. This study will contribute towards the gap in the literature in the effectiveness of a self-efficacy enhancing psychosocial self-management program among diabetes patients in Malaysia within a primary care setting.


Options:
A: Difference in Diabetes Empowerment Scale (DES) scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time (Week 1, Week 5, Week 18, Week 30); Difference in Diabetes Management Self-Efficacy Scale (DMSES) scores between OHP+TAU (experimental group) and TAU alone (control group), and within OHP plus TAU across time (Week 1, Week 5, Week 18, Week 30)
B: HIV-related transmission acts (18 months); Baby's health status (18 months); Maternal adherence to HIV-related and general health routines (18 months); Mental health (18 months); Social support (18 months)
C: Number of significantly improved child and maternal outcomes (2 Years)
D: Change in Grief Intensity (Baseline, 2 months post-intervention); Change in Mental Health (Baseline, 2 months post-intervention)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Protocol For The Randomized Controlled Trial Of Pulsed Short Wave Therapy In Cesarean Section
Brief Summary: This clinical study is designed to assesses the benefit of adding pulsed shortwave therapy to the postoperative pain and recovery protocol following Cesarean section. Pulsed shortwave therapy is a safe adjunct pain therapy for acute and chronic pain.


Options:
A: Pain measurement (up to post operateive day 2); Patient Distress score (up to post operateive day 2)
B: Daily average postoperative pain scores (An average of pain scores at 8:00 am and 4:00 pm, up to 7 days postoperation); Postoperative functional recovery (In the morning of postoperative day 3)
C: Medication Use (Data collected daily for 7 Days)
D: quantity of narcotics used in-hospital (4 days)

Answer: C