TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: Purpose: to investigate the postoperative outcomes of Retrograde intrarenal surgery versus percutaneous nephrolithotomy in 2 to 4 cm kidney stones.


Options:
A: Analgesic demand (Postoperative 24 hours); Stone clearance (3 months)
B: To assess the value of tranexamic acid (12 months)
C: SFR (3 month)
D: N/A

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effectiveness of Community-based Football Compared With Usual Care on Quality of Life in Men With Prostate Cancer: the FC Prostate Community Randomized Controlled Trial
Brief Summary: Prostate cancer is the most common malignancy in men. Three million are currently living in the United States with the disease and this number is expected to rise to four million in 2024. Most live many years with the disease and experience significant morbidity both due to disease progression and treatment toxicity. Exercise has shown to improve QoL and reduce treatment toxicity. Moreover epidemiological evidence has suggested that physical activity improves survival.

Football has been shown to induce positive effects on body composition and bone markers in a subgroup of prostate cancer patients, those receiving androgen deprivation therapy.

The objective is to examine the effectiveness of football in prostate cancer survivors.


Options:
A: Mean change in quality of life from baseline to week 12 (12 weeks)
B: Falls (Baseline up to 12 months)
C: Specific aim 1: To determine whether there are any changes in lymphedema in breast cancer survivors who participate in a one-year randomized exercise intervention of twice-weekly strength training, as compared to a non-exercising group. (1 year)
D: Physical function (baseline, 3, 6 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Ketamine in Refractory Convulsive Status Epilepticus in Children: a Multicenter, Randomized, Controlled, Open-label, No-profit, With Sequential Design Study.
Brief Summary: To evaluate the efficacy of intravenous administration of ketamine in the treatment of refractory convulsive status epilepticus in children compared to administration of midazolam at high doses, thiopental and / or propofol.


Options:
A: recurrence of febrile seizure (two years)
B: Length of Seizure After Study Medication Administration (24 hours)
C: Number of participants with resolution of refractory convulsive status epilepticus (participant wil be followed for 24 hours after discontinuation of study drug)
D: whether the presenting seizure stopped or not with a single dose of assigned anticonvulsant agent within 10 minutes of administration

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
Brief Summary: This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic science investigation are designed to understand the mechanisms by which local estrogen treatment affects connective tissues of the pelvic floor and determine whether its use before and after prolapse repair will (i) improve success rates of the surgical intervention and minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor disorders.


Options:
A: Prolapse symptom score (POP-SS) (7 months)
B: Vaginal tissue samples obtained at the time of vaginal repair of pelvic organ prolapse will be analyzed for epithelial and subepithelial thickness, vascularity and inflammatory cells using standard H&E stains. (baseline and 2-12 weeks after treatment (at time of surgery))
C: Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse (12 months)
D: Vaginal infections (60 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: COBALT: Evaluation of CAR19 T-cells as an Optimal Bridge to Allogeneic Transplantation
Brief Summary: The purpose of this study is to administer novel cluster of differentiation antigen 19 (CD19) specific Chimeric Antigen Receptor T-cells (CAR19 T-cells) to patients with relapsed or resistant Diffuse Large B Cell Lymphoma (DLBCL) to assess the safety and efficacy of this strategy as a bridge to allogeneic transplantation.


Options:
A: The types and Incidence of adverse events (Up to 12 months)
B: Overall Response Rate (ORR) Per Independent Review Committee (IRC) in Main Cohort (60 months)
C: Frequency, relatedness, severity and duration of treatment emergent and treatment related adverse events (35 days); Number of first cycle dose limiting toxicities (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) (up to 1 year)
D: Feasibility of adequate leucapheresis collection and generation of CAR19 T cells. (1 month); Toxicity evaluation following CAR19 T-cell administration. (1 year); Efficacy of CAR19 T-cells. (1 year)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Efficacy of Laser Acupuncture on Pruritus in Patients With Chronic Kidney Disease Undergoing Hemodialysis: A Multiple Centers, Randomized, Assessor- and Participant-blind, Controlled, Cross-over Clinical Trial
Brief Summary: Uremic pruritus is a clinically significant symptom which imposes heavy impact on the quality of life of patients with chronic kidney disease undergoing hemodialysis. In order to investigate the clinical efficacy and mechanism, the investigators designed a multiple centers, randomized, assessor- and participant-blind, controlled, cross-over clinical trial. This trial will be conducted at Taichung branch, Feng-yuan branch and the Eastern branch of CMUH.


Options:
A: Itching intensity (7 weeks)
B: Severity of Pruritis as measured by a visual analogue scale (VAS) (3 months)
C: Pruritus Visual Analogue Scale (20 weeks)
D: Change in pruritus degree measured by VAS(Visual Analogue Scale) score (4 weeks (2 weeks measurement with only conventional treatment + 2 weeks measurement with conventional treatment & investigational products))

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Timing of Morning Rounds for Postpartum Hospitalized Women: A Randomized Controlled Quality Improvement Trial
Brief Summary: In postpartum hospitalized women, does delayed morning rounding improve patient satisfaction?


Options:
A: Complications detected (3 days after delivery); Successful referrals (10 days after delivery (survey and administrative records)); Care Seeking Behavior around complications and well baby check-up (10 days after delivery (survey)); Knowledge of danger signs (10 days after delivery (survey)); Breastfeeding (10 days and 9 weeks after delivery (survey))
B: score on Hospital Consumer Assessment of Healthcare Provers and Systems (HCAPS) survey (2 months)
C: Use of unplanned maternal and child healthcare services (inpatient, Emergency Department (ED), urgent/acute care, primary care, and mental health) in the first 14 days after delivery (3 years)
D: The rate of exclusive breastfeeding at 3 months post-birth. (3 months post birth)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Controlled, Pilot Clinical Trial to Assess the Feasibility of a Healthy Eating and Physical Activity Program in Endometrial Cancer Survivors
Brief Summary: Endometrial cancer is the most common gynaecological cancer in developed countries with more than 75% of the patients surviving for at least five years. However, most endometrial cancer survivors are overweight and obese and do not meet the current nutrition and physical activity recommendations. This can lower their quality of life and increase their risk for chronic diseases. Behaviour change interventions can help them feel better about themselves and improve their quality of life. Applying them shortly after treatment seems ideal as cancer survivors feel motivated to make changes about their lifestyle at this time point.

This study is to see if the investigators can design a project to measure how well a psycho-educational healthy eating and physical activity programme tailored to the survivors' needs works. Sixty-four endometrial cancer survivors diagnosed during the previous three years, and are all clear will be put by chance into one of two groups. One will receive the program. The other will receive usual care until the end of the trial and, then, a discussion and a self-help guide about eating well and being active following cancer treatment. This will help us to see if the programme makes a difference compared with usual care. The results will inform a larger study to test if a lifestyle program can improve the quality of life of uterine cancer survivors compared with usual care. The investigators will change the programme materials in response to the investigators' findings, making them available to services. The results will inform practice and research.


Options:
A: Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Weight loss as measured by weight, body mass index (BMI), waist circumference, Weight Efficacy Life Style Questionnaire, Three Factor Eating Inventory Questionnaire, and Leisure Score index at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36) (baseline, 3, 6, and 12 months); Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months)
B: Weight loss (2 years)
C: Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study) (6 months)
D: Pathological complete response (6 months)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Controlled, Pilot Clinical Trial to Assess the Feasibility of a Healthy Eating and Physical Activity Program in Endometrial Cancer Survivors
Brief Summary: Endometrial cancer is the most common gynaecological cancer in developed countries with more than 75% of the patients surviving for at least five years. However, most endometrial cancer survivors are overweight and obese and do not meet the current nutrition and physical activity recommendations. This can lower their quality of life and increase their risk for chronic diseases. Behaviour change interventions can help them feel better about themselves and improve their quality of life. Applying them shortly after treatment seems ideal as cancer survivors feel motivated to make changes about their lifestyle at this time point.

This study is to see if the investigators can design a project to measure how well a psycho-educational healthy eating and physical activity programme tailored to the survivors' needs works. Sixty-four endometrial cancer survivors diagnosed during the previous three years, and are all clear will be put by chance into one of two groups. One will receive the program. The other will receive usual care until the end of the trial and, then, a discussion and a self-help guide about eating well and being active following cancer treatment. This will help us to see if the programme makes a difference compared with usual care. The results will inform a larger study to test if a lifestyle program can improve the quality of life of uterine cancer survivors compared with usual care. The investigators will change the programme materials in response to the investigators' findings, making them available to services. The results will inform practice and research.


Options:
A: Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study) (6 months)
B: Breast Cancer Recurrence (Lifetime)
C: Fatigue in Breast Cancer Survivors (12 weeks)
D: Change in skeletal muscle area (cm2) between individualized nutritional counselling versus usual nutritional care (During 9 weeks of first line chemotherapy)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Randomised, Controlled, Pilot Clinical Trial to Assess the Feasibility of a Healthy Eating and Physical Activity Program in Endometrial Cancer Survivors
Brief Summary: Endometrial cancer is the most common gynaecological cancer in developed countries with more than 75% of the patients surviving for at least five years. However, most endometrial cancer survivors are overweight and obese and do not meet the current nutrition and physical activity recommendations. This can lower their quality of life and increase their risk for chronic diseases. Behaviour change interventions can help them feel better about themselves and improve their quality of life. Applying them shortly after treatment seems ideal as cancer survivors feel motivated to make changes about their lifestyle at this time point.

This study is to see if the investigators can design a project to measure how well a psycho-educational healthy eating and physical activity programme tailored to the survivors' needs works. Sixty-four endometrial cancer survivors diagnosed during the previous three years, and are all clear will be put by chance into one of two groups. One will receive the program. The other will receive usual care until the end of the trial and, then, a discussion and a self-help guide about eating well and being active following cancer treatment. This will help us to see if the programme makes a difference compared with usual care. The results will inform a larger study to test if a lifestyle program can improve the quality of life of uterine cancer survivors compared with usual care. The investigators will change the programme materials in response to the investigators' findings, making them available to services. The results will inform practice and research.


Options:
A: Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study) (6 months)
B: Weight loss (2 years)
C: Physical function as assessed by Short-Form Health Survey (SF-36) with physical function subscale and late effects lower body subscales at baseline and years 1 and 2 following study completion (one year)
D: Quality of life as measured by Functional Assessment of Cancer Therapy for General Cancer (FACT-G) and Functional Assessment of Cancer Therapy for Fatigue (FACT-F) at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Weight loss as measured by weight, body mass index (BMI), waist circumference, Weight Efficacy Life Style Questionnaire, Three Factor Eating Inventory Questionnaire, and Leisure Score index at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months); Functional status as measured by ECOG performance status, and short-form health survey with 36 questions (SF-36) (baseline, 3, 6, and 12 months); Comorbidities as measured by Charlson Co-Morbidity Score at baseline, 3, 6, and 12 months (baseline, 3, 6, and 12 months)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Fascia Iliaca Block in the Emergency Department for Analgesia After Femoral Neck Fracture
Brief Summary: Femoral neck fracture is very common in the elderly and can produce severe to moderate pain. As this pathology is not life-threatening, waiting time in the emergency department may be prolonged due to the high number of unforeseen cases with patients remaining in pain.

Fascia iliaca block consists of injecting local anaesthetics below the fascia iliaca, resulting in the anaesthesia of the femoral, the lateral cutaneous and the obturator nerves, with effective analgesia.


Options:
A: Pain scores at rest (45 minutes after the injection)
B: Incidence of delirium (From hospital admission to home discharge, an average of 14 days)
C: Pain level (Pre operatively); Pain medication requirement (Pre operatively); Pain level (Four hours after surgery); Pain medication requirement (Four hours after surgery); Pain level (One day after surgery); Pain medication requirement (One day after surgery); Pain level (Two days after surgery); Pain medication requirement (Two days after surgery); Pain level (Three days after surgery); Pain medication requirement (Three days after surgery)
D: Consumption of opioids

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of Feeding Infant Formula With Enriched Protein Fractions
Brief Summary: This study is intended to measure declarative or stored memory and behavior between infants who consume one of two infant formulas through approximately one year of age.


Options:
A: Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height² (At age 11 years and 18 years)
B: Change in weight (Baseline to 4 months of age)
C: Sequence Recall using 3-dimensional props (365 days of age)
D: Weight Gain Velocity (up to 24 weeks)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Double-blind, Randomized, Placebo-controlled, Phase III Trial on the Efficacy and Tolerability of a 6-week Treatment With Budesonide Effervescent Tablets vs. Placebo for Induction of Clinico-pathological Remission in Adult Patients With Active Eosinophilic Esophagitis
Brief Summary: The purpose of this study is to prove the superiority of a 6-weeks treatment with budesonide effervescent tablets versus placebo for the induction of clinico-pathological remission in patients with acute eosinophilic esophagitis.


Options:
A: Post-Treatment Maximum Eosinophil Count (Aim 1) (8 weeks); Post-treatment Dysphagia Score (Aim 1) (8 weeks)
B: Rate of clinico-pathological remission (6 weeks)
C: The primary endpoint in this study is the number of patients (responder) with a reduction of 75% or more in eosinophils per HPF (distal or proximal esophagus) from baseline to week 13. (13 weeks)
D: Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) (From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24)); Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. (From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24)); Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. (From first dose of study treatment (Day 1) up to Long-term Follow-up Phase (Week 34)); Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline (Screening, Weeks 4, 8 and 12); Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points (Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24); Change From Baseline in Heart Rate at the Indicated Time Points (Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24); Change From Baseline in Temperature at the Indicated Time Points (Screening, Day 1, Weeks 4, 8, 12, 16, 20 and 24); Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit. (Day 1, Weeks 4, 8, 12, 24, and 34); Number of Participants Achieving a Reduction in Peak Esophageal Eosinophil Count to < 5 Cells Per High Power Field (HPF) at Week 12 (Week 12); Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab (Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34); Plasma Clearance (CL) of Mepolizumab (Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Controlled and Prospective Randomised Study to Compare Complete Lymph Node Dissection Versus Watchful Waiting in Patients With Malignant Melanoma With a Tumour Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node
Brief Summary: Sentinel lymph node biopsy (SLNB) is considered as standard diagnostic procedure in melanoma patients carrying a reasonable risk for metastases. In numerous studies the prognostic role of micro metastases in the sentinel node (SN) was described. However, the prognostic value of a complete lymph node dissection in patients with a positive SN is still unclear.

This study was planned to analyse the survival outcome of patients with a positive SN receiving complete lymphadenectomy versus watchful waiting.


Options:
A: Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone (From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks))
B: Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants (From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months))
C: Distant metastases free survival (3 Years)
D: Relapse-free Survival (RFS) (Approximately 3.5 years)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Creative Music Therapy for Premature Infants: Testing a Possible Influence on Brain Structure, Function and Neurobehavioral Outcome
Brief Summary: This study investigates whether creative music therapy applied to premature infants will facilitate brain growth and development at term equivalent assessed by magnetic resonance imaging. Secondary objective are improvement of neurobehavioral outcomes of premature infants at 24 months, as well as at 5 years of age.


Options:
A: Bonding between primary caregiver and infant (6 months)
B: Index of Multisensory Processing (IMP) (At enrollment up to 36 weeks gestation (prior to intervention), and at intervention completion up to 42 weeks gestation)
C: Brain volume (40 gestational weeks)
D: Change in Heart Rate Variability (Pre intervention (baseline), during the intervention and immediately after the intervention)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effect of Vitamin D Replacement on Maternal and Neonatal Outcomes: a Randomized Controlled Trial in Pregnant Women With Hypovitaminosis D
Brief Summary: The optimal vitamin D replacement dose during pregnancy remains undefined. Therefore, the aim of this study is to test the hypothesis that a daily equivalent dose of vitamin D of 3,000 IU/day is needed for Middle Eastern women, to optimize maternal vitamin D level and neonatal musculoskeletal parameters, specifically knee-heel length at birth and bone mineral content at one month of age.


Options:
A: 25(OH)D Plasma Concentrations (18 weeks gestation for mother); 25(OH)D Plasma Concentrations (28 weeks gestation for mother); 25(OH)D Plasma Concentrations (36 weeks gestation for mother); 25(OH)D Plasma Concentrations (16 weeks post-partum for mother & infant)
B: The proportions of women who will reach the IOM defined desirable 25(OH)D level ≥20ng/ml. (At delivery); Infant bone mineral content (BMC) (one to six weeks)
C: Persistent wheeze (0 to 3 years of age)
D: Asthma or Recurrent Wheeze in First 3 Years of Life (First 3 years of life.); Achieved Maternal 25(OH)D Level of ≥ 30 ng/mL at Third Trimester Sampling. (32-38 weeks gestation)

Answer: B