TrialPanorama/Dataset huggingface dataset:
Please select the outcome measures that correspond to the clinical trial below.
Title: Prevention of Seroma Formation and Wound Complications Using NPWT Devices
Brief Summary: The specific aim of this study is to improve post-operative wound care in the morbidly-obese body-contouring patient population following massive weight loss undergoing either panniculectomy or formal abdominoplasty, those patients undergoing complex abdominal wall reconstruction (i.e. ventral hernia repair) and breast reconstruction with acellular dermal matrix, as well as patients undergoing regular lipo-abdominoplasty by comparing the effectiveness of standard closed-suction drains versus the immediate application of continuous negative pressure via a NPWT (negative pressure wound therapy) device attached to non-compressible drains. Additionally, we aim to demonstrate increases both in cost-effectiveness and quality of life in these patients with the use of the NPWT wound care apparatus.

Hypothesis 1 Continuous negative pressure devices decrease the incidence of wound complications in comparison with conventional closed suction drains when used in patients after massive weight loss undergoing body-contouring procedures (panniculectomies alone and formal abdominoplasties), and in patients undergoing VHR and breast reconstruction with acellular dermal matrix, as well as those undergoing regular lipo-abdominoplasty.

Hypothesis 2 Although initially more costly than traditional closed suction drains, the use of continuous negative pressure devices will in the long-term result in lower total health care costs in the above-stated patient population due to a decreased need for additional procedures and/or clinical management, including surgical interventions, hospital admissions, administration of antibiotics, multiple follow-up office visits, and chronic wound care.

Hypothesis 3 Better quality of life is associated with the use of continuous negative pressure devices compared to closed suction drains in these patient populations.


Options:
A: Incidence of wound management complications (90 days); Incidence of wound management complications in groups treated with different types of postopNPWT (90 days)
B: Post-operative Seroma Formation (Two weeks following drain removal)
C: Postoperative Surgical Site Infection (SSI) (30 days following operation)
D: superficial site infection via southampton scoring system (higher score - worse outcome) (5 days); Wound Dehisence (5 days)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Evaluation of the Therapeutic Effect of Bandage Contact Lenses on Dry Eye Caused by Sjogren's Syndrome
Brief Summary: The purpose of this study is to evaluate the therapeutic effect and safety of therapeutic bandage contact lenses treating dry eye caused by Sjögren's syndrome.


Options:
A: To compare the score reduction in the Ocular Surface Disease Index (OSDI) between patients treated with autologous serum and conventional artificial tears. (5 weeks)
B: Corneal epithelial damage evaluated by fluorescein staining (micron meter squares) with digital photos (28 days treatment)
C: C Corneal fluorescein staining (up to 12 weeks)
D: Diagnostic Test Data for Disease Using Tear Osmolarity Threshold > 308 mOsm/L (Single visit); Diagnostic Test Data for Disease Using Schirmer Test Threshold < 7 mm (Single visit); Diagnostic Test Data for Disease Using Tear Film Breakup Time Threshold < 5 Seconds (Single visit); Diagnostic Test Data for Disease Using Corneal Staining Threshold > Grade 4/15 (Single visit); Diagnostic Test Data for Disease Using Conjunctival Staining Threshold > Grade 3/12 (Single visit); Diagnostic Test Data for Disease Using Meibomian Gland Grading Threshold > Grade 5/27 (Single visit); Diagnostic Test Data for Disease Using Ocular Surface Disease Index Threshold > 15/100 (Single visit)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Helping Hand (AHH) to Activate Patient-Centered Depression Care Among Low-Income Patients
Brief Summary: Study Hypotheses (Ho) and Research Questions (RQ):

* Ho1. AHH will significantly improve patient depression treatment acceptance/adherence and depression symptoms vs UC at 6 and 12 months post-baseline.
* Ho2. A Helping Hand (AHH) will significantly improve and sustain patient self-care management in Self-Efficacy for Managing Chronic Disease (SEMCD) and Quality of Life vs UC at 6 and 12 months post-baseline.
* RQ1. What is the association between depression symptoms and concurrent chronic illness self-care management over time by group?
* RQ2. Will AHH reduce hospitalizations and Emergency Room visits and improve clinic appointment-keeping?
* RQ3. Will patient care satisfaction and reported barriers to self-care management vary by study group?
* RQ4. What factors are identified via qualitative assessments of patients, promotoras, Department of Health Services (DHS) medical and social work providers, and DHS clinic/organizational leadership regarding satisfaction with, sustainable uptake of, and suggested modifications of the AHH promotora delivery model?
* RQ5. What potential technology applications would enhance promotoras delivering patient-centered self-care training and resource navigation, communicating and integrating care with DHS, and disseminating AHH?


Options:
A: Number of Participants Practicing Safe Lead Exposure Prevention Behaviors (Pre Test) (Baseline); Number of Participants Practicing Safe Lead Exposure Prevention Behaviors (Post Test) (Up to 8-weeks post-treatment)
B: body mass index (24 months)
C: Mammogram receipt (1 week)
D: Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline (6- and12-month follow-ups)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Helping Hand (AHH) to Activate Patient-Centered Depression Care Among Low-Income Patients
Brief Summary: Study Hypotheses (Ho) and Research Questions (RQ):

* Ho1. AHH will significantly improve patient depression treatment acceptance/adherence and depression symptoms vs UC at 6 and 12 months post-baseline.
* Ho2. A Helping Hand (AHH) will significantly improve and sustain patient self-care management in Self-Efficacy for Managing Chronic Disease (SEMCD) and Quality of Life vs UC at 6 and 12 months post-baseline.
* RQ1. What is the association between depression symptoms and concurrent chronic illness self-care management over time by group?
* RQ2. Will AHH reduce hospitalizations and Emergency Room visits and improve clinic appointment-keeping?
* RQ3. Will patient care satisfaction and reported barriers to self-care management vary by study group?
* RQ4. What factors are identified via qualitative assessments of patients, promotoras, Department of Health Services (DHS) medical and social work providers, and DHS clinic/organizational leadership regarding satisfaction with, sustainable uptake of, and suggested modifications of the AHH promotora delivery model?
* RQ5. What potential technology applications would enhance promotoras delivering patient-centered self-care training and resource navigation, communicating and integrating care with DHS, and disseminating AHH?


Options:
A: overall health-related quality of life (6 months)
B: First recurrent suicide behavior (suicide attempted and completed suicide) (Minimum 1.5 year)
C: Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c (Baseline to 12 months); Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); Systolic Blood Pressure at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 Months, 12 months); LDL Cholesterol at Baseline and 12 Months (Measured at Baseline and 12 months); Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months (Measured at Baseline, 6 months and 12 months)
D: Response Rate - 50 Percent or Greater Reduction in Patient Health Survey-9 (PHQ-9) Score Since Baseline (6- and12-month follow-ups)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: School Gardens and Physical Activity
Brief Summary: The purpose of this study is to determine whether school gardens affect children's physical activity.


Options:
A: change in physical activity (change from baseline to follow-ups at 6, 12, 18 months)
B: Changes in Academic Achievement in Elementary Students (Baseline to 3 Years)
C: Math Skills, as measured by a 45-minute standardized math test specifically designed for this age group by the developer of the Danish national tests (MG) (Hoegrefe Forlag). (Change from Baseline Math Skills at 9 months)
D: Intake of unhealthy foods, unhealthy drinks, healthy foods assessed by a photo-based method (volume) (6 months post baseline); Intake of unhealthy foods, unhealthy drinks, healthy foods assessed by a photo-based method (volume) (18 months post baseline)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Elective Blastocyst Vitrification for Endometrial Receptivity Enhancement in High-responder Patients Undergoing in Vitro Fertilisation/Intracytoplasmatic Sperm Injection (IVF/ICSI)
Brief Summary: A randomised controlled open-label clinical trial to compare the clinical pregnancy rates between fresh embryo transfer and elective all-embryo vitrification with thawing and transfer in a subsequent cycle in high-responders


Options:
A: cumulative live birth rate of a single PGD treatment (1 year)
B: Clinical pregnancy rates (7 weeks)
C: Implantation rate (8 weeks after replacement)
D: Live birth rate (up to 24 weeks)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Elective Blastocyst Vitrification for Endometrial Receptivity Enhancement in High-responder Patients Undergoing in Vitro Fertilisation/Intracytoplasmatic Sperm Injection (IVF/ICSI)
Brief Summary: A randomised controlled open-label clinical trial to compare the clinical pregnancy rates between fresh embryo transfer and elective all-embryo vitrification with thawing and transfer in a subsequent cycle in high-responders


Options:
A: Ongoing pregnancy (12 weeks of gestation)
B: Clinical pregnancy rates (7 weeks)
C: Clinical pregnancy (fetal heartbeat observed on ultrasound at 7 weeks gestation) (7 weeks gestation)
D: Ongoing pregnancy rates (Two years)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Metabolic and Molecular Effects of a Mediterranean Diet and Intermittent Fasting
Brief Summary: The purpose of this research study is to evaluate the effects of intermittent fasting in subjects that are eating a Mediterranean diet or a Western diet. This study is part of ongoing research in the prevention and treatment of age-related diseases at Washington University School of Medicine.


Options:
A: Decrease in high sensitivity C-reactive protein (hsCRP) (16 weeks-- Baseline, 8 weeks, 16 weeks)
B: Progression-free-survival (6 months)
C: Blood biomarkers (After two weeks, 3 and 6 months); Blood biomarkers (After two weeks, 3 and 6 months); Blood biomarker (After two weeks, 3 and 6 months); Blood biomarker (After two weeks, 3 and 6 months)
D: Endothelium Dependent Dilation (6 weeks)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY
Brief Summary: The purpose of this study is to assess the safety and efficacy of switching from Remicade to the biosimilar treatment Remsima in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and chronic plaque psoriasis


Options:
A: Time to relapse after discontinuation of IFX (48 weeks)
B: The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 (at Week 6)
C: Occurrence of disease worsening (52 weeks)
D: Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76 (Baseline up to Week 76)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial
Brief Summary: The Pamela Study is a clinical trial carried out during pregnancy to assess the potential effects of physical activity during pregnancy among previously inactive women. The trial is nested into a birth cohort of more than 4000 dyads (mother-child) and took place in Pelotas, Brazil.


Options:
A: Prematurity (Women will be interviewed at hospital soon after birth (up to 2 days after delivering))
B: Placental weight (At delivery); Fetal birth weight (At delivery); Change from baseline in maternal gestational weight (38-42 weeks of gestation)
C: Maternal gestational weight gain (40-42 weeks)
D: Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire (Week 10-14 gestation (baseline), week 36-39 (after intervention))

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial
Brief Summary: The Pamela Study is a clinical trial carried out during pregnancy to assess the potential effects of physical activity during pregnancy among previously inactive women. The trial is nested into a birth cohort of more than 4000 dyads (mother-child) and took place in Pelotas, Brazil.


Options:
A: Infant growth (Growth from birth to anthrometry at 12mo)
B: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)
C: Diagnosis of gestational diabetes mellitus (After the 14 week intervention period (28 weeks gestation))
D: Prematurity (Women will be interviewed at hospital soon after birth (up to 2 days after delivering))

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial
Brief Summary: The Pamela Study is a clinical trial carried out during pregnancy to assess the potential effects of physical activity during pregnancy among previously inactive women. The trial is nested into a birth cohort of more than 4000 dyads (mother-child) and took place in Pelotas, Brazil.


Options:
A: UI reduction (12 months)
B: Prematurity (Women will be interviewed at hospital soon after birth (up to 2 days after delivering))
C: Urinary Incontinence (Prevalence) (6 months postpartum (end of intervention))
D: Gestational diabetes (20 and 36 weeks pregnancy and 3 months post partum); Gestational diabetes (18 months postpartum)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Study Comparing Symbicort® 'as Needed' With Terbutaline 'as Needed' and With Pulmicort® Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma.
Brief Summary: The purpose of this study is to test if Symbicort® (budesonide/formoterol) Turbuhaler® is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort® 'as needed' will be compared with: 1) terbutaline Turbuhaler® 'as needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline Turbuhaler® 'as needed'.


Options:
A: Forced Expiratory Volume in 1 Second (FEV1) - Post Dose (60 minutes post-dose in clinic visits at baseline, and week 0, 3, 7, 12 and Trt Avg); Forced Expiratory Volume in 1 Second (FEV1) - Pre Dose (Pre AM dose in clinic visits at baseline, and week 3, 7, 12 and Trt Avg)
B: Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma (12 weeks)
C: Change in evening PEF (Daily throughout the 12 week treatment period)
D: 'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No) (Weekly, up to 52 weeks)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Clinical Study Comparing Symbicort® 'as Needed' With Terbutaline 'as Needed' and With Pulmicort® Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma.
Brief Summary: The purpose of this study is to test if Symbicort® (budesonide/formoterol) Turbuhaler® is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort® 'as needed' will be compared with: 1) terbutaline Turbuhaler® 'as needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline Turbuhaler® 'as needed'.


Options:
A: 'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No) (Weekly, up to 52 weeks)
B: Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis (up to 52 weeks); Annual Severe Asthma Exacerbation Rate - Superiority Analysis (up to 52 weeks)
C: The Percentage of Participants Who Had Experienced Asthma Exacerbation(s) at the End of the Study (week 52)
D: Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1. (End of 12-week treatment period)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: Lung Imaging for Ventilatory Setting in ARDS
Brief Summary: To compare in ARDS patients 2 ventilatory Strategies : One based on Lung Morphology (Focal versus non-Focal ARDS) versus ARDS networks Guidelines (PEEP based on FiO2). In Focal ARDS prone position will be promote early, with low PEEP and moderate Vt. In non-Focal ARDS, Recruitment maneuvers, high PEEP and low V twill be used.

The investigators made the hypothesis that ventilation according to Lung morphology my decrease mortality at D90.


Options:
A: Hospital Mortality
B: Mortality rate (at day 90)
C: 60 day mortality (60 days)
D: Oxygenation as measured by the PO2/FiO2 (P/F) ratio (72 hours from enrollment)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: Lung Imaging for Ventilatory Setting in ARDS
Brief Summary: To compare in ARDS patients 2 ventilatory Strategies : One based on Lung Morphology (Focal versus non-Focal ARDS) versus ARDS networks Guidelines (PEEP based on FiO2). In Focal ARDS prone position will be promote early, with low PEEP and moderate Vt. In non-Focal ARDS, Recruitment maneuvers, high PEEP and low V twill be used.

The investigators made the hypothesis that ventilation according to Lung morphology my decrease mortality at D90.


Options:
A: Development of ARDS (28 days)
B: Mortality (at 28 days)
C: Mortality rate (at day 90)
D: All-cause hospital mortality (Randomised patients will be ventilated according to their assigned ventilation strategy for up to 60 days, until they die on the ventilator or are successfully (for >24 hours) liberated from mechanical ventilation.)

Answer: C
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Safety and Efficacy of Dl-3-n-butylphthalide and Cerebrolysin on Neurological and Behavioral Outcomes in Acute Ischemic Stroke: a Randomized, Double-blind Study.
Brief Summary: The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12 hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a 10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were also analyzed among the three groups.


Options:
A: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)
B: the improvement ratio of Fugl-Meyer assessment (after 3 weeks)
C: Global disability on modified Rankin scale at 90 days.
D: National Institutes of Health Stroke Scale Score (At 11-day and 21-day after therapy)

Answer: D
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Safety and Efficacy of Dl-3-n-butylphthalide and Cerebrolysin on Neurological and Behavioral Outcomes in Acute Ischemic Stroke: a Randomized, Double-blind Study.
Brief Summary: The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12 hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a 10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were also analyzed among the three groups.


Options:
A: National Institutes of Health Stroke Scale Score (At 11-day and 21-day after therapy)
B: Global disability on modified Rankin scale at 90 days.
C: the improvement ratio of Fugl-Meyer assessment (after 3 weeks)
D: Modified Rankin Scale (90 days after start of treatment); Barthel Index (90 days after start of treatment); NIH Stroke Scale (90 days after start of treatment)

Answer: A
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Safety and Efficacy of Dl-3-n-butylphthalide and Cerebrolysin on Neurological and Behavioral Outcomes in Acute Ischemic Stroke: a Randomized, Double-blind Study.
Brief Summary: The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12 hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a 10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were also analyzed among the three groups.


Options:
A: Modified Rankin Scale (90 days after start of treatment); Barthel Index (90 days after start of treatment); NIH Stroke Scale (90 days after start of treatment)
B: National Institutes of Health Stroke Scale Score (At 11-day and 21-day after therapy)
C: the improvement ratio of Fugl-Meyer assessment (after 3 weeks)
D: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)

Answer: B
Please select the outcome measures that correspond to the clinical trial below.
Title: A Comparison of Safety and Efficacy of Dl-3-n-butylphthalide and Cerebrolysin on Neurological and Behavioral Outcomes in Acute Ischemic Stroke: a Randomized, Double-blind Study.
Brief Summary: The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12 hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a 10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were also analyzed among the three groups.


Options:
A: Modified Rankin Scale score at day 90 (or earlier in the event of patient withdrawal). (Day 90)
B: National Institutes of Health Stroke Scale Score (At 11-day and 21-day after therapy)
C: Global disability on modified Rankin scale at 90 days.
D: Modified Rankin Scale (90 days after start of treatment); Barthel Index (90 days after start of treatment); NIH Stroke Scale (90 days after start of treatment)

Answer: B