TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Percentage of Transfusion Dependent Participants With a ≥20% Reduction in Red Blood Cell Transfusion Burden From Baseline During a Rolling 12-week Interval
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Blood brain-derived neurotrophic factor (BDNF)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: maximal tolerance dose
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Lactobacilli count
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: pain scores from IV insertion
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: memory task
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: change from baseline in frequency of headache days
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: Post-surgical complication rate
Endpoint domain: Adverse events/effects
Primary endpoint: Short-term Safety of FMT as Measured by Absence or Presence of Related Serious Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Long-term Safety of FMT as Measured by Absence or Presence of Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Compete Remission (CR) Rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change of documentation of aspirin therapy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change of documentation of blood pressure in patients with hypertension
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change of documentation of fasting LDL
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change of documentation of patients screened about tobacco use
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Bone volume evaluation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: State Anxiety Test
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Minimal alveolar concentration of Sevoflurane
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Soft Tissue Ischemia/Loss
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Number of Participants With Delayed Wound Healing
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Tobacco and Nicotine-containing Products Cessation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AUC0-6h of Pain Intensity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Improved and normalized liver status
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Improvement in EEG
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Evaluation of ANI
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Evaluation of pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Disappearance of lesions
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from baseline psychometric properties
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Number of adverse events of any severity
Endpoint domain: Adverse events/effects
Primary endpoint: Area-under-the-plasma concentration-time curve (AUC0-infinity)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: percentage of patients enrolled in a clinical trial
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: percentage of patients who undergo K-Ras mutation study
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Percentage of patients with K-Ras mutation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Falls (number)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cognitive status
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Urinary sulfatoxymelatonin secretion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: LVOT velocity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: TDI S wave
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in Upper Extremity Activity Counts
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Upper Extremity Position
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Montreal Cognitive Assessment Scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Five Times Sit-to-Stand Test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: CO2 reactivity of cerebral vessels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Feasibility of TIL procurement
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Safety of TIL procurement
Endpoint domain: Adverse events/effects
Primary endpoint: Total hip T-Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Bone and mineral outcomes
Primary endpoint: Maximum observed concentration (Cmax) of lebrikizumab
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time to maximum concentration (Tmax) of lebrikizumab
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area under the concentration-time curve to the last measurable concentration (AUC0-last) of lebrikizumab
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Intelligibility
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Incidence of Adverse Events (AE) or Serious Adverse Events (SAE)
Endpoint domain: Adverse events/effects
Primary endpoint: Efficacy of nerve blockade in reducing migraine pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time in Range Overnight
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number and proportion of patients with ILD
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Rate of successful manufacture of GD2CART
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum tolerated dose (MTD)/RP2D of GD2CART
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Safety of GD2CART
Endpoint domain: Adverse events/effects
Primary endpoint: Chronic toxicity
Endpoint domain: Adverse events/effects
Primary endpoint: BOLD activity in the ventral visual stream
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Composite of pharmacokinetics
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in depression severity
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: percentage of eosinophils in induced sputum
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Sensitivity, specificity and predictive values of the delirium monitor
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area under curve of omega-3 food supplements
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Peak plasma concentration of omega-3 food supplements
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in ANS function (HRV and PPGA)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Effect of Naltrexone
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Hamilton Depression Rating Scale (HDRS)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Area under the curve (AUC0-t, AUC0-inf)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Degree of Tattoo Clearing
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Carotid Procedure and Device Related Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Pharmacokinetic profile of pioglitazone
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pharmacokinetic profile of S-warfarin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pharmacokinetic profile of omeprazole
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pharmacokinetic profile of midazolam
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from Baseline in Rosenberg Self Esteem Scale (RSE)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change from Baseline in Contingencies of Self Worth Scale (CSW)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change from Baseline in Sociocultural Attitudes Towards Appearance Questionnaire-3 (SATAQ-3)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Expression of Periostin in periodontal tissues
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Improvement of clinical condition
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Subjective Happiness
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Function measured by Oswestry Disability Index
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Change from Baseline Percent (%) Body Fat
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: healed ulcer
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Number of Participants With Adverse Events Related to Investigational Product
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants With the Indicated Shift From Baseline in Blood Pressure at Any Time Post-Baseline
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Incidence of stressing events
Endpoint domain: Adverse events/effects
Primary endpoint: number of patients with at least one adverse event
Endpoint domain: Adverse events/effects
Primary endpoint: Increase in muscle strength
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Rate of successful completion of the tDCS treatment course
Endpoint domain: Life impact
Endpoint subdomain: Role functioning
Primary endpoint: Rates of treatment associated adverse effects of tDCS
Endpoint domain: Adverse events/effects
Primary endpoint: Operator Radiation Exposure
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: PHQ-9 Depression Symptoms
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Prevention of grade 3-4 diarrhea
Endpoint domain: Adverse events/effects
Primary endpoint: Accuracy of ultrasound for diagnosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Proportion of participants with palliative care visit
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Cmax of Ulipristal Acetate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AUClast of Ulipristal Acetate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Biomarker analysis in COPD/Emphysema/Lung cancer
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: ASP1517 concentrations in plasma
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Count of Participants With Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Immunologic Response to Peptide Vaccination Pre and Post Vaccination
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Insulin action measures
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Long term Disease free survival rates
Endpoint domain: Mortality/survival
Primary endpoint: Standardized uptake value (SUV) of 89Zr-pembrolizumab in tumor lesions
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Visual scoring of 89Zr-pembrolizumab uptake in tumor lesions
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Rating of willingness to have person with opioid use disorder marry into their family
Endpoint domain: Life impact
Endpoint subdomain: Social functioning
Primary endpoint: Rating of willingness to have person with opioid use disorder as a neighbor
Endpoint domain: Life impact
Endpoint subdomain: Social functioning
Primary endpoint: Feeling thermometer measure of warmth toward people with opioid use disorder
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Response to treatment (ACR20)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Disease response (complete hematologic response, cytogenetic response)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Progression
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Response rate by RECIST 1.1
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Completion of the Mayo Clinic Upper Digestive Disease Survey
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change From Baseline in Morning Pre-dose Trough FEV1
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: BMI change at 3 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Number of repeat abortions
Endpoint domain: Mortality/survival
Primary endpoint: Change in number of episodes of urgency urinary incontinence
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: early urinary continence recovery
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Microhardness (KHN)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: CR/Cri rate of AZA based and LDAC based
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Reduced operating times
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Cognitive decline at 24 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Number of CNS relapses
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Urine spermine levels in the diagnosis of prostate cancer
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Urine spermine levels in prognostic prediction of prostate cancer
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Annual Asthma Exacerbation Rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence of Cardiac Complications
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Presence of Retinal Vascular Dysregulation (RVD)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Time to clearing of viral shedding
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Area Under the Plasma Concentration-Time Curve (AUC0-12h)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale
Endpoint domain: Life impact
Endpoint subdomain: Pain
Primary endpoint: Number of Patients With Objective Treatment Response (Complete or Partial) in the CNS
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Patients Experiencing a Clinical Benefit
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Frequency of Participants with Azer-cel related Adverse Events (AEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Mean Overall Diet Quality by Healthy Eating Index-2015 Scores Immediately Post-intervention
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean Overall Diet Quality by Healthy Eating Index-2015 Scores at 16 Weeks Post-intervention
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: satisfaction and compliance
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Word List Memory Test performance
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cognitive functioning
Primary endpoint: Grade 3-4 Acute GVHD
Endpoint domain: Adverse events/effects
Primary endpoint: Output rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pain level
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Freedom from major adverse events (MAEs) at 30 days
Endpoint domain: Adverse events/effects
Primary endpoint: dosimetric coverage of liver lesions
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean Area Under the Curve for Rise in Breakfast Post-prandial
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Initial body temperature
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Self-efficacy for managing opioid medications
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Appearance of xerosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Changes in attitude
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change in corneal thickness
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Periapical health at year 1
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Periapical health at year 4
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pain evaluation
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Percentage of Participants with Atopic Dermatitis (AD)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Global Flushing Severity Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Activity energy expenditure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in concentration of ASA metabolites in plasma
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in concentration of ASA metabolites in nevus tissue
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in concentration of prostaglandin E2 (PGE2) in plasma
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in concentration of prostaglandin E2 (PGE2) in nevus tissue
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percent changes in lumbar vertebral bone mineral density
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: EuroQoL (EQ-5D-5l)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: protein intake
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nutritional outcomes
Primary endpoint: Change of Fahn-Tolosa-Marin (FTM) scale score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percent of participants who agree to participate
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: 6-hour postprandial blood glucose excursion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Range of motion of the subtalar inversion/eversion
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Cytokine blood levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: 30-day treatment failure rate
Endpoint domain: Adverse events/effects
Primary endpoint: Postpartum posttraumatic stress disorder (PTSD)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Confirmed Hypercalcemia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Biodistribution of 18F-Fluoroacetate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of seizures/month
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neurological outcomes
Primary endpoint: Changes in HbA1C values
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Number and/or rates of subjects with treatment-related adverse events as assessed by hematology tests
Endpoint domain: Adverse events/effects
Primary endpoint: Number and/or rates of subjects with treatment-related adverse events as assessed by blood chemistry tests
Endpoint domain: Adverse events/effects
Primary endpoint: Number and/or rates of subjects with treatment-related adverse events as assessed by urinalysis
Endpoint domain: Adverse events/effects