TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Change in Endothelial Function (EF)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in WOMAC Questionnaire score
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Quantity of androgen receptor message expression
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change From Baseline in Mini-Mental State Examination (MMSE) Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in Patient-reported Angina Frequency
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Nitroglycerin (NTG) Consumption
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Postoperative COVID-19 infection
Endpoint domain: Adverse events/effects
Primary endpoint: Mean Change From Baseline in HCV Viral Load
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Subjective improvement of POP symptoms
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Percentage of blood eosinophils with expression of CD69 marker
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Time to a new mood episode
Endpoint domain: Mortality/survival
Primary endpoint: Individual goal settings
Endpoint domain: Life impact
Endpoint subdomain: Personal circumstances
Primary endpoint: hospital admission rate of pneumonia patients
Endpoint domain: Resource use
Endpoint subdomain: Hospital
Primary endpoint: incidence rate of IPD
Endpoint domain: Mortality/survival
Primary endpoint: Change in Mitochondrial Activity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rabies Neutralizing Antibodies
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Unknown adverse reactions
Endpoint domain: Adverse events/effects
Primary endpoint: Achievement of local anesthesia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Change in Fugl-Meyer Stroke Assessment Scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in peak-to-peak motor evoked potential amplitude and motor threshold elicited by transcranial magnetic stimulation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Incidence of local and systemic side effects
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Modified Rodnan Skin Score (MRSS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Change in Forced Vital Capacity (FVC)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Change in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Change of Modified gingival index
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Adverse Events (Grade 3 or Higher)
Endpoint domain: Adverse events/effects
Primary endpoint: Tinnitus Handicap Inventory 12 total score
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Tinnitus Rating Scale
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Plasma metabolome profile
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Fecal microbiota
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Duration of the hospital stay due to respiratory infection
Endpoint domain: Resource use
Endpoint subdomain: Hospital
Primary endpoint: Safety of IV therapy with autologous Mesenchymal Stem Cells
Endpoint domain: Adverse events/effects
Primary endpoint: Hemodialysis efficacy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Postoperative bowel function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: No appearance of more than one injury
Endpoint domain: Adverse events/effects
Primary endpoint: Radiologic reduction of the lesion
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants With Major and/or Minor Erythroid Responses
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Occurrence of major postoperative complications
Endpoint domain: Adverse events/effects
Primary endpoint: Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Germline alterations in BRCA1/2 and other ovarian cancer predisposing genes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: incidence of hemorrhagic events
Endpoint domain: Adverse events/effects
Primary endpoint: Change in tumor SUVmax
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Increase in IIEF ED Domain Questionnaire score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: DOLOPLUS 2 score
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Plasma VEGF and HIF1-alpha levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Standard uptake value as measured by 3'-deoxy-3'-[18F] fluorothymidine (FLT)-PET/CT scans
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence of dipyrone usage
Endpoint domain: Adverse events/effects
Primary endpoint: Change in PD-1 expression by alveolar macrophages
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change in IL-10 production by alveolar macrophages
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Improvement in pre-challenge FEV1%
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Percentage of patients with Dose-Limiting Toxicities
Endpoint domain: Adverse events/effects
Primary endpoint: Prevalence of low BMD and vertebral fractures
Endpoint domain: Physiological/clinical
Endpoint subdomain: Bone and mineral outcomes
Primary endpoint: Improvement of bone mineral density measured by DEXA
Endpoint domain: Physiological/clinical
Endpoint subdomain: Bone and mineral outcomes
Primary endpoint: Reflux symptom index
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Reflux finding score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Decreased levels of estradiol (E2)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: composite cardiovascular events (CCE)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Proportion of children presenting signs of psychological suffering
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Rate of progression of disease
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Hepatitis B Envelope Antigen Seroconversion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change in Glycosylated Hemoglobin (HbA1c) at 6 Months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in Glycosylated Hemoglobin (HbA1c) at 12 Months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: stability and relapse rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Change from Baseline BAPAC score at 3 months
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Severity of psychosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean duration of post-operative air leakage
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of treatment-emergent AESI per 100 PYs of infections and malignancies
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of subjects with SAEs
Endpoint domain: Adverse events/effects
Primary endpoint: Number of treatment-emergent SAEs per 100 patient years (PYs)
Endpoint domain: Adverse events/effects
Primary endpoint: score of process-oriented visual assessments
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: score of outcome-oriented visual assessments
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Genotype Anaerobic Bacterial populations
Endpoint domain: Physiological/clinical
Endpoint subdomain: Microbiological outcomes
Primary endpoint: Concordance rate of endoscopic diagnosis and histologic diagnosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Response rates to tipifarib
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Serious Adverse Events (SAE) Causally Related to Primary Vaccination or Related to Hepatitis A or B Infection or Related to Study Participation (Blood Sampling)
Endpoint domain: Adverse events/effects
Primary endpoint: Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Quality of endoscopic visualization
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Changes in kidney function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Changes in liver function
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in muscle injury marker function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Changes in muscle tenderness
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Procedure-related Complication Free Rate
Endpoint domain: Adverse events/effects
Primary endpoint: Chronic Success Rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Clinical attachment level (CAL)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Absence of clinical complications
Endpoint domain: Adverse events/effects
Primary endpoint: Freedom from access site closure-related complications requiring hospital intervention
Endpoint domain: Adverse events/effects
Primary endpoint: Rate of major venous access site closure-related complications
Endpoint domain: Adverse events/effects
Primary endpoint: Completion of questionnaires
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Frequency of delivery <=32 weeks
Endpoint domain: Mortality/survival
Primary endpoint: Success Rate of First-attempt of Spinal Anaesthesia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Disease Relapse Rate
Endpoint domain: Mortality/survival
Primary endpoint: Pathological Complete Response (PCR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Change in Pain Assessment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Tolerance to Transcutaneous Electrical Stimulation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: peri-procedural myocardial damage
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Mental component score (MCS) of the SF-36 questionnaire
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: MCL scores
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from baseline in total Young Mania Rating Scale (YMRS) score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clinical Benefit Rate
Endpoint domain: Mortality/survival
Primary endpoint: Changes in the Metabolomic Profile
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Absolute angular error (AAE) of shoulder joint
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Need for Endotracheal Ventilation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: FEV1 AUC 0-60 (% decrease from post-dose/pre-challenge FEV1)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl required for sensory block
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area under the concentration curve from 0-12 hours
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of patients reported
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Proportion of recommended pre-travel vaccinations administered
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of recommended pre-travel oral pharmacotherapies dispensed
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Analgesic Use
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Change of PTSD symptoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Veterans Rand-12 (VR-12)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Knee Injury and Osteoarthritis Outcomes Survey (KOOS Jr)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Total Exercise Duration (TED) change
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Grade 1-4 Treatment Related Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Indications for esophagogastroduodenoscopic procedures
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Mean Change in SCOPA-COG Summary Score
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: return to normalization of gait
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in osteopontin level in CSF
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: illness related distress regarding survival
Endpoint domain: Mortality/survival
Primary endpoint: aesthetic satisfaction
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Levodopa equivalent dose per day
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean Nighttime Systolic Blood Pressure (SBP)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Mean Nighttime Diastolic Blood Pressure (DBP)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Vertical Jump Distance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Reduction in wound area
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Changes in 18FDG lung uptake (TLG variation)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Patient-reported total sleep time
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: Progress in GMFCS scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Tolerability as determined by gastrointestinal symptom rating scale (GSRS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: recruitment rate per year
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Proportion of subjects with plasma HIV-1 RNA <400 copies/mL at Week 48
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of subjects who permanently discontinue randomized treatment due to adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Low Back Pain Disability
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Cognitive function assessment
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Percentage of Participants With Death or Disease Progression
Endpoint domain: Mortality/survival
Primary endpoint: Incidence of Composite, Serious Adverse Events Within 7 Days Post Procedure
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants With Mortality
Endpoint domain: Mortality/survival
Primary endpoint: Hearing-related Quality of Life Measure
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Number of Participants With an Ototoxic Hearing Shift
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: number of participants with acute kidney injury
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Plasma pharmacokinetic parameters (Cmax, AUC)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Prognostic impact of resting resistances
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in MADRS scores
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Uric acid level in spermatozoa and seminal plasma
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Percentage of patients whose wearable activity monitor provides movement data
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percent of patients who achieve data capture success defined as having both PRO data and accelerometry data transmitted to the investigators in 80% of the observation days
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Complications associated with the procedure
Endpoint domain: Adverse events/effects
Primary endpoint: Resistance (Moisture in the adhesive)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clearance of treated common wart(s)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Number of treated patients
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Change from baseline lips pressure
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Need for adalimumab dose escalation
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Success of adalimumab dose escalation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Frequency and types of adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Discontinuation rate due to adverse event
Endpoint domain: Adverse events/effects
Primary endpoint: Mean Change in Calculated Low Density Lipoprotein Cholesterol
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Mean Change in Plasma Triglycerides
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Mean Change in High Density Lipoprotein Cholesterol
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Number of patients with hospital admission or death
Endpoint domain: Mortality/survival
Primary endpoint: Change in Average Finger Temperature
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Postoperative Nausea
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Postoperative Vomiting
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Medication need
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: First Occurrence of Composite Endpoint (CV Death or HF Hospitalization)
Endpoint domain: Mortality/survival
Primary endpoint: Nutrient Level Estimation Accuracy
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Perceptions of Health
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Taste and Purchase Intent
Endpoint domain: Life impact
Endpoint subdomain: null
Primary endpoint: Cellular immune response to vaccination
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Serum antibody response to vaccination
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Frequency of vaccine-associated adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Glycemic levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: rate of device related complications
Endpoint domain: Adverse events/effects
Primary endpoint: CNC Word Recognition Scores
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: HbA1c Change From Baseline at Week 24
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Maximum tolerated dose of M2ES
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Overall Response Rate (ORR) Per RECIST 1.1
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Absence of local recurrence
Endpoint domain: Mortality/survival