TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: MRI Progression over 30 to 36 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Change in Mattis Dementia Rating Scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Cognitive functional scales
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Walking while talking test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Embryo haploid rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: Reproductive system and breast outcomes
Primary endpoint: Maximal oxygen uptake (V̇O2max)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Progression Free Survival at 6 Months (PFS6)
Endpoint domain: Mortality/survival
Primary endpoint: Peak Chest and Pelvis Interface Pressures
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in parent reported socialization subscale scores of the VABS-2
Endpoint domain: Life impact
Endpoint subdomain: Social functioning
Primary endpoint: Hamilton Depression Scale-17 item (HAMD-17)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Clinical Global Impressions-Improvement (CGI-I)
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Number of subjects with MTD of HCB101
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in fMRI resting-state salience network community structure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Completion of instillations
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: TMJ Range of Motion
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cervical Mobility
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Sensitivity of the plasma free GAGome MCED test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Specificity of the plasma free GAGome MCED test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Fugl-Meyer Assessment (FMA) for Upper Extremity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Modifications of gastrointestinal symptoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Modifications of body mass index (BMI)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Modifications of immune function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Quantification of essential long-chain polyunsaturated fatty acids
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Time to Return to Work (T-RTW)
Endpoint domain: Life impact
Endpoint subdomain: Role functioning
Primary endpoint: Disabilities of the Arm, Shoulder, and Hand questionnaire (Quick DASH)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Work Rehabilitation Questionnaire (WORQ)
Endpoint domain: Life impact
Endpoint subdomain: Role functioning
Primary endpoint: Repeatability of the Resonant Frequency measure
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in Electroencephalograms (EEG) functional connectivity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Percent overlap between spatial maps of source-localized EEG connectivity and fMRI-based MDD-rTMS responsive network
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: first-line nurse managers' knowledge
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: managerial actions of first-line nurse managers
Endpoint domain: Life impact
Endpoint subdomain: Delivery of care
Primary endpoint: nurses' perceived first-line nurse managers' caring behavior
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: nurse outcomes
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Incidence of all-cause mortality or fatal stroke/stroke with disability
Endpoint domain: Mortality/survival
Primary endpoint: Proportion of subjects with moderate or greater paravalvular leak
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Rate of Initiation of Salvage Radiation Therapy to CNS
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: ASQ-3 scores
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Neurodevelopmental profile of SLC13A5 deficiency as measured using Mullen Scales of Early Learning
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Seizure burden and semiology as measured using the Seizure Global Impression of Change
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Neurodevelopmental profile of SLC13A5 deficiency as measured using the Vineland-III Adaptive Behavior Scale
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Constipation severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Cases Who Received Excessive Post-procedural Antimicrobials
Endpoint domain: Adverse events/effects
Primary endpoint: Fibrosis prediction
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: EEG spectral beta power
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Change in severity of post-concussive symptoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Urine Angiotensin-(1-7)/Creatinine Ratio
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Manual Systolic Blood Pressure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Depressive episodes
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Parenting self-efficacy
Endpoint domain: Life impact
Endpoint subdomain: Personal circumstances
Primary endpoint: Parenting responsiveness
Endpoint domain: Life impact
Endpoint subdomain: Personal circumstances
Primary endpoint: Eating Disorders Examination - Questionnaire (EDE-Q)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Pain impact change
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: Sleep disturbance change
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: salivary levels of paxillin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Occlusal equilibrations
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Muscle activities
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Safety of the intervention as noted by parameters for serum bloodwork
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Safety of the intervention as noted by parameters for vitals signs prior to participation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Safety of the intervention as noted by a timely log of adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Cardiovascular system outcomes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in walking recovery
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate of change in walking recovery
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Degree of bone necrosis in head and neck femur
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Maximum Tolerated Dose (MTD) of MBF-362
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from Baseline in Growth Parameters
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants With a Postbaseline Corrected QT Interval Using Fridericia's Formula (QTcF) of >500 millisecond (msec) and an Increase from Baseline to Any Postbaseline Timepoint in QTcF of >60 msec
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Efficacy of niraparib
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Canadian Occupation Performance Measure (COPM)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Cerebral Palsy Quality Of Life scale (CP-QOL)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Smartphone app for gait and Balance Assessment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Baseline endogenous glucose production
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Postprandial endogenous glucose production
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Baseline postprandial glucose uptake
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Postprandial glucose uptake
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Meal derived glucose disposal
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: IMACS score improvement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AUC of ROC curve
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Achievement of target CD34+ cells/kg
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Correct diagnosis of cause of low hemoglobin
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Correct diagnosis of cause of low glomerular filtration
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Severity of Carpal Tunnel Syndrome
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Efficacy Endpoints
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Tegner Activity Scale (TAS)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Simple Knee Value (SKV)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: International Knee Documentation Committee (IKDC)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Quantitative urine biomarker levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of days covered (PDC)
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: cumulative GU toxicity
Endpoint domain: Adverse events/effects
Primary endpoint: Markers of kidney injury
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Number of patients with severe bleeding
Endpoint domain: Adverse events/effects
Primary endpoint: Change from baseline in urine protein creatinine ratio (UPCR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Annualized estimated glomerular filtration rate (eGFR) slope
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Percent Change in Lactate Dehydrogenase (LDH)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Termination of POAF
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Time in POAF
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in youth reported parent-youth communication scale
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change in mean score on externalizing and internalizing behaviors
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in proportion of youth who state they plan to delay having sexual intercourse until they graduate from high school
Endpoint domain: Life impact
Endpoint subdomain: Personal circumstances
Primary endpoint: level of growth hormone and insulin like growth factor 1
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at the Index and Recurrent Episodes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Percentage of Participants who are Asymptomatic and Symptomatic at the Index and Recurrent Episodes
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants who Died due to CMV Infection From HSCT and Index Date
Endpoint domain: Mortality/survival
Primary endpoint: Heart Failure Relapse assessed through left ventricular ejection fraction (LVEF)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Heart Failure Relapse assessed through pro-BNP
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Number of patients with heart failure Relapse assessed through signs of heart failure
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of patients with heart failure Relapse assessed through symptoms of heart failure
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in hypoxia level during radiotherapy
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in tumour tissue and microenvironment during radiotherapy
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Proportion of women using modern contraception
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Mental set shifting
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Frequency and nature of adverse events (AEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Microbial colonization from baseline to 1 hour
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Microbial colonization from baseline to 8 hours
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Microbial colonization from baseline to 8 hours post last dose
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Microbial colonization from baseline to 48 hours post last dose
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants With Related or Serious Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Mechanics-dependent Adjustment of Paretic Foot Placement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of participants with moderate or severe anxiety
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: HIV infection rates
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Linkage of PrEP
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Incidence of type I diabetes
Endpoint domain: Mortality/survival
Primary endpoint: Salivary Raman fingerprint
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Muscle Weakness Assessment by Neuropathy Impairment Score (NIS) Subscale Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Walking Capacity Assessment by Polyneuropathy Disability (PND) Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Muscle Strength Assessment by Medical Research Council (MRC) Scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Levels of ctDNA
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Levels of tumor tissue biomarkers
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Levels of blood biomarkers
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: 5 year invasive disease free survival (iDFS)
Endpoint domain: Mortality/survival
Primary endpoint: Frequency of severe oral mucositis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time to severe oral mucositis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Visible Plaque Index
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: aMMP-8 chaiside test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time difference in reporting of genotyping results
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Diagnostic performance of Ultrasound and MRI
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Non-Alcoholic Fatty Liver Disease (NAFLD) activity score (NAS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of participants providing serum samples
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Inventory of physiotherapeutic care
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Extraction of extravesicular particles and RNA from urine fluids
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Vertebral fractures
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Coronary artery plaque burden
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Median nerve changes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Estimation of FEV1
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Estimation of FVC
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Identification of airway changes associated disease exacerbations
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Worst clinical outcome at 12 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clinical Remission of Diarrhea
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Helicobacter pylori Stool Antigen Test
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Global impression of change after treatment
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change in the number of visits to the Emergency Room (ER) due to pain
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Change in Fall Risk Self-Assessment
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change in Functional Status Questionnaire - Basic Activities of Daily Living (ADL)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Reduced pain impact
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: Assessment of Normal Joint Motion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Assessment of cervical proprioception
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Change from baseline in sperm motility at 12 weeks
Endpoint domain: Physiological/clinical
Endpoint subdomain: Reproductive system and breast outcomes
Primary endpoint: Change from baseline in sperm count at 12 weeks
Endpoint domain: Physiological/clinical
Endpoint subdomain: Reproductive system and breast outcomes
Primary endpoint: Change in fat mass regain after initial weight loss
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in ghrelin
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Change in gastric inhibitory polypeptide
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Severity and numbers of treatment-emergent AEs
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Heart Rate from onset of Brexanolone administration until discharge
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in Blood Pressure from onset of Brexanolone administration until discharge
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in Cortisol from onset of Brexanolone administration until discharge
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Change in percentage of milliliters of alcohol consumed during the 2-hour ad-libitum drinking paradigm
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Potency of antihypertensive medication
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Number of participants of any Adverse Events (AEs)/Serious Adverse Events (SAEs) related investigational product
Endpoint domain: Adverse events/effects
Primary endpoint: Determination of Dose-limiting toxicity (DLT) levels of EN001
Endpoint domain: Adverse events/effects
Primary endpoint: Determination of Maximum tolerated dose (MTD) levels of EN001
Endpoint domain: Adverse events/effects
Primary endpoint: Affinity Technology Interaction Scale
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Shunt ratio
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes