TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Dactylitis Severity Score (DSS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change From Baseline in Prebronchodilator Percent-Predicted Forced Expiratory Volume in 1 Second
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Number of Severe Asthma Exacerbations Per Patient
Endpoint domain: Adverse events/effects
Primary endpoint: Incidence of SBP
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Severity Adverse Event (SAE)
Endpoint domain: Adverse events/effects
Primary endpoint: score for MET
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: standard functional evaluation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Length of delivery tear
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Change in economic status
Endpoint domain: Resource use
Endpoint subdomain: Societal/carer burden
Primary endpoint: Change in food security
Endpoint domain: Life impact
Endpoint subdomain: Personal circumstances
Primary endpoint: Change in HIV vulnerability
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: prevalence of Escherichia Coli B2 group producing colibactin
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Detection of target lesions
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Histology following VelaShape treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Histology following Contour I V3 treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Plasma 25-hydroxyvitamin D concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Plasma PK of [14C] tazemetostat and its metabolite EPZ-6930
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Total recovery and relative excretion of radioactivity in urine and feces
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Whole brain Binding Potential (BP) of 18F-DPA-714
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: ion channel expression
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Forced Expiratory Volume In One Second
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Non-TVF (Target-vessel failure) rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Visualization of muscular architecture of pelvic sphincters
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Levodopa Area Under the Concentration-time Curve (AUC0-24)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate of UTIs
Endpoint domain: Adverse events/effects
Primary endpoint: Sustained Virologic Response 12 Weeks (SVR 12)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Adverse Events Resulting in Discontinuation
Endpoint domain: Adverse events/effects
Primary endpoint: Incidence of symptomatic Patent ductus arteriosus
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Immunogenicity of Inactivated, Split-Virion Influenza vaccine
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Tumor Texture
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Time to first hospitalization for heart failure
Endpoint domain: Mortality/survival
Primary endpoint: Time until ready for discharge
Endpoint domain: Resource use
Endpoint subdomain: Hospital
Primary endpoint: Satisfactory scores
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change in Disease Activity Score (DAS-28)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Reduction in Respiratory Abnormality
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Acute Infection rate
Endpoint domain: Adverse events/effects
Primary endpoint: Clinical and Mycological Therapeutic Response
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Reduction in amount of analgesia
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Days Free of Delirium or Coma
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Proportions of responders of postvoid residual urine (PVR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Sustained virological response after treatment (SVR12)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Awakening Salivary Cortisol level (ug/dL)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: ED50 doses for intranasal dexmedetomidine
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: ED95 doses for intranasal dexmedetomidine
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Score of physical movement
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Proportion of Subjects Achieving Target Ulcer Closure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Average Adjusted Symptom Score
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change in levels of 8-F2 isoprostanes
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in levels of 3-nitrotyrosine (3-NT)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in levels of 8-hydroxy-2'-deoxyguanosine (8-OHdG)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in levels of urate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in levels of matrix metalloproteinase-9 (MMP-9)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Peri-implant bone resorption
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Bacterial Vaginosis (BV) Incidence by Modified Amsel Criteria
Endpoint domain: Adverse events/effects
Primary endpoint: Bacterial Vaginosis (BV) Incidence by Nugent Scoring (Nugent 7-10)
Endpoint domain: Adverse events/effects
Primary endpoint: Trichomonas Vaginalis (TV) Incidence by Culture
Endpoint domain: Adverse events/effects
Primary endpoint: Vaginal Candidiasis Incidence by Wet Mount Microscopy
Endpoint domain: Adverse events/effects
Primary endpoint: Incidence of complications of ERCP
Endpoint domain: Adverse events/effects
Primary endpoint: Proportion of subjects with PASI75
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Motor learning behavioral measures
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Executive function behavioral measures
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Area under the plasma versus concentration time curve (AUC)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area of flare evoked by cutaneous electrical stimulation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Conversion to open
Endpoint domain: Adverse events/effects
Primary endpoint: Re-admissions
Endpoint domain: Resource use
Endpoint subdomain: Hospital
Primary endpoint: Re-operations
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Percentage of patients with complete cytoreduction
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Clinical Global Impression-Change (CGI-C)
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Daily Average Blood Glucose (Avg. BG)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Iron Status
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: composite response rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean recovery time for T4/T1 ratio > 90%
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Progression-Free Survival (PFS) in all participants
Endpoint domain: Mortality/survival
Primary endpoint: Progression-Free Survival (PFS) in participants with high folate receptor alpha level
Endpoint domain: Mortality/survival
Primary endpoint: Proportion of patients with a documented treatment plan concordant with NCCN guidelines
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of patients whose delivered treatment in induction and post-induction phase chemotherapy is consistent with NCCN guidelines
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: frequency of alcohol and drug use
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: number of women with persistent hypertension
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Consensus agreement
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Hip migration Percentage
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: sitting diastolic blood pressure reduction
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Number of Patients Who Experience Dose Limiting Toxicities by Dose Level
Endpoint domain: Adverse events/effects
Primary endpoint: Non-operative time
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: safety as measured by adverse experiences
Endpoint domain: Adverse events/effects
Primary endpoint: laboratory safety test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Serum CsA (C0) level
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Patients With Laboratory Test Values of Potential Clinical Importance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Growth Parameters Z-scores
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Condylar volume
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Primary success rate of intubation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Change in Level of Cognition
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Efficacy of perampanel
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neurological outcomes
Primary endpoint: Incidence of adverse events until day 28
Endpoint domain: Adverse events/effects
Primary endpoint: Clinical Status (7-point Ordinal Scale) assessed at Day 28
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Average Fatigue Severity Scale (FSS) Score
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: blood concentration of MTX
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Diagnosis delay
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: OQ-45
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: HSCL-11
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Electromyography Amplitude
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Electromyography Latency
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Standard deviation of the mean glucose levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Mean absolute glucose
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: incidence of wound dehiscence
Endpoint domain: Adverse events/effects
Primary endpoint: Rutgeerts score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Functional Outcome measured by NIHSS
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Bitter taste thresholds
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Taste intensity and hedonic ratings of vegetables
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of patients allocated to the Evaluation Pathway
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: Incidence of delayed graft function
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Serum levels of posaconazole
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: SUVmax
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: TBRmax
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: SUVmean
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Percentage of Patients With Modified Complete TMA Response
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Sedative response
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: plasma vasopressin level
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: V2 receptor mRNA in the endolymphatic sac
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Reduction in OSA Severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Long-term Reduction in OSA Severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in plasma human growth hormone (hGH) levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Neuropathy Incidence Rate
Endpoint domain: Adverse events/effects
Primary endpoint: Bone apposition and fixation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Clinical outcomes of NTMPD patients
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Allograft rejection status
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of M7583
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of M7583
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Observed Drug Concentration (Cmax) of M7583
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Oculomotor profiles concordance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Preoperative Hemoglobin Level
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Performance of intra and extra oral inspection of the oral mucosa
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Overall Hemagglutinin Inhibition (HAI) H1N1 Titer
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Overall Hemagglutinin Inhibition (HAI) H3N2 Titer
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Overall Hemagglutinin Inhibition (HAI) B Titer
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Overall HAI H1N1 Seroconversion Rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Overall HAI H3N2 Seroconversion Rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Toxicities graded using the NCI Common Toxicity Criteria
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants With Dose Limiting Toxicities (DLTs) in Part A1
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Part A
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants With Laboratory Test Abnormalities in Part A
Endpoint domain: Adverse events/effects
Primary endpoint: Mean maximum observed drug concentration (Cmax) in blood
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean time to reach the maximum concentration (tmax) in blood
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean total clearance (CL) from blood
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes of maximal inspiratory pressure (MIP)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Changes of maximal expiratory pressure (MEP)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Changes of forced expiratory volume in one second (FEV1)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Changes of forced vital capacity (FVC)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Changes of diaphragmatic surface electromyography (EMGdi)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Compliance to osteoporosis drug therapy
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Persistence to osteoporosis drug therapy
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Number of patients with Overt bleeding
Endpoint domain: Adverse events/effects
Primary endpoint: Self-care agency and self-care behaviors
Endpoint domain: Life impact
Endpoint subdomain: Personal circumstances
Primary endpoint: Expression Levels of p-S6 Based Immunohistochemistry (Histoscore)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Expression Levels of p-ERK Based Immunohistochemistry (Histoscore)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Expression Levels of p-AKT Based Immunohistochemistry (Histoscore)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pre-Operative Everolimus Blood Levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Post-Operative Everolimus Blood Levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of ulcers achieving 100% epithelialization
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Feasibility to collect CD34+ peripheral blood cell stem cells
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: diminution of nocturnal interictal discharges and tonic seizures
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Area Under the Plasma Concentration-Time Curve of HSG4112
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Plasma Concentration of HSG4112
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Half-Life of HSG4112
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area under the concentration - time curve (AUC)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Safety and tolerability measured by side effects
Endpoint domain: Adverse events/effects
Primary endpoint: peak ALT and AST levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pain during stent indwell period
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: CD4+ T cell responses in the blood
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Rate of hematological response lasting 4 weeks
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Change in YGTSS-TTS
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Improved maternal and child health behaviors
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change in echocardiographic parameters
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Number of Ventricular Tachycardia Episodes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Measure bioactive compounds in human milk
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Quantify the infant intestinal gene expression profile in stool
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Measure the infant intestinal gene expression profile in stool
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Response at Week 4 of Treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from Baseline in Child Vocal Responsivity
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change from Baseline in Child Vocal Initiations
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change from Baseline in Parent-Child Shared Smiling
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing