TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Frequency of positive test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean Post-operative hemoglobin
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Change in MRI-PDFF from Baseline to Week 24
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in MRI-PDFF from Baseline to Week 12
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Number of Subjects With at Least 30 Days of Daily Impedance Measurements
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: levels of Anandamide
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Levels of Brain Derived Neurotrophic Factor (BDNF)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Arterial Pressure Waveforms
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Overall Response Rate (PR or Better)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Spielberger State Anxiety Inventory (S-STAI)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Accuracy of ForeseeHome to detect reactivation of CNV
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Characterization of particles in exhaled breath
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Recurrent pericardial effusion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Need for repeated pericardiocentesis
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Change From Baseline in Initial Walking Distance
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Absolute Walking Distance Measured by Treadmill
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Accuracy of diagnostic model
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Wound area
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Wound perimeter
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum concentration (Cmax) for ethinylestradiol/gestodene in plasma
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area under the plasma/serum/blood concentration (AUC0-t) time curve for ethinylestradiol/gestodene
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Predictive ability of biomarkers for chemotherapy activity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from baseline BMI at 8 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Changes in Intraocular Pressure (IOP)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Ocular outcomes
Primary endpoint: swelling of hip joint
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: skin allergic reaction
Endpoint domain: Adverse events/effects
Primary endpoint: Respiratory reaction
Endpoint domain: Adverse events/effects
Primary endpoint: lower extremity kinetics during walking
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: talar cartilage deformation before and after walking
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Objective nasal hyperreactivity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Clinical Events
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cardiac Images
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: number of cumulus-oocyte-complexes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Reproductive system and breast outcomes
Primary endpoint: clearance of sunitinib at steady state
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Immediate Toxicity
Endpoint domain: Adverse events/effects
Primary endpoint: postprandial incremental glucose AUC
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change Lewis Score Index
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Change in Intestinal Inflammation Measured by Faecal Calprotectin
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: mean duration of diarrhea
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Mean Cecal Intubation Time
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Piper Fatigue Scale
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: Change in the score of The Wolf Motor Function Test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in the score of The Action Research Arm Test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in the Modified Ashworth Scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: perfusion of cuff muscle
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Objective/subjective symptoms improvements
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: absolute bioavailability of bexagliflozin tablets
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Total bleeding rate during ESD procedure
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Vocal cord visualisation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Renal dysfunction measured by serum creatinine
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Change from baseline in NIH Stroke Scale (NIHSS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Donor T-cell chimerism at 1-year post transplant
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean Absolute Relative Difference (MARD) for Paired CGM and Reference Glucose Measurements
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence of Device-related or Sensor Insertion/Removal Procedure-related Serious Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Change in air quality
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Latency of covert-saccades
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Percent Change in Normalized Total Atheroma Volume
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: One-year Event Free Survival (EFS)
Endpoint domain: Mortality/survival
Primary endpoint: Frequency of Primary Symptoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of patients approached who consent to participate
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Measure of Acceptability using semi-structured interviews
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change in PAR-ENT-QoL questionnaire score
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Number of newborns with Congenital malformations
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Relative change in cardiac uptake of 18F florbetapir
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change in HDL-C and LDL-C
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: percent stent strut coverage
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in metabolic syndrome
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Severe radiographical damage
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Swiss Spinal Stenosis (SSS) Questionnaire Score
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Complete epithelialization of the wound
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: observed levels of pain
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: safety and local tolerability of FSH-GEX™
Endpoint domain: Adverse events/effects
Primary endpoint: FSH pharmacokinetic parameters of FSH-GEX™
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in Colonic Transit Time (CTT)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Patient reported symptom or documented post-operative infection
Endpoint domain: Adverse events/effects
Primary endpoint: 2 year event-free survival
Endpoint domain: Mortality/survival
Primary endpoint: Blood Pressure Change From Baseline
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Morphine consumption rates
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Sensitivity of Fall Detection
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUC(0-inf)] of Crizotinib
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum Plasma Concentration (Cmax) of Crizotinib
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Terminal Elimination Half-life (t1/2) of Crizotinib
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Hamilton Depression Rating Scale change from baseline
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Pain Empathy Rating Scores
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Rest energetic cost
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Laboratory test values grading
Endpoint domain: Adverse events/effects
Primary endpoint: AUC0-inf - Area Under Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AUC0-t - Area Under Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Occurrence of SAEs and AEs related to ESMYA
Endpoint domain: Adverse events/effects
Primary endpoint: Response to radiation at one year
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Change in motor evoked potentials (MEPs)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Percent change in bone quality
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Tinnitus Severity Index
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Positive and negative predicted value
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Concentration of Anti-Protein D Antibodies
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Concentration of Anti-Pneumococcal Antibodies
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: ASIA Motor Recovery
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neurological outcomes
Primary endpoint: Maximum serum concentration (C max) of PF-06946151 SDV
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximum serum concentration (C max) of PF-06946151 MDV
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area under the serum PF-06946151 SDV concentration-time profile (AUC last)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants Using Wheelchair or Being Bedridden
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Serum Phosphorus Levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Metabolic Availability of Tryptophan
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Patient Health Questionnaire-Adolescent (PHQ-8)
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Acute kidney injury after operation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Area under the Insulin Degludec concentration-time curve
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Maximum observed Insulin Degludec concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Morning Peak Expiratory Flow
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Self-report physical and mental health
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Hip disability and Osteoarthritis Outcome Score (HOOS)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference (PI)
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function (PF)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: End-of-life care preferences
Endpoint domain: Life impact
Endpoint subdomain: Personal circumstances
Primary endpoint: Prolongation of gestation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Motor disability
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Neuropsychological evaluation
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Average number of heavy drinking days
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: time of the procedure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: amount of postoperative pain
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: End Expiratory Lung Volumes
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Post-operative hypothermia
Endpoint domain: Adverse events/effects
Primary endpoint: Micronutrient deficiency identification
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Abscopal Response Rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Percentage of Participants With CDI Recurrence
Endpoint domain: Mortality/survival
Primary endpoint: Percentage of Participants With One or More Adverse Events During 4 Weeks Following Infusion Treatment
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of Participants With One or More Serious Drug-related Adverse Events During 4 Weeks Following Infusion Treatment
Endpoint domain: Adverse events/effects
Primary endpoint: Total serum iron
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Reduction in weekly average pain score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Self-perceived dry mouth
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Self-perceived halitosis
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Fitbit mean sleep quantity
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: Fitbit mean sleep efficiency
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: Occurrence of Grade 3 and 4 treatment-related adverse events
Endpoint domain: Adverse events/effects
Primary endpoint: Proportion of eyes with hyporeflective zone
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: changes in pain intensity score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes of muscle strength
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Changes of physical function
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes of body weight
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Innate immune responses
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change From Baseline in Root Canal Bleeding Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Hair growth rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time to ultrasound visualization of agitated saline in the right heart
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Quality of recovery, postoperative day one
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Quality of recovery, postoperative day two
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Percentage of ex-premature infants admitted to PICU
Endpoint domain: Mortality/survival
Primary endpoint: Percentage of ex-premature infants admitted to PICU with critical respiratory diseases
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Number of Participants With Grade 1 or 2 Oral Mucositis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean Number of Days for Mucositis to Heal
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percent change in use of reliable contraceptives
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Safety/tolerability of repeated injection of CAD106
Endpoint domain: Adverse events/effects
Primary endpoint: Change in Child BMI-z score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Modified change in BMI z-score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Neuromuscular Function
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean Percent Changes in BMD at 6 Months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Mean Percent Changes in BMD at 12 Months
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Postoperative Opioid Requirement
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Change in Hamilton Depression Rating Scale (HAM-D) Scores
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Number of Youth Self-Harm Episodes
Endpoint domain: Adverse events/effects
Primary endpoint: Youth Suicidal Ideation
Endpoint domain: Adverse events/effects
Primary endpoint: Changes on Breastfeeding status
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes on maternal breastfeeding self-efficacy
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Hepatic Histological Improvement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: CT Bone Erosion Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Compliance of the combination treatment
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: change in muscle mass
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Time of Maximum observed serum concentration (Tmax)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Sensitivity and specificity for the diagnosis of cervical intraepithelial neoplasia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Changes in arterial stiffness
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Ratio of area under the glucose infusion rate curve (AUCGIR) 0-5 hours to AUCGIR 0-24 hours
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: amelioration of disorders of regulation of states
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: safety and toxicity profile
Endpoint domain: Adverse events/effects
Primary endpoint: t1/2β
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Expression of tumor specific microRNAs (miRs)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Prognosis of HPV-negative HNSCC
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Suicidality as assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)
Endpoint domain: Adverse events/effects
Primary endpoint: Sleep habits as assessed using a participant-recorded sleep diary
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: Retention in Care at 12 Months
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Rate of Fatal Opioid Overdose
Endpoint domain: Mortality/survival
Primary endpoint: Rate of Non-fatal Opioid Overdose
Endpoint domain: Adverse events/effects