xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06036095</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00024667</org_study_id>
      <nct_id>NCT06036095</nct_id>
    </id_info>
    <brief_title>Inhalational Anesthesia vs. Intravenous Anesthesia</brief_title>
    <acronym>GASvsIV</acronym>
    <official_title>Optimizing Anesthesia to Prevent Postoperative Cognitive and Functional Decline in Older Adults: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Oregon Health and Science University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Oregon Health and Science University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Traditionally, general anesthesia is maintained with inhalational anesthesia (GAS), but there&#xD;
        is a gap in knowledge regarding whether intravenous anesthesia (IV) can prevent deleterious&#xD;
        postoperative outcomes in the geriatric surgical population. The goal of this clinical trial&#xD;
        is to determine whether intravenous anesthesia (IV) leads to a decreased incidence of&#xD;
        postoperative delirium (POD), postoperative cognitive dysfunction (POCD), and functional&#xD;
        decline, and improved patient-reported outcomes (PROs) in older adults undergoing non-cardiac&#xD;
        surgery when compared to the standard inhalational anesthesia (GAS). This single-center, 1:1&#xD;
        randomized, double-blind (patient &amp; outcome assessor) clinical trial will compare&#xD;
        inhalational vs. intravenous anesthesia on POD, POCD, functional status, patient-reported&#xD;
        outcomes (PROs), and blood-based biomarkers in older patients undergoing elective, inpatient,&#xD;
        non-cardiac surgery. Upon enrollment, 260 women and men ≥ 75 years undergoing elective&#xD;
        noncardiac surgery under general anesthesia will be randomized to 2 groups: IV or GAS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Aim 1: Determine the effects of intravenous vs. inhalational anesthesia on incidence of&#xD;
        postoperative delirium and postoperative cognitive dysfunction in older adults undergoing&#xD;
        non-cardiac surgery.&#xD;
  &#xD;
        Hypothesis: Intravenous anesthesia is associated with a lower incidence of POD and POCD&#xD;
        compared to inhalational anesthesia.&#xD;
  &#xD;
        Primary outcomes: Incidence of postoperative delirium and postoperative cognitive dysfunction&#xD;
        Secondary outcomes: delirium severity, delirium duration Aim 2: Determine the effects of&#xD;
        intravenous vs. inhalational anesthesia on incidence of postoperative functional decline and&#xD;
        patient-reported outcomes in older adults undergoing non-cardiac surgery.&#xD;
  &#xD;
        Hypothesis: Intravenous anesthesia is associated with a lower incidence of postoperative&#xD;
        functional decline and improved patient-reported outcomes (PROs) compared to inhalational&#xD;
        anesthesia.&#xD;
  &#xD;
        Primary outcomes: Incidence of postoperative functional decline; patient-reported outcome&#xD;
        scores Aim 3: Determine the effects of intravenous vs. inhalational anesthesia on blood&#xD;
        phosphorylated tau 181 (p-tau181) and other blood biomarkers in older adults undergoing&#xD;
        non-cardiac surgery.&#xD;
  &#xD;
        Hypothesis 1: Elevated preop blood p-tau181 is associated with increased POD and POCD;&#xD;
        Hypothesis 2: Postoperative increase in blood p-tau181 is greater with GAS relative to IV;&#xD;
        Hypothesis 3: Postop increases in blood biomarkers of neuroinflammation and AD pathology are&#xD;
        greater with GAS relative to IV.&#xD;
  &#xD;
        Primary outcomes: preoperative levels of blood p-tau181 and change in levels from&#xD;
        preoperative baseline to postoperative.&#xD;
  &#xD;
        Secondary outcomes: Other candidate biomarkers include those previously implicated in POD or&#xD;
        POCD: p-tau217, Aβ,54 NF-L,55 High mobility group box protein 1 (HMGB1),60 S100β,76&#xD;
        interleukin (IL)-6,58 IL-1β,22 IL-10,46 tumor necrosis factor (TNF)-α,22 CCL2,62 and glial&#xD;
        fibrillary acidic protein (GFAP).77&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 14, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2026</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>This single-center, 1:1 randomized, double-blind (patient &amp; outcome assessor) clinical trial will compare inhalational (sevoflurane) vs. intravenous (propofol) anesthesia on POD, POCD, functional status, PROs, and biomarkers in patients ≥ 75 years undergoing elective, inpatient, non-cardiac surgery at Oregon Health &amp; Science University.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Effects of intravenous vs. inhalational anesthesia on incidence of postoperative delirium in older surgical patients with the 3D-Confusion Assessment Method (3D-CAM-S) and the CAM-ICU-7.</measure>
      <time_frame>through postoperative day 3</time_frame>
      <description>Incidence of postoperative delirium with the 3D-Confusion Assessment Method (3D-CAM) in non-intubated patients and the CAM-ICU-7 in intubated patients. Delirium will be assessed postoperative in PACU and twice daily on postoperative days 1-3 while the patient is in the hospital.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Determine the effects of intravenous vs. inhalational anesthesia on the incidence of postoperative neurocognitive disorder in older adults undergoing non-cardiac surgery using neuropsychiatric composite score.</measure>
      <time_frame>Change from preoperative baseline to one year.</time_frame>
      <description>Postoperative neurocognitive disorder. Change from preoperative baseline cognitive dysfunction using neuropsychiatric composite score. Battery of neuropsychological tests: Animal Verbal Fluency Test, Trail Making Test A &amp; B, Digit Symbol Test, Logical Memory Immediate &amp; Delayed Recall, and CERAD Word List Immediate and Delayed recall. MASQ will be used for subjective cognitive decline. Functional status will be measured by FAQ.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Determine the effects of intravenous vs. inhalational anesthesia on incidence of delirium duration (days) and severity, measured by 3D-CAM-S, and CAM-ICU-7 in older adults undergoing non-cardiac surgery.</measure>
      <time_frame>through postoperative day 3</time_frame>
      <description>delirium severity and duration. Delirium will be assessed postoperative in PACU and twice daily on postoperative days 1-3.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effects of intravenous vs. inhalational anesthesia on levels of blood phosphorylated tau 181 (p-tau181) in older surgical patients.. Change from preoperative baseline blood p-tau181 to postoperative day 1, 3 months and 12 months.</measure>
      <time_frame>Change from baseline through one year.</time_frame>
      <description>change in levels of preoperative levels of blood p-tau181 from preoperative baseline to 12 months postoperative</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine the effects of intravenous vs. inhalational anesthesia on incidence of postoperative functional decline using ADL, FAQ, and FRAIL in older adults undergoing non-cardiac surgery.</measure>
      <time_frame>Change from baseline through one year</time_frame>
      <description>Incidence of postoperative functional decline. Change from preoperative baseline postoperative functional decline to postoperative 12 months.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Determine the effects of intravenous vs. inhalational anesthesia on patient-reported outcomes (PROMIS-29+2 Profile v2.1) in older adults undergoing non-cardiac surgery.</measure>
      <time_frame>Change from baseline through one year</time_frame>
      <description>patient-reported outcome scores, PROMIS-29+2 Profile v2.1 (PROPr) assesses patient-reported measures of anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, participation in social activities, pain, and cognition. Measured at preoperative baseline, 3 months postoperatively, and 12 months postoperatively</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">260</enrollment>
    <condition>Neurocognitive Disorders</condition>
    <condition>Anesthesia</condition>
    <condition>Post-operative Delirium</condition>
    <condition>Post-operative Cognitive Dysfunction</condition>
    <arm_group>
      <arm_group_label>Inhalational Anesthesia</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Inhalational maintenance of anesthesia group using sevoflurane</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intravenous Anesthesia</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Intravenous maintenance of anesthesia group using propofol</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sevoflurane</intervention_name>
      <description>Inhalational maintenance of anesthesia group using sevoflurane</description>
      <arm_group_label>Inhalational Anesthesia</arm_group_label>
      <other_name>Inhalational Anesthesia</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Propofol</intervention_name>
      <description>Intravenous maintenance of anesthesia group using propofol</description>
      <arm_group_label>Intravenous Anesthesia</arm_group_label>
      <other_name>Intravenous Anesthesia</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Men and women ≥ 75 years&#xD;
  &#xD;
            -  Sufficient vision and hearing to complete all tests&#xD;
  &#xD;
            -  Proficient in spoken and written English&#xD;
  &#xD;
            -  Scheduled for elective, inpatient, noncardiac surgery, expected to last at least 120&#xD;
               minutes requiring general anesthesia&#xD;
  &#xD;
            -  Informant available with frequent (at least 1 hour/day or 1 day/week) contact with the&#xD;
               subject to verify CDR rating.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Urgent or emergent surgery&#xD;
  &#xD;
            -  Diagnosed dementia (or MoCA&lt;19)&#xD;
  &#xD;
            -  History of stroke, Parkinson's disease, major psychiatric disease (Schizophrenia), or&#xD;
               severe traumatic brain injury&#xD;
  &#xD;
            -  Ongoing alcohol or substance abuse (per DSM V criteria)&#xD;
  &#xD;
            -  Allergy to propofol or sevoflurane&#xD;
  &#xD;
            -  Personal or family history of malignant hyperthermia&#xD;
  &#xD;
            -  Planned postoperative intubation&#xD;
  &#xD;
            -  Brain surgery&#xD;
  &#xD;
            -  Surgery requiring TIVA or GAS (i.e. cases involving neuromonitoring)&#xD;
  &#xD;
            -  Surgical procedure requiring general, regional, or neuraxial anesthetic occurring&#xD;
               within 3 months (before or after) surgical date&#xD;
  &#xD;
            -  Any patient or perioperative factor considered a contraindication to randomization to&#xD;
               either experimental group by the surgeon or anesthesiologist.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>75 Years</minimum_age>
      <maximum_age>105 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Katie J. Schenning, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Oregon Health and Science University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kimberly N. Chun, BS</last_name>
      <phone>503-494-7437</phone>
      <email>chunk@ohsu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sarah L. Feller, BS</last_name>
      <phone>503-494-6233</phone>
      <email>fellersa@ohsu.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Oregon Health &amp; Science University</name>
        <address>
          <city>Portland</city>
          <state>Oregon</state>
          <zip>97239</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sarah Feller, BS</last_name>
        <email>fellersa@ohsu.edu</email>
      </contact>
      <contact_backup>
        <last_name>Kimberly Chun, BS</last_name>
        <email>chunk@ohsu.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Katie Schenning, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 18, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
      <investigator_full_name>Katie J. Schenning</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Emergence Delirium</mesh_term>
      <mesh_term>Postoperative Cognitive Complications</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
      <mesh_term>Neurocognitive Disorders</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anesthetics</mesh_term>
      <mesh_term>Propofol</mesh_term>
      <mesh_term>Sevoflurane</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>In order to promote advancement of this field of study, we will make data generated from this project available. Participants will sign a data repository consent form so de-identified data is able to be maintained indefinitely on secure servers at Oregon Health &amp; Science University. This will enable us to combine these data with other datasets for future analyses, and to share with collaborators and other interested scientists. Other researchers would sign a data use agreement and then receive the de-identified data requested.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06036095
  org study id: STUDY00024667
  nct id: NCT06036095
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  Traditionally, general anesthesia is maintained with inhalational anesthesia (GAS), but there
        is a gap in knowledge regarding whether intravenous anesthesia (IV) can prevent deleterious
        postoperative outcomes in the geriatric surgical population. The goal of this clinical trial
        is to determine whether intravenous anesthesia (IV) leads to a decreased incidence of
        postoperative delirium (POD), postoperative cognitive dysfunction (POCD), and functional
        decline, and improved patient-reported outcomes (PROs) in older adults undergoing non-cardiac
        surgery when compared to the standard inhalational anesthesia (GAS). This single-center, 1:1
        randomized, double-blind (patient & outcome assessor) clinical trial will compare
        inhalational vs. intravenous anesthesia on POD, POCD, functional status, patient-reported
        outcomes (PROs), and blood-based biomarkers in older patients undergoing elective, inpatient,
        non-cardiac surgery. Upon enrollment, 260 women and men ≥ 75 years undergoing elective
        noncardiac surgery under general anesthesia will be randomized to 2 groups: IV or GAS.
  Aim 1: Determine the effects of intravenous vs. inhalational anesthesia on incidence of
        postoperative delirium and postoperative cognitive dysfunction in older adults undergoing
        non-cardiac surgery.
  
        Hypothesis: Intravenous anesthesia is associated with a lower incidence of POD and POCD
        compared to inhalational anesthesia.
  
        Primary outcomes: Incidence of postoperative delirium and postoperative cognitive dysfunction
        Secondary outcomes: delirium severity, delirium duration Aim 2: Determine the effects of
        intravenous vs. inhalational anesthesia on incidence of postoperative functional decline and
        patient-reported outcomes in older adults undergoing non-cardiac surgery.
  
        Hypothesis: Intravenous anesthesia is associated with a lower incidence of postoperative
        functional decline and improved patient-reported outcomes (PROs) compared to inhalational
        anesthesia.
  
        Primary outcomes: Incidence of postoperative functional decline; patient-reported outcome
        scores Aim 3: Determine the effects of intravenous vs. inhalational anesthesia on blood
        phosphorylated tau 181 (p-tau181) and other blood biomarkers in older adults undergoing
        non-cardiac surgery.
  
        Hypothesis 1: Elevated preop blood p-tau181 is associated with increased POD and POCD;
        Hypothesis 2: Postoperative increase in blood p-tau181 is greater with GAS relative to IV;
        Hypothesis 3: Postop increases in blood biomarkers of neuroinflammation and AD pathology are
        greater with GAS relative to IV.
  
        Primary outcomes: preoperative levels of blood p-tau181 and change in levels from
        preoperative baseline to postoperative.
  
        Secondary outcomes: Other candidate biomarkers include those previously implicated in POD or
        POCD: p-tau217, Aβ,54 NF-L,55 High mobility group box protein 1 (HMGB1),60 S100β,76
        interleukin (IL)-6,58 IL-1β,22 IL-10,46 tumor necrosis factor (TNF)-α,22 CCL2,62 and glial
        fibrillary acidic protein (GFAP).77
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This single-center, 1:1 randomized, double-blind (patient & outcome assessor) clinical trial will compare inhalational (sevoflurane) vs. intravenous (propofol) anesthesia on POD, POCD, functional status, PROs, and biomarkers in patients ≥ 75 years undergoing elective, inpatient, non-cardiac surgery at Oregon Health & Science University.
  primary purpose: Prevention
  masking: Double (Participant, Outcomes Assessor)
  measure: Effects of intravenous vs. inhalational anesthesia on incidence of postoperative delirium in older surgical patients with the 3D-Confusion Assessment Method (3D-CAM-S) and the CAM-ICU-7.
  time frame: through postoperative day 3
  description: Incidence of postoperative delirium with the 3D-Confusion Assessment Method (3D-CAM) in non-intubated patients and the CAM-ICU-7 in intubated patients. Delirium will be assessed postoperative in PACU and twice daily on postoperative days 1-3 while the patient is in the hospital.
  measure: Determine the effects of intravenous vs. inhalational anesthesia on the incidence of postoperative neurocognitive disorder in older adults undergoing non-cardiac surgery using neuropsychiatric composite score.
  time frame: Change from preoperative baseline to one year.
  description: Postoperative neurocognitive disorder. Change from preoperative baseline cognitive dysfunction using neuropsychiatric composite score. Battery of neuropsychological tests: Animal Verbal Fluency Test, Trail Making Test A & B, Digit Symbol Test, Logical Memory Immediate & Delayed Recall, and CERAD Word List Immediate and Delayed recall. MASQ will be used for subjective cognitive decline. Functional status will be measured by FAQ.
  measure: Determine the effects of intravenous vs. inhalational anesthesia on incidence of delirium duration (days) and severity, measured by 3D-CAM-S, and CAM-ICU-7 in older adults undergoing non-cardiac surgery.
  time frame: through postoperative day 3
  description: delirium severity and duration. Delirium will be assessed postoperative in PACU and twice daily on postoperative days 1-3.
  measure: Effects of intravenous vs. inhalational anesthesia on levels of blood phosphorylated tau 181 (p-tau181) in older surgical patients.. Change from preoperative baseline blood p-tau181 to postoperative day 1, 3 months and 12 months.
  time frame: Change from baseline through one year.
  description: change in levels of preoperative levels of blood p-tau181 from preoperative baseline to 12 months postoperative
  measure: Determine the effects of intravenous vs. inhalational anesthesia on incidence of postoperative functional decline using ADL, FAQ, and FRAIL in older adults undergoing non-cardiac surgery.
  time frame: Change from baseline through one year
  description: Incidence of postoperative functional decline. Change from preoperative baseline postoperative functional decline to postoperative 12 months.
  measure: Determine the effects of intravenous vs. inhalational anesthesia on patient-reported outcomes (PROMIS-29+2 Profile v2.1) in older adults undergoing non-cardiac surgery.
  time frame: Change from baseline through one year
  description: patient-reported outcome scores, PROMIS-29+2 Profile v2.1 (PROPr) assesses patient-reported measures of anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, participation in social activities, pain, and cognition. Measured at preoperative baseline, 3 months postoperatively, and 12 months postoperatively
  arm group label: Inhalational Anesthesia
  arm group type: Active Comparator
  description: Inhalational maintenance of anesthesia group using sevoflurane
  arm group label: Intravenous Anesthesia
  arm group type: Active Comparator
  description: Intravenous maintenance of anesthesia group using propofol
  intervention type: Drug
  intervention name: Sevoflurane
  description: Inhalational maintenance of anesthesia group using sevoflurane
  arm group label: Inhalational Anesthesia
  other name: Inhalational Anesthesia
  intervention type: Drug
  intervention name: Propofol
  description: Intravenous maintenance of anesthesia group using propofol
  arm group label: Intravenous Anesthesia
  other name: Intravenous Anesthesia
  criteria: 
  gender: All
  minimum age: 75 Years
  maximum age: 105 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Katie J. Schenning, MD
  role: Principal Investigator
  affiliation: Oregon Health and Science University
  last name: Kimberly N. Chun, BS
  phone: 503-494-7437
  email: chunk@ohsu.edu
  last name: Sarah L. Feller, BS
  phone: 503-494-6233
  email: fellersa@ohsu.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Oregon Health and Science University
  investigator full name: Katie J. Schenning
  investigator title: Associate Professor
  mesh term: Emergence Delirium
  mesh term: Postoperative Cognitive Complications
  mesh term: Cognitive Dysfunction
  mesh term: Neurocognitive Disorders
  mesh term: Anesthetics
  mesh term: Propofol
  mesh term: Sevoflurane
  sharing ipd: Yes
  ipd description: In order to promote advancement of this field of study, we will make data generated from this project available. Participants will sign a data repository consent form so de-identified data is able to be maintained indefinitely on secure servers at Oregon Health & Science University. This will enable us to combine these data with other datasets for future analyses, and to share with collaborators and other interested scientists. Other researchers would sign a data use agreement and then receive the de-identified data requested.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code