chemNLP/clinical-trials-v2 · Datasets at Hugging Face

NCT0426xxxx/NCT04269031.xml

<clinical_study>  <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/NCT04269031</url> </required_header> <id_info> <org_study_id>D6800C00001</org_study_id> <nct_id>NCT04269031</nct_id> </id_info> <brief_title>A First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD2373 After Single Dose Administration in Healthy Male Subjects of African Ancestry.</brief_title> <official_title>A Phase I, First-in-Human, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2373 Following Single Ascending Dose Administrations to Healthy Male Subjects of African Ancestry</official_title> <sponsors> <lead_sponsor> <agency>AstraZeneca</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>Parexel</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>AstraZeneca</source> <oversight_info> <has_dmc>Yes</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> This is a Phase 1 study to assess the the safety, tolerability and pharmacokinetics (PK) of AZD2373, following subcutaneous (SC) administration of single ascending doses (SAD) of AZD2373 in healthy male subjects of African ancestry. </textblock> </brief_summary> <detailed_description> <textblock> This study will be conducted as a single-centre, randomised, placebo-controlled, single-blind study to assess the effect of AZD2373 following ascending dose sequential group design administrations to healthy male subjects of African ancestry. The study will include 6 single dose cohorts with the option to include 2 additional cohorts based on emerging data from preceding cohorts in the study.  Approximately 48 male subjects aged 18 to 55 years at the time of informed consent (inclusive) will be randomized with the aim to have 8 subjects participate in each cohort. Within each cohort, 6 subjects will receive AZD2373 and 2 subjects will receive placebo.  Sentinel dosing will be applied for each cohort and will be divided into 2 groups:  - Group 1 (sentinel group): 1 active, 1 placebo;  - Group 2 (the rest of the cohort): 5 active, 1 placebo. The safety data of up to 72 hours post-dose in Group 1 will be reviewed by the Principal Investigator (PI) before the subjects in Group 2 are dosed.  The study will comprise:  - A Screening Period of maximum 35 days;  - A Treatment Period during which subjects will be resident at the Clinical Unit from the day before investigational medicinal product (IMP) administration (Day -1) until at least 72 hours after IMP administration; discharged from the Clinical Unit on Day 4;  - Follow-up Visits on 1, 1.5, 2, 3, 4, 5, 6, and 8 weeks (Visits 3 to 10); and  - A Final Follow up Visit 10 weeks after the last IMP dose.  The visit occurring at 5 weeks post dose (Visit 5) is optional. The expected duration for any subject participating in the study is approximately 10 weeks (excluding an up to 28-day Screening Period). </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">February 13, 2020</start_date> <completion_date type="Actual">August 31, 2021</completion_date> <primary_completion_date type="Actual">August 31, 2021</primary_completion_date> <phase>Phase 1</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Sequential Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Investigator)</masking> <masking_description>This study is single-blind (in which the study center staff remain blinded during the clinical conduct of a given cohort) with regard to treatment (AZD2373 or placebo) at each dose level. Study subjects will be blinded to treatment allocation throughout the study.</masking_description> </study_design_info> <primary_outcome> <measure>Number of subjects with adverse events and/or abnormal findings in vital signs, and/or clinical laboratory assessments and/or physical examination and/or electrocardiogram (ECG) evaluation and/or telemetry and/or injection site reactions</measure> <time_frame>Screening Visit to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To assess adverse events as a variable of safety and tolerability of subcutaneous (SC) single ascending dose (SAD) administrations of AZD2373</description> </primary_outcome> <secondary_outcome> <measure>Area under plasma concentration-time curve from time zero extrapolated to infinity (AUC)</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.</description> </secondary_outcome> <secondary_outcome> <measure>Area under the plasma concentration curve from time zero to the time of last quantifiable analyte concentration (AUClast)</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.</description> </secondary_outcome> <secondary_outcome> <measure>Area under the plasma concentration-time curve from time zero to 72 hours after dosing [AUC(0-72)]</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.</description> </secondary_outcome> <secondary_outcome> <measure>Area under the plasma concentration-time curve from time zero to 48 hours after dosing [AUC (0-48)]</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.</description> </secondary_outcome> <secondary_outcome> <measure>Observed maximum plasma concentration (Cmax)</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.</description> </secondary_outcome> <secondary_outcome> <measure>Time to reach peak or maximum observed concentration or response following drug administration (tmax)</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.</description> </secondary_outcome> <secondary_outcome> <measure>Half-life associated with terminal slope (λz) of a semi logarithmic concentration-time curve (t½λz)</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.</description> </secondary_outcome> <secondary_outcome> <measure>Apparent total body clearance of drug from plasma after extravascular administration [CL/F]</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.</description> </secondary_outcome> <secondary_outcome> <measure>Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.</description> </secondary_outcome> <secondary_outcome> <measure>Mean residence time of the unchanged drug in the systemic circulation (MRT)</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.</description> </secondary_outcome> <secondary_outcome> <measure>Terminal elimination rate constant (λz)</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.</description> </secondary_outcome> <secondary_outcome> <measure>Time of the last quantifiable concentration [tlast Ae(0-last)]</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.</description> </secondary_outcome> <secondary_outcome> <measure>Cumulative fraction (%) of dose excreted unchanged into the urine from time zero to the last measured time point [fe(0-last)]</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.</description> </secondary_outcome> <secondary_outcome> <measure>Amount of analyte excreted into the urine from time t1 to t2 [Ae(t1-t2)]</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.</description> </secondary_outcome> <secondary_outcome> <measure>Fraction of dose excreted unchanged into the urine from time t1 to t2 [fe(t1-t2)]</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.</description> </secondary_outcome> <secondary_outcome> <measure>Renal clearance of drug from plasma, estimated by dividing Ae(0-t) by AUC(0-t) where the 0-t interval is the same for both Ae and AUC (CLR)</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.</description> </secondary_outcome> <secondary_outcome> <measure>Apolipoprotein L1 (APOL1) concentrations and change from baseline</measure> <time_frame>Visit 2 to final Follow-up Visit (Week 10 post last dose)</time_frame> <description>To assess the effect of SC SAD administrations of AZD2373 on plasma concentrations of APOL1 protein</description> </secondary_outcome> <number_of_arms>6</number_of_arms> <enrollment type="Actual">30</enrollment> <condition>Healthy Volunteers</condition> <arm_group> <arm_group_label>Cohort 1</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>On Day 1, randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 1 (6 subjects) or matching placebo (2 subjects).</description> </arm_group> <arm_group> <arm_group_label>Cohort 2</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>On Day 1, randomized subjects will receive a SC injection of AZD2373 dose 2 (6 subjects) or matching placebo (2 subjects).</description> </arm_group> <arm_group> <arm_group_label>Cohort 3</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>On Day 1, randomized subjects will receive a SC injection of AZD2373 dose 3 (6 subjects) or matching placebo (2 subjects).</description> </arm_group> <arm_group> <arm_group_label>Cohort 4</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>On Day 1, randomized subjects will receive a SC injection of AZD2373 dose 4 (6 subjects) or matching placebo (2 subjects).</description> </arm_group> <arm_group> <arm_group_label>Cohort 5</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>On Day 1, randomized subjects will receive a SC injection of AZD2373 dose 5 (6 subjects) or matching placebo (2 subjects).</description> </arm_group> <arm_group> <arm_group_label>Cohort 6</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>On Day 1, randomized subjects will receive a SC injection of AZD2373 dose 6 (6 subjects) or matching placebo (2 subjects).</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>AZD2373 subcutaneous injection</intervention_name> <description>Randomised subjects will receive a single ascending dose of AZD2373 by SC injection (dose 1, dose 2, dose 3, dose 4, dose 5 and dose 6).</description> <arm_group_label>Cohort 1</arm_group_label> <arm_group_label>Cohort 2</arm_group_label> <arm_group_label>Cohort 3</arm_group_label> <arm_group_label>Cohort 4</arm_group_label> <arm_group_label>Cohort 5</arm_group_label> <arm_group_label>Cohort 6</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Placebo</intervention_name> <description>Randomised subjects will receive a single ascending dose of placebo (saline solution) by SC injection.</description> <arm_group_label>Cohort 1</arm_group_label> <arm_group_label>Cohort 2</arm_group_label> <arm_group_label>Cohort 3</arm_group_label> <arm_group_label>Cohort 4</arm_group_label> <arm_group_label>Cohort 5</arm_group_label> <arm_group_label>Cohort 6</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Provision of signed and dated, written informed consent prior to any study specific procedures.  - Healthy male subjects of West African ancestry aged 18 to 55 years (inclusive, at time of informed consent) with suitable veins for cannulation or repeated venipuncture.  - Have a body mass index (BMI) between 18 and 35 kg/m^2 (inclusive) and weigh at least 50 kg and no more than 120 kg (inclusive).  - Provision of signed, written and dated informed consent for study participation which includes mandatory genotyping (study objective). NOTE: If a subject would decline to participate in the mandatory genotyping component of the study, the subject will not be included in the study.  Exclusion Criteria:  - Subjects with known ancestry outside of West Africa.  - History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.  - History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.  - Any clinically important illness, medical/surgical procedure or trauma within 4 weeks prior to administration of IMP on Study Day 1.  - Any laboratory values with the following deviations:  1. Alanine aminotransferase or aspartate aminotransferase greater than upper limit of normal and clinically significant as determined by the PI.  2. White blood cell (WBC) count < 3.0 x 10^9/L.  3. Hemoglobin (Hb) below lower limit normal .  - Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results, other than those described above, as judged by the PI. </textblock> </criteria> <gender>Male</gender> <gender_based>Yes</gender_based> <gender_description>Male 18-55 years</gender_description> <minimum_age>18 Years</minimum_age> <maximum_age>55 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Ronald Goldwater, Dr.</last_name> <role>Principal Investigator</role> <affiliation>PAREXEL Early Phase Clinical Unit Baltimore</affiliation> </overall_official> <location> <facility> <name>Research Site</name> <address> <city>Brooklyn</city> <state>Maryland</state> <zip>21225</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>July 2023</verification_date> <study_first_submitted>February 12, 2020</study_first_submitted> <study_first_submitted_qc>February 12, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>July 7, 2023</last_update_submitted> <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc> <last_update_posted type="Actual">July 10, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>First-in-Human</keyword> <keyword>Randomized</keyword> <keyword>Single-blind</keyword> <keyword>Placebo controlled</keyword> <keyword>AZD2373</keyword> <keyword>Single Ascending Dose</keyword> <keyword>Sentinel Dosing</keyword> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.</ipd_description> <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame> <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_access_criteria> <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url> </patient_data>  </clinical_study>

This is a Phase 1 study to assess the the safety, tolerability and pharmacokinetics (PK) of AZD2373, following subcutaneous (SC) administration of single ascending doses (SAD) of AZD2373 in healthy male subjects of African ancestry. This study will be conducted as a single-centre, randomised, placebo-controlled, single-blind study to assess the effect of AZD2373 following ascending dose sequential group design administrations to healthy male subjects of African ancestry. The study will include 6 single dose cohorts with the option to include 2 additional cohorts based on emerging data from preceding cohorts in the study. Approximately 48 male subjects aged 18 to 55 years at the time of informed consent (inclusive) will be randomized with the aim to have 8 subjects participate in each cohort. Within each cohort, 6 subjects will receive AZD2373 and 2 subjects will receive placebo. Sentinel dosing will be applied for each cohort and will be divided into 2 groups: - Group 1 (sentinel group): 1 active, 1 placebo; - Group 2 (the rest of the cohort): 5 active, 1 placebo. The safety data of up to 72 hours post-dose in Group 1 will be reviewed by the Principal Investigator (PI) before the subjects in Group 2 are dosed. The study will comprise: - A Screening Period of maximum 35 days; - A Treatment Period during which subjects will be resident at the Clinical Unit from the day before investigational medicinal product (IMP) administration (Day -1) until at least 72 hours after IMP administration; discharged from the Clinical Unit on Day 4; - Follow-up Visits on 1, 1.5, 2, 3, 4, 5, 6, and 8 weeks (Visits 3 to 10); and - A Final Follow up Visit 10 weeks after the last IMP dose. The visit occurring at 5 weeks post dose (Visit 5) is optional. The expected duration for any subject participating in the study is approximately 10 weeks (excluding an up to 28-day Screening Period). Inclusion Criteria: - Provision of signed and dated, written informed consent prior to any study specific procedures. - Healthy male subjects of West African ancestry aged 18 to 55 years (inclusive, at time of informed consent) with suitable veins for cannulation or repeated venipuncture. - Have a body mass index (BMI) between 18 and 35 kg/m^2 (inclusive) and weigh at least 50 kg and no more than 120 kg (inclusive). - Provision of signed, written and dated informed consent for study participation which includes mandatory genotyping (study objective). NOTE: If a subject would decline to participate in the mandatory genotyping component of the study, the subject will not be included in the study. Exclusion Criteria: - Subjects with known ancestry outside of West Africa. - History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. - History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs. - Any clinically important illness, medical/surgical procedure or trauma within 4 weeks prior to administration of IMP on Study Day 1. - Any laboratory values with the following deviations: 1. Alanine aminotransferase or aspartate aminotransferase greater than upper limit of normal and clinically significant as determined by the PI. 2. White blood cell (WBC) count < 3.0 x 10^9/L. 3. Hemoglobin (Hb) below lower limit normal . - Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results, other than those described above, as judged by the PI.

NCT0426xxxx/NCT04269044.xml

<clinical_study>  <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/NCT04269044</url> </required_header> <id_info> <org_study_id>20-006-LFH</org_study_id> <nct_id>NCT04269044</nct_id> </id_info> <brief_title>The Efficacy of a Novel, Non-contact EKG in the NICU</brief_title> <official_title>The Efficacy of a Novel, Non-contact EKG in the NICU</official_title> <sponsors> <lead_sponsor> <agency>Northwestern Medicine</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Northwestern Medicine</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> We will be comparing a novel, non-contact EKG waveform and heart rate to the standard of care, contact-based EKG waveform and heart rate in neonates, who have sensitive skin. </textblock> </brief_summary> <overall_status>Unknown status</overall_status> <last_known_status>Not yet recruiting</last_known_status> <start_date type="Anticipated">March 15, 2020</start_date> <completion_date type="Anticipated">December 31, 2020</completion_date> <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>difference in heart rate</measure> <time_frame>1 hour</time_frame> <description>we will compare the two heart rate figures from both EKG sources</description> </primary_outcome> <enrollment type="Anticipated">10</enrollment> <condition>Electrocardiogram Electrode Site Reaction</condition> <intervention> <intervention_type>Diagnostic Test</intervention_type> <intervention_name>non-contact EKG</intervention_name> <description>ultra-sensitive, non-contact EKG pad will be placed beneath the infant</description> <other_name>standard, contact EKG</other_name> </intervention> <eligibility> <study_pop> <textblock> We will be studying neonates in the NICU. They have sensitive skin and thus a suspected benefit from switching to a non-contact EKG </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Apgar at 5 min >/= 7  - Admitted to the NICU  - Indication for standard EKG monitoring  Exclusion Criteria:  - Apgar < 7 at 5 min  - Not in the NICU  - Not being monitored with standard EKG monitors </textblock> </criteria> <gender>All</gender> <minimum_age>N/A</minimum_age> <maximum_age>30 Days</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Northwestern Lake Forest Hospital</name> <address> <city>Lake Forest</city> <state>Illinois</state> <zip>60045</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>February 2020</verification_date> <study_first_submitted>February 11, 2020</study_first_submitted> <study_first_submitted_qc>February 11, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>February 11, 2020</last_update_submitted> <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc> <last_update_posted type="Actual">February 13, 2020</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Northwestern Medicine</investigator_affiliation> <investigator_full_name>Andrew Gostine, MD</investigator_full_name> <investigator_title>Anesthesiologist and Intensivist</investigator_title> </responsible_party> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

We will be comparing a novel, non-contact EKG waveform and heart rate to the standard of care, contact-based EKG waveform and heart rate in neonates, who have sensitive skin. We will be studying neonates in the NICU. They have sensitive skin and thus a suspected benefit from switching to a non-contact EKG Inclusion Criteria: - Apgar at 5 min >/= 7 - Admitted to the NICU - Indication for standard EKG monitoring Exclusion Criteria: - Apgar < 7 at 5 min - Not in the NICU - Not being monitored with standard EKG monitors

NCT0426xxxx/NCT04269057.xml

<clinical_study>  <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/NCT04269057</url> </required_header> <id_info> <org_study_id>2019-10</org_study_id> <nct_id>NCT04269057</nct_id> </id_info> <brief_title>Change of NLRP3 Inflammasome Expression Level, Symptoms, and Functional Status in HFpEF Patients Treated With ARNI</brief_title> <official_title>Change of NLRP3 Inflammasome Expression Level, Symptoms, and Functional Status in Patients With Heart Failure With Preserved Ejection Fraction Treated With ARNI</official_title> <sponsors> <lead_sponsor> <agency>Chongqing Medical University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Chongqing Medical University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> Underlying inflammation has been increasingly recognized in heart failure with a preserved ejection fraction(HFpEF). But there is no study reported the relationship between NLRP3 inflammasome and HFpEF. In this study, investigators propose a scientific hypothesis that the expression of NLRP3 inflammasome is elevated in patients with HFpEF, and the level of TNFα, IL-1β and NLRP3 inflammasome is lower in patients treated with sacubitril/valsartan. </textblock> </brief_summary> <detailed_description> <textblock> The study will integrate data from two trials involving a total of 90 participants with heart failure. Depending on the using of ARNI, participants in HFpEF group will be divided into two groups. The diagnostic criteria for HFpEF is: (1) left ventricular ejection fraction ≥50%； (2）with the symptoms and/or signs of heart failure; (3) BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL; (4) at least one additional criterion: a.relevant structural heart disease(LVH and/or LAE); b.diastolic dysfunction. The primary outcome are the change from baseline in TNFα, IL-1β, NLRP3 inflammasome, and so on assessed at 12 weeks. The key secondary outcomes include changes in echocardiographic measures, quality of life, etc. And then compare the rate of above indicators of two trials. </textblock> </detailed_description> <overall_status>Unknown status</overall_status> <last_known_status>Recruiting</last_known_status> <start_date type="Actual">October 1, 2019</start_date> <completion_date type="Anticipated">October 1, 2020</completion_date> <primary_completion_date type="Anticipated">October 1, 2020</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Retrospective</time_perspective> </study_design_info> <primary_outcome> <measure>The change from baseline in TNFα, IL-1β, NLRP3 inflammasome, and so on assessed at 12 weeks</measure> <time_frame>12 weeks</time_frame> <description>Measuring the level of TNFα, IL-1β, NLRP3 inflammasome, and so on from blood samples at 12 weeks, seperately by PCR and ELISA</description> </primary_outcome> <secondary_outcome> <measure>The change from baseline in echocardiographic measures and so on</measure> <time_frame>12 months</time_frame> <description>Observed the change of ejection fraction, left atrial volume index and so on measured by echocardiogram.</description> </secondary_outcome> <secondary_outcome> <measure>The change from baseline in quality of life</measure> <time_frame>12 months</time_frame> <description>Measured by Kansas City Cardiomyopathy Questionnaire. The score ranges from 0 to 100. The higher score means the better health-related quality of life.</description> </secondary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Anticipated">90</enrollment> <condition>Heart Failure</condition> <arm_group> <arm_group_label>HFpEF</arm_group_label> <description>heart failure patients with preserved ejection fraction who using ARNI</description> </arm_group> <arm_group> <arm_group_label>HFrEF</arm_group_label> <description>heart failure patients with reduced ejection fraction who using ARNI</description> </arm_group> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> monocytes and serum </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> heart failure patients </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - left ventricular ejection fraction ≥50%；  - with the symptoms and/or signs of heart failure；  - BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL；  - at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction.  Exclusion Criteria:  - LVEF less than 45% at any time;  - severe infection;  - ACS;  - pregnancy;  - eGFR <30 mL/min/1.73 m2, etc. </textblock> </criteria> <gender>All</gender> <minimum_age>N/A</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Dongying Zhang, doctor</last_name> <role>Study Director</role> <affiliation>First Affiliated Hospital of Chongqing Medical University</affiliation> </overall_official> <overall_contact> <last_name>Dongying Zhang, doctor</last_name> <phone>+8613608398395</phone> <email>zdy.chris@qq.com</email> </overall_contact> <location> <facility> <name>The First Affiliated Hospital of Chongqing Medical University</name> <address> <city>Chongqing</city> <country>China</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Dongying Zhang, doctor</last_name> <phone>+8613608398395</phone> <email>zdy.chris@qq.com</email> </contact> </location> <location_countries> <country>China</country> </location_countries> <verification_date>February 2020</verification_date> <study_first_submitted>January 13, 2020</study_first_submitted> <study_first_submitted_qc>February 12, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>February 12, 2020</last_update_submitted> <last_update_submitted_qc>February 12, 2020</last_update_submitted_qc> <last_update_posted type="Actual">February 17, 2020</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Chongqing Medical University</investigator_affiliation> <investigator_full_name>Dongying Zhang</investigator_full_name> <investigator_title>Associate Professor</investigator_title> </responsible_party> <keyword>NLRP3 protein</keyword> <keyword>human</keyword> <condition_browse>  <mesh_term>Heart Failure</mesh_term> </condition_browse>  </clinical_study>

Underlying inflammation has been increasingly recognized in heart failure with a preserved ejection fraction(HFpEF). But there is no study reported the relationship between NLRP3 inflammasome and HFpEF. In this study, investigators propose a scientific hypothesis that the expression of NLRP3 inflammasome is elevated in patients with HFpEF, and the level of TNFα, IL-1β and NLRP3 inflammasome is lower in patients treated with sacubitril/valsartan. The study will integrate data from two trials involving a total of 90 participants with heart failure. Depending on the using of ARNI, participants in HFpEF group will be divided into two groups. The diagnostic criteria for HFpEF is: (1) left ventricular ejection fraction ≥50%； (2）with the symptoms and/or signs of heart failure; (3) BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL; (4) at least one additional criterion: a.relevant structural heart disease(LVH and/or LAE); b.diastolic dysfunction. The primary outcome are the change from baseline in TNFα, IL-1β, NLRP3 inflammasome, and so on assessed at 12 weeks. The key secondary outcomes include changes in echocardiographic measures, quality of life, etc. And then compare the rate of above indicators of two trials. monocytes and serum heart failure patients Inclusion Criteria: - left ventricular ejection fraction ≥50%； - with the symptoms and/or signs of heart failure； - BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL； - at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction. Exclusion Criteria: - LVEF less than 45% at any time; - severe infection; - ACS; - pregnancy; - eGFR <30 mL/min/1.73 m2, etc.

NCT0426xxxx/NCT04269070.xml

<clinical_study>  <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/NCT04269070</url> </required_header> <id_info> <org_study_id>STUDY00010172</org_study_id> <nct_id>NCT04269070</nct_id> </id_info> <brief_title>WorkWell: Work-based Activity and Metabolic Health</brief_title> <official_title>WorkWell: A Pre-clinical Pilot Study of Increased Standing and Light-intensity Physical Activity in Prediabetic Sedentary Office Workers</official_title> <sponsors> <lead_sponsor> <agency>Arizona State University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Arizona State University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This study will test whether a range of pre-clinical cardiometabolic biomarkers can be improved via regular intervals of standing and light-intensity physical activity in real-world office environments. </textblock> </brief_summary> <detailed_description> <textblock> This pilot study is being conducted to determine whether a range of pre-clinical cardiometabolic biomarkers (measured via gut microbiome, blood draw) can be improved via regular intervals of standing and light-intensity physical activity (i.e., leisurely walking) in real-world office environments. This trial is meant to generate pilot data which will lead to additional clinical trials.  Primary Hypothesis: Increasing both standing and light-intensity physical activity will improve biomarkers of metabolic function, as measured by blood metabolites and differential abundance of gut microbiome composition, compared to a control condition of normal workplace behavior. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">March 25, 2021</start_date> <completion_date type="Actual">April 30, 2023</completion_date> <primary_completion_date type="Actual">April 30, 2023</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Crossover Assignment</intervention_model> <intervention_model_description>This is a crossover trial where study participants will experience two conditions following a baseline usua behavior conditions. All study participants will experience each of the conditions: a standing condition, and a light intensity physical activity (LPA) intervention.</intervention_model_description> <primary_purpose>Other</primary_purpose> <masking>Single (Outcomes Assessor)</masking> <masking_description>Flow-mediated dilation outcome: Images that are obtained will be analyzed by a blinded researcher using a previously validated, edge-detection software</masking_description> </study_design_info> <primary_outcome> <measure>Change in 2-hour postprandial area-under-the-curve blood glucose at 2 weeks</measure> <time_frame>2 weeks</time_frame> <description>Participants will be asked to wear the Abbott Freestyle Libre continuous glucose monitor during the usual behavior condition (week 1) and both experimental conditions (weeks 2-3 and weeks 5-6). Research staff will insert the CGM sensor at the screening and study visits. The training for this insertion will be conducted by a registered research nurse. The CGM sensors have been designed and tested to be worn continuously for up to 14 days. Sensors will be placed and removed by trained research staff at appropriate time-points throughout the study. Postprandial period will follow a standardize lunch meal. Area-under-the-curve calculations will be based on 2 hours following delivery of this lunch meal.</description> </primary_outcome> <secondary_outcome> <measure>Change in baseline workplace standing time at 2 weeks</measure> <time_frame>2 weeks</time_frame> <description>Participants will be asked to wear an activPAL accelerometer throughout the entire intervention period. Data from the devices will be downloaded at each study visit. The activPAL device is worn on the right thigh and is equipped with low energy Bluetooth and will communicate wirelessly with the provided smartphone application to provide feedback to the participant and compliance with the protocol. Workplace time will be assessed by a self-report log and activPAL time will be extracted based on these reports.</description> </secondary_outcome> <secondary_outcome> <measure>Change in baseline workplace stepping time at 2 weeks</measure> <time_frame>2 weeks</time_frame> <description>Participants will be asked to wear an activPAL accelerometer throughout the entire intervention period. Data from the devices will be downloaded at each study visit. The activPAL device is worn on the right thigh and is equipped with low energy Bluetooth and will communicate wirelessly with the provided smartphone application to provide feedback to the participant and compliance with the protocol. Workplace time will be assessed by a self-report log and activPAL time will be extracted based on these reports.</description> </secondary_outcome> <other_outcome> <measure>Treatment acceptability/satisfaction</measure> <time_frame>2 weeks</time_frame> <description>Intervention acceptability questionnaire at the end of each condition will elicit each participant's perceived acceptability of the intervention.</description> </other_outcome> <other_outcome> <measure>Change in fasting blood glucose at 2 weeks</measure> <time_frame>2 weeks</time_frame> <description>After verifying fasting for 10-12 hours, a blood sample (about 15 ml, approximately 1 tablespoon) will be collected via venipuncture to measure markers of glucose. After withdrawal, blood will be centrifuged at 1,100 x g at 4°C for 20 minutes, and serum, plasma and erythrocytes will be aliquoted and stored at -80 degrees Celsius for subsequent analysis upon sample collection completion. Blood will be drawn by Arizona Biomedical Collaborative Laboratory clinical staff.</description> </other_outcome> <other_outcome> <measure>Change in femoral artery reactivity at 2 weeks</measure> <time_frame>2 weeks</time_frame> <description>Femoral Artery Flow Mediated Dilation (FAFMD) Endothelium-dependent dilation of the femoral artery will be measured using B-mode ultrasound (Terason uSmart 3300+™, Burlington MA) using guidelines set forth by the Brachial Artery Reactivity Task Force.</description> </other_outcome> <other_outcome> <measure>Change in central aortic diastolic and systolic blood pressure at 2 weeks</measure> <time_frame>2 weeks</time_frame> <description>All participants will lay down in a dimly lit room and have resting blood pressure measured using an automated blood pressure machine. Thereafter, an appropriately sized blood pressure cuff will be placed on the left arm and central and peripheral blood pressures will be assessed using the non-invasive SphygmoCor system.</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">15</enrollment> <condition>PreDiabetes</condition> <condition>Obesity</condition> <arm_group> <arm_group_label>Move, Stand</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Usual behavior condition, followed by the standing condition, followed by the LPA condition.</description> </arm_group> <arm_group> <arm_group_label>Stand, Move</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Usual behavior condition, followed by the LPA condition, followed by the standing condition.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Standing condition</intervention_name> <description>Participants will be asked to stand an additional 6 minutes per hour above their median standing time from the observed time in the usual behavior condition.</description> <arm_group_label>Move, Stand</arm_group_label> <arm_group_label>Stand, Move</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Light physical activity (LPA) condition</intervention_name> <description>Participants will be asked to perform 6 additional minutes per hour above their median LPA time from the observed time in the usual behavior condition.</description> <arm_group_label>Move, Stand</arm_group_label> <arm_group_label>Stand, Move</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Usual behavior condition</intervention_name> <description>Participants will be asked to perform their normal work activities in their normal work environment for one week. There will be no modifications to their work environment or instructions given of what activities to partake in. This period will be used to understand their normal standing and LPA behaviors to determine the personalized changes to their standing and LPA behaviors in the other conditions.</description> <arm_group_label>Move, Stand</arm_group_label> <arm_group_label>Stand, Move</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Women and men age 18 yrs and older  - Holds a job where primary work activities are done seated  - Has the space and ability to use a sit-to-stand workstation in their primary workspace  - Works in an office setting or remotely for ≥ 4 days per week  - Have a BMI ≥ 25.0 (≥23.0 for individuals of Asian descent)  Exclusion Criteria:  - Currently taking diabetes medication  - Taking any of the following medications or treatments:  - Medication to control high blood pressure  - Medication to treat high glucose  - Blood thinners  - Hormone replacement therapy (in the past 12 months)  - Corticosteroids  - High dose statins (Dr. Reaven, MD to adjudicate eligibility based on dosage)  - 2nd generation antipsychotics  - Current or previous foot or lower limb injuries  - Current use of sit-stand workstation  - Current smoker  - Neuromuscular or cardiovascular disorders or other serious active medical issues, including deep vein thrombosis or respiratory issues  - Has a physical impairment or musculoskeletal condition that will prevent the subject from standing or light-intensity walking for a maximum of 30 minutes  - Has been advised to avoid prolonged periods of sitting or standing by a physician or other healthcare provider  - History of inflammatory bowel or intestinal malabsorption conditions  - Use of prebiotics, probiotics or antibiotics in the last 3 months  - Serious food allergies or restrictions  - Participants who will be travelling 3 or more days out of their typical week </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <location> <facility> <name>Arizona State University</name> <address> <city>Tempe</city> <state>Arizona</state> <zip>85281</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>May 2023</verification_date> <study_first_submitted>January 3, 2020</study_first_submitted> <study_first_submitted_qc>February 12, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>May 8, 2023</last_update_submitted> <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 10, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>sedentary</keyword> <keyword>prediabetes</keyword> <keyword>lifestyle modification</keyword> <keyword>cardiometabolic health</keyword> <condition_browse>  <mesh_term>Prediabetic State</mesh_term> <mesh_term>Glucose Intolerance</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Undecided</sharing_ipd> </patient_data>  </clinical_study>

This study will test whether a range of pre-clinical cardiometabolic biomarkers can be improved via regular intervals of standing and light-intensity physical activity in real-world office environments. This pilot study is being conducted to determine whether a range of pre-clinical cardiometabolic biomarkers (measured via gut microbiome, blood draw) can be improved via regular intervals of standing and light-intensity physical activity (i.e., leisurely walking) in real-world office environments. This trial is meant to generate pilot data which will lead to additional clinical trials. Primary Hypothesis: Increasing both standing and light-intensity physical activity will improve biomarkers of metabolic function, as measured by blood metabolites and differential abundance of gut microbiome composition, compared to a control condition of normal workplace behavior. Inclusion Criteria: - Women and men age 18 yrs and older - Holds a job where primary work activities are done seated - Has the space and ability to use a sit-to-stand workstation in their primary workspace - Works in an office setting or remotely for ≥ 4 days per week - Have a BMI ≥ 25.0 (≥23.0 for individuals of Asian descent) Exclusion Criteria: - Currently taking diabetes medication - Taking any of the following medications or treatments: - Medication to control high blood pressure - Medication to treat high glucose - Blood thinners - Hormone replacement therapy (in the past 12 months) - Corticosteroids - High dose statins (Dr. Reaven, MD to adjudicate eligibility based on dosage) - 2nd generation antipsychotics - Current or previous foot or lower limb injuries - Current use of sit-stand workstation - Current smoker - Neuromuscular or cardiovascular disorders or other serious active medical issues, including deep vein thrombosis or respiratory issues - Has a physical impairment or musculoskeletal condition that will prevent the subject from standing or light-intensity walking for a maximum of 30 minutes - Has been advised to avoid prolonged periods of sitting or standing by a physician or other healthcare provider - History of inflammatory bowel or intestinal malabsorption conditions - Use of prebiotics, probiotics or antibiotics in the last 3 months - Serious food allergies or restrictions - Participants who will be travelling 3 or more days out of their typical week

NCT0426xxxx/NCT04269083.xml

<clinical_study>  <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/NCT04269083</url> </required_header> <id_info> <org_study_id>GR-2016-02361134</org_study_id> <nct_id>NCT04269083</nct_id> </id_info> <brief_title>A Biomarker-driven Therapeutic Strategy for Esophageal Cancer Chemoradiotherapy in Patients With Resectable Adenocarcinoma of the ESophagus and Esophagogastric Junction</brief_title> <acronym>BoRgES</acronym> <official_title>A Biomarker-driven Therapeutic Strategy for Esophageal Cancer, the BoRgES Trial: a Multicenter Randomized Phase II Study of BIRC3-expression Directed Preoperative Chemoradiotherapy in Patients With Resectable Adenocarcinoma of the ESophagus and Esophagogastric Junction</official_title> <sponsors> <lead_sponsor> <agency>Azienda Ospedaliera Universitaria Integrata Verona</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Azienda Ospedaliera Universitaria Integrata Verona</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Preoperative chemoradiotherapy followed by surgery has been accepted as the standard of care for resectable adenocarcinoma of the esophagus and esophagogastric junction (EGJ). However, in a large part of the cases the tumor is extremely resistant to chemoradiotherapy, and those patients do not benefit from this treatment but are exposed to its negative consequences such as toxicity and delayed surgical therapy. The hypothesis is that a biomarker-driven therapeutic strategy in which patients will receive preoperative chemoradiotherapy or upfront surgery based on the basal tumor expression of BIRC3 could improve the R0 resection rate if compared with a standard strategy in unselected patients. </textblock> </brief_summary> <detailed_description> <textblock> BoRgES trial is a multicenter, randomized phase II study of BIRC3-expression directed preoperative chemoradiotherapy in patients with resectable adenocarcinoma of the esophagus and EGJ. The main objective of this proposal is to provide evidence for a novel therapeutic strategy with enormous significance for patients affected by this disease.  Only a part of the patients with esophageal adenocarcinoma benefit from neoadjuvant therapy, and the clinical efficacy of chemoradiotherapy is reduced by the pre-existence of cellular drug resistance. Thus, there is an urgent need to identify patients who could not benefit from preoperative treatment. The study will define an innovative therapeutic strategy directed by the expression of BIRC3 as a predictive marker for discriminating patients who will most likely be resistant to preoperative chemoradiotherapy. </textblock> </detailed_description> <overall_status>Not yet recruiting</overall_status> <start_date type="Anticipated">May 24, 2020</start_date> <completion_date type="Anticipated">August 24, 2024</completion_date> <primary_completion_date type="Anticipated">March 24, 2024</primary_completion_date> <phase>N/A</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>open-label, multicenter, randomized phase II study</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>R0, number of patients achieving R0 resection.</measure> <time_frame>3 years</time_frame> <description>number of patients achieving R0 resection.</description> </primary_outcome> <secondary_outcome> <measure>OS</measure> <time_frame>3 years</time_frame> <description>overall survival</description> </secondary_outcome> <secondary_outcome> <measure>DFS</measure> <time_frame>3 years</time_frame> <description>disease free survival</description> </secondary_outcome> <secondary_outcome> <measure>tumour response</measure> <time_frame>3 years</time_frame> <description>tumour response evaluated either by Mandard's tumour regression grade</description> </secondary_outcome> <secondary_outcome> <measure>safety profile</measure> <time_frame>3 years</time_frame> <description>safety profile (incidence of ≥ grade 3 adverse events using Common Terminology Criteria for Adverse Events - CTCAE - version 4.0).</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">128</enrollment> <condition>Esophageal Cancer</condition> <arm_group> <arm_group_label>experimental arm</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>fresh specimens from the tumour and normal mucosa will be collected endoscopically at diagnosis and placed immediately into RNALater to isolate RNA. The mRNA expression of BIRC3 will be quantified using a SYBR green-based real-time PCR analysis; the BIRC3 median expression in normal mucosa samples will be used as calibrator. Patients with a tumor expression level of BIRC3 lower than the established cutoff will receive a standard carboplatin/paclitaxel regimen with concurrent radiotherapy followed by surgery. Patients with an expression of BIRC3 higher or equal than the cutoff (chemoradiation resistant patients) will undergo upfront surgery.</description> </arm_group> <arm_group> <arm_group_label>control arm</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>fresh specimens from the tumour and normal mucosa will be collected endoscopically at diagnosis and placed immediately into RNALater to isolate RNA. The mRNA expression of BIRC3 will be quantified using a SYBR green-based real-time PCR analysis; the BIRC3 median expression in normal mucosa samples will be used as calibrator. Patients with a tumor expression level of BIRC3 lower than the established cutoff will receive a standard carboplatin/paclitaxel regimen with concurrent radiotherapy followed by surgery. Patients with an expression of BIRC3 higher or equal than the cutoff (chemoradiation resistant patients) will undergo upfront surgery.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>BIRC3</intervention_name> <description>BIRC3-expression directed preoperative chemoradiotherapy in patients with resectable adenocarcinoma of the esophagus and EGJ</description> <arm_group_label>control arm</arm_group_label> <arm_group_label>experimental arm</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Histologically proven adenocarcinoma of the esophagus and EGJ (Siewert I/II) surgical resectable (cT2-4a, N0-1, M0), as determined by Endoscopic Ultra Sound (EUS) and or PET-TC scan. cT1N1 tumors are eligible, T1N0 tumors and in situ carcinoma are not eligible.  - If tumor extends below the EGJ junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE junction. The tumor must not extend more than 2 cm into the stomach (Siewert III). Gastric cancers with minor involvement of the GE junction or esophagus are not eligible.  - Age >18, no age upper limit unless patient would be unable to tolerate chemoradiotherapy.  - Have given written informed consent prior to any study-specific procedures.  - ECOG performance status 0-2.  - No prior thoracic radiotherapy allowed.  - Adequate hematological, renal, cardiac, hepatic and pulmonary functions.  Exclusion Criteria:  - </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <verification_date>February 2020</verification_date> <study_first_submitted>February 6, 2020</study_first_submitted> <study_first_submitted_qc>February 12, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>April 16, 2020</last_update_submitted> <last_update_submitted_qc>April 16, 2020</last_update_submitted_qc> <last_update_posted type="Actual">April 17, 2020</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>esophageal-gastric junction cancer, preoperative chemoradiotherapy, BIRC3</keyword> <condition_browse>  <mesh_term>Adenocarcinoma</mesh_term> <mesh_term>Esophageal Neoplasms</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Preoperative chemoradiotherapy followed by surgery has been accepted as the standard of care for resectable adenocarcinoma of the esophagus and esophagogastric junction (EGJ). However, in a large part of the cases the tumor is extremely resistant to chemoradiotherapy, and those patients do not benefit from this treatment but are exposed to its negative consequences such as toxicity and delayed surgical therapy. The hypothesis is that a biomarker-driven therapeutic strategy in which patients will receive preoperative chemoradiotherapy or upfront surgery based on the basal tumor expression of BIRC3 could improve the R0 resection rate if compared with a standard strategy in unselected patients. BoRgES trial is a multicenter, randomized phase II study of BIRC3-expression directed preoperative chemoradiotherapy in patients with resectable adenocarcinoma of the esophagus and EGJ. The main objective of this proposal is to provide evidence for a novel therapeutic strategy with enormous significance for patients affected by this disease. Only a part of the patients with esophageal adenocarcinoma benefit from neoadjuvant therapy, and the clinical efficacy of chemoradiotherapy is reduced by the pre-existence of cellular drug resistance. Thus, there is an urgent need to identify patients who could not benefit from preoperative treatment. The study will define an innovative therapeutic strategy directed by the expression of BIRC3 as a predictive marker for discriminating patients who will most likely be resistant to preoperative chemoradiotherapy. Inclusion Criteria: - Histologically proven adenocarcinoma of the esophagus and EGJ (Siewert I/II) surgical resectable (cT2-4a, N0-1, M0), as determined by Endoscopic Ultra Sound (EUS) and or PET-TC scan. cT1N1 tumors are eligible, T1N0 tumors and in situ carcinoma are not eligible. - If tumor extends below the EGJ junction into the proximal stomach, the bulk of the tumor must involve the esophagus or GE junction. The tumor must not extend more than 2 cm into the stomach (Siewert III). Gastric cancers with minor involvement of the GE junction or esophagus are not eligible. - Age >18, no age upper limit unless patient would be unable to tolerate chemoradiotherapy. - Have given written informed consent prior to any study-specific procedures. - ECOG performance status 0-2. - No prior thoracic radiotherapy allowed. - Adequate hematological, renal, cardiac, hepatic and pulmonary functions. Exclusion Criteria: -

NCT0426xxxx/NCT04269096.xml

<clinical_study>  <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/NCT04269096</url> </required_header> <id_info> <org_study_id>Pro00066577</org_study_id> <nct_id>NCT04269096</nct_id> </id_info> <brief_title>Laparoscopic Cholecystectomy Care Protocol</brief_title> <official_title>Compliance With Laparoscopic Cholecystectomy Care Protocol</official_title> <sponsors> <lead_sponsor> <agency>Prisma Health-Upstate</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Prisma Health-Upstate</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> The purpose of this study is to determine compliance with the Prisma Health-Upstate Laparoscopic Cholecystectomy Perioperative Protocol. </textblock> </brief_summary> <detailed_description> <textblock> Evidence based medicine calls for the application of scientific advances to clinical care. In an effort to address the most common complications of a surgical procedure, perioperative protocols have recently been created in an effort to apply best practices consistently and enhance the recovery from surgery. In addition to evaluating the validity of the protocol components themselves, it is valuable to measure compliance with said protocol. Failure to complete the steps of a care pathway may be caused by several reasons, and a study of application of these steps may help future efforts at standardization of care.  The purpose of this study is to determine compliance with the Prisma Health-Upstate Laparoscopic Cholecystectomy Perioperative Protocol.  Hospital inpatient data from patient charts, office charts, and hospital medical data systems of Prisma Health-Upstate System will be used to review the records of all patients age 18-75 years, inpatient and outpatient, who had surgery for choledocolithiasis between January 1, 2016 to April 1, 2017. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">January 1, 2016</start_date> <completion_date type="Actual">April 1, 2021</completion_date> <primary_completion_date type="Actual">April 1, 2017</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Retrospective</time_perspective> </study_design_info> <primary_outcome> <measure>Protocol Compliance</measure> <time_frame>15 months</time_frame> <description>Percent compliance with protocol components</description> </primary_outcome> <secondary_outcome> <measure>Length of Stay</measure> <time_frame>15 months</time_frame> <description>Post acute care unit length of stay will be measured in minutes</description> </secondary_outcome> <enrollment type="Actual">500</enrollment> <condition>Laparoscopic Cholecystectomy</condition> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Protocol Compliance</intervention_name> <description>Compliance with the Prisma Health-Upstate Laparoscopic Cholecystectomy Perioperative Protocol</description> </intervention> <eligibility> <study_pop> <textblock> Patients between the ages of 18 years and 75 years who had surgery for choledocolithiasis at Prisma Health-Upstate. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Patients between the ages of 18 years and 75 years who had surgery for choledocholithiasis at Prisma Health-Upstate.  Exclusion Criteria:  - Patients under 18 years of age and older than 75 years of age. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>75 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>William Hand, MD</last_name> <role>Principal Investigator</role> <affiliation>Prisma Health-Upstate</affiliation> </overall_official> <location> <facility> <name>Greenville Memorial Hospital</name> <address> <city>Greenville</city> <state>South Carolina</state> <zip>29605</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>April 2021</verification_date> <study_first_submitted>February 11, 2020</study_first_submitted> <study_first_submitted_qc>February 11, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>April 12, 2021</last_update_submitted> <last_update_submitted_qc>April 12, 2021</last_update_submitted_qc> <last_update_posted type="Actual">April 13, 2021</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of this study is to determine compliance with the Prisma Health-Upstate Laparoscopic Cholecystectomy Perioperative Protocol. Evidence based medicine calls for the application of scientific advances to clinical care. In an effort to address the most common complications of a surgical procedure, perioperative protocols have recently been created in an effort to apply best practices consistently and enhance the recovery from surgery. In addition to evaluating the validity of the protocol components themselves, it is valuable to measure compliance with said protocol. Failure to complete the steps of a care pathway may be caused by several reasons, and a study of application of these steps may help future efforts at standardization of care. The purpose of this study is to determine compliance with the Prisma Health-Upstate Laparoscopic Cholecystectomy Perioperative Protocol. Hospital inpatient data from patient charts, office charts, and hospital medical data systems of Prisma Health-Upstate System will be used to review the records of all patients age 18-75 years, inpatient and outpatient, who had surgery for choledocolithiasis between January 1, 2016 to April 1, 2017. Patients between the ages of 18 years and 75 years who had surgery for choledocolithiasis at Prisma Health-Upstate. Inclusion Criteria: - Patients between the ages of 18 years and 75 years who had surgery for choledocholithiasis at Prisma Health-Upstate. Exclusion Criteria: - Patients under 18 years of age and older than 75 years of age.

NCT0426xxxx/NCT04269109.xml

<clinical_study>  <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/NCT04269109</url> </required_header> <id_info> <org_study_id>Pro00085849</org_study_id> <nct_id>NCT04269109</nct_id> </id_info> <brief_title>Opioid Sparing Pain Management Strategy</brief_title> <official_title>A Multi-modal, Opioid Sparing Pain Management Strategy in Cardiac Surgery</official_title> <sponsors> <lead_sponsor> <agency>Prisma Health-Upstate</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Prisma Health-Upstate</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The purpose of this research study is to compare the amount of morphine milligram equivalents consumed post operatively until discharge between the control cohort and intervention cohort. </textblock> </brief_summary> <detailed_description> <textblock> Retrospective data will be collected on patients admitted to Prisma Health-Upstate Greenville Memorial Hospital in the Cardiovascular Intensive Care Unit following cardiovascular surgery. They will be divided into two cohorts, a control cohort from September 1, 2018 - October 31, 2018 and an intervention cohort from March 1, 2019 - April 30, 2019. A study investigator will assess each participant's electronic medical record through the electronic medical record database - EPIC to determine eligibility per the protocol. Demographic information will be collected, including age, date of birth, race, sex, height, weight, and ethnicity. Extubation and reintubation status will be collected along with medical history, type of cardiovascular procedure, medications, length of stay, pain scores, complications, and labs. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">September 1, 2018</start_date> <completion_date type="Actual">March 1, 2021</completion_date> <primary_completion_date type="Actual">April 30, 2019</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Retrospective</time_perspective> </study_design_info> <primary_outcome> <measure>Morphine Milligram Equivalents Comparison</measure> <time_frame>1 year</time_frame> <description>Compare the amount of morphine milligram equivalents consumed post operatively until discharge between groups.</description> </primary_outcome> <secondary_outcome> <measure>Ileus</measure> <time_frame>1 year</time_frame> <description>Compare incidence of postoperative ileus between both cohorts.</description> </secondary_outcome> <secondary_outcome> <measure>Delirium</measure> <time_frame>1 year</time_frame> <description>Compare incidence of delirium between both cohorts.</description> </secondary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Actual">150</enrollment> <condition>Cardiac Surgical Procedures</condition> <arm_group> <arm_group_label>Control Cohort</arm_group_label> <description>A control cohort from September 1, 2018 - October 31, 2018</description> </arm_group> <arm_group> <arm_group_label>Intervention Cohort</arm_group_label> <description>An intervention cohort from March 1, 2019 - April 30, 2019</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Multi-modal Opioid Sparing Pain Management Protocol</intervention_name> <description>Incorporating multimodal opioid sparing ERAS techniques for cardiac surgery patients should show a decrease in the amount of opioids received, reduction in incidence of chronic pain, ileus, delirium, and potential for opioid addiction post-operatively. Between the dates of November 2018 through February 2019, a multi-modal, opioid sparing pain management protocol was evolving and a protocol was put into place. This study will compare outcomes before and after implementation of the protocol between the dates of September 1, 2018 - October 31, 2018 and March 1, 2019 - April 30, 2019.</description> <arm_group_label>Control Cohort</arm_group_label> <arm_group_label>Intervention Cohort</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> This retrospective study is a self-controlled comparison of patients undergoing cardiovascular surgery by cardiovascular surgeons at Greenville Memorial Hospital. </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Adult patients 18 and over  - Patients who underwent cardiac surgery requiring a coronary pulmonary bypass machine during September 1, 2018 - April 30, 2019  Exclusion Criteria:  - Patients being placed on Extracorporeal Membrane Oxygenation </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Caroline McKillop, MD</last_name> <role>Principal Investigator</role> <affiliation>Prisma Health-Upstate</affiliation> </overall_official> <location> <facility> <name>Prisma Health-Upstate</name> <address> <city>Greenville</city> <state>South Carolina</state> <zip>29605</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <reference> <citation>Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. Erratum In: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text.</citation> <PMID>26827847</PMID> </reference> <reference> <citation>Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.</citation> <PMID>30113379</PMID> </reference> <reference> <citation>Li M, Zhang J, Gan TJ, Qin G, Wang L, Zhu M, Zhang Z, Pan Y, Ye Z, Zhang F, Chen X, Lin G, Huang L, Luo W, Guo Q, Wang E. Enhanced recovery after surgery pathway for patients undergoing cardiac surgery: a randomized clinical trial. Eur J Cardiothorac Surg. 2018 Sep 1;54(3):491-497. doi: 10.1093/ejcts/ezy100.</citation> <PMID>29514224</PMID> </reference> <verification_date>April 2021</verification_date> <study_first_submitted>February 11, 2020</study_first_submitted> <study_first_submitted_qc>February 11, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>April 12, 2021</last_update_submitted> <last_update_submitted_qc>April 12, 2021</last_update_submitted_qc> <last_update_posted type="Actual">April 13, 2021</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <intervention_browse>  <mesh_term>Analgesics, Opioid</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The purpose of this research study is to compare the amount of morphine milligram equivalents consumed post operatively until discharge between the control cohort and intervention cohort. Retrospective data will be collected on patients admitted to Prisma Health-Upstate Greenville Memorial Hospital in the Cardiovascular Intensive Care Unit following cardiovascular surgery. They will be divided into two cohorts, a control cohort from September 1, 2018 - October 31, 2018 and an intervention cohort from March 1, 2019 - April 30, 2019. A study investigator will assess each participant's electronic medical record through the electronic medical record database - EPIC to determine eligibility per the protocol. Demographic information will be collected, including age, date of birth, race, sex, height, weight, and ethnicity. Extubation and reintubation status will be collected along with medical history, type of cardiovascular procedure, medications, length of stay, pain scores, complications, and labs. This retrospective study is a self-controlled comparison of patients undergoing cardiovascular surgery by cardiovascular surgeons at Greenville Memorial Hospital. Inclusion Criteria: - Adult patients 18 and over - Patients who underwent cardiac surgery requiring a coronary pulmonary bypass machine during September 1, 2018 - April 30, 2019 Exclusion Criteria: - Patients being placed on Extracorporeal Membrane Oxygenation

NCT0426xxxx/NCT04269122.xml

<clinical_study>  <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/NCT04269122</url> </required_header> <id_info> <org_study_id>301NHV01</org_study_id> <nct_id>NCT04269122</nct_id> </id_info> <brief_title>A Study to Assess Plasma Ammonia Time-Normalized Area Under the Curve and Rate of Ureagenesis in Healthy Adult Subjects</brief_title> <official_title>A Single-Center Study to Assess Plasma Ammonia Time-Normalized Area Under the Curve From Time Zero to 24 Hours and Rate of Ureagenesis in Healthy Adult Subjects</official_title> <sponsors> <lead_sponsor> <agency>Ultragenyx Pharmaceutical Inc</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Ultragenyx Pharmaceutical Inc</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> The objective of the study is to characterize 24-hour plasma ammonia levels, characterize urea production rates in healthy normal subjects. </textblock> </brief_summary> <detailed_description> <textblock> During Part 1, eligible subjects will be asked to participate in 3 inpatient visits, each lasting up to 3 days (Day -1 to Day 2). Each visit will assess 24-hour ammonia levels in plasma and rate of urea production for 4 hours following ingestion of [1-13C]sodium acetate. Sodium acetate is used as a tracer to measure the rate of ureagenesis.  During Part 2, eligible subjects will be asked to participate in 1 inpatient visit, lasting up to 3 days (Day -1 to Day 2). The visit will assess 24-hour ammonia levels in plasma and rate of urea production for 4 hours following ingestion of [1-13C]sodium acetate. Sodium acetate is used as a tracer to measure the rate of ureagenesis. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">August 2, 2019</start_date> <completion_date type="Actual">February 20, 2020</completion_date> <primary_completion_date type="Actual">February 20, 2020</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Other</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>Plasma Ammonia Area Under the Curve (AUC0-24)</measure> <time_frame>Part 1, Day 1 (Visits 1-3) and Part 2, Day 1:Predose (0hour) up to 24 hours post dose</time_frame> <description>Characterization of ammonia production over 24hr</description> </primary_outcome> <primary_outcome> <measure>Rate of Ureagenesis Based On Presence of [1-13C] In Urea</measure> <time_frame>Part 1, Day 1 (Visits 1-3) and Part 2, Day 1: Predose (0hour) up to 4 hours post dose</time_frame> <description>Characterization of nitrogen flux as determined by production of urea. Sodium acetate is used as a tracer to measure the rate of ureagenesis.</description> </primary_outcome> <primary_outcome> <measure>Intra- and inter-subject coefficient of variation (CV) of AUC0-24 and Rate of Ureagenesis</measure> <time_frame>Part 1 Treatment Period: 17 days; Part 2 Treatment Period: 3 days</time_frame> <description>Comparative analysis of both parameters</description> </primary_outcome> <number_of_groups>2</number_of_groups> <enrollment type="Actual">120</enrollment> <condition>Ornithine Transcarbamylase Deficiency</condition> <arm_group> <arm_group_label>Part 1</arm_group_label> <description>30 eligible subjects will be asked to participate in 3 inpatient visits, each lasting up to 3 days (Day -1 to Day 2). Each visit will assess 24-hour ammonia levels in plasma and rate of urea production for 4 hours following ingestion of [1-13C]sodium acetate. Sodium acetate is used as a tracer to measure the rate of ureagenesis.</description> </arm_group> <arm_group> <arm_group_label>Part 2</arm_group_label> <description>90 eligible subjects will be asked to participate in 1 inpatient visit, each lasting up to 3 days (Day -1 to Day 2). Each visit will assess 24-hour ammonia levels in plasma and rate of urea production for 4 hours following ingestion of [1-13C]sodium acetate. Sodium acetate is used as a tracer to measure the rate of ureagenesis.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>No Intervention</intervention_name> <description>No intervention</description> <arm_group_label>Part 1</arm_group_label> <arm_group_label>Part 2</arm_group_label> </intervention> <biospec_retention>Samples Without DNA</biospec_retention> <biospec_descr> <textblock> Urine and plasma </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> Healthy Volunteers at a Phase 1 unit </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Body mass index between 18 and 30 kg/m2, inclusive.  Exclusion Criteria:  - History of liver disease as evidenced by any of the following: portal hypertension, ascites, splenomegaly, esophageal varices, hepatic encephalopathy, or a liver biopsy with evidence of stage 3 fibrosis.  - Significant hepatic inflammation or cirrhosis as evidenced by imaging or any of the following laboratory abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than the upper limit of normal (ULN), total bilirubin >1.5 × ULN, alkaline phosphatase >2.5 × ULN. NOTE: the ALT and/or AST levels may be repeated.  - Subject has a history of gout.  - Plasma ammonia level that is not within normal limits at Screening in the opinion of the Investigator or Sponsor.  - Received any vaccine within 14 days prior to Screening.  - Pregnant, lactating, or intending to become pregnant at any time during the study.  - Blood transfusion within 8 weeks prior to Screening.diuretics, cyclophosphamide and other cytotoxic agents, tolbutamide, chlorpropamide, diazoxide, dichlorphenamide, pyrazinamide, probenecid, theophylline/aminophylline, riluzole, warfarin and other antithrombotic agents, supplements containing aluminum hydroxide, or iron supplements within 30 days of Part 1or Part 2. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>55 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Medical Director</last_name> <role>Study Director</role> <affiliation>Ultragenyx Pharmaceutical</affiliation> </overall_official> <location> <facility> <name>PPD Phase 1 Unit</name> <address> <city>Austin</city> <state>Texas</state> <zip>78744</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>March 2020</verification_date> <study_first_submitted>February 10, 2020</study_first_submitted> <study_first_submitted_qc>February 11, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>March 27, 2020</last_update_submitted> <last_update_submitted_qc>March 27, 2020</last_update_submitted_qc> <last_update_posted type="Actual">March 30, 2020</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Ornithine Carbamoyltransferase Deficiency Disease</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

The objective of the study is to characterize 24-hour plasma ammonia levels, characterize urea production rates in healthy normal subjects. During Part 1, eligible subjects will be asked to participate in 3 inpatient visits, each lasting up to 3 days (Day -1 to Day 2). Each visit will assess 24-hour ammonia levels in plasma and rate of urea production for 4 hours following ingestion of [1-13C]sodium acetate. Sodium acetate is used as a tracer to measure the rate of ureagenesis. During Part 2, eligible subjects will be asked to participate in 1 inpatient visit, lasting up to 3 days (Day -1 to Day 2). The visit will assess 24-hour ammonia levels in plasma and rate of urea production for 4 hours following ingestion of [1-13C]sodium acetate. Sodium acetate is used as a tracer to measure the rate of ureagenesis. Urine and plasma Healthy Volunteers at a Phase 1 unit Inclusion Criteria: - Body mass index between 18 and 30 kg/m2, inclusive. Exclusion Criteria: - History of liver disease as evidenced by any of the following: portal hypertension, ascites, splenomegaly, esophageal varices, hepatic encephalopathy, or a liver biopsy with evidence of stage 3 fibrosis. - Significant hepatic inflammation or cirrhosis as evidenced by imaging or any of the following laboratory abnormalities: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than the upper limit of normal (ULN), total bilirubin >1.5 × ULN, alkaline phosphatase >2.5 × ULN. NOTE: the ALT and/or AST levels may be repeated. - Subject has a history of gout. - Plasma ammonia level that is not within normal limits at Screening in the opinion of the Investigator or Sponsor. - Received any vaccine within 14 days prior to Screening. - Pregnant, lactating, or intending to become pregnant at any time during the study. - Blood transfusion within 8 weeks prior to Screening.diuretics, cyclophosphamide and other cytotoxic agents, tolbutamide, chlorpropamide, diazoxide, dichlorphenamide, pyrazinamide, probenecid, theophylline/aminophylline, riluzole, warfarin and other antithrombotic agents, supplements containing aluminum hydroxide, or iron supplements within 30 days of Part 1or Part 2.

NCT0426xxxx/NCT04269135.xml

<clinical_study>  <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/NCT04269135</url> </required_header> <id_info> <org_study_id>REDI 170474</org_study_id> <nct_id>NCT04269135</nct_id> </id_info> <brief_title>Fit, Healthy and Smart Preschool Children: PREFIT-Chile</brief_title> <acronym>PREFIT-Chile</acronym> <official_title>Preschool Children: Fit, Healthy and Smart: PREFIT-Chile - Study Linking Physical Fitness to Non Invasive Health-Related Markers and Executive Function</official_title> <sponsors> <lead_sponsor> <agency>Playa Ancha University</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>University of Chile</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Universidad de Granada</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Playa Ancha University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Introduction: Investigating the interrelationship between physical condition, non-invasive health markers and executive function in preschoolers, is based on the current health and cognitive development situation of this population, especially the low socioeconomic level. National figures estimate that the prevalence of overweight / obesity in the preschool population reaches 53.6%, exposing not only the development of cardiovascular and metabolic diseases, but also affect cognitive potential.  Physical condition is a powerful health marker independent of nutritional status. Its evaluation together with the evaluation of non-invasive health markers and executive function in preschoolers inside educational establishments is essential to investigate alterations at an early age that could be prevented with adequate interventions in schools. However, to achieve this, valid, reliable and comparable tools are needed internationally.  Objective: to analyze the factors that affect the configuration of a diagnostic model which includes the physical fitness and physical activity levels, motor development, non-invasive risk factors and neuropsychological development in preschoolers.  Methods: Observational study, case only, cross sectional. Enrollment 544 preschool child 4 to 5 years old. Primary Outcome is Physical fitness to "Prefit Battery", Secondary outcome non-invasive risk factors (Blood pressure, BMI, Waist circumference, neck circumference) Physical activity, Motor skills and Neuropsychological development.  expected results: Determine the degree of association of physical fitness with non-invasive risk factors and neuropsychological development in preschoolers, determine the influence that physical activity level and motor development have on physical fitness and development a diagnostic model which includes the physical fitness and physical activity levels, motor development, non-invasive risk factors and neuropsychological development in Chilean preschoolers. </textblock> </brief_summary> <detailed_description> <textblock> In recent years it has been demonstrated that physical fitness , which is linked to a higher level of physical activity has a positive effect on the health status of adults, adolescents and children, especially by lowering the probability of developing overweight and/or obesity. At the same time, recent research has shown that there is a positive relationship between fitness with brain structure and executive function in children.  In Chile, overweight and obesity constitute a public health problem in children. National figures show that the prevalence of overweight / obesity among preschool children reached 53.6% in 2018 exposing the children not only the development of cardiovascular and metabolic diseases , but also affecting motor and cognitive development. Obesity has been shown to influence a country´s economic development, such as salary and productivity. The Economic Commission for Latin America and the Caribbean in 2017 determined that the health cost derived from obesity In Chile was equivalent to 0,2% of the national Gross Domestic Product. It is expected that by 2078, the estimated annual cost produced by an increasing prevalence overweight / obesity will be approximately 1 billion dollars.  Because it is not economically viable in Chile to determine in every overweight/obese child the probability of developing chronic diseases later in life, it is of utmost importance to have valid, simple and reliable indicators to discriminate at an early age, children that are at greatest risk. In this respect, physical fitness appears as a powerful health marker independent of the nutritional status. Evaluation of fitness as well as that of non-invasive health markers, motor development and neuropsychological development in preschool children in schools, constitute an excellent opportunity to investigate at an early age, alterations that could be prevented with adequate interventions in schools that would probably be significantly less costly than interventions applied later on. To achieve this goal, valid and reliable tools have to be developed that are also comparable with similar ones developed elsewhere.  With this background, The research objective is to analyze the factors that affect the configuration of a diagnostic model which includes the physical fitness and physical activity levels, motor development, non-invasive risk factors and neuropsychological development in preschoolers.  The hypothesis is that there is a positive association between physical fitness, non-invasive health markers and neuropsychological functions in preschool children, thus enabling to generate a predictive diagnostic model based on physical fitness.  1. The primary outcome is to determine the degree of association of physical fitness with non-invasive risk factors and neuropsychological development in preschoolers  2. The second outcome is to determine the influence that physical activity level and motor development have on physical fitness among preschool children.  This research aims a) to establish that physical fitness in preschool children may be considered as a diagnostic tool of the health status of children (independent of their nutritional status), and b) to determine the possible impact that the physical fitness level has on neuropsychological development </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">June 1, 2019</start_date> <completion_date type="Actual">March 30, 2020</completion_date> <primary_completion_date type="Actual">March 30, 2020</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Only</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>Measurement of "Physical fitness"</measure> <time_frame>"1 Day" on "45 minute"</time_frame> <description>Results from PREFIT battery; is composed of the following tests: the 20 m shuttle-run test for assessing cardiorespiratory fitness, the handgrip-strength and the standing long-jump tests for assessing muscular musculoskeletal fitness, and the 4x10 m shuttle-run.</description> </primary_outcome> <secondary_outcome> <measure>Measurement "Blood Pressure"</measure> <time_frame>"1 Day" on "15 minutes"</time_frame> <description>Measured in the right arm, The child stay a quiet for 3-5 min before measurement, with the back supported and feet uncrossed on the floor.</description> </secondary_outcome> <secondary_outcome> <measure>Estimated "Body Mass Index"</measure> <time_frame>"1 Day" on "10 minute"</time_frame> <description>Measured the weight (kg) and Height (m), then applicate the equation weight/height^2 to determinate de value.</description> </secondary_outcome> <secondary_outcome> <measure>Measurement "Waist circumference"</measure> <time_frame>"1 Day" on "10 minutes"</time_frame> <description>The child stands erect with the abdomen relaxed, the arms at the sides and the feet together. The tester faces the child and places an inelastic tape around him / her, in a horizontal plane, The measurement will be made at the level of the navel and so that the tape forms a horizontal plane parallel to the ground.</description> </secondary_outcome> <secondary_outcome> <measure>Measurement "neck circumference"</measure> <time_frame>"1 Day" on "10 minute"</time_frame> <description>The child stands tall, arms at the sides and feet together. The tester looks at the Child and places an inelastic tape around of thyroid cartilage</description> </secondary_outcome> <secondary_outcome> <measure>Measurement "Physical activity"</measure> <time_frame>"7 Days"</time_frame> <description>The equipment will be located in the right hip area with an adjustable elastic belt. Record the information with an interval of 15 seconds (time) with a frequency of 100 Hz, the above is executed by means of the Actilife-6 software</description> </secondary_outcome> <secondary_outcome> <measure>Measurement "Motor Skills"</measure> <time_frame>"1 Day" "45 minutes"</time_frame> <description>the standardized instrument called Test of Gross Motor Development (TGMD-2) will be used. Which measures 12 gross motor skills</description> </secondary_outcome> <secondary_outcome> <measure>Measurement "Neuropsychological development"</measure> <time_frame>"1Day" "30 minutes"</time_frame> <description>It will be evaluated by means of standardized tests, battery of child computerized neuropsychological evaluation (BENCI), which requires children to perform a series of activities on an iPad, where the following functions will be evaluated: Visomotor coordination, Processing speed, Language and Executive function (only in 5 years)</description> </secondary_outcome> <enrollment type="Actual">868</enrollment> <condition>Child, Preschool</condition> <eligibility> <study_pop> <textblock> Preschoolers from 4 to 5 years old, incorporated into the school system and attending kindergartens and schools, residents of the central area of Chile, to detail IV region of "Coquimbo", V region of "Valparaíso", VI region of the "Liberator Bernardo O'Higgins" and the "Metropolitan" Region </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Preschool child, 4 to 5 years old, Speaking Spanish and Agree to the commitment  Exclusion Criteria:  - Chronic pediatric disease (except for obesity) Cardiovascular or metabolic disease, neurological, respiratory bronchial disease and Orthopedic limitation. </textblock> </criteria> <gender>All</gender> <minimum_age>4 Years</minimum_age> <maximum_age>5 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Johana P Soto-Sánchez, PhD</last_name> <role>Principal Investigator</role> <affiliation>Playa Ancha University</affiliation> </overall_official> <location> <facility> <name>Playa Ancha University</name> <address> <city>Valparaíso</city> <zip>2340000</zip> <country>Chile</country> </address> </facility> </location> <location_countries> <country>Chile</country> </location_countries> <reference> <citation>Burkhalter TM, Hillman CH. A narrative review of physical activity, nutrition, and obesity to cognition and scholastic performance across the human lifespan. Adv Nutr. 2011 Mar;2(2):201S-6S. doi: 10.3945/an.111.000331. Epub 2011 Mar 10.</citation> <PMID>22332052</PMID> </reference> <results_reference> <citation>Chaddock-Heyman L, Erickson KI, Holtrop JL, Voss MW, Pontifex MB, Raine LB, Hillman CH, Kramer AF. Aerobic fitness is associated with greater white matter integrity in children. Front Hum Neurosci. 2014 Aug 19;8:584. doi: 10.3389/fnhum.2014.00584. eCollection 2014.</citation> <PMID>25191243</PMID> </results_reference> <results_reference> <citation>Chaddock-Heyman L, Hillman CH, Cohen NJ, Kramer AF. III. The importance of physical activity and aerobic fitness for cognitive control and memory in children. Monogr Soc Res Child Dev. 2014 Dec;79(4):25-50. doi: 10.1111/mono.12129.</citation> <PMID>25387414</PMID> </results_reference> <results_reference> <citation>Junta Nacional Escolar de Auxilio y Becas (JUNAEB). Informe Mapa Nutricional 2018 de Chile. Lira, M. 2019</citation> </results_reference> <results_reference> <citation>Fernández, A., Martínez, R., Carrasco, I., & Palma, A. (2017). Impacto social y económico de la malnutrición: modelo de análisis y estudio piloto en Chile, el Ecuador y México. Retrieved from https://www.cepal.org/es/publicaciones/41247-impacto-social-economico-la-malnutricion-modelo-analisis-estudio-piloto-chile</citation> </results_reference> <results_reference> <citation>Ortega FB, Cadenas-Sanchez C, Sanchez-Delgado G, Mora-Gonzalez J, Martinez-Tellez B, Artero EG, Castro-Pinero J, Labayen I, Chillon P, Lof M, Ruiz JR. Systematic review and proposal of a field-based physical fitness-test battery in preschool children: the PREFIT battery. Sports Med. 2015 Apr;45(4):533-55. doi: 10.1007/s40279-014-0281-8.</citation> <PMID>25370201</PMID> </results_reference> <verification_date>September 2020</verification_date> <study_first_submitted>February 7, 2020</study_first_submitted> <study_first_submitted_qc>February 12, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>September 14, 2020</last_update_submitted> <last_update_submitted_qc>September 14, 2020</last_update_submitted_qc> <last_update_posted type="Actual">September 16, 2020</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Playa Ancha University</investigator_affiliation> <investigator_full_name>Johana Soto Sánchez</investigator_full_name> <investigator_title>Physical Education Teacher</investigator_title> </responsible_party> <keyword>Physical fitness</keyword> <keyword>Risk factors</keyword> <keyword>Anthropometrics</keyword> <keyword>Blood pressure</keyword> <keyword>Neuropsychological Tests</keyword> <keyword>Physical activity</keyword> <keyword>Motor skills</keyword> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Introduction: Investigating the interrelationship between physical condition, non-invasive health markers and executive function in preschoolers, is based on the current health and cognitive development situation of this population, especially the low socioeconomic level. National figures estimate that the prevalence of overweight / obesity in the preschool population reaches 53.6%, exposing not only the development of cardiovascular and metabolic diseases, but also affect cognitive potential. Physical condition is a powerful health marker independent of nutritional status. Its evaluation together with the evaluation of non-invasive health markers and executive function in preschoolers inside educational establishments is essential to investigate alterations at an early age that could be prevented with adequate interventions in schools. However, to achieve this, valid, reliable and comparable tools are needed internationally. Objective: to analyze the factors that affect the configuration of a diagnostic model which includes the physical fitness and physical activity levels, motor development, non-invasive risk factors and neuropsychological development in preschoolers. Methods: Observational study, case only, cross sectional. Enrollment 544 preschool child 4 to 5 years old. Primary Outcome is Physical fitness to "Prefit Battery", Secondary outcome non-invasive risk factors (Blood pressure, BMI, Waist circumference, neck circumference) Physical activity, Motor skills and Neuropsychological development. expected results: Determine the degree of association of physical fitness with non-invasive risk factors and neuropsychological development in preschoolers, determine the influence that physical activity level and motor development have on physical fitness and development a diagnostic model which includes the physical fitness and physical activity levels, motor development, non-invasive risk factors and neuropsychological development in Chilean preschoolers. In recent years it has been demonstrated that physical fitness , which is linked to a higher level of physical activity has a positive effect on the health status of adults, adolescents and children, especially by lowering the probability of developing overweight and/or obesity. At the same time, recent research has shown that there is a positive relationship between fitness with brain structure and executive function in children. In Chile, overweight and obesity constitute a public health problem in children. National figures show that the prevalence of overweight / obesity among preschool children reached 53.6% in 2018 exposing the children not only the development of cardiovascular and metabolic diseases , but also affecting motor and cognitive development. Obesity has been shown to influence a country´s economic development, such as salary and productivity. The Economic Commission for Latin America and the Caribbean in 2017 determined that the health cost derived from obesity In Chile was equivalent to 0,2% of the national Gross Domestic Product. It is expected that by 2078, the estimated annual cost produced by an increasing prevalence overweight / obesity will be approximately 1 billion dollars. Because it is not economically viable in Chile to determine in every overweight/obese child the probability of developing chronic diseases later in life, it is of utmost importance to have valid, simple and reliable indicators to discriminate at an early age, children that are at greatest risk. In this respect, physical fitness appears as a powerful health marker independent of the nutritional status. Evaluation of fitness as well as that of non-invasive health markers, motor development and neuropsychological development in preschool children in schools, constitute an excellent opportunity to investigate at an early age, alterations that could be prevented with adequate interventions in schools that would probably be significantly less costly than interventions applied later on. To achieve this goal, valid and reliable tools have to be developed that are also comparable with similar ones developed elsewhere. With this background, The research objective is to analyze the factors that affect the configuration of a diagnostic model which includes the physical fitness and physical activity levels, motor development, non-invasive risk factors and neuropsychological development in preschoolers. The hypothesis is that there is a positive association between physical fitness, non-invasive health markers and neuropsychological functions in preschool children, thus enabling to generate a predictive diagnostic model based on physical fitness. 1. The primary outcome is to determine the degree of association of physical fitness with non-invasive risk factors and neuropsychological development in preschoolers 2. The second outcome is to determine the influence that physical activity level and motor development have on physical fitness among preschool children. This research aims a) to establish that physical fitness in preschool children may be considered as a diagnostic tool of the health status of children (independent of their nutritional status), and b) to determine the possible impact that the physical fitness level has on neuropsychological development Preschoolers from 4 to 5 years old, incorporated into the school system and attending kindergartens and schools, residents of the central area of Chile, to detail IV region of "Coquimbo", V region of "Valparaíso", VI region of the "Liberator Bernardo O'Higgins" and the "Metropolitan" Region Inclusion Criteria: - Preschool child, 4 to 5 years old, Speaking Spanish and Agree to the commitment Exclusion Criteria: - Chronic pediatric disease (except for obesity) Cardiovascular or metabolic disease, neurological, respiratory bronchial disease and Orthopedic limitation.

NCT0426xxxx/NCT04269148.xml

<clinical_study>  <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/NCT04269148</url> </required_header> <id_info> <org_study_id>2018-147</org_study_id> <nct_id>NCT04269148</nct_id> </id_info> <brief_title>Validity and Reliability of the Turkish Version of the McMaster University Head and Neck Radiotherapy Questionnaire</brief_title> <official_title>Validity and Reliability of the Turkish Version of the McMaster University Head and Neck Radiotherapy Questionnaire</official_title> <sponsors> <lead_sponsor> <agency>Izmir Bakircay University</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Gazi University</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Izmir Bakircay University</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> More than half of the patients with head and neck cancer are locally advanced patients. Radiotherapy is the primary treatment option for many patients with stage III and stage IV diagnosed with head and neck cancer. Radiation often causes tissue reactions by increasing local symptoms of the tumor and adding new symptoms to them. The acute effects of radiation are pain and burns associated with mucosal irritations and skin irritations, the root smell of the necrotic tumor and damaged normal tissues, dry skin, skin irritation, pain and dryness of mucosal membranes, decreased appetite, loss of chewing and swallowing skills, and hoarseness. The aim of this study is to make the validity, reliability and cultural adaptation of McMaster University Head and Neck Radiotherapy Inventory in Turkish. </textblock> </brief_summary> <detailed_description> <textblock> Although there are various surveys in the literature that evaluate the quality of life of head and neck cancer patients, apart from the "McMaster University Head and Neck Radiotherapy Questionnaire", there is no other questionnaire designed specifically for local advanced stage III and stage IV head and neck cancer and treatment of specific morbidity at a certain time. Patients in these stages often have difficulties in oral communication, nutritional disorders and loss of chewing and swallowing skills leading to dehydration, bad mouth odors, appearance problems affecting social and family life, and often significant morbidity including severe pain symptoms. </textblock> </detailed_description> <overall_status>Unknown status</overall_status> <last_known_status>Recruiting</last_known_status> <start_date type="Actual">March 13, 2020</start_date> <completion_date type="Anticipated">December 2021</completion_date> <primary_completion_date type="Anticipated">October 2021</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Other</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>McMaster University Head and Neck Radiotherapy Questionnaire</measure> <time_frame>At baseline</time_frame> <description>McMaster University Head and Neck Radiotherapy Questionnaire: This questionnaire includes 22 questions covering signs and symptoms related to 6 categories: oral cavity, throat, skin, digestive system, energy and psychosocial. n each category, there are at least 3 questions related to that category. There are 7 possible answer options in each question using Likert scale. High scores obtained according to the scoring system used indicate low toxicity. The final score of the survey is expressed as the average of the scores from 22 questions. In addition, the independent scores of each category are the average of the scores from the questions belonging to that category [1].</description> </primary_outcome> <secondary_outcome> <measure>The Functional Assessment of Cancer Therapy - Head and Neck Cancer Version 4</measure> <time_frame>At baseline</time_frame> <description>This scale consists of 5 categories that evaluate physical (7 items), social (7 items), emotional (6 items), functional status (7 items) and a subscale consisting of 11 questions specifically developed for head and neck cancer. In this assessment consisting of 38 items in total, each field can be scored among themselves and a total score is also calculated. The increase in the total score shows that the quality of life is higher. Each item is scored by patients with a Likert type classification ranging from 0 (none) to 4 (too many).</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Anticipated">90</enrollment> <condition>Quality of Life</condition> <condition>Head and Neck Cancer</condition> <arm_group> <arm_group_label>Head and Neck Cancer patients</arm_group_label> <description>Turkish patients diagnosed with head and neck cancer</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>Measurement of Quality of Life</intervention_name> <description>Quality of life will be measured using McMaster University Head and Neck Radiotherapy Questionnaire and The Functional Assessment of Cancer Therapy - Head and Neck Cancer Version 4</description> <arm_group_label>Head and Neck Cancer patients</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Turkish patients diagnosed with head and neck patients </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Voluntarily accepting to participate in the study  - Patients whose native language is Turkish  - Undergoing or receiving radiotherapy treatment  - At least 3 weeks have passed since the beginning of radiotherapy  Exclusion Criteria:  - The patient does not have sufficient functions of bone marrow, liver and kidney  - To have scored less than 70 from Karnofsky Performance Scale </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>80 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Kadirhan Ozdemir, PhD.</last_name> <phone>+905069439059</phone> <email>kadirhanozdemir@gmail.com</email> </overall_contact> <location> <facility> <name>Kadirhan Ozdemir</name> <address> <city>İzmir</city> <zip>06580</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Kadirhan Ozdemir</last_name> <phone>05069439059</phone> <email>kadirhanozdemir@gmail.com</email> </contact> </location> <location_countries> <country>Turkey</country> </location_countries> <reference> <citation>Browman GP, Levine MN, Hodson DI, Sathya J, Russell R, Skingley P, Cripps C, Eapen L, Girard A. The Head and Neck Radiotherapy Questionnaire: a morbidity/quality-of-life instrument for clinical trials of radiation therapy in locally advanced head and neck cancer. J Clin Oncol. 1993 May;11(5):863-72. doi: 10.1200/JCO.1993.11.5.863.</citation> <PMID>8487051</PMID> </reference> <reference> <citation>List MA, D'Antonio LL, Cella DF, Siston A, Mumby P, Haraf D, Vokes E. The Performance Status Scale for Head and Neck Cancer Patients and the Functional Assessment of Cancer Therapy-Head and Neck Scale. A study of utility and validity. Cancer. 1996 Jun 1;77(11):2294-301. doi: 10.1002/(SICI)1097-0142(19960601)77:113.0.CO;2-S.</citation> <PMID>8635098</PMID> </reference> <reference> <citation>Webster K, Cella D, Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System: properties, applications, and interpretation. Health Qual Life Outcomes. 2003 Dec 16;1:79. doi: 10.1186/1477-7525-1-79.</citation> <PMID>14678568</PMID> </reference> <verification_date>September 2021</verification_date> <study_first_submitted>February 8, 2020</study_first_submitted> <study_first_submitted_qc>February 12, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>September 1, 2021</last_update_submitted> <last_update_submitted_qc>September 1, 2021</last_update_submitted_qc> <last_update_posted type="Actual">September 2, 2021</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Izmir Bakircay University</investigator_affiliation> <investigator_full_name>Kadirhan Ozdemir, PT, PhD.</investigator_full_name> <investigator_title>Head of Geriatric Rehabilitation Department</investigator_title> </responsible_party>  </clinical_study>

More than half of the patients with head and neck cancer are locally advanced patients. Radiotherapy is the primary treatment option for many patients with stage III and stage IV diagnosed with head and neck cancer. Radiation often causes tissue reactions by increasing local symptoms of the tumor and adding new symptoms to them. The acute effects of radiation are pain and burns associated with mucosal irritations and skin irritations, the root smell of the necrotic tumor and damaged normal tissues, dry skin, skin irritation, pain and dryness of mucosal membranes, decreased appetite, loss of chewing and swallowing skills, and hoarseness. The aim of this study is to make the validity, reliability and cultural adaptation of McMaster University Head and Neck Radiotherapy Inventory in Turkish. Although there are various surveys in the literature that evaluate the quality of life of head and neck cancer patients, apart from the "McMaster University Head and Neck Radiotherapy Questionnaire", there is no other questionnaire designed specifically for local advanced stage III and stage IV head and neck cancer and treatment of specific morbidity at a certain time. Patients in these stages often have difficulties in oral communication, nutritional disorders and loss of chewing and swallowing skills leading to dehydration, bad mouth odors, appearance problems affecting social and family life, and often significant morbidity including severe pain symptoms. Turkish patients diagnosed with head and neck patients Inclusion Criteria: - Voluntarily accepting to participate in the study - Patients whose native language is Turkish - Undergoing or receiving radiotherapy treatment - At least 3 weeks have passed since the beginning of radiotherapy Exclusion Criteria: - The patient does not have sufficient functions of bone marrow, liver and kidney - To have scored less than 70 from Karnofsky Performance Scale

NCT0426xxxx/NCT04269161.xml

<clinical_study>  <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/NCT04269161</url> </required_header> <id_info> <org_study_id>2003117</org_study_id> <nct_id>NCT04269161</nct_id> </id_info> <brief_title>NICU Oxygen Control Study</brief_title> <official_title>NICU Oxygen Control Study</official_title> <sponsors> <lead_sponsor> <agency>University of Missouri-Columbia</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Sacred Heart Health System</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University of Missouri-Columbia</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_unapproved_device>Yes</is_unapproved_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> Prematurely born infants in the hospital neonatal intensive care unit (NICU) will be included in the study. This clinical trial is a randomized crossover study to show that our automated oxygen control device performance is no worse than a NICU nurse in keeping a premature neonate's SPO2 within the prescribed range. Since subjects receive the device (automatic oxygen control) and the standard of care (manual control by a nurse), every subject serves as their own perfectly matched control. Performance measures include the average time it takes for the SpO2 to return to the desired range (primary endpoint) and the total amount of time that the SpO2 is within the desired range (secondary endpoint). The device will be applied to premature infants on respiratory support humidified high flow nasal cannula (HFNC) with oxygen controlled using a blend valve. Two groups include one that begins the study period with the device and one that begins the study period without the device. The two groups are switched between manual and automatic every 6 hours into the trial period and complete a total of 6 days. The target number of subjects is 60. We will analyze the study as a superiority trial if there is strong evidence of superiority. </textblock> </brief_summary> <detailed_description> <textblock> We intend to enroll between 20-30 subjects at each of two separate institutions (University of Missouri Women's and Children's Hospital and Studer Family Children's Hospital in Pensacola, FL). The subjects will be premature infants <34 weeks post conceptual age (PCA) requiring respiratory support. This randomized clinical trial will utilize a 24 period 2 treatment crossover design to show that the device performs no worse than (non-inferiority trial) an NICU nurse in keeping a premature neonate's SpO2 within the prescribed range while the infant is on respiratory support. Due to the nature of the study, any masking of the intervention is not possible. Upon enrollment, the subjects will be randomized into enrollment in two groups (A and B). The primary endpoint will be the mean time required to re-establish SpO2 within the prescribed range, as measured from the time an out-of-range alarm is triggered. A secondary endpoint will be proportion of time SpO2 is within the prescribed range, using an area-under-the-curve approach (with a discrete state) to account for varying time-on-test. These outcome measures are complementary because the former doesn't account for the number of alarms, while the latter does. This is important because the oxygen control device operates continuously in a proactive manner, rather than only reacting due alarms, so it is doing more than mimicking the nurse -- the second measure allows us to capture that.  Group A will initially have the automatic device interface with HFNC for 6 hours. The device will have the target SpO2 parameters ordered by the treating physician input into the device. A study laptop will interface with the device, cardiopulmonary monitor, and pulse oximeter to record the data for the study. Sensors will be used to record all adjustments to the device/respiratory support equipment (i.e. blend valve and flow valve used in HFNC). These sensors will continuously record the data for later analysis. The device will constantly evaluate data sent to it from the pulse oximeter and bedside monitor recording all of the data and alarms. In response to alarms, displayed data, doctor's orders, etc., nurses will continue to apply manual inputs to make adjustments to flow and provide tactile stimulus to the subject but not adjust FiO2 unless manual mode is selected. Recorded sensor measurements and manual inputs by the nurse will be used to refine the existing models as well as new models of response in HR, RR, and SpO2 to flow adjustments and tactile stimulus.  After the first 6 hours, the device will be switched to manual mode for the subject (nurse makes all adjustments for FiO2), but the laptop and sensor data logging system will continue to record data from the patient and the respiratory support equipment. This will record the information for the nurse intervention/baseline care part of the study, which continue for 6 hours. During the entire process, the bedside nurse will keep a diary of any events/interventions using the time prominently displayed on the monitoring laptop. This "time-stamped" diary system will allow for easier retrieval of and comparison to the data from the device and monitoring laptop. Also, the monitoring laptop will have a record of all the data, including alarms from the pulse oximeter as well as the bedside monitor to allow for easier retrieval of data related to alarm events and interventions. The laptop will also record any interventions made by the device to allow for easier retrieval of data related to device interventions. The treatment will then alternate periods of each treatment for a total of 6 days (24 6-hour periods).  Group B will have the exact opposite order as group A. Group B infants will initially have the laptop interface with all of the monitors and sensor measurements. However, the nurse intervention/baseline care stage of the study will take place for the first 6 hours. Next, group B will have the device interface with their respiratory equipment, and the data will be recorded as described above for the next 6 hours of the study. The the treatment will alternate every 6 hours for a total of 6 days.  This design was chosen because the premature infants should have fewer events as they grow older each day, and it will help take into account this potential bias. Also, the subjects will be randomized to group A or B in sets of 8 (i.e. in each group of 8 envelopes, 4 will be group A and 4 will be group B). During the entire study process the infants will receive normal NICU care and the parameters for the SpO2 range will be set by the physician caring for the infant. There are also built in manual overrides for the device which allow the NICU to make changes while the subject is on the device phase of the study. The device will be able to record these changes and the staff will record their manual interventions in the study diary.  We have planned our sample size using a non-inferiority test for a cross-over design, based on our primary endpoint, t_delta. For a given patient, define t_delta = (mean elapsed time needed for device to re-establish SpO2 after alarm) - (mean elapsed time needed for nurse to re-establish SpO2 after alarm). The margin of non- inferiority will be chosen as t_delta > -10 sec, so that a device which is no worse than 10 sec, on average, than a nurse will be considered non-inferior. Assuming the standard deviation of t_delta =12 and the true mean difference is zero under the alternate hypothesis, a sample size of 48 achieves 88% with alpha=0.05. If there is 16% patient drop-out before crossover, so that the final n=40, the power drops to 82%. In all analysis, a (paired) t-test will be used. Our secondary endpoint is secondary endpoint is the proportion of time SpO2 is within the prescribed range, using an area-under-the-curve approach (with a discrete state) to account for varying time-on-test. Our secondary endpoint will be analyzed in a similar manner.  We will plan for one interim analysis to determine if the trial should be stoopped early due to futility (strong evidence of inferiority, where a confidence interval for t_delta lies entirely to the left of -10 and doesn't intersect -10) or for efficacy (strong evidence of superiority with margin > +20 sec). This will be carried out when n=32 (16 subjects per site) is attained and stopping decisions will be based on O'Brien-Fleming stopping principles. The interim analysis will be carried out by an independent statistician on the University of Missouri's Data Safety and Monitoring Committee, which is also available to monitor the study for adverse events if requested by the IRB. In the event that the patient drop-out is greater than 16% before crossover, then a more complicated estimation procedure will be employed using mixed effects models; otherwise, complete cases will be used. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 24, 2022</start_date> <completion_date type="Anticipated">May 17, 2024</completion_date> <primary_completion_date type="Anticipated">May 17, 2024</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>Randomized</allocation> <intervention_model>Crossover Assignment</intervention_model> <primary_purpose>Basic Science</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Nurse elapsed time to respond to SpO2 alarm.</measure> <time_frame>Desaturation events occurring over the 12 6-hour manual study periods.</time_frame> <description>Mean elapsed time needed for the nurse to re- establish SpO2 within the desired range after an alarm. The alarms and alarm times are recorded directly from the bedside monitor and the responses are measured directly in terms of the blend valve position and SpO2 response measured by the pulse oximeter.</description> </primary_outcome> <primary_outcome> <measure>Device elapsed time to respond to SpO2 alarm.</measure> <time_frame>Desaturation events occurring over the 12 6-hour manual study periods.</time_frame> <description>Mean elapsed time needed for the device to re- establish SpO2 within the desired range after an alarm. The alarms and alarm times are recorded directly from the bedside monitor and the responses are measured directly in terms of the blend valve position and SpO2 response measured by the pulse oximeter.</description> </primary_outcome> <secondary_outcome> <measure>Time SpO2 is within the prescribed range for manual control by the nurse.</measure> <time_frame>The 12 6-hour manual study periods.</time_frame> <description>Proportion of time SpO2 is within the prescribed range computed using an area-under-the-curve approach for data taken during manual control by the nurse.</description> </secondary_outcome> <secondary_outcome> <measure>Time SpO2 is within the prescribed range for automatic control by the device.</measure> <time_frame>The 12 6-hour manual study periods.</time_frame> <description>Proportion of time SpO2 is within the prescribed range computed using an area-under-the-curve approach for data taken during automatic control using the device.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">60</enrollment> <condition>Hyperoxia</condition> <condition>Hypoxia</condition> <arm_group> <arm_group_label>Automatic Oxygen Control</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>In this arm, an automatic oxygen control device will be used to make adjustments to the blend of oxygen and air supplied to the subject.</description> </arm_group> <arm_group> <arm_group_label>Manual Oxygen Control</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>In this arm, a nurse will manually make adjustments to the blend of oxygen and air supplied to the subject as in the standard of care.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Automatic control of inspired oxygen</intervention_name> <description>A device will be used to automatically adjust the blend of oxygen and air with the ability to return to manual control as needed.</description> <arm_group_label>Automatic Oxygen Control</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Infants admitted to the NICU  - Less than 31 weeks estimated gestational age or less than 1500 grams at birth  - Currently on high flow nasal cannula or bubble CPAP  - Require at least 2 adjustments to the FiO2 per shift and/or have at least 2 desaturation events per shift  Exclusion Criteria:  - Infants admitted to the NICU with congenital heart disease.  - Infants who are set on a minimum FiO2 set point by their healthcare provider </textblock> </criteria> <gender>All</gender> <minimum_age>N/A</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>John A Pardalos, MD</last_name> <role>Principal Investigator</role> <affiliation>University of Missouri-Columbia</affiliation> </overall_official> <overall_contact> <last_name>John A Pardalos, MD</last_name> <phone>(573) 882-2272</phone> <email>Pardalosj@health.missouri.edu</email> </overall_contact> <location> <facility> <name>Studer Family Children's Hospital at Sacred Heart</name> <address> <city>Pensacola</city> <state>Florida</state> <zip>32513-2700</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Ramak R Amjad, MD</last_name> <phone>850-416-7000</phone> </contact> <investigator> <last_name>Ramak R Amjad, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>University of Missouri</name> <address> <city>Columbia</city> <state>Missouri</state> <zip>65212</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>John A Pardalos, MD</last_name> <phone>573-882-2272</phone> <email>Pardalosj@health.missouri.edu</email> </contact> <investigator> <last_name>John A Pardalos, MD</last_name> <role>Principal Investigator</role> </investigator> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>May 2023</verification_date> <study_first_submitted>February 11, 2020</study_first_submitted> <study_first_submitted_qc>February 11, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>May 19, 2023</last_update_submitted> <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 22, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>University of Missouri-Columbia</investigator_affiliation> <investigator_full_name>Roger C Fales</investigator_full_name> <investigator_title>Associate Professor of Mechanical and Aerospace Engineering</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Hypoxia</mesh_term> <mesh_term>Hyperoxia</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

Prematurely born infants in the hospital neonatal intensive care unit (NICU) will be included in the study. This clinical trial is a randomized crossover study to show that our automated oxygen control device performance is no worse than a NICU nurse in keeping a premature neonate's SPO2 within the prescribed range. Since subjects receive the device (automatic oxygen control) and the standard of care (manual control by a nurse), every subject serves as their own perfectly matched control. Performance measures include the average time it takes for the SpO2 to return to the desired range (primary endpoint) and the total amount of time that the SpO2 is within the desired range (secondary endpoint). The device will be applied to premature infants on respiratory support humidified high flow nasal cannula (HFNC) with oxygen controlled using a blend valve. Two groups include one that begins the study period with the device and one that begins the study period without the device. The two groups are switched between manual and automatic every 6 hours into the trial period and complete a total of 6 days. The target number of subjects is 60. We will analyze the study as a superiority trial if there is strong evidence of superiority. We intend to enroll between 20-30 subjects at each of two separate institutions (University of Missouri Women's and Children's Hospital and Studer Family Children's Hospital in Pensacola, FL). The subjects will be premature infants <34 weeks post conceptual age (PCA) requiring respiratory support. This randomized clinical trial will utilize a 24 period 2 treatment crossover design to show that the device performs no worse than (non-inferiority trial) an NICU nurse in keeping a premature neonate's SpO2 within the prescribed range while the infant is on respiratory support. Due to the nature of the study, any masking of the intervention is not possible. Upon enrollment, the subjects will be randomized into enrollment in two groups (A and B). The primary endpoint will be the mean time required to re-establish SpO2 within the prescribed range, as measured from the time an out-of-range alarm is triggered. A secondary endpoint will be proportion of time SpO2 is within the prescribed range, using an area-under-the-curve approach (with a discrete state) to account for varying time-on-test. These outcome measures are complementary because the former doesn't account for the number of alarms, while the latter does. This is important because the oxygen control device operates continuously in a proactive manner, rather than only reacting due alarms, so it is doing more than mimicking the nurse -- the second measure allows us to capture that. Group A will initially have the automatic device interface with HFNC for 6 hours. The device will have the target SpO2 parameters ordered by the treating physician input into the device. A study laptop will interface with the device, cardiopulmonary monitor, and pulse oximeter to record the data for the study. Sensors will be used to record all adjustments to the device/respiratory support equipment (i.e. blend valve and flow valve used in HFNC). These sensors will continuously record the data for later analysis. The device will constantly evaluate data sent to it from the pulse oximeter and bedside monitor recording all of the data and alarms. In response to alarms, displayed data, doctor's orders, etc., nurses will continue to apply manual inputs to make adjustments to flow and provide tactile stimulus to the subject but not adjust FiO2 unless manual mode is selected. Recorded sensor measurements and manual inputs by the nurse will be used to refine the existing models as well as new models of response in HR, RR, and SpO2 to flow adjustments and tactile stimulus. After the first 6 hours, the device will be switched to manual mode for the subject (nurse makes all adjustments for FiO2), but the laptop and sensor data logging system will continue to record data from the patient and the respiratory support equipment. This will record the information for the nurse intervention/baseline care part of the study, which continue for 6 hours. During the entire process, the bedside nurse will keep a diary of any events/interventions using the time prominently displayed on the monitoring laptop. This "time-stamped" diary system will allow for easier retrieval of and comparison to the data from the device and monitoring laptop. Also, the monitoring laptop will have a record of all the data, including alarms from the pulse oximeter as well as the bedside monitor to allow for easier retrieval of data related to alarm events and interventions. The laptop will also record any interventions made by the device to allow for easier retrieval of data related to device interventions. The treatment will then alternate periods of each treatment for a total of 6 days (24 6-hour periods). Group B will have the exact opposite order as group A. Group B infants will initially have the laptop interface with all of the monitors and sensor measurements. However, the nurse intervention/baseline care stage of the study will take place for the first 6 hours. Next, group B will have the device interface with their respiratory equipment, and the data will be recorded as described above for the next 6 hours of the study. The the treatment will alternate every 6 hours for a total of 6 days. This design was chosen because the premature infants should have fewer events as they grow older each day, and it will help take into account this potential bias. Also, the subjects will be randomized to group A or B in sets of 8 (i.e. in each group of 8 envelopes, 4 will be group A and 4 will be group B). During the entire study process the infants will receive normal NICU care and the parameters for the SpO2 range will be set by the physician caring for the infant. There are also built in manual overrides for the device which allow the NICU to make changes while the subject is on the device phase of the study. The device will be able to record these changes and the staff will record their manual interventions in the study diary. We have planned our sample size using a non-inferiority test for a cross-over design, based on our primary endpoint, t_delta. For a given patient, define t_delta = (mean elapsed time needed for device to re-establish SpO2 after alarm) - (mean elapsed time needed for nurse to re-establish SpO2 after alarm). The margin of non- inferiority will be chosen as t_delta > -10 sec, so that a device which is no worse than 10 sec, on average, than a nurse will be considered non-inferior. Assuming the standard deviation of t_delta =12 and the true mean difference is zero under the alternate hypothesis, a sample size of 48 achieves 88% with alpha=0.05. If there is 16% patient drop-out before crossover, so that the final n=40, the power drops to 82%. In all analysis, a (paired) t-test will be used. Our secondary endpoint is secondary endpoint is the proportion of time SpO2 is within the prescribed range, using an area-under-the-curve approach (with a discrete state) to account for varying time-on-test. Our secondary endpoint will be analyzed in a similar manner. We will plan for one interim analysis to determine if the trial should be stoopped early due to futility (strong evidence of inferiority, where a confidence interval for t_delta lies entirely to the left of -10 and doesn't intersect -10) or for efficacy (strong evidence of superiority with margin > +20 sec). This will be carried out when n=32 (16 subjects per site) is attained and stopping decisions will be based on O'Brien-Fleming stopping principles. The interim analysis will be carried out by an independent statistician on the University of Missouri's Data Safety and Monitoring Committee, which is also available to monitor the study for adverse events if requested by the IRB. In the event that the patient drop-out is greater than 16% before crossover, then a more complicated estimation procedure will be employed using mixed effects models; otherwise, complete cases will be used. Inclusion Criteria: - Infants admitted to the NICU - Less than 31 weeks estimated gestational age or less than 1500 grams at birth - Currently on high flow nasal cannula or bubble CPAP - Require at least 2 adjustments to the FiO2 per shift and/or have at least 2 desaturation events per shift Exclusion Criteria: - Infants admitted to the NICU with congenital heart disease. - Infants who are set on a minimum FiO2 set point by their healthcare provider

NCT0426xxxx/NCT04269174.xml

<clinical_study>  <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/NCT04269174</url> </required_header> <id_info> <org_study_id>AssiutU The utility of Biofire</org_study_id> <nct_id>NCT04269174</nct_id> </id_info> <brief_title>The Utility of Biofire Filmarray in Evaluation of Entero Pathogens Triggers in Patients With Chronic Diarrhea</brief_title> <official_title>The Utility of Biofire Filmarray in Evaluation of Entero Pathogens Triggers in Patients With Chronic Diarrhea</official_title> <sponsors> <lead_sponsor> <agency>Shaimaa Mahmoud Abd El-mouez</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Assiut University</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Chronic diarrhea is a common condition and a key symptom in many disorders. It is a major cause of morbidity and mortality worldwide and one of the most common reasons for referral to a gastroenterology clinic.The prevalence varies depending on population and the definition of diarrhea used. It affects approximately 5% of the population at any given point in time, although the exact prevalence is unknown. Diarrhea is associated with 4 pathophysiological mechanisms: osmotic, secretory, exudative and altered motility. It is more useful to classify patients presenting with symptoms of diarrhea according to ''functional'' or ''organic'' characteristics. It is usually difficult to make a reliable differentiation between organic and functional causes in patients with chronic diarrhea based only on history and physical examination .  The standard evaluation of patients with chronic diarrhea that begins with a detailed history, a careful physical examination and then basic diagnostic tests is critical for optimal treatment and prevention. Initially, thought needs to exclude several other possibilities as (a) fecal incontinence masquerading as diarrhea, (b) iatrogenic diarrhea due to drugs, surgery, or therapeutic radiation, (c) chronic infections, and (d) irritable bowel syndrome with diarrhea (IBS-D).  The detection of a broad array of potentially offending agents has traditionally required a combination of microbiologic approaches, including bacterial culture, antigen detection, microscopy, and polymerase chain reaction (PCR). The new multiplex PCR-based panels have several advantages over conventional methods including (i) reduced sample volume requirements, (ii) broad coverage without the need to select specific tests, (iii) enhanced ability to detect coinfections (iv) increased sensitivity and specificity as high as 97-100% and (v) higher throughput.The food and drug administration (FDA) cleared and recommended the use of FilmArray GI panel (BioFire Diagnostics), which targets 22 analytes (bacteria with bacterial toxin, viruses, and parasites) </textblock> </brief_summary> <detailed_description> <textblock> Investigations:  • Routine laboratory investigation: Complete blood picture and differential WBCs count, liver, kidney function tests, RBG, Na, K, CRP, ESR.  • Microbilogical Investigations:  To ensure that good specimens are provided for examination, it is important to note the following:  - A sterile clean dry container must be used for the collection of fecal samples.  - The specimen should be brought to the lab as soon as possible.  - The specimen container should be clearly labeled with the patient's name, date, and time of passage of the specimen.  A) Conventional methods:  Stool samples will be cultured on Selenite broth then subcultured on blood agar, chocolate agar, MacConkeys agar, Sorbitol MacConkys agar: Xylose Lysine Deoxycholate agar (XLD) ,Sabouraud dextrose agar (SDA), blood agar with 10um/ml ampicillin , Cambylobacter CVA agar plates.  1. Identification of the bacterial organism:  Pure colonies of isolated microorganisms were identified by:  - Morphology on agar.  - Gram stain film was made from the growth to identify morphology of the organism.  - Biochemical reactions tests.  2. Detection of antibiotic sensitivity pattern according to CLSI 2019 by disc diffusion method  3. Confirmation of results by automated microbial system VITEK 2Compact.  B) Multiplex PCR: for Identification of different causative organisms by Biofire microarray (BioMerieux,France) </textblock> </detailed_description> <overall_status>Unknown status</overall_status> <last_known_status>Not yet recruiting</last_known_status> <start_date type="Anticipated">February 2020</start_date> <completion_date type="Anticipated">January 2021</completion_date> <primary_completion_date type="Anticipated">December 2020</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Other</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>Evaluation of utility of multiplex PCR in diagnosis of patients with chronic diarrhea.</measure> <time_frame>one year</time_frame> <description>The performance of the FilmArray test in the diarrhea for each pathogen on the panel.</description> </primary_outcome> <primary_outcome> <measure>To identify antibiotic sensitivity pattern of microbes</measure> <time_frame>one year</time_frame> <description>Antibiotic sensitivity patterns for causative microbes.</description> </primary_outcome> <secondary_outcome> <measure>Epidemiology of infectious causes in chronic diarrhoea</measure> <time_frame>one year</time_frame> <description>causes of chronic diarrhoea of enrolled specimens will be evaluated at the end of the study.</description> </secondary_outcome> <enrollment type="Anticipated">50</enrollment> <condition>Chronic Diarrhoea</condition> <condition>Antibiotic Resistant Strain</condition> <condition>Polymerase Chain Reaction</condition> <eligibility> <study_pop> <textblock> patients with chronic diarrhea recruited from Al-Rajhi Liver Hospital, Assiut University Hospitals, Assiut, Egypt.  1. Inclusion criteria:  Patients with diarrhea > 4 weeks  2. Exclusion criteria:  Age below 18 years old and diarhhoea < 4 weeks. </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Patients with diarrhea > 4 weeks  Exclusion Criteria:  - Age below 18 years old and diarhhoea < 4 weeks. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Shaimaa M Abd Elmouez, doctor</last_name> <phone>0201206053222</phone> <email>shaimaamahmoud886@gmail.com</email> </overall_contact> <overall_contact_backup> <last_name>asmaa om ahmed, professor</last_name> <phone>0201033153328</phone> <email>asomar_12@yahoo.com</email> </overall_contact_backup> <results_reference> <citation>Maharshak N, Ringel Y, Katibian D, Lundqvist A, Sartor RB, Carroll IM, Ringel-Kulka T. Fecal and Mucosa-Associated Intestinal Microbiota in Patients with Diarrhea-Predominant Irritable Bowel Syndrome. Dig Dis Sci. 2018 Jul;63(7):1890-1899. doi: 10.1007/s10620-018-5086-4. Epub 2018 May 17.</citation> <PMID>29777439</PMID> </results_reference> <results_reference> <citation>Buss SN, Leber A, Chapin K, Fey PD, Bankowski MJ, Jones MK, Rogatcheva M, Kanack KJ, Bourzac KM. Multicenter evaluation of the BioFire FilmArray gastrointestinal panel for etiologic diagnosis of infectious gastroenteritis. J Clin Microbiol. 2015 Mar;53(3):915-25. doi: 10.1128/JCM.02674-14. Epub 2015 Jan 14.</citation> <PMID>25588652</PMID> </results_reference> <verification_date>February 2020</verification_date> <study_first_submitted>February 11, 2020</study_first_submitted> <study_first_submitted_qc>February 12, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>February 12, 2020</last_update_submitted> <last_update_submitted_qc>February 12, 2020</last_update_submitted_qc> <last_update_posted type="Actual">February 17, 2020</last_update_posted> <responsible_party> <responsible_party_type>Sponsor-Investigator</responsible_party_type> <investigator_affiliation>Assiut University</investigator_affiliation> <investigator_full_name>Shaimaa Mahmoud Abd El-mouez</investigator_full_name> <investigator_title>Principe investigator</investigator_title> </responsible_party> <keyword>organic and functiona diarrhoea</keyword> <keyword>pattern</keyword> <keyword>utility</keyword> <condition_browse>  <mesh_term>Diarrhea</mesh_term> </condition_browse>  </clinical_study>

Chronic diarrhea is a common condition and a key symptom in many disorders. It is a major cause of morbidity and mortality worldwide and one of the most common reasons for referral to a gastroenterology clinic.The prevalence varies depending on population and the definition of diarrhea used. It affects approximately 5% of the population at any given point in time, although the exact prevalence is unknown. Diarrhea is associated with 4 pathophysiological mechanisms: osmotic, secretory, exudative and altered motility. It is more useful to classify patients presenting with symptoms of diarrhea according to ''functional'' or ''organic'' characteristics. It is usually difficult to make a reliable differentiation between organic and functional causes in patients with chronic diarrhea based only on history and physical examination . The standard evaluation of patients with chronic diarrhea that begins with a detailed history, a careful physical examination and then basic diagnostic tests is critical for optimal treatment and prevention. Initially, thought needs to exclude several other possibilities as (a) fecal incontinence masquerading as diarrhea, (b) iatrogenic diarrhea due to drugs, surgery, or therapeutic radiation, (c) chronic infections, and (d) irritable bowel syndrome with diarrhea (IBS-D). The detection of a broad array of potentially offending agents has traditionally required a combination of microbiologic approaches, including bacterial culture, antigen detection, microscopy, and polymerase chain reaction (PCR). The new multiplex PCR-based panels have several advantages over conventional methods including (i) reduced sample volume requirements, (ii) broad coverage without the need to select specific tests, (iii) enhanced ability to detect coinfections (iv) increased sensitivity and specificity as high as 97-100% and (v) higher throughput.The food and drug administration (FDA) cleared and recommended the use of FilmArray GI panel (BioFire Diagnostics), which targets 22 analytes (bacteria with bacterial toxin, viruses, and parasites) Investigations: • Routine laboratory investigation: Complete blood picture and differential WBCs count, liver, kidney function tests, RBG, Na, K, CRP, ESR. • Microbilogical Investigations: To ensure that good specimens are provided for examination, it is important to note the following: - A sterile clean dry container must be used for the collection of fecal samples. - The specimen should be brought to the lab as soon as possible. - The specimen container should be clearly labeled with the patient's name, date, and time of passage of the specimen. A) Conventional methods: Stool samples will be cultured on Selenite broth then subcultured on blood agar, chocolate agar, MacConkeys agar, Sorbitol MacConkys agar: Xylose Lysine Deoxycholate agar (XLD) ,Sabouraud dextrose agar (SDA), blood agar with 10um/ml ampicillin , Cambylobacter CVA agar plates. 1. Identification of the bacterial organism: Pure colonies of isolated microorganisms were identified by: - Morphology on agar. - Gram stain film was made from the growth to identify morphology of the organism. - Biochemical reactions tests. 2. Detection of antibiotic sensitivity pattern according to CLSI 2019 by disc diffusion method 3. Confirmation of results by automated microbial system VITEK 2Compact. B) Multiplex PCR: for Identification of different causative organisms by Biofire microarray (BioMerieux,France) patients with chronic diarrhea recruited from Al-Rajhi Liver Hospital, Assiut University Hospitals, Assiut, Egypt. 1. Inclusion criteria: Patients with diarrhea > 4 weeks 2. Exclusion criteria: Age below 18 years old and diarhhoea < 4 weeks. Inclusion Criteria: - Patients with diarrhea > 4 weeks Exclusion Criteria: - Age below 18 years old and diarhhoea < 4 weeks.

NCT0426xxxx/NCT04269187.xml

<clinical_study>  <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/NCT04269187</url> </required_header> <id_info> <org_study_id>DUS in critically ill patients</org_study_id> <nct_id>NCT04269187</nct_id> </id_info> <brief_title>Diaphragmatic Ultrasound With Theophylline Therapeutic Trials</brief_title> <official_title>Diaphragmatic Ultrasound in Critically Ill Patients With Therapeutic Theophylline Trials</official_title> <sponsors> <lead_sponsor> <agency>Assiut University</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Assiut University</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Critically ill patients are a group of patients with special needs during hospitalization. The vast majority of them is mechanically ventilated and requires continuous assessment of vital parameters.  It is quite impressive that assessment of respiratory muscles, and specifically of the diaphragm, is lacking in the daily practice of ICU.  The diaphragm-the main inspiratory muscle-is considered so important in ICU. A lot of time in ICUs is spent on weaning patients from mechanical ventilation. Although weaning from mechanical ventilation can be a rapid and uneventful process for the majority of the patients, it can be difficult in as many as 20-30% of them (1)(2). It is during weaning that the diaphragm becomes the major pathophysiological determinant of weaning failure or success.  Weaning failure is defined as failing a spontaneous breathing trial or developing a post-extubation respiratory distress that requires re-intubation or non-invasive ventilation within 48 h following extubation (3).  So, identification of reliable predictors of weaning failure may represent potential avenues of treatment that could reduce the incidence of weaning failure and its associated morbidity.  Known predictors of weaning failure include chronic obstructive airway disease (3), cardiac failure(4-6), lung de-recruitment (7), pneumonia (8) and diaphragmatic dysfunction (9).  Rapid shallow breathing index (RSBI) is a clinical predictor of failure of weaning from mechanical ventilation and it is widely used in clinical research and in practice (10).  However, diaphragmatic ultrasonography could be a promising tool for predicting reintubation within 48 hours of extubation. As it permits direct assessment of diaphragm function.  It should be mentioned that diaphragmatic dysfunction among patients hospitalized in the intensive care unit (ICU) is commonly attributed to critical illness polyneuropathy and myopathy. Mechanical ventilation, even after a short period of time, can also induce diaphragmatic dysfunction.  Recent researches have shown that theophylline improves diaphragmatic contractility in isolated muscle preparations in animals and in normal human subjects. The question now does the theophylline have a significant role in critical ill patients with diaphragmatic dysfunction whether they are diabetic or not ? </textblock> </brief_summary> <detailed_description> <textblock> All patients will be subjected to:  1. medical history.  2. clinical examination.  3. diaphragmatic ultrasound : diaphragmatic thickness and excursion will be assessed.  4. theophyllin treatment; 200 mg/d orally for 12 days then reassessment of diaphragm by ultrasound.  5. weaning trial ; Patients are considered ready for weaning when they meet all the following criteria: fraction of inspired oxygen (FiO2) < 0.5, positive end expiratory pressure (PEEP) ≤ 5 cm water , Pa O2/Fi O2> 200, respiratory rate (RR) <30 breaths/min, alert and cooperative, and hemodynamically stable in the absence of any vasopressor therapy support.(11)  1. rapid shallow breathing index (RSBI) will be measured. It's defined as the ratio between the respiratory rate (breaths/min) and tidal volume (TV) (liters).  2. 2-hour spontaneous breathing trial with a T-piece and zero pressure support (before extubation).  3. extubation is done & follow up for 48 hours </textblock> </detailed_description> <overall_status>Unknown status</overall_status> <last_known_status>Not yet recruiting</last_known_status> <start_date type="Anticipated">April 2020</start_date> <completion_date type="Anticipated">June 2022</completion_date> <primary_completion_date type="Anticipated">April 2022</primary_completion_date> <phase>Early Phase 1</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> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>how much improvement in diaphragmatic thickness and excursion after theophylline treatment.</measure> <time_frame>Baseline</time_frame> <description>how much improvement in diaphragmatic thickness and excursion after theophylline treatment.</description> </primary_outcome> <secondary_outcome> <measure>number of successful weaning trials based on diaphragmatic ultrasound findings</measure> <time_frame>Baseline</time_frame> <description>number of successful weaning trials based on diaphragmatic ultrasound findings</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">46</enrollment> <condition>Diaphragmatic Dysfunction in Critically Ill Patients</condition> <arm_group> <arm_group_label>With theophylline treatment</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>This group will be for: diaphragmatic ultrasound after admission to ICU and before administration of theophylline; 200 mg/d orally for 12 days then reassessment of diaphragm by ultrasound.</description> </arm_group> <arm_group> <arm_group_label>No theophylline treatment</arm_group_label> <arm_group_type>No Intervention</arm_group_type> <description>This group will be for: diaphragmatic ultrasound after admission to ICU then reassessment of diaphragm by ultrasound before discharge</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Theophylline</intervention_name> <description>Theophylline oral 200 mg daily for 12 days</description> <arm_group_label>With theophylline treatment</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - The inclusion criteria are as follows: critical ill patients that are admitted to our ICU whether they are mechanically ventilated or not .  Exclusion Criteria:  - exclusion criteria are the presence of pneumothorax or ascites, a history of either neuromuscular disease or thoracic surgery, congenital diaphragmatic hernia, the presence of a tracheostomy tube,chronic obstructive pulmonary disease (COPD) patients, asthma and poor image quality. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Hanan Sharaf ElDin, Lecturer</last_name> <role>Study Director</role> <affiliation>Assiut university; internal medicine department</affiliation> </overall_official> <overall_official> <last_name>Sahar Farghaly, Lecturer</last_name> <role>Study Director</role> <affiliation>Assuit university; chest diseases department</affiliation> </overall_official> <overall_official> <last_name>Hanan Mahmoud, Professor</last_name> <role>Study Director</role> <affiliation>Assuit university; internal medicine department</affiliation> </overall_official> <overall_contact> <last_name>Doaa Roshdy Abdul satar</last_name> <phone>01024588594</phone> <email>doaa.elenany@Yahoo.com</email> </overall_contact> <link> <url>https://www.ncbi.nlm.nih.gov/pubmed/7921460/</url> <description>Related Info</description> </link> <link> <url>https://www.google.com/url?sa=t&source=web&rct=j&url=https://daneshyari.com/article/preview/5562965.pdf&ved=2ahUKEwitvd-7m73nAhWmRhUIHX_jCRQQFjAAegQIAxAB&usg=AOvVaw3dzzyX2YgXmojGd_nnAw97</url> <description>Related Info</description> </link> <reference> <citation>Brochard L, Rauss A, Benito S, Conti G, Mancebo J, Rekik N, Gasparetto A, Lemaire F. Comparison of three methods of gradual withdrawal from ventilatory support during weaning from mechanical ventilation. Am J Respir Crit Care Med. 1994 Oct;150(4):896-903. doi: 10.1164/ajrccm.150.4.7921460.</citation> <PMID>7921460</PMID> </reference> <reference> <citation>Farghaly S, Hasan AA. Diaphragm ultrasound as a new method to predict extubation outcome in mechanically ventilated patients. Aust Crit Care. 2017 Jan;30(1):37-43. doi: 10.1016/j.aucc.2016.03.004. Epub 2016 Apr 22.</citation> <PMID>27112953</PMID> </reference> <verification_date>February 2020</verification_date> <study_first_submitted>February 6, 2020</study_first_submitted> <study_first_submitted_qc>February 12, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>February 12, 2020</last_update_submitted> <last_update_submitted_qc>February 12, 2020</last_update_submitted_qc> <last_update_posted type="Actual">February 13, 2020</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Assiut University</investigator_affiliation> <investigator_full_name>Doaa Roshdy Abdul Satar Mohamed</investigator_full_name> <investigator_title>Resident doctor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Critical Illness</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Theophylline</mesh_term> </intervention_browse>  </clinical_study>

Critically ill patients are a group of patients with special needs during hospitalization. The vast majority of them is mechanically ventilated and requires continuous assessment of vital parameters. It is quite impressive that assessment of respiratory muscles, and specifically of the diaphragm, is lacking in the daily practice of ICU. The diaphragm-the main inspiratory muscle-is considered so important in ICU. A lot of time in ICUs is spent on weaning patients from mechanical ventilation. Although weaning from mechanical ventilation can be a rapid and uneventful process for the majority of the patients, it can be difficult in as many as 20-30% of them (1)(2). It is during weaning that the diaphragm becomes the major pathophysiological determinant of weaning failure or success. Weaning failure is defined as failing a spontaneous breathing trial or developing a post-extubation respiratory distress that requires re-intubation or non-invasive ventilation within 48 h following extubation (3). So, identification of reliable predictors of weaning failure may represent potential avenues of treatment that could reduce the incidence of weaning failure and its associated morbidity. Known predictors of weaning failure include chronic obstructive airway disease (3), cardiac failure(4-6), lung de-recruitment (7), pneumonia (8) and diaphragmatic dysfunction (9). Rapid shallow breathing index (RSBI) is a clinical predictor of failure of weaning from mechanical ventilation and it is widely used in clinical research and in practice (10). However, diaphragmatic ultrasonography could be a promising tool for predicting reintubation within 48 hours of extubation. As it permits direct assessment of diaphragm function. It should be mentioned that diaphragmatic dysfunction among patients hospitalized in the intensive care unit (ICU) is commonly attributed to critical illness polyneuropathy and myopathy. Mechanical ventilation, even after a short period of time, can also induce diaphragmatic dysfunction. Recent researches have shown that theophylline improves diaphragmatic contractility in isolated muscle preparations in animals and in normal human subjects. The question now does the theophylline have a significant role in critical ill patients with diaphragmatic dysfunction whether they are diabetic or not ? All patients will be subjected to: 1. medical history. 2. clinical examination. 3. diaphragmatic ultrasound : diaphragmatic thickness and excursion will be assessed. 4. theophyllin treatment; 200 mg/d orally for 12 days then reassessment of diaphragm by ultrasound. 5. weaning trial ; Patients are considered ready for weaning when they meet all the following criteria: fraction of inspired oxygen (FiO2) < 0.5, positive end expiratory pressure (PEEP) ≤ 5 cm water , Pa O2/Fi O2> 200, respiratory rate (RR) <30 breaths/min, alert and cooperative, and hemodynamically stable in the absence of any vasopressor therapy support.(11) 1. rapid shallow breathing index (RSBI) will be measured. It's defined as the ratio between the respiratory rate (breaths/min) and tidal volume (TV) (liters). 2. 2-hour spontaneous breathing trial with a T-piece and zero pressure support (before extubation). 3. extubation is done & follow up for 48 hours Inclusion Criteria: - The inclusion criteria are as follows: critical ill patients that are admitted to our ICU whether they are mechanically ventilated or not . Exclusion Criteria: - exclusion criteria are the presence of pneumothorax or ascites, a history of either neuromuscular disease or thoracic surgery, congenital diaphragmatic hernia, the presence of a tracheostomy tube,chronic obstructive pulmonary disease (COPD) patients, asthma and poor image quality.

NCT0426xxxx/NCT04269200.xml

<clinical_study>  <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/NCT04269200</url> </required_header> <id_info> <org_study_id>D9311C00001</org_study_id> <secondary_id>2019-004112-60</secondary_id> <secondary_id>GOG-3041</secondary_id> <secondary_id>ENGOT-EN10</secondary_id> <secondary_id>D9311C00001</secondary_id> <nct_id>NCT04269200</nct_id> </id_info> <brief_title>Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer</brief_title> <acronym>DUO-E</acronym> <official_title>A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination With Durvalumab, Followed by Maintenance Durvalumab With or Without Olaparib in Patients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer (DUO-E)</official_title> <sponsors> <lead_sponsor> <agency>AstraZeneca</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>The Gynecologic Oncology Group (GOG) Foundation Inc</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>The European Network for Gynaecological Oncological Trial groups (ENGOT)</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>AstraZeneca</source> <oversight_info> <has_dmc>Yes</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> A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer. </textblock> </brief_summary> <detailed_description> <textblock> This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer.  Target patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">May 5, 2020</start_date> <completion_date type="Anticipated">March 5, 2025</completion_date> <primary_completion_date type="Anticipated">September 26, 2023</primary_completion_date> <phase>Phase 3</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>double-blind, placebo-controlled</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Progression Free Survival (PFS) for Arm B vs Arm A and Arm C vs Arm A</measure> <time_frame>Up to 4 years</time_frame> <description>Defined as the time from randomisation until the date of objective disease progression (per RECIST 1.1 as assessed by investigator) or death (by any cause in the absence of progression)</description> </primary_outcome> <secondary_outcome> <measure>Second Progression (PFS2)</measure> <time_frame>Up to 6 years</time_frame> <description>Defined as the time from randomisation to the earliest of progression event subsequent to first subsequent therapy (assessed by the investigator per local standard clinical practice and may involve any of the following: objective radiological imaging, symptomatic progression), or death due to any cause</description> </secondary_outcome> <secondary_outcome> <measure>Overall Survival (OS)</measure> <time_frame>Up to 6 years</time_frame> <description>Defined as the time from randomisation to death due to any cause</description> </secondary_outcome> <secondary_outcome> <measure>Objective Response Rate (ORR)</measure> <time_frame>Up to 4 years</time_frame> <description>Defined as the proportion of patients with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR) as determined by the Investigator at local site.</description> </secondary_outcome> <secondary_outcome> <measure>Duration of response (DoR)</measure> <time_frame>Up to 4 years</time_frame> <description>Defined as time from the date of first documented response until date of documented progression or death in the absence of disease progression</description> </secondary_outcome> <secondary_outcome> <measure>Time to first subsequent therapy (TFST)</measure> <time_frame>Up to 6 years</time_frame> <description>Defined as the time from randomisation to the earlier of start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment or death due to any cause</description> </secondary_outcome> <secondary_outcome> <measure>Time to second subsequent therapy (TSST)</measure> <time_frame>Up to 6 years</time_frame> <description>Defined as the time from randomisation to the earlier of start date of the second subsequent anti-cancer therapy after discontinuation of first subsequent treatment or death due to any cause.</description> </secondary_outcome> <secondary_outcome> <measure>Time to discontinuation or death (TDT)</measure> <time_frame>Up to 6 years</time_frame> <description>Defined as the time from randomisation to the earlier of the date of study treatment discontinuation or death.</description> </secondary_outcome> <secondary_outcome> <measure>The pharmacokinetics (PK) of durvalumab will be determined after steady state doses</measure> <time_frame>Up to 4 years</time_frame> <description>Determination of durvalumab concentration in serum</description> </secondary_outcome> <secondary_outcome> <measure>Safety and tolerability of drugs by assessment of AEs/SAEs</measure> <time_frame>Up to 6 years</time_frame> <description>Graded according to the National Cancer Institute (NCI CTCAE)</description> </secondary_outcome> <secondary_outcome> <measure>The immunogenicity of durvalumab as determined by concentration of Anti-drug antibodies (ADA) to durvalumab</measure> <time_frame>Up to 4 years</time_frame> <description>Determination concentration of Anti-drug antibodies (ADA) to durvalumab in serum</description> </secondary_outcome> <number_of_arms>3</number_of_arms> <enrollment type="Anticipated">699</enrollment> <condition>Endometrial Neoplasms</condition> <arm_group> <arm_group_label>Arm A (control)</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets).</description> </arm_group> <arm_group> <arm_group_label>Arm B (durvalumab+placebo)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo</description> </arm_group> <arm_group> <arm_group_label>Arm C (durvalumab+olaparib)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>olaparib</intervention_name> <description>Olaparib tablets</description> <arm_group_label>Arm C (durvalumab+olaparib)</arm_group_label> </intervention> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>durvalumab</intervention_name> <description>Durvalumab by intravenous infusion</description> <arm_group_label>Arm B (durvalumab+placebo)</arm_group_label> <arm_group_label>Arm C (durvalumab+olaparib)</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>durvalumab placebo</intervention_name> <description>Matching placebo for intravenous infusion</description> <arm_group_label>Arm A (control)</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>olaparib placebo</intervention_name> <description>Placebo tablets to match olaparib</description> <arm_group_label>Arm A (control)</arm_group_label> <arm_group_label>Arm B (durvalumab+placebo)</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Carboplatin</intervention_name> <description>Standard of care chemotherapy</description> <arm_group_label>Arm A (control)</arm_group_label> <arm_group_label>Arm B (durvalumab+placebo)</arm_group_label> <arm_group_label>Arm C (durvalumab+olaparib)</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Paclitaxel</intervention_name> <description>Standard of care chemotherapy</description> <arm_group_label>Arm A (control)</arm_group_label> <arm_group_label>Arm B (durvalumab+placebo)</arm_group_label> <arm_group_label>Arm C (durvalumab+olaparib)</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Age ≥18 years at the time of screening and female.  - Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.  - Patient must have endometrial cancer in one of the following categories:  1. Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy),  2. Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy)  3. Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor.  - Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse  - FPPE tumor sample must be available for MMR evaluation.  - Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment.  Exclusion Criteria:  - History of leptomeningeal carcinomatosis.  - Brain metastases or spinal cord compression.  - Prior treatment with PARP inhibitors.  - Any prior exposure to immune-mediated therapy, including (but not limited to) other anti CTLA-4, anti-PD-1, anti-PD-L1, or anti-programmed-cell-death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines. </textblock> </criteria> <gender>Female</gender> <gender_based>Yes</gender_based> <gender_description>Female subjects only</gender_description> <minimum_age>18 Years</minimum_age> <maximum_age>150 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Shannon N. Westin, MD, MPH, FACOG</last_name> <role>Principal Investigator</role> <affiliation>The University of Texas MD Anderson Cancer Center</affiliation> </overall_official> <overall_contact> <last_name>AstraZeneca Clinical Study Information Center</last_name> <phone>1-877-240-9479</phone> <email>information.center@astrazeneca.com</email> </overall_contact> <location> <facility> <name>Research Site</name> <address> <city>Tucson</city> <state>Arizona</state> <zip>85719</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Concord</city> <state>California</state> <zip>94520-2278</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>La Jolla</city> <state>California</state> <zip>92093</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Long Beach</city> <state>California</state> <zip>90806</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>San Francisco</city> <state>California</state> <zip>94158</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Santa Barbara</city> <state>California</state> <zip>93105</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Aurora</city> <state>Colorado</state> <zip>80012</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Fort Lauderdale</city> <state>Florida</state> <zip>33316</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Gainesville</city> <state>Florida</state> <zip>32610</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Tampa</city> <state>Florida</state> <zip>33612</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Savannah</city> <state>Georgia</state> <zip>31404</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Honolulu</city> <state>Hawaii</state> <zip>96826</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Arlington Heights</city> <state>Illinois</state> <zip>60005</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Chicago</city> <state>Illinois</state> <zip>60612</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Chicago</city> <state>Illinois</state> <zip>60637</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Hinsdale</city> <state>Illinois</state> <zip>60521</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Indianapolis</city> <state>Indiana</state> <zip>46237</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Ames</city> <state>Iowa</state> <zip>50010</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Louisville</city> <state>Kentucky</state> <zip>40207</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Baton Rouge</city> <state>Louisiana</state> <zip>70817</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Boston</city> <state>Massachusetts</state> <zip>02111</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Saint Paul</city> <state>Minnesota</state> <zip>55125</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Jackson</city> <state>Mississippi</state> <zip>39216</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Las Vegas</city> <state>Nevada</state> <zip>89169</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Lebanon</city> <state>New Hampshire</state> <zip>03756</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Camden</city> <state>New Jersey</state> <zip>08103</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Paramus</city> <state>New Jersey</state> <zip>07652</zip> <country>United States</country> </address> </facility> <status>Terminated</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Teaneck</city> <state>New Jersey</state> <zip>07666</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Brooklyn</city> <state>New York</state> <zip>11203</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>New York</city> <state>New York</state> <zip>10011</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>New York</city> <state>New York</state> <zip>10029</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Poughkeepsie</city> <state>New York</state> <zip>12601</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Pinehurst</city> <state>North Carolina</state> <zip>28374</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Cleveland</city> <state>Ohio</state> <zip>44109</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Cleveland</city> <state>Ohio</state> <zip>44124</zip> <country>United States</country> </address> </facility> <status>Terminated</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Cleveland</city> <state>Ohio</state> <zip>44195</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Columbus</city> <state>Ohio</state> <zip>43215</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Dayton</city> <state>Ohio</state> <zip>45459</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Oklahoma City</city> <state>Oklahoma</state> <zip>73104</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Tulsa</city> <state>Oklahoma</state> <zip>74134</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Eugene</city> <state>Oregon</state> <zip>97401</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Portland</city> <state>Oregon</state> <zip>97239-3011</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Tigard</city> <state>Oregon</state> <zip>97223</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Pittsburgh</city> <state>Pennsylvania</state> <zip>15224</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Willow Grove</city> <state>Pennsylvania</state> <zip>19090</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Providence</city> <state>Rhode Island</state> <zip>02905</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Sioux Falls</city> <state>South Dakota</state> <zip>57105</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Chattanooga</city> <state>Tennessee</state> <zip>37403</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Germantown</city> <state>Tennessee</state> <zip>38138</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Knoxville</city> <state>Tennessee</state> <zip>37920</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Bedford</city> <state>Texas</state> <zip>76022</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Dallas</city> <state>Texas</state> <zip>75231</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Houston</city> <state>Texas</state> <zip>77026</zip> <country>United States</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Houston</city> <state>Texas</state> <zip>77030</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>San Antonio</city> <state>Texas</state> <zip>78240</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Sugar Land</city> <state>Texas</state> <zip>77479</zip> <country>United States</country> </address> </facility> <status>Terminated</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Tyler</city> <state>Texas</state> <zip>75702</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Webster</city> <state>Texas</state> <zip>77598</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Fairfax</city> <state>Virginia</state> <zip>22031</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Norfolk</city> <state>Virginia</state> <zip>23502</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Seattle</city> <state>Washington</state> <zip>98195</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Morgantown</city> <state>West Virginia</state> <zip>26505</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Madison</city> <state>Wisconsin</state> <zip>53792</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Milwaukee</city> <state>Wisconsin</state> <zip>53226</zip> <country>United States</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Bedford Park</city> <zip>5042</zip> <country>Australia</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Campbelltown</city> <zip>2560</zip> <country>Australia</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Clayton</city> <zip>3168</zip> <country>Australia</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Kogarah</city> <zip>2217</zip> <country>Australia</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Malvern</city> <zip>3144</zip> <country>Australia</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Melbourne</city> <zip>3000</zip> <country>Australia</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Nedlands</city> <zip>6009</zip> <country>Australia</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Sydney</city> <zip>NSW 2145</zip> <country>Australia</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Bruges</city> <zip>8000</zip> <country>Belgium</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Bruxelles</city> <zip>1200</zip> <country>Belgium</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Charleroi</city> <zip>6000</zip> <country>Belgium</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Gent</city> <zip>9000</zip> <country>Belgium</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Hasselt</city> <zip>3500</zip> <country>Belgium</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Kortrijk</city> <zip>8500</zip> <country>Belgium</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Leuven</city> <zip>3000</zip> <country>Belgium</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Libramont-Chevigny</city> <zip>6800</zip> <country>Belgium</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Liège</city> <zip>4000</zip> <country>Belgium</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Belo Horizonte</city> <zip>30130-090</zip> <country>Brazil</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Belo Horizonte</city> <zip>30150-274</zip> <country>Brazil</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Curitiba</city> <zip>80520-174</zip> <country>Brazil</country> </address> </facility> <status>Terminated</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Passo Fundo</city> <zip>99010-080</zip> <country>Brazil</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Pelotas</city> <zip>96020-080</zip> <country>Brazil</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Porto Alegre</city> <zip>90020-090</zip> <country>Brazil</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Porto Alegre</city> <zip>90035-003</zip> <country>Brazil</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Porto Alegre</city> <zip>90110-270</zip> <country>Brazil</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Rio de Janeiro</city> <zip>20231-050</zip> <country>Brazil</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Sao Paulo</city> <zip>01246-000</zip> <country>Brazil</country> </address> </facility> <status>Terminated</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Sao Paulo</city> <zip>01317-001</zip> <country>Brazil</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>São José do Rio Preto</city> <zip>15090-000</zip> <country>Brazil</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Calgary</city> <state>Alberta</state> <zip>T2N 4N2</zip> <country>Canada</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Toronto</city> <state>Ontario</state> <zip>M4N 3M5</zip> <country>Canada</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Toronto</city> <state>Ontario</state> <zip>M5G 2M9</zip> <country>Canada</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Montreal</city> <state>Quebec</state> <zip>H1T 2M4</zip> <country>Canada</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Montreal</city> <state>Quebec</state> <zip>H2L 4M1</zip> <country>Canada</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Montreal</city> <state>Quebec</state> <zip>H3A 1A1</zip> <country>Canada</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Montreal</city> <state>Quebec</state> <zip>H3T 1E2</zip> <country>Canada</country> </address> </facility> <status>Terminated</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Chicoutimi</city> <zip>G7H 5H6</zip> <country>Canada</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Beijing</city> <zip>100021</zip> <country>China</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Beijing</city> <zip>100034</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Beijing</city> <zip>100142</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Beijing</city> <zip>100730</zip> <country>China</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Changchun</city> <zip>130012</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Changchun</city> <zip>130021</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Changsha</city> <zip>410003</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Changsha</city> <zip>410008</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Chengdu</city> <zip>610041</zip> <country>China</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Chengdu</city> <zip>610041</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Chongqing</city> <zip>400038</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Chongqing</city> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Dalian</city> <zip>116001</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Dalian</city> <zip>116027</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Guangdong</city> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Guangzhou</city> <zip>510060</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Haikou</city> <zip>570311</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Harbin</city> <zip>150081</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Hefei</city> <zip>230031</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Kunming</city> <zip>650118</zip> <country>China</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Nanjing</city> <zip>210009</zip> <country>China</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Nanning</city> <zip>530021</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Shanghai</city> <zip>200032</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Shenyang</city> <zip>110042</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Taiyuan</city> <zip>030001</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Tianjin</city> <zip>300060</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Wuhan</city> <zip>430022</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Wuhan</city> <zip>430030</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Zhanjiang</city> <zip>524001</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Zhengzhou</city> <zip>450008</zip> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Zhengzhou</city> <zip>450052</zip> <country>China</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Zhengzhou</city> <country>China</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Barranquilla</city> <zip>80020</zip> <country>Colombia</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Bogota</city> <zip>110321</zip> <country>Colombia</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Bogota</city> <zip>111321</zip> <country>Colombia</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Bogota</city> <zip>111411</zip> <country>Colombia</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Bogota</city> <zip>111511</zip> <country>Colombia</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Cali</city> <zip>760043</zip> <country>Colombia</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Cali</city> <zip>760043</zip> <country>Colombia</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Medellin</city> <zip>50030</zip> <country>Colombia</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Medellín</city> <country>Colombia</country> </address> </facility> <status>Terminated</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Monteria</city> <zip>23001</zip> <country>Colombia</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Pereira</city> <zip>660001</zip> <country>Colombia</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Rionegro</city> <zip>54048</zip> <country>Colombia</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Tallinn</city> <zip>1131</zip> <country>Estonia</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Tartu</city> <zip>50406</zip> <country>Estonia</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Berlin</city> <zip>13125</zip> <country>Germany</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Berlin</city> <zip>13353</zip> <country>Germany</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Bonn</city> <zip>53127</zip> <country>Germany</country> </address> </facility> <status>Terminated</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Chemnitz</city> <zip>09116</zip> <country>Germany</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Dresden</city> <zip>01307</zip> <country>Germany</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Frankfurt am Main</city> <zip>65929</zip> <country>Germany</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Karlsruhe</city> <zip>76133</zip> <country>Germany</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Konstanz</city> <zip>78464</zip> <country>Germany</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Leipzig</city> <zip>4103</zip> <country>Germany</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Athens</city> <zip>11528</zip> <country>Greece</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Chaidari</city> <zip>124 62</zip> <country>Greece</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Marousi</city> <zip>151 23</zip> <country>Greece</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Thessaloniki</city> <zip>54645</zip> <country>Greece</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>HKG</city> <country>Hong Kong</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Hong Kong</city> <country>Hong Kong</country> </address> </facility> <status>Recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Hong Kong</city> <country>Hong Kong</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Tun Mun</city> <country>Hong Kong</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Budapest</city> <zip>1062</zip> <country>Hungary</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Budapest</city> <zip>1083</zip> <country>Hungary</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Budapest</city> <zip>1122</zip> <country>Hungary</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Budapest</city> <zip>1145</zip> <country>Hungary</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Debrecen</city> <zip>4032</zip> <country>Hungary</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Győr</city> <zip>9024</zip> <country>Hungary</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Szolnok</city> <zip>5004</zip> <country>Hungary</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Bangalore</city> <zip>560017</zip> <country>India</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Bangalore</city> <zip>560027</zip> <country>India</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Hisar</city> <zip>125005</zip> <country>India</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Ludhiana</city> <zip>141001</zip> <country>India</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Mumbai</city> <zip>400012</zip> <country>India</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Mysuru</city> <zip>570021</zip> <country>India</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Nagpur</city> <zip>440003</zip> <country>India</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Nashik</city> <zip>422005</zip> <country>India</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>New Delhi</city> <zip>110075</zip> <country>India</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Pune</city> <zip>411004</zip> <country>India</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Be'er Ya'akov</city> <zip>70300</zip> <country>Israel</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Hadera</city> <zip>3810101</zip> <country>Israel</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Jerusalem</city> <zip>91031</zip> <country>Israel</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Nahariya</city> <zip>22100</zip> <country>Israel</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Tel Aviv</city> <zip>6423906</zip> <country>Israel</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Chuo-ku</city> <zip>104-0045</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Kashiwa-shi</city> <zip>277-8567</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Koto-ku</city> <zip>135-8550</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Kurume-shi</city> <zip>830-0011</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Kyoto-shi</city> <zip>606-8507</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Matsuyama-shi</city> <zip>791-0280</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Minato-ku</city> <zip>105-8471</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Nagoya-shi</city> <zip>464-8681</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Nakagami-gun</city> <zip>903-0215</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Niigata-shi</city> <zip>951-8520</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Osaka-shi</city> <zip>541-8567</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Osaka</city> <zip>637086</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Sapporo-shi</city> <zip>003-0804</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Shinjuku-ku</city> <zip>160-8582</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Sunto-gun</city> <zip>411-8777</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Toon-Shi</city> <zip>791-0295</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Tsu-shi</city> <zip>514-8507</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Yokohama-shi</city> <zip>236-0004</zip> <country>Japan</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Goyang-si</city> <zip>10408</zip> <country>Korea, Republic of</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Seoul</city> <zip>01812</zip> <country>Korea, Republic of</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Seoul</city> <zip>03080</zip> <country>Korea, Republic of</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Seoul</city> <zip>03722</zip> <country>Korea, Republic of</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Seoul</city> <zip>06351</zip> <country>Korea, Republic of</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Seoul</city> <zip>06591</zip> <country>Korea, Republic of</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Seoul</city> <zip>138-736</zip> <country>Korea, Republic of</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Suwon</city> <zip>443380</zip> <country>Korea, Republic of</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Yangsan-si</city> <zip>50612</zip> <country>Korea, Republic of</country> </address> </facility> <status>Terminated</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Kaunas</city> <zip>50161</zip> <country>Lithuania</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Vilnius</city> <zip>08661</zip> <country>Lithuania</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Vilnius</city> <zip>8660</zip> <country>Lithuania</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Aguascalientes</city> <zip>20116</zip> <country>Mexico</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Ciudad de Mexico</city> <zip>01120</zip> <country>Mexico</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Durango</city> <zip>34000</zip> <country>Mexico</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Guadalajara</city> <zip>44600</zip> <country>Mexico</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Mexico</city> <zip>06700</zip> <country>Mexico</country> </address> </facility> <status>Terminated</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Monterrey</city> <zip>64000</zip> <country>Mexico</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Oaxaca</city> <zip>68000</zip> <country>Mexico</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Queretaro</city> <zip>76090</zip> <country>Mexico</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>San Luis Potosi</city> <zip>78200</zip> <country>Mexico</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Veracruz</city> <zip>91910</zip> <country>Mexico</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Gdansk</city> <zip>80-214</zip> <country>Poland</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Lublin</city> <zip>20-081</zip> <country>Poland</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Olsztyn</city> <zip>10-228</zip> <country>Poland</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Olsztyn</city> <zip>10-560</zip> <country>Poland</country> </address> </facility> <status>Terminated</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Wroclaw</city> <zip>53-413</zip> <country>Poland</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Łódź</city> <zip>93-513</zip> <country>Poland</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Anzorey</city> <zip>361350</zip> <country>Russian Federation</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Chelyabinsk</city> <zip>454087</zip> <country>Russian Federation</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Kazan, Tatarstan</city> <zip>420029</zip> <country>Russian Federation</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Krasnodar</city> <zip>350040</zip> <country>Russian Federation</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Moscow</city> <zip>115478</zip> <country>Russian Federation</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Moscow</city> <zip>117997</zip> <country>Russian Federation</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Moskva</city> <zip>115682</zip> <country>Russian Federation</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Saransk</city> <zip>430032</zip> <country>Russian Federation</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Sochi</city> <zip>354000</zip> <country>Russian Federation</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>St Petersburg</city> <zip>197341</zip> <country>Russian Federation</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>St. Petersburg</city> <zip>198255</zip> <country>Russian Federation</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Singapore</city> <zip>119228</zip> <country>Singapore</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Singapore</city> <zip>169610</zip> <country>Singapore</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Singapore</city> <zip>258499</zip> <country>Singapore</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Singapore</city> <zip>329563</zip> <country>Singapore</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Barcelona</city> <zip>08208</zip> <country>Spain</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Barcelona</city> <zip>08908</zip> <country>Spain</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>El Palmar</city> <zip>30120</zip> <country>Spain</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Girona</city> <zip>17007</zip> <country>Spain</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Jaén</city> <zip>23007</zip> <country>Spain</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Madrid</city> <zip>28034</zip> <country>Spain</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Madrid</city> <zip>28046</zip> <country>Spain</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Mallorca</city> <zip>07120</zip> <country>Spain</country> </address> </facility> <status>Active, not recruiting</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Sevilla</city> <zip>41013</zip> <country>Spain</country> </address> </facility> <status>Withdrawn</status> </location> <location> <facility> <name>Research Site</name> <address> <city>Vigo</city> <zip>36312</zip> <country>Spain</country> </address> </facility> <status>Withdrawn</status> </location> <location_countries> <country>Australia</country> <country>Belgium</country> <country>Brazil</country> <country>Canada</country> <country>China</country> <country>Colombia</country> <country>Estonia</country> <country>Germany</country> <country>Greece</country> <country>Hong Kong</country> <country>Hungary</country> <country>India</country> <country>Israel</country> <country>Japan</country> <country>Korea, Republic of</country> <country>Lithuania</country> <country>Mexico</country> <country>Poland</country> <country>Russian Federation</country> <country>Singapore</country> <country>Spain</country> <country>United States</country> </location_countries> <verification_date>December 2022</verification_date> <study_first_submitted>February 10, 2020</study_first_submitted> <study_first_submitted_qc>February 12, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>December 14, 2022</last_update_submitted> <last_update_submitted_qc>December 14, 2022</last_update_submitted_qc> <last_update_posted type="Actual">December 15, 2022</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Cancer of Endometrium</keyword> <keyword>Cancer of the Endometrium</keyword> <keyword>Carcinoma of Endometrium</keyword> <keyword>Endometrial Cancer</keyword> <keyword>Endometrial Carcinoma</keyword> <keyword>Endometrium Cancer</keyword> <keyword>Neoplasms, Endometrial</keyword> <condition_browse>  <mesh_term>Endometrial Neoplasms</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Paclitaxel</mesh_term> <mesh_term>Carboplatin</mesh_term> <mesh_term>Durvalumab</mesh_term> <mesh_term>Olaparib</mesh_term> <mesh_term>Antibodies, Monoclonal</mesh_term> </intervention_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure</ipd_time_frame> <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure</ipd_access_criteria> <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url> </patient_data>  </clinical_study>

A study to assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer. This Phase III study will assess the efficacy and safety of durvalumab in combination with platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial cancer. Target patient population: Adult female patients with histologically confirmed diagnosis of epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly diagnosed Stage IV, or recurrent endometrial cancer Inclusion Criteria: - Age ≥18 years at the time of screening and female. - Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed. - Patient must have endometrial cancer in one of the following categories: 1. Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following surgery or diagnostic biopsy), 2. Newly diagnosed Stage IV disease (with or without disease following surgery or diagnostic biopsy) 3. Recurrence of disease (measurable or non-measurable disease per RECIST 1.1) where the potential for cure by surgery alone or in combination is poor. - Naïve to first line systemic anti-cancer treatment. For patients with recurrent disease only, prior systemic anti-cancer treatment is allowed only if it was administered in the adjuvant setting and there is at least 12 months from date of last dose of systemic anti-cancer treatment administered to date of subsequent relapse - FPPE tumor sample must be available for MMR evaluation. - Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days of starting study treatment. Exclusion Criteria: - History of leptomeningeal carcinomatosis. - Brain metastases or spinal cord compression. - Prior treatment with PARP inhibitors. - Any prior exposure to immune-mediated therapy, including (but not limited to) other anti CTLA-4, anti-PD-1, anti-PD-L1, or anti-programmed-cell-death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.

NCT0426xxxx/NCT04269213.xml

<clinical_study>  <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/NCT04269213</url> </required_header> <id_info> <org_study_id>I 501719</org_study_id> <secondary_id>NCI-2019-08946</secondary_id> <secondary_id>I 501719</secondary_id> <nct_id>NCT04269213</nct_id> </id_info> <brief_title>CPX-351 for the Treatment of Secondary Acute Myeloid Leukemia in Patients Younger Than 60 Years Old</brief_title> <official_title>A Phase II Study of CPX-351 in Younger Patients &lt; 60 Years Old With Secondary Acute Myeloid Leukemia</official_title> <sponsors> <lead_sponsor> <agency>Roswell Park Cancer Institute</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>Jazz Pharmaceuticals</agency> <agency_class>Industry</agency_class> </collaborator> </sponsors> <source>Roswell Park Cancer Institute</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine (CPX-351) works in treating patients with secondary acute myeloid leukemia who are younger than 60 years old. Drugs used in chemotherapy, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. </textblock> </brief_summary> <detailed_description> <textblock> PRIMARY OBJECTIVE:  I. To determine the complete response rate including morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) as defined by the International Working Group Criteria.  SECONDARY OBJECTIVE:  I. To determine CR + CRi duration, event free survival (EFS), overall survival (OS), patients successfully proceeding to allogenic hematopoietic cell transplant, and adverse events (AE).  OUTLINE:  INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously (IV) over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity.  RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity.  CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.  After completion of study treatment, patients are followed up at 30 days, and then every 3 months for up to 5 years. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">July 29, 2021</start_date> <completion_date type="Anticipated">January 29, 2024</completion_date> <primary_completion_date type="Anticipated">January 29, 2024</primary_completion_date> <phase>Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Complete response rate (morphological complete remission [CR] and incomplete blood count recovery [CRi])</measure> <time_frame>At day 45</time_frame> <description>Defined by the International Working Group Criteria. Will be summarized using frequencies and relative frequencies.</description> </primary_outcome> <secondary_outcome> <measure>CR + CRi duration</measure> <time_frame>Time from CR or CRi until relapse or last follow-up, assessed up to 5 years</time_frame> <description>Will be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.</description> </secondary_outcome> <secondary_outcome> <measure>Event free survival</measure> <time_frame>Time from treating until disease progression/relapse, death due to disease, or last follow-up, assessed up to 5 years</time_frame> <description>Will be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.</description> </secondary_outcome> <secondary_outcome> <measure>Overall survival</measure> <time_frame>Time from treatment until death due to any cause or last follow-up, assessed up to 5 years</time_frame> <description>Will be summarized using standard Kaplan-Meier methods, where estimates of the median obtained with 90% confidence intervals.</description> </secondary_outcome> <secondary_outcome> <measure>Allogeneic hematopoietic cell transplant rate</measure> <time_frame>Up to 5 years</time_frame> <description>Transplant rate estimated using a 90% confidence interval obtained using Jeffrey's prior method.</description> </secondary_outcome> <secondary_outcome> <measure>Incidence of adverse events</measure> <time_frame>Up to 5 years</time_frame> <description>Will be reported by grade using frequencies and relative frequencies.</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Anticipated">46</enrollment> <condition>Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome</condition> <condition>Acute Myeloid Leukemia With Myelodysplasia-Related Changes</condition> <condition>Secondary Acute Myeloid Leukemia</condition> <condition>Therapy-Related Acute Myeloid Leukemia</condition> <arm_group> <arm_group_label>Treatment (CPX-351)</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>Liposome-encapsulated Daunorubicin-Cytarabine</intervention_name> <description>Given IV</description> <arm_group_label>Treatment (CPX-351)</arm_group_label> <other_name>CPX-351</other_name> <other_name>Cytarabine-Daunorubicin Liposome for Injection</other_name> <other_name>Liposomal AraC-Daunorubicin CPX-351</other_name> <other_name>Liposomal Cytarabine-Daunorubicin</other_name> <other_name>Liposome-encapsulated Combination of Daunorubicin and Cytarabine</other_name> <other_name>Vyxeos</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - Newly diagnosed:  - Therapy-related acute myeloid leukemia (AML)  - AML with antecedent myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)  - AML with MDS-related changes (as per World Health Organization [WHO])  - Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2  - Plasma creatinine =< 1.5 x upper limit of normal (ULN)  - Total bilirubin < 2.0 mg/dL  - Serum alanine aminotransferase and aspartate aminotransferase < 3 x ULN  - Left ventricular ejection fraction by echocardiogram or multiple-gated acquisition >= 50%  - Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately  - Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment and commit to two forms of birth control  - Men must use a latex condom during any sexual contact with women of childbearing potential  - Willing to adhere to protocol specific requirements  - Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure  Exclusion Criteria:  - Prior treatment of AML  - Known clinically active central nervous system (CNS) leukemia  - Core-binding factor leukemia  - Acute promyelocytic leukemia  - Uncontrolled other malignancy  - Prior anthracycline exposure > 368 mg/m^2 of daunorubicin or equivalent  - Cardiovascular disease resulting in heart failure (New York Heart Association class III or IV), unstable angina (angina symptoms at rest), or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months  - Hypersensitivity to cytarabine, daunorubicin, or liposomal drugs  - Known active HIV infection  - Known history of active hepatitis B or C infection  - Pre-existing liver disease (e.g. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis)  - Evidence of ongoing, uncontrolled systemic infection  - Pregnant or breastfeeding women  - Subject with concurrent severe and/or uncontrolled medical or psychiatric conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy  - History of Wilson disease or other copper-handling disorders  - Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>59 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Amanda C Przespolewski</last_name> <role>Principal Investigator</role> <affiliation>Roswell Park Cancer Institute</affiliation> </overall_official> <location> <facility> <name>University of Nebraska Medical Center</name> <address> <city>Omaha</city> <state>Nebraska</state> <zip>68198</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Vijaya Bhatt, MD</last_name> <phone>402-559-8500</phone> <email>vijaya.bhatt@unmc.edu</email> </contact> </location> <location> <facility> <name>Roswell Park Cancer Institute</name> <address> <city>Buffalo</city> <state>New York</state> <zip>14263</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Amanda C. Przespolewski</last_name> <phone>716-845-3287</phone> <email>amanda.przespolewski@roswellpark.org</email> </contact> <investigator> <last_name>Amanda C. Przespolewski</last_name> <role>Principal Investigator</role> </investigator> </location> <location> <facility> <name>Allegheny Health Network Cancer Institute - West Penn Hospital</name> <address> <city>Pittsburgh</city> <state>Pennsylvania</state> <zip>15224</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Salman Fazal, MD</last_name> <phone>412-578-4484</phone> <email>Salman.Fazal@ahn.org</email> </contact> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>May 2023</verification_date> <study_first_submitted>February 11, 2020</study_first_submitted> <study_first_submitted_qc>February 11, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>May 11, 2023</last_update_submitted> <last_update_submitted_qc>May 11, 2023</last_update_submitted_qc> <last_update_posted type="Actual">May 12, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Leukemia</mesh_term> <mesh_term>Leukemia, Myeloid</mesh_term> <mesh_term>Leukemia, Myeloid, Acute</mesh_term> <mesh_term>Neoplasm Metastasis</mesh_term> <mesh_term>Myelodysplastic Syndromes</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Cytarabine</mesh_term> <mesh_term>Daunorubicin</mesh_term> </intervention_browse>  </clinical_study>

This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine (CPX-351) works in treating patients with secondary acute myeloid leukemia who are younger than 60 years old. Drugs used in chemotherapy, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. PRIMARY OBJECTIVE: I. To determine the complete response rate including morphologic complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) as defined by the International Working Group Criteria. SECONDARY OBJECTIVE: I. To determine CR + CRi duration, event free survival (EFS), overall survival (OS), patients successfully proceeding to allogenic hematopoietic cell transplant, and adverse events (AE). OUTLINE: INDUCTION: Patients receive liposome-encapsulated daunorubicin-cytarabine intravenously (IV) over 90 minutes on days 1, 3, and 5 in the absence of disease progression or unacceptable toxicity. RE-INDUCTION: Patients who do not achieve remission receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Beginning 5-8 weeks after the start of the last induction, patients who achieve CR receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 45 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, and then every 3 months for up to 5 years. Inclusion Criteria: - Newly diagnosed: - Therapy-related acute myeloid leukemia (AML) - AML with antecedent myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) - AML with MDS-related changes (as per World Health Organization [WHO]) - Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 - Plasma creatinine =< 1.5 x upper limit of normal (ULN) - Total bilirubin < 2.0 mg/dL - Serum alanine aminotransferase and aspartate aminotransferase < 3 x ULN - Left ventricular ejection fraction by echocardiogram or multiple-gated acquisition >= 50% - Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately - Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment and commit to two forms of birth control - Men must use a latex condom during any sexual contact with women of childbearing potential - Willing to adhere to protocol specific requirements - Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: - Prior treatment of AML - Known clinically active central nervous system (CNS) leukemia - Core-binding factor leukemia - Acute promyelocytic leukemia - Uncontrolled other malignancy - Prior anthracycline exposure > 368 mg/m^2 of daunorubicin or equivalent - Cardiovascular disease resulting in heart failure (New York Heart Association class III or IV), unstable angina (angina symptoms at rest), or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months - Hypersensitivity to cytarabine, daunorubicin, or liposomal drugs - Known active HIV infection - Known history of active hepatitis B or C infection - Pre-existing liver disease (e.g. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis) - Evidence of ongoing, uncontrolled systemic infection - Pregnant or breastfeeding women - Subject with concurrent severe and/or uncontrolled medical or psychiatric conditions that in the opinion of the investigator may impair the participation in the study or the evaluation of safety and/or efficacy - History of Wilson disease or other copper-handling disorders - Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

NCT0426xxxx/NCT04269226.xml

<clinical_study>  <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/NCT04269226</url> </required_header> <id_info> <org_study_id>20190409</org_study_id> <nct_id>NCT04269226</nct_id> </id_info> <brief_title>Effect of Automatic Recruitment Maneuver on Peroperative Lung Mechanics of Obese Laparoscopic Abdominal Surgery Patients</brief_title> <official_title>The Effect of Automatic Recruitment Maneuver on Peroperative Lung Mechanics and Postoperative Kidney Functions of Obese Patients Undergoing Laparoscopic Abdominal Surgery</official_title> <sponsors> <lead_sponsor> <agency>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This study aims to demonstrate the effects of automatic recruitment maneuver on peroperative lung mechanics of obese patients undergoing laparoscopic abdominal surgery.  128 obese patients undergoing abdominal laparoscopic surgery are randomly going to be assigned to automatic recruitment maneuver group and no recruitment maneuver group (control group). Both groups are going to be taken to the operating table. Electrocardiography (ECG), noninvasive blood pressure (NIBP), pulse oximeter and peripheral oxygen saturation (SpO2) and post-intubation end-tidal carbon dioxide (EtCO2) and train of four (TOF) monitoring will be performed. Then, general anesthesia induction procedure will be started. Following intubation, patients will be ventilated according to the ideal weight within the scope of intraoperative protective ventilation strategy and in pressure-controlled ventilation (PCV) mode. Then, automatic recruitment maneuver will be applied to the recruitment group twice, after insufflation and desufflation. It will not be applied to the control group. During recruitment maneuver, PEEP (Positive end-expiratory pressure), where dynamic compliance is measured highest, will be the ideal PEEP (Positive end-expiratory pressure) for the patient, and PEEP (Positive end-expiratory pressure) will be adjusted at this value after recruitment. If MAP (mean arterial pressure) is <60 mmHg during the maneuver, the maneuver will be terminated and these patients will be excluded from the study. Respiratory mechanics for both groups (peak pressure, plateau pressure, driver pressure, static compliance, dynamic compliance, EtCO2) and hemodynamic parameters (heart peak, mean arterial pressure, SpO2) at 5 different times (T1: post intubation; T2 : after insufflation; T3: 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver) will be recorded. Throughout the surgery, insufflation pressure will be kept as 10-13 cmH20. At the end of the surgery, the anesthesia maintenance of all patients will be terminated and the routine wake-up phase will be initiated. Creatinine values and hourly urine outputs of all patients routinely monitored at the postoperative 24th hour will be recorded on the case follow-up form. </textblock> </brief_summary> <overall_status>Unknown status</overall_status> <last_known_status>Recruiting</last_known_status> <start_date type="Actual">April 9, 2019</start_date> <completion_date type="Anticipated">May 9, 2020</completion_date> <primary_completion_date type="Anticipated">April 9, 2020</primary_completion_date> <phase>N/A</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> <primary_purpose>Treatment</primary_purpose> <masking>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>Peak airway pressure</measure> <time_frame>1 week</time_frame> <description>This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg(T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)</description> </primary_outcome> <primary_outcome> <measure>Plateau airway pressure</measure> <time_frame>1 week</time_frame> <description>This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg(T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)</description> </primary_outcome> <primary_outcome> <measure>Driver airway pressure</measure> <time_frame>1 week</time_frame> <description>This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)</description> </primary_outcome> <primary_outcome> <measure>Static airway compliance</measure> <time_frame>1 week</time_frame> <description>This will me measured at 5 different times using mechanic ventilator and will be reported as This will me measured at 5 different times using mechanic ventilator and will be reported as cmH2O (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)</description> </primary_outcome> <primary_outcome> <measure>Dynamic airway compliance</measure> <time_frame>1 week</time_frame> <description>This will me measured at 5 different times using mechanic ventilator and will be reported as This will me measured at 5 different times using mechanic ventilator and will be reported as cmH2O (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)</description> </primary_outcome> <primary_outcome> <measure>End tidal CO2 pressure</measure> <time_frame>1 week</time_frame> <description>This will me measured at 5 different times using mechanic ventilator and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)</description> </primary_outcome> <secondary_outcome> <measure>Heart rate</measure> <time_frame>1 week</time_frame> <description>This will me measured at 5 different times using electrocardiography and will be reported as beat per minute (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)</description> </secondary_outcome> <secondary_outcome> <measure>Mean arterial pressure</measure> <time_frame>1 week</time_frame> <description>This will me measured at 5 different times using non invasive blood pressure monitor and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)</description> </secondary_outcome> <secondary_outcome> <measure>SpO2</measure> <time_frame>1 week</time_frame> <description>SpO2 will me measured at 5 different times using pulse oximetry and will be reported as mmHg (T1: post intubation; T2: post insufflation; T3 : 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver)</description> </secondary_outcome> <secondary_outcome> <measure>Creatinine</measure> <time_frame>24th hour</time_frame> <description>Creatinine values will be measured at 24th our using blood tests and will be reported as mg/dL</description> </secondary_outcome> <secondary_outcome> <measure>Urine output</measure> <time_frame>24th hour</time_frame> <description>This will be measured hourly for the first 24 hours, using urinary catheter and will be reported as ml per hour.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">128</enrollment> <condition>Recruitment</condition> <condition>Obesity, Morbid</condition> <condition>Laparoscopy</condition> <arm_group> <arm_group_label>Recruitment maneuver</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Recruitment maneuver</description> </arm_group> <arm_group> <arm_group_label>No recruitment maneuver</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>No recruitment maneuver</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Recruitment maneuver</intervention_name> <description>Following intubation, patients will be ventilated according to the ideal weight within the scope of intraoperative protective ventilation strategy and in pressure-controlled ventilation (PCV) mode. Then, automatic recruitment maneuver will be applied to the recruitment group twice, after insufflation and desufflation. It will not be applied to the control group. During recruitment maneuver, PEEP (Positive end-expiratory pressure), where dynamic compliance is measured highest, will be the ideal peep for the patient, and PEEP will be adjusted at this value after recruitment.</description> <arm_group_label>Recruitment maneuver</arm_group_label> </intervention> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>No recruitment maneuver</intervention_name> <description>Usual ventilation procedures will be applied.</description> <arm_group_label>No recruitment maneuver</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Patients between the ages of 18 and 65  2. Body mass index (BMI)> 30 patients undergoing laparoscopic abdominal surgery  3. ASA (American Society of Anesthesiologists) 2-3 patients  Exclusion Criteria:  1. Smokers  2. Patients with previous abdominal surgery  3. Patients with obstructive / restrictive lung disease,  4. Patients with coronary artery disease, heart failure  5. Patients with chronic kidney failure </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_contact> <last_name>Basak Bayrak, MD</last_name> <phone>+902124147171</phone> <email>basakbayrak2009@gmail.com</email> </overall_contact> <location> <facility> <name>Bakırköy Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi</name> <address> <city>Istanbul</city> <zip>34147</zip> <country>Turkey</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Basak Bayrak, MD</last_name> <phone>+902124147171</phone> <email>basakbayrak2009@gmail.com</email> </contact> </location> <location_countries> <country>Turkey</country> </location_countries> <verification_date>February 2020</verification_date> <study_first_submitted>February 9, 2020</study_first_submitted> <study_first_submitted_qc>February 12, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>February 12, 2020</last_update_submitted> <last_update_submitted_qc>February 12, 2020</last_update_submitted_qc> <last_update_posted type="Actual">February 13, 2020</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Obesity, Morbid</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This study aims to demonstrate the effects of automatic recruitment maneuver on peroperative lung mechanics of obese patients undergoing laparoscopic abdominal surgery. 128 obese patients undergoing abdominal laparoscopic surgery are randomly going to be assigned to automatic recruitment maneuver group and no recruitment maneuver group (control group). Both groups are going to be taken to the operating table. Electrocardiography (ECG), noninvasive blood pressure (NIBP), pulse oximeter and peripheral oxygen saturation (SpO2) and post-intubation end-tidal carbon dioxide (EtCO2) and train of four (TOF) monitoring will be performed. Then, general anesthesia induction procedure will be started. Following intubation, patients will be ventilated according to the ideal weight within the scope of intraoperative protective ventilation strategy and in pressure-controlled ventilation (PCV) mode. Then, automatic recruitment maneuver will be applied to the recruitment group twice, after insufflation and desufflation. It will not be applied to the control group. During recruitment maneuver, PEEP (Positive end-expiratory pressure), where dynamic compliance is measured highest, will be the ideal PEEP (Positive end-expiratory pressure) for the patient, and PEEP (Positive end-expiratory pressure) will be adjusted at this value after recruitment. If MAP (mean arterial pressure) is <60 mmHg during the maneuver, the maneuver will be terminated and these patients will be excluded from the study. Respiratory mechanics for both groups (peak pressure, plateau pressure, driver pressure, static compliance, dynamic compliance, EtCO2) and hemodynamic parameters (heart peak, mean arterial pressure, SpO2) at 5 different times (T1: post intubation; T2 : after insufflation; T3: 5 minutes after insufflation / after the first recruitment maneuver; T4: after desufflation; T5: 5 minutes after desufflation / after the second recruitment maneuver) will be recorded. Throughout the surgery, insufflation pressure will be kept as 10-13 cmH20. At the end of the surgery, the anesthesia maintenance of all patients will be terminated and the routine wake-up phase will be initiated. Creatinine values and hourly urine outputs of all patients routinely monitored at the postoperative 24th hour will be recorded on the case follow-up form. Inclusion Criteria: 1. Patients between the ages of 18 and 65 2. Body mass index (BMI)> 30 patients undergoing laparoscopic abdominal surgery 3. ASA (American Society of Anesthesiologists) 2-3 patients Exclusion Criteria: 1. Smokers 2. Patients with previous abdominal surgery 3. Patients with obstructive / restrictive lung disease, 4. Patients with coronary artery disease, heart failure 5. Patients with chronic kidney failure

NCT0426xxxx/NCT04269239.xml

<clinical_study>  <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/NCT04269239</url> </required_header> <id_info> <org_study_id>H - 45617 HealthyHab</org_study_id> <nct_id>NCT04269239</nct_id> </id_info> <brief_title>Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation</brief_title> <acronym>HH</acronym> <official_title>Effectiveness of Healthy Habits for Hospitalized Older Adults to Optimize Rehabilitation</official_title> <sponsors> <lead_sponsor> <agency>Baylor College of Medicine</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Baylor College of Medicine</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This study aims to evaluate behavioral interventions in conjunction with medical rehabilitation to promote functional health in patients recovering from orthopedic surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits. The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments. </textblock> </brief_summary> <detailed_description> <textblock> Improving healthy habits such as sleep, nutrition or physical activity is expected to enhance rehabilitation in knee or hip arthroplasty patients, by increasing their ability to attend and adhere to rehabilitation recommendations following surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits (physical activity, nutrition, pain-coping techniques, etc). The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments at baseline (prior to surgery), post-hospital, post-intervention and at a 6 month follow-up visit. </textblock> </detailed_description> <overall_status>Recruiting</overall_status> <start_date type="Actual">April 30, 2021</start_date> <completion_date type="Anticipated">November 30, 2023</completion_date> <primary_completion_date type="Actual">June 1, 2023</primary_completion_date> <phase>N/A</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>Participants will be assigned to either the a healthy habits group or a sleep habits group.</intervention_model_description> <primary_purpose>Treatment</primary_purpose> <masking>Double (Participant, Outcomes Assessor)</masking> </study_design_info> <primary_outcome> <measure>Insomnia Severity Index (ISI)</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.</description> </primary_outcome> <primary_outcome> <measure>Insomnia Severity Index (ISI)</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.</description> </primary_outcome> <primary_outcome> <measure>Insomnia Severity Index (ISI)</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.</description> </primary_outcome> <primary_outcome> <measure>Insomnia Severity Index (ISI)</measure> <time_frame>6 months after completing the intervention</time_frame> <description>ISI is a questionnaire that provides a clinically meaningful index of insomnia. It is a 7-item validated self-report scale that assesses subjective symptoms of insomnia. Items are scored on a 0-4 scale to yield a score of 0-28. Higher scores indicate greater insomnia severity. A cutoff score of ≥ 8 is optimal to detect clinical levels of insomnia.</description> </primary_outcome> <primary_outcome> <measure>Wrist actigraphy</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>A wearable device will be used to measure participant sleep over seven days.</description> </primary_outcome> <primary_outcome> <measure>Wrist actigraphy</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>A wearable device will be used to measure participant sleep over seven days.</description> </primary_outcome> <primary_outcome> <measure>Wrist actigraphy</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>A wearable device will be used to measure participant sleep over seven days.</description> </primary_outcome> <primary_outcome> <measure>Wrist actigraphy</measure> <time_frame>6 months after completing the intervention</time_frame> <description>A wearable device will be used to measure participant sleep over seven days.</description> </primary_outcome> <secondary_outcome> <measure>PROMIS Physical Function (short form)</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'</description> </secondary_outcome> <secondary_outcome> <measure>PROMIS Physical Function (short form)</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'</description> </secondary_outcome> <secondary_outcome> <measure>PROMIS Physical Function (short form)</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'</description> </secondary_outcome> <secondary_outcome> <measure>PROMIS Physical Function (short form)</measure> <time_frame>6 months after completing the intervention</time_frame> <description>The PROMIS physical function short form is a 10 item questionnaire used to assess patient perceived motor abilities. Participants are asked five questions to rank 'from not at all' to 'cannot do' how their health limits their involvement in different activities. Five additional questions ask participants if they are able to complete activities of daily living ranked from 'without any difficulty' to 'unable to do'</description> </secondary_outcome> <secondary_outcome> <measure>PROMIS Mobility</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.</description> </secondary_outcome> <secondary_outcome> <measure>PROMIS Mobility</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.</description> </secondary_outcome> <secondary_outcome> <measure>PROMIS Mobility</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.</description> </secondary_outcome> <secondary_outcome> <measure>PROMIS Mobility</measure> <time_frame>6 months after completing the intervention</time_frame> <description>The PROMIS Mobility questionnaire has 14 questions also used to used to assess patient perceived motor abilities. Participants are asked to respond on a five-point scale from 'without any difficulty' to 'unable to do' about their ability to perform various physical activities.</description> </secondary_outcome> <secondary_outcome> <measure>Short Physical Performance Battery (SPPB ) motor</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.</description> </secondary_outcome> <secondary_outcome> <measure>Short Physical Performance Battery (SPPB ) motor</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.</description> </secondary_outcome> <secondary_outcome> <measure>Short Physical Performance Battery (SPPB ) motor</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.</description> </secondary_outcome> <secondary_outcome> <measure>Short Physical Performance Battery (SPPB ) motor</measure> <time_frame>6 months after completing the intervention</time_frame> <description>The Short Physical Performance Battery (SPPB ) is an objective assessment tool for evaluating lower extremity functioning, developed by the NIA. Motor tests include: a chair stand test, standing balance test (side by side stand, semi-tandem stand, tandem stand.),and gait speed test. The three motor tests are scored and a global score is obtained.</description> </secondary_outcome> <secondary_outcome> <measure>PROMIS Applied Cognitive Abilities</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.</description> </secondary_outcome> <secondary_outcome> <measure>PROMIS Applied Cognitive Abilities</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.</description> </secondary_outcome> <secondary_outcome> <measure>PROMIS Applied Cognitive Abilities</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.</description> </secondary_outcome> <secondary_outcome> <measure>PROMIS Applied Cognitive Abilities</measure> <time_frame>6 months after completing the intervention</time_frame> <description>The PROMIS Applied Cognitive Abilities is a 8 item questionnaire used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a 5 point scale from 'not at all' to 'very much' their perceived cognitive performance over the past seven days.</description> </secondary_outcome> <secondary_outcome> <measure>PROMIS Applied Cognitive Abilities- General Concerns</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.</description> </secondary_outcome> <secondary_outcome> <measure>PROMIS Applied Cognitive Abilities- General Concerns</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.</description> </secondary_outcome> <secondary_outcome> <measure>PROMIS Applied Cognitive Abilities- General Concerns</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.</description> </secondary_outcome> <secondary_outcome> <measure>PROMIS Applied Cognitive Abilities - General Concerns</measure> <time_frame>6 months after completing the intervention</time_frame> <description>The PROMIS Applied Cognitive Abilities is a 6 item questionnaire also used to assess patient perceived cognitive abilities based on self-report. Participants are asked to rank on a five point scale from 'never' to 'very often' the incidence of perceived cognitive impairment over the past seven days.</description> </secondary_outcome> <secondary_outcome> <measure>Tele-neuropsychology (T-NP) Battery</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall) Cognition tests will be scored.</description> </secondary_outcome> <secondary_outcome> <measure>Tele-neuropsychology (T-NP) Battery</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored.</description> </secondary_outcome> <secondary_outcome> <measure>Tele-neuropsychology (T-NP) Battery</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>The T-NP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored.</description> </secondary_outcome> <secondary_outcome> <measure>Tele-neuropsychology (T-NP) Battery</measure> <time_frame>6 months after completing the intervention</time_frame> <description>The TNP Battery consists of cognitive tests which measure verbal memory, verbal and phonemic fluency, working memory (list sorting, list learning, delayed recall). Cognition tests will be scored.</description> </secondary_outcome> <secondary_outcome> <measure>Activities of Daily Living (ADLs)</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"</description> </secondary_outcome> <secondary_outcome> <measure>Activities of Daily Living (ADLs)</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"</description> </secondary_outcome> <secondary_outcome> <measure>Activities of Daily Living (ADLs)</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"</description> </secondary_outcome> <secondary_outcome> <measure>Activities of Daily Living (ADLs)</measure> <time_frame>6 months after completing the intervention</time_frame> <description>The ADL questionnaire measure self-reported activities of daily living (ADLs). The questionnaire assesses need for assistance in 7 activities of daily living (i.e., eating, dressing, grooming, mobility, transferring, bathing, and continence) - questions are answered as "need help" or "don't need help"</description> </secondary_outcome> <secondary_outcome> <measure>Instrumental ADLs (IADL) scale</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.</description> </secondary_outcome> <secondary_outcome> <measure>Instrumental ADLs (IADL) scale</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.</description> </secondary_outcome> <secondary_outcome> <measure>Instrumental ADLs (IADL) scale</measure> <time_frame>7-14 days after completing the 8 week intervention period and</time_frame> <description>The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.</description> </secondary_outcome> <secondary_outcome> <measure>Instrumental ADLs (IADL) scale</measure> <time_frame>6 months after completing the intervention</time_frame> <description>The IADL questionnaire is an 8-item scale designed to assesses the need for assistance in telephone use, shopping, food preparation, housekeeping, laundry, transportation, taking medicines and finances. Higher scores indicate greater independence. The questions are answered in a "yes" or "no" format.</description> </secondary_outcome> <secondary_outcome> <measure>Sleep Diary</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.</description> </secondary_outcome> <secondary_outcome> <measure>Sleep Diary</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.</description> </secondary_outcome> <secondary_outcome> <measure>Sleep Diary</measure> <time_frame>During the 8 week intervention</time_frame> <description>The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.</description> </secondary_outcome> <secondary_outcome> <measure>Sleep Diary</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.</description> </secondary_outcome> <secondary_outcome> <measure>Sleep Diary</measure> <time_frame>6 months after completing the intervention</time_frame> <description>The sleep diary has 9 core items that query: 1) napping, 2) bedtime, 3) time of first attempt to sleep, 4) time to fall asleep, 5) number of awakenings, 6) duration of awakenings, 7) final wake-up time, 8) rise time, 9) a rating of sleep quality, and an optional space for writing comments.</description> </secondary_outcome> <secondary_outcome> <measure>Knee injury and osteoarthritis outcome score (KOOS)</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.</description> </secondary_outcome> <secondary_outcome> <measure>Knee injury and osteoarthritis outcome score (KOOS)</measure> <time_frame>6 months after completing intervention</time_frame> <description>This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how knee pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.</description> </secondary_outcome> <secondary_outcome> <measure>Hip disability and osteoarthritis outcome score (HOOS)</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how hip pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.</description> </secondary_outcome> <secondary_outcome> <measure>Hip disability and osteoarthritis outcome score (HOOS)</measure> <time_frame>6 months after completing intervention</time_frame> <description>This questionnaire is divided into subscales of pain, symptoms, activities of daily living, sports/recreation and quality of life. Questions about how hip pain affects participant in each of these categories answered on a scale of None, Mild, Moderate, Severe or Extremely.</description> </secondary_outcome> <secondary_outcome> <measure>StepWatch</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>A wearable device will measure physical activity over a seven day period.</description> </secondary_outcome> <secondary_outcome> <measure>StepWatch</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>A wearable device will measure physical activity over a seven day period.</description> </secondary_outcome> <secondary_outcome> <measure>StepWatch</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>A wearable device will measure physical activity over a seven day period.</description> </secondary_outcome> <secondary_outcome> <measure>StepWatch</measure> <time_frame>6 months after completing the intervention</time_frame> <description>A wearable device will measure physical activity over a seven day period.</description> </secondary_outcome> <other_outcome> <measure>PROMIS Pain Intensity</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.</description> </other_outcome> <other_outcome> <measure>PROMIS Pain Intensity</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.</description> </other_outcome> <other_outcome> <measure>PROMIS Pain Intensity</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.</description> </other_outcome> <other_outcome> <measure>PROMIS Pain Intensity</measure> <time_frame>6 months after completing the intervention</time_frame> <description>The PROMIS Pain Intensity is a 3 question questionnaire that asks participants to rank intensity of past and current pain over the last seven days on a five point scale from 'had no pain' to 'very severe'.</description> </other_outcome> <other_outcome> <measure>PROMIS Pain Interference</measure> <time_frame>7-14 days before schedule surgery</time_frame> <description>The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.</description> </other_outcome> <other_outcome> <measure>PROMIS Pain Interference</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.</description> </other_outcome> <other_outcome> <measure>PROMIS Pain Interference</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.</description> </other_outcome> <other_outcome> <measure>PROMIS Pain Interference</measure> <time_frame>6 months after completing the intervention</time_frame> <description>The PROMIS Pain Interference is a 6 question questionnaire that ask participants to rank how pain interfered with aspects of their daily life on a five point scale from 'not at all' to 'very much'.</description> </other_outcome> <other_outcome> <measure>PROMIS Fatigue</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.</description> </other_outcome> <other_outcome> <measure>PROMIS Fatigue</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.</description> </other_outcome> <other_outcome> <measure>PROMIS Fatigue</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.</description> </other_outcome> <other_outcome> <measure>PROMIS Fatigue</measure> <time_frame>6 months after completing the intervention</time_frame> <description>The PROMIS Fatigue questionnaire has 8 questions that ask participants on a five point scale of either 'not at all' to very much' or 'never' to 'always' different statements about fatigue and how it impacted their activities of daily living.</description> </other_outcome> <other_outcome> <measure>PROMIS Emotional Distress-Depressesion</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.</description> </other_outcome> <other_outcome> <measure>PROMIS Emotional Distress-Depressesion</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.</description> </other_outcome> <other_outcome> <measure>PROMIS Emotional Distress-Depressesion</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.</description> </other_outcome> <other_outcome> <measure>PROMIS Emotional Distress-Depressesion</measure> <time_frame>6 months after completing the intervention</time_frame> <description>The PROMIS Emotional Distress-Depression questionnaire has 8 questions that asks participants to rank on a five point scale form 'never' to 'always' the frequency of different negative feelings over the past seven days.</description> </other_outcome> <other_outcome> <measure>PROMIS Psychosocial Illness Impact - Negative</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.</description> </other_outcome> <other_outcome> <measure>PROMIS Psychosocial Illness Impact - Negative</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.</description> </other_outcome> <other_outcome> <measure>PROMIS Psychosocial Illness Impact - Negative</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.</description> </other_outcome> <other_outcome> <measure>PROMIS Psychosocial Illness Impact - Negative</measure> <time_frame>6 months after completing the intervention</time_frame> <description>The PROMIS Psychosocial Illness Impact - Negative questionnaire has 16 questions that query participants about 8 aspects of psychosocial well being over the past seven days ranked on a five point scale from 'not at all' to 'very much'.</description> </other_outcome> <other_outcome> <measure>PROMIS Satisfaction with Social Roles and Activities</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.</description> </other_outcome> <other_outcome> <measure>PROMIS Satisfaction with Social Roles and Activities</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.</description> </other_outcome> <other_outcome> <measure>PROMIS Satisfaction with Social Roles and Activities</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.</description> </other_outcome> <other_outcome> <measure>PROMIS Satisfaction with Social Roles and Activities</measure> <time_frame>6 months after completing the intervention</time_frame> <description>The PROMIS Satisfaction with Social Roles and Activities questionnaire has 4 questions that assess participants satisfaction in their social roles ranked on a five point scale from 'not at all' to 'very much'.</description> </other_outcome> <other_outcome> <measure>PROMIS Ability to Participate in Social Roles and Activity</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.</description> </other_outcome> <other_outcome> <measure>PROMIS Ability to Participate in Social Roles and Activity</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.</description> </other_outcome> <other_outcome> <measure>PROMIS Ability to Participate in Social Roles and Activity</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.</description> </other_outcome> <other_outcome> <measure>PROMIS Ability to Participate in Social Roles and Activity</measure> <time_frame>6 months after completing the intervention</time_frame> <description>The PROMIS Ability to Participate in Social Roles and Activity questionnaire has four questions that asks participants about their ability to participate socially ranked on a five point scale from 'not at all' to 'very much'.</description> </other_outcome> <other_outcome> <measure>Rehabilitation Attendance</measure> <time_frame>From hospital discharge until subject notifies study staff they have stopped attending, on average around 12 weeks.</time_frame> <description>Weekly rehabilitation attendance will be measured via patient self-report.</description> </other_outcome> <other_outcome> <measure>Plasma IL-6</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).</description> </other_outcome> <other_outcome> <measure>Plasma IL-6</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).</description> </other_outcome> <other_outcome> <measure>Plasma IL-6</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).</description> </other_outcome> <other_outcome> <measure>Plasma IL-6</measure> <time_frame>6 months after completing the intervention</time_frame> <description>Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Interleukin-6 (IL-6).</description> </other_outcome> <other_outcome> <measure>Plasma CRP</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)</description> </other_outcome> <other_outcome> <measure>Plasma CRP</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)</description> </other_outcome> <other_outcome> <measure>Plasma CRP</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)</description> </other_outcome> <other_outcome> <measure>Plasma CRP</measure> <time_frame>6 months after completing the intervention</time_frame> <description>Blood samples will be taken by study staff to measure circulating proinflammatory cytokine C-reactive protein (CRP)</description> </other_outcome> <other_outcome> <measure>Plasma VWF</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)</description> </other_outcome> <other_outcome> <measure>Plasma VWF</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)</description> </other_outcome> <other_outcome> <measure>Plasma VWF</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)</description> </other_outcome> <other_outcome> <measure>Plasma VWF</measure> <time_frame>6 months after completing the intervention</time_frame> <description>Blood samples will be taken by study staff to measure circulating proinflammatory cytokine vonWillebrand factor (VWF)</description> </other_outcome> <other_outcome> <measure>Plasma TNFalpha</measure> <time_frame>7-14 days before scheduled surgery</time_frame> <description>Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)</description> </other_outcome> <other_outcome> <measure>Plasma TNFalpha</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)</description> </other_outcome> <other_outcome> <measure>Plasma TNFalpha</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)</description> </other_outcome> <other_outcome> <measure>Plasma TNFalpha</measure> <time_frame>6 months after completing the intervention</time_frame> <description>Blood samples will be taken by study staff to measure circulating proinflammatory cytokine Tumor Necrosis Factor alpha (TNFa)</description> </other_outcome> <other_outcome> <measure>Medication Monitoring Form</measure> <time_frame>7-14 days before schedule surgery</time_frame> <description>Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.</description> </other_outcome> <other_outcome> <measure>Medication Monitoring Form</measure> <time_frame>7-14 days after hospital discharge</time_frame> <description>Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.</description> </other_outcome> <other_outcome> <measure>Medication Monitoring Form</measure> <time_frame>7-14 days after completing the 8 week intervention period</time_frame> <description>Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.</description> </other_outcome> <other_outcome> <measure>Medication Monitoring Form</measure> <time_frame>6 months after completing the intervention</time_frame> <description>Medication Monitoring Form will be used to track medication use. Medications will be coded by drug class.</description> </other_outcome> <other_outcome> <measure>Treatment Expectation Questionnaire</measure> <time_frame>Immediately prior to beginning the intervention</time_frame> <description>This questionnaire 8-question measure provided before treatment. It will be used to collect information on participants' reasons for treatment as well as their expectations of treatment (e.g., its effectiveness, the amount of effort it will take, confidence in their doctor). Participant will mark answers to each question on a visual analog scale (e.g., from Not Confident at all to Very Confident).</description> </other_outcome> <other_outcome> <measure>Treatment Satisfaction Questionnaire</measure> <time_frame>Immediately following the completion of the intervention</time_frame> <description>Treatment Satisfaction Scale is a 10-question measure provided after treatment. It measures participants' perceptions on the treatment's effectiveness, benefits, and influence on quality of life (e.g., improvements in work productivity, mood, etc.). Questions are measured on a 5-point Likert scale from Not at all to Very Much.</description> </other_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Anticipated">124</enrollment> <condition>Insomnia</condition> <condition>Pain</condition> <condition>Osteoarthritis, Knee</condition> <condition>Osteoarthritis, Hip</condition> <arm_group> <arm_group_label>Healthy Habits</arm_group_label> <arm_group_type>Other</arm_group_type> <description>This group will meet with a study therapist to discuss strategies to implement healthy habits that may enhance recovery from knee or hip surgery.</description> </arm_group> <arm_group> <arm_group_label>Sleep Habits</arm_group_label> <arm_group_type>Other</arm_group_type> <description>This group will meet with a study therapist to discuss strategies to implement healthy sleep habits that may enhance recovery from knee or hip surgery.</description> </arm_group> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Healthy Habits</intervention_name> <description>Participants in this group will be coached during four hour-long sessions on topics such as physical activity, nutrition, pain coping skills, bladder health, diabetes, heart health, eyes/vision, hearing, and doctor-patient communication.</description> <arm_group_label>Healthy Habits</arm_group_label> </intervention> <intervention> <intervention_type>Behavioral</intervention_type> <intervention_name>Sleep Habits</intervention_name> <description>Participants in this group will be coached during four hour-long sessions on topics such as sleep education, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene education, and relapse prevention.</description> <arm_group_label>Sleep Habits</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Patients with a minimum age of 40 years, no maximum age limit, planning on having a hip or knee arthroplasty.  2. The ability to communicate during the screening process (e.g., no aphasia or other severe language impairment).  3. Meet DSM-5 criteria for insomnia disorder assessed by Duke Structured Interview for Sleep Disorders.  4. Score ≥8 on the Insomnia Severity Index (ISI) or ≥5 on the Pittsburgh Sleep Quality Index (PSQI).  5. Referral and attendance of medical rehabilitation post-discharge.  Exclusion Criteria:  1. Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in the past year).  2. Presence of psychotic disorder, substance abuse or dependence, or bipolar disorder assessed by MINI International Neuropsychiatric Inventory (to increase generalizability other psychiatric comorbidities such as depression or anxiety will not be excluded).  3. Untreated comorbid sleep disorders based on structured diagnostic interview including: narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea risk.  4. Cognitive impairment defined as <20 on the Mini Mental Status Exam (MMSE) that could potentially limit comprehension of the intervention. Note, while an MMSE of <24 is often used as a cutoff for cognitive impairment, we do not wish to exclude those with mild cognitive problems from this study as there is evidence that individuals with mild cognitive problems still benefit from insomnia treatments. </textblock> </criteria> <gender>All</gender> <minimum_age>40 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Sara Nowakowski, PhD</last_name> <role>Principal Investigator</role> <affiliation>Baylor College of Medicine</affiliation> </overall_official> <overall_contact> <last_name>Doris Escobedo</last_name> <phone>713-487-5540</phone> <email>doris.escobedo@bcm.edu</email> </overall_contact> <overall_contact_backup> <last_name>Emily Lantz, PhD</last_name> <email>ejlantz@utmb.edu</email> </overall_contact_backup> <location> <facility> <name>University of Texas Medical Branch</name> <address> <city>Galveston</city> <state>Texas</state> <zip>77555</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Emily Lantz, PhD</last_name> <phone>409-772-0643</phone> <email>ejlantz@utmb.edu</email> </contact> </location> <location> <facility> <name>Baylor College of Medicine Medical Center</name> <address> <city>Houston</city> <state>Texas</state> <zip>77030</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Doris Escobedo</last_name> <phone>713-487-5540</phone> <email>doris.escobedo@bcm.edu</email> </contact> </location> <location> <facility> <name>Kelsey Seybold Clinic</name> <address> <city>Houston</city> <state>Texas</state> <zip>77054</zip> <country>United States</country> </address> </facility> <status>Recruiting</status> <contact> <last_name>Edina Dervisefendic</last_name> <email>edina.dervisefendic@kelseyresearch.com</email> </contact> <contact_backup> <last_name>Ashley Alexander</last_name> <phone>713-442-1222</phone> <email>Ashley.Alexander@KelseyResearch.com</email> </contact_backup> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>August 2023</verification_date> <study_first_submitted>February 10, 2020</study_first_submitted> <study_first_submitted_qc>February 12, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>August 22, 2023</last_update_submitted> <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 23, 2023</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Baylor College of Medicine</investigator_affiliation> <investigator_full_name>Sara Nowakowski</investigator_full_name> <investigator_title>Associate Professor</investigator_title> </responsible_party> <keyword>Knee Arthroplasty</keyword> <keyword>Hip Arthroplasty</keyword> <keyword>Rehabilitation</keyword> <condition_browse>  <mesh_term>Osteoarthritis</mesh_term> <mesh_term>Osteoarthritis, Knee</mesh_term> <mesh_term>Osteoarthritis, Hip</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This study aims to evaluate behavioral interventions in conjunction with medical rehabilitation to promote functional health in patients recovering from orthopedic surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits. The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments. Improving healthy habits such as sleep, nutrition or physical activity is expected to enhance rehabilitation in knee or hip arthroplasty patients, by increasing their ability to attend and adhere to rehabilitation recommendations following surgery. Half of the subjects in this study will be assigned to an intervention that meets with a study therapist to discuss implementing healthy habits (physical activity, nutrition, pain-coping techniques, etc). The other half of subjects will assigned to an intervention group that meets with a study therapists to discuss implementing healthy sleep habits. Both groups will undergo several physical and cognitive assessments at baseline (prior to surgery), post-hospital, post-intervention and at a 6 month follow-up visit. Inclusion Criteria: 1. Patients with a minimum age of 40 years, no maximum age limit, planning on having a hip or knee arthroplasty. 2. The ability to communicate during the screening process (e.g., no aphasia or other severe language impairment). 3. Meet DSM-5 criteria for insomnia disorder assessed by Duke Structured Interview for Sleep Disorders. 4. Score ≥8 on the Insomnia Severity Index (ISI) or ≥5 on the Pittsburgh Sleep Quality Index (PSQI). 5. Referral and attendance of medical rehabilitation post-discharge. Exclusion Criteria: 1. Evidence of recent severe mental health disorders (e.g., suicide attempt or psychiatric hospitalization in the past year). 2. Presence of psychotic disorder, substance abuse or dependence, or bipolar disorder assessed by MINI International Neuropsychiatric Inventory (to increase generalizability other psychiatric comorbidities such as depression or anxiety will not be excluded). 3. Untreated comorbid sleep disorders based on structured diagnostic interview including: narcolepsy, periodic leg movement disorder, and/or obstructive sleep apnea risk. 4. Cognitive impairment defined as <20 on the Mini Mental Status Exam (MMSE) that could potentially limit comprehension of the intervention. Note, while an MMSE of <24 is often used as a cutoff for cognitive impairment, we do not wish to exclude those with mild cognitive problems from this study as there is evidence that individuals with mild cognitive problems still benefit from insomnia treatments.

NCT0426xxxx/NCT04269252.xml

<clinical_study>  <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/NCT04269252</url> </required_header> <id_info> <org_study_id>USA710-4003</org_study_id> <nct_id>NCT04269252</nct_id> </id_info> <brief_title>CHI-907 CBD Extract and Experiences of Test Anxiety</brief_title> <official_title>A Randomized Controlled Test of the Effects of CHI-907 on Experiences of Test Anxiety Among College Students</official_title> <sponsors> <lead_sponsor> <agency>Canopy Growth Corporation</agency> <agency_class>Industry</agency_class> </lead_sponsor> <collaborator> <agency>James Madison University</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>Canopy Growth Corporation</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> This is a randomized, placebo-controlled study examining the effects of CHI-907 on test anxiety specifically, and state anxiety more broadly. </textblock> </brief_summary> <overall_status>Terminated</overall_status> <why_stopped> Recruitment challenges due to COVID </why_stopped> <start_date type="Actual">February 3, 2020</start_date> <completion_date type="Actual">June 1, 2021</completion_date> <primary_completion_date type="Actual">June 1, 2021</primary_completion_date> <phase>Phase 2</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> <primary_purpose>Other</primary_purpose> <masking>Double (Participant, Investigator)</masking> </study_design_info> <primary_outcome> <measure>Optimal single-dose of CHI-907 to reduce test anxiety</measure> <time_frame>The test session visit is 3.5 hours long.</time_frame> <description>Subjects will report their level of test anxiety using the State Test Anxiety Visual Analog Scale (STAI-VAS) pre-test, mid-test, and post-test. The STAI-VAS is a measure from 0 (not anxious at all) to 100 (anxious).</description> </primary_outcome> <primary_outcome> <measure>Minimal single-dose of CHI-907 to reduce test anxiety</measure> <time_frame>The test session visit is 3.5 hours long.</time_frame> <description>Subjects will report their level of test anxiety using the State Test Anxiety Visual Analog Scale (STAI-VAS) pre-test, mid-test, and post-test. The STAI-VAS is a measure from 0 (not anxious at all) to 100 (anxious).</description> </primary_outcome> <number_of_arms>4</number_of_arms> <enrollment type="Actual">32</enrollment> <condition>Anxiety</condition> <arm_group> <arm_group_label>CHI-804 at 6 mL</arm_group_label> <arm_group_type>Placebo Comparator</arm_group_type> <description>Standard 6 mL dose of placebo oil.</description> </arm_group> <arm_group> <arm_group_label>CHI-907 at 1.5 mL</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Subjects are assigned to receive one dose of CHI-907.</description> </arm_group> <arm_group> <arm_group_label>CHI-907 at 3 mL</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Subjects are assigned to receive one dose of CHI-907.</description> </arm_group> <arm_group> <arm_group_label>CHI-907 at 6 mL</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Subjects are assigned to receive one dose of CHI-907.</description> </arm_group> <intervention> <intervention_type>Other</intervention_type> <intervention_name>CHI-907</intervention_name> <description>CHI-907 is a high CBD extract.</description> <arm_group_label>CHI-907 at 1.5 mL</arm_group_label> <arm_group_label>CHI-907 at 3 mL</arm_group_label> <arm_group_label>CHI-907 at 6 mL</arm_group_label> </intervention> <intervention> <intervention_type>Other</intervention_type> <intervention_name>CHI-804</intervention_name> <description>CHI-804 is the placebo formulation.</description> <arm_group_label>CHI-804 at 6 mL</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. Healthy adult between 18 and 55-years-old (inclusive).  2. Willing and able to provide informed consent and attend a 2.5 hour, in-person session.  3. Self-reports completing a college-level introductory level statistics class with a grade of "C" or better.  4. Scores a 3.0 or higher on the Westside Test Anxiety Scale.  5. Female of childbearing potential must not be pregnant or currently breastfeeding.  6. If using medication, the student has maintained a stable regimen on existing medications for at least one month prior to participation in the study and throughout the study.  7. Agrees to abide by all study restrictions and comply with all study procedures.  Exclusion Criteria:  1. Known history of significant allergic condition, significant hypersensitivity to the IP, or allergic reaction to cannabis, cannabinoid medications, or excipients of the investigational product.  2. Exposed to any investigational drug or device < 30 days prior to screening or plans to take an investigational drug in the near future.  3. Used cannabis, synthetic cannabinoid or cannabinoid analogue, synthetic cannabinoid receptor agonist, or any CBD- or THC-containing product within 30 days of screening or during the study.  4. Current or past primary DSM-5 diagnosis other than an anxiety disorder that the Investigator determines would interfere in testing or interfere in evaluation of the study testing.  5. Total score of 8 or higher on the Alcohol Use Disorders Identification Test.  6. Total score of 12 or higher on the Drug Abuse Screening Test.  7. An acute or progressive disease that is likely to require changes in drug therapy during the study, or interfere with the objectives of the study, or the ability to adhere to protocol requirements.  8. Currently prescribed medications with likely THC- or CBD- interactions.  9. History of suicide attempt in the last year.  10. Endorses current suicidal intent during the baseline assessment.  11. Positive drug screen for THC, barbiturates, amphetamines, benzodiazepines, and/or opiates at baseline assessment.  12. Clinically significant condition or abnormal findings during screening or the baseline assessment that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study testing.  13. Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol.  14. Female student of childbearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter.  15. Male student whose partner is of childbearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter.  16. Any other significant disease or disorder which, in the opinion of the investigator, may either put the student at risk because of participation in the study, may influence the result of the study, or affect the student's ability to participate in the study.  17. History of diagnosis related to hepatic function and/or significantly impaired hepatic function (alanine aminotransferase [ALT] >5 ´ upper limit of normal [ULN] or total bilirubin [TBL] >2 ´ ULN) OR the ALT or aspartate aminotransferase (AST) >3 ´ ULN and TBL >2 ´ ULN (or international normalized ratio [INR] >1.5).  18. Plans for the student to travel outside their country of residence during the study.  19. Body mass index (BMI) of underweight (18 kg/m2 and below) or obese (30 kg/m2 and above) or waist:hip ratio that is considered high health risk (0.86 and higher for women, 1.0 and higher for men). </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>55 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Mark Ware, MD</last_name> <role>Study Director</role> <affiliation>Canopy Growth Corporation</affiliation> </overall_official> <location> <facility> <name>James Madison University</name> <address> <city>Harrisonburg</city> <state>Virginia</state> <zip>22807</zip> <country>United States</country> </address> </facility> </location> <location_countries> <country>United States</country> </location_countries> <verification_date>June 2021</verification_date> <study_first_submitted>February 7, 2020</study_first_submitted> <study_first_submitted_qc>February 12, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>June 1, 2021</last_update_submitted> <last_update_submitted_qc>June 1, 2021</last_update_submitted_qc> <last_update_posted type="Actual">June 4, 2021</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Anxiety</keyword> <keyword>Test Anxiety</keyword> <keyword>CBD</keyword> <condition_browse>  <mesh_term>Anxiety Disorders</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data>  </clinical_study>

This is a randomized, placebo-controlled study examining the effects of CHI-907 on test anxiety specifically, and state anxiety more broadly. Inclusion Criteria: 1. Healthy adult between 18 and 55-years-old (inclusive). 2. Willing and able to provide informed consent and attend a 2.5 hour, in-person session. 3. Self-reports completing a college-level introductory level statistics class with a grade of "C" or better. 4. Scores a 3.0 or higher on the Westside Test Anxiety Scale. 5. Female of childbearing potential must not be pregnant or currently breastfeeding. 6. If using medication, the student has maintained a stable regimen on existing medications for at least one month prior to participation in the study and throughout the study. 7. Agrees to abide by all study restrictions and comply with all study procedures. Exclusion Criteria: 1. Known history of significant allergic condition, significant hypersensitivity to the IP, or allergic reaction to cannabis, cannabinoid medications, or excipients of the investigational product. 2. Exposed to any investigational drug or device < 30 days prior to screening or plans to take an investigational drug in the near future. 3. Used cannabis, synthetic cannabinoid or cannabinoid analogue, synthetic cannabinoid receptor agonist, or any CBD- or THC-containing product within 30 days of screening or during the study. 4. Current or past primary DSM-5 diagnosis other than an anxiety disorder that the Investigator determines would interfere in testing or interfere in evaluation of the study testing. 5. Total score of 8 or higher on the Alcohol Use Disorders Identification Test. 6. Total score of 12 or higher on the Drug Abuse Screening Test. 7. An acute or progressive disease that is likely to require changes in drug therapy during the study, or interfere with the objectives of the study, or the ability to adhere to protocol requirements. 8. Currently prescribed medications with likely THC- or CBD- interactions. 9. History of suicide attempt in the last year. 10. Endorses current suicidal intent during the baseline assessment. 11. Positive drug screen for THC, barbiturates, amphetamines, benzodiazepines, and/or opiates at baseline assessment. 12. Clinically significant condition or abnormal findings during screening or the baseline assessment that would, in the opinion of the Investigator, preclude study participation or interfere with the evaluation of the study testing. 13. Demonstrates behavior indicating unreliability or inability to comply with the requirements of the protocol. 14. Female student of childbearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter. 15. Male student whose partner is of childbearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter. 16. Any other significant disease or disorder which, in the opinion of the investigator, may either put the student at risk because of participation in the study, may influence the result of the study, or affect the student's ability to participate in the study. 17. History of diagnosis related to hepatic function and/or significantly impaired hepatic function (alanine aminotransferase [ALT] >5 ´ upper limit of normal [ULN] or total bilirubin [TBL] >2 ´ ULN) OR the ALT or aspartate aminotransferase (AST) >3 ´ ULN and TBL >2 ´ ULN (or international normalized ratio [INR] >1.5). 18. Plans for the student to travel outside their country of residence during the study. 19. Body mass index (BMI) of underweight (18 kg/m2 and below) or obese (30 kg/m2 and above) or waist:hip ratio that is considered high health risk (0.86 and higher for women, 1.0 and higher for men).

NCT0426xxxx/NCT04269265.xml

<clinical_study>  <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/NCT04269265</url> </required_header> <id_info> <org_study_id>IDIM-2018-27222</org_study_id> <secondary_id>U01AI141981</secondary_id> <nct_id>NCT04269265</nct_id> </id_info> <brief_title>The Effect of Inflammation and Damage to Lymph Node Structures on Durable Protective Immunity Following Yellow Fever Vaccination</brief_title> <official_title>The Effect of Inflammation and Damage to Lymph Node Structures on Durable Protective Immunity Following Yellow Fever Vaccination</official_title> <sponsors> <lead_sponsor> <agency>University of Minnesota</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency> <agency_class>NIH</agency_class> </collaborator> </sponsors> <source>University of Minnesota</source> <oversight_info> <has_dmc>Yes</has_dmc> <is_fda_regulated_drug>Yes</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> <is_us_export>Yes</is_us_export> </oversight_info> <brief_summary> <textblock> Hypothesis: Infections other than HIV can cause LN inflammation and collagen damage to the fibroblastic reticular cell network (FRCn), which will lead to CD4 T cell depletion and impaired vaccine responses. This protocol will study yellow fever vaccine (YFV) in two cohorts of people, one from Uganda and the other from Minnesota where we collect lymphoid tissues (LT) and peripheral blood monocytes (PBMCs) before and after vaccination using a new technique to catalog infectious burden of the individual, determine the relationship between IA, Infections, and immune response. </textblock> </brief_summary> <detailed_description> <textblock> The primary aim of this study is to determine the difference between antibody titers in the two study groups and study the relationship between endemic infections, IA, the FRCn, and CD4 and CD8 T cell subsets and the magnitude and durability of neutralizing antibody response to YFV in a cohort shown to have elevated IA, a damaged FRCn, and pan T cell depletion and a cohort that does not. This is a single arm, open-label, two cohort study of healthy adults in Kampala, Uganda and in Minnesota, USA. The cohort in Uganda will be 30 adults (15 men and 15 women) and the cohort in Minnesota will be 16 adults (8 men and 8 women). Everyone will be screened to ensure there are no contraindications to receiving YFV (e.g., immunosuppression) or the planned procedures. The inclusion and exclusion criteria are discussed in detail in the protocol that is included in the appendix. Participants will have an inguinal lymph node and adjacent adipose tissue biopsy and leukapheresis prior to YFV and again 3 weeks after the vaccine administration. The vaccine will be given in the contralateral thigh from the first LN biopsy so that the second biopsy will be from a draining LN. PBMC and plasma as well as urine and stool will be collected at regular intervals over the 18-month follow-up period and leukapheresis will be done again at the month 18 visit. </textblock> </detailed_description> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">July 1, 2020</start_date> <completion_date type="Anticipated">June 30, 2025</completion_date> <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date> <phase>Phase 1/Phase 2</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Basic Science</primary_purpose> <masking>None (Open Label)</masking> </study_design_info> <primary_outcome> <measure>Peak Neutralizing Antibody Titer</measure> <time_frame>18 months</time_frame> <description>Peak titer of neutralizing antibody to yellow fever vaccination. Outcome reported as Log YF Antibody titer.</description> </primary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">43</enrollment> <condition>Yellow Fever</condition> <arm_group> <arm_group_label>All Participants</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>In this single-arm study, all participants will receive the intervention</description> </arm_group> <intervention> <intervention_type>Biological</intervention_type> <intervention_name>Yellow Fever Vaccine</intervention_name> <description>YF-VAX®, Yellow Fever Vaccine, for subcutaneous use</description> <arm_group_label>All Participants</arm_group_label> <other_name>YF-VAX</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - No contraindication to Yellow Fever vaccine (immunosuppressed for any reason or on an immunosuppressive drug where a live virus vaccine is contraindicated).  - If female of childbearing age must agree to contraception for one month following administration of the vaccination.  Exclusion Criteria:  - History of yellow fever or previous vaccination for yellow fever  - Known bleeding disorder  - Prior surgery complicated by clotting abnormality  - Psychiatric or behavioral disorder that, in the opinion of the investigator, will make it difficult for the participant to complete the study  - History of acute hypersensitivity reaction to any component of the vaccine (including gelatin, eggs, egg products, or chicken protein).  - Thymus disorder associated with abnormal immune function  - Immunosuppression from any of the following: HIV infection or AIDS, malignant neoplasms, primary immunodeficiencies, transplantation, transplantation, immunosuppressive or immunomodulatory therapy (corticosteroids, alkylating agents, antimetabolites, TNF inhibitors, IL-1 blocking agents, monoclonal antibodies targeting immune cells), previous radiation therapy.  - Pregnant or breastfeeding at the time of vaccination.  - Planning to conceive within 28 days of enrollment and vaccination with the yellow fever vaccine. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>60 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Timothy Schacker, MD</last_name> <role>Principal Investigator</role> <affiliation>University of Minnesota</affiliation> </overall_official> <location> <facility> <name>University of Minnesota</name> <address> <city>Minneapolis</city> <state>Minnesota</state> <zip>55455</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>Joint Clinical Research Centre</name> <address> <city>Kampala</city> <zip>10005</zip> <country>Uganda</country> </address> </facility> </location> <location_countries> <country>Uganda</country> <country>United States</country> </location_countries> <verification_date>August 2023</verification_date> <study_first_submitted>February 11, 2020</study_first_submitted> <study_first_submitted_qc>February 11, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>August 21, 2023</last_update_submitted> <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc> <last_update_posted type="Actual">August 23, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Yellow Fever</mesh_term> <mesh_term>Inflammation</mesh_term> <mesh_term>Fever</mesh_term> </condition_browse> <patient_data> <sharing_ipd>No</sharing_ipd> </patient_data> <provided_document_section> <provided_document> <document_type>Informed Consent Form</document_type> <document_has_protocol>No</document_has_protocol> <document_has_icf>Yes</document_has_icf> <document_has_sap>No</document_has_sap> <document_date>August 30, 2022</document_date> <document_url>https://ClinicalTrials.gov/ProvidedDocs/65/NCT04269265/ICF_000.pdf</document_url> </provided_document> </provided_document_section>  </clinical_study>

Hypothesis: Infections other than HIV can cause LN inflammation and collagen damage to the fibroblastic reticular cell network (FRCn), which will lead to CD4 T cell depletion and impaired vaccine responses. This protocol will study yellow fever vaccine (YFV) in two cohorts of people, one from Uganda and the other from Minnesota where we collect lymphoid tissues (LT) and peripheral blood monocytes (PBMCs) before and after vaccination using a new technique to catalog infectious burden of the individual, determine the relationship between IA, Infections, and immune response. The primary aim of this study is to determine the difference between antibody titers in the two study groups and study the relationship between endemic infections, IA, the FRCn, and CD4 and CD8 T cell subsets and the magnitude and durability of neutralizing antibody response to YFV in a cohort shown to have elevated IA, a damaged FRCn, and pan T cell depletion and a cohort that does not. This is a single arm, open-label, two cohort study of healthy adults in Kampala, Uganda and in Minnesota, USA. The cohort in Uganda will be 30 adults (15 men and 15 women) and the cohort in Minnesota will be 16 adults (8 men and 8 women). Everyone will be screened to ensure there are no contraindications to receiving YFV (e.g., immunosuppression) or the planned procedures. The inclusion and exclusion criteria are discussed in detail in the protocol that is included in the appendix. Participants will have an inguinal lymph node and adjacent adipose tissue biopsy and leukapheresis prior to YFV and again 3 weeks after the vaccine administration. The vaccine will be given in the contralateral thigh from the first LN biopsy so that the second biopsy will be from a draining LN. PBMC and plasma as well as urine and stool will be collected at regular intervals over the 18-month follow-up period and leukapheresis will be done again at the month 18 visit. Inclusion Criteria: - No contraindication to Yellow Fever vaccine (immunosuppressed for any reason or on an immunosuppressive drug where a live virus vaccine is contraindicated). - If female of childbearing age must agree to contraception for one month following administration of the vaccination. Exclusion Criteria: - History of yellow fever or previous vaccination for yellow fever - Known bleeding disorder - Prior surgery complicated by clotting abnormality - Psychiatric or behavioral disorder that, in the opinion of the investigator, will make it difficult for the participant to complete the study - History of acute hypersensitivity reaction to any component of the vaccine (including gelatin, eggs, egg products, or chicken protein). - Thymus disorder associated with abnormal immune function - Immunosuppression from any of the following: HIV infection or AIDS, malignant neoplasms, primary immunodeficiencies, transplantation, transplantation, immunosuppressive or immunomodulatory therapy (corticosteroids, alkylating agents, antimetabolites, TNF inhibitors, IL-1 blocking agents, monoclonal antibodies targeting immune cells), previous radiation therapy. - Pregnant or breastfeeding at the time of vaccination. - Planning to conceive within 28 days of enrollment and vaccination with the yellow fever vaccine.

NCT0426xxxx/NCT04269278.xml

<clinical_study>  <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/NCT04269278</url> </required_header> <id_info> <org_study_id>B-2002/595-301</org_study_id> <nct_id>NCT04269278</nct_id> </id_info> <brief_title>Dexmedetomidine and Blood Coagulation</brief_title> <official_title>The Effect of Dexmedetomidine on Blood Coagulation: In Vitro, Volunteer Study Using Rotational Thromboelastometry</official_title> <sponsors> <lead_sponsor> <agency>Seoul National University Bundang Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Seoul National University Bundang Hospital</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Dexmedetomidine may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of dexmedetomidine. The investigators have therefore performed the present study to measure the effect of dexmedetomidine on the coagulation pathway according to the drug concentration level using a rotational thromboelastometry test. </textblock> </brief_summary> <overall_status>Completed</overall_status> <start_date type="Actual">February 12, 2020</start_date> <completion_date type="Actual">December 30, 2020</completion_date> <primary_completion_date type="Actual">December 30, 2020</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Case-Control</observational_model> <time_perspective>Cross-Sectional</time_perspective> </study_design_info> <primary_outcome> <measure>FIBTEM</measure> <time_frame>During the rotational thromboelastometry analysis/ an average of 1 hour</time_frame> <description>Fibrinolytic pathway values of rotational thromboelastometry analysis/ FIBTEM is not an acronym.</description> </primary_outcome> <secondary_outcome> <measure>INTEM</measure> <time_frame>During the rotational thromboelastometry analysis/ an average of 1 hour</time_frame> <description>Intrinsic pathway values of rotational thromboelastometry analysis/ INTEM is not an acronym.</description> </secondary_outcome> <secondary_outcome> <measure>EXTEM</measure> <time_frame>During the rotational thromboelastometry analysis/ an average of 1 hour</time_frame> <description>Extrinsic pathway values of rotational thromboelastometry analysis/ EXTEM is not an acronym.</description> </secondary_outcome> <number_of_groups>4</number_of_groups> <enrollment type="Actual">11</enrollment> <condition>Blood Coagulation Disorder</condition> <arm_group> <arm_group_label>0 ng/ml</arm_group_label> <description>Blood specimen which was added 0 ul of dexmedetomidine</description> </arm_group> <arm_group> <arm_group_label>0.5 ng/ml</arm_group_label> <description>Blood specimen which was added 0.25 ul of dexmedetomidine</description> </arm_group> <arm_group> <arm_group_label>1.0 ng/ml</arm_group_label> <description>Blood specimen which was added 0.5 ul of dexmedetomidine</description> </arm_group> <arm_group> <arm_group_label>1.5 ng/ml</arm_group_label> <description>Blood specimen which was added 0.75 ul of dexmedetomidine</description> </arm_group> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>0 ul of dexmedetomidine</intervention_name> <description>Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 ul) using dexmedetomidine</description> <arm_group_label>0 ng/ml</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>0.25 ul of dexmedetomidine</intervention_name> <description>Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.25 ul) using dexmedetomidine</description> <arm_group_label>0.5 ng/ml</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>0.5 ul of dexmedetomidine</intervention_name> <description>Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.5 ul) using dexmedetomidine</description> <arm_group_label>1.0 ng/ml</arm_group_label> </intervention> <intervention> <intervention_type>Drug</intervention_type> <intervention_name>0.75 ul of dexmedetomidine</intervention_name> <description>Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.75 ul) using dexmedetomidine</description> <arm_group_label>1.5 ng/ml</arm_group_label> </intervention> <eligibility> <study_pop> <textblock> Healthy volunteers </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Healthy volunteers  - Age: 20 to 65 years  - Body weight > 50 kg  - Volunteers who provided informed consent  Exclusion Criteria:  - Hematologic disease  - Anticoagulant medication </textblock> </criteria> <gender>All</gender> <minimum_age>20 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Hyo-Seok Na, MD., PhD.</last_name> <role>Principal Investigator</role> <affiliation>Seoul National University Bundang Hospital</affiliation> </overall_official> <location> <facility> <name>Seoul National University Bundang Hospital</name> <address> <city>Seongnam-si</city> <state>Gyeonggi-do</state> <zip>13620</zip> <country>Korea, Republic of</country> </address> </facility> </location> <location_countries> <country>Korea, Republic of</country> </location_countries> <verification_date>June 2021</verification_date> <study_first_submitted>February 11, 2020</study_first_submitted> <study_first_submitted_qc>February 11, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>June 30, 2021</last_update_submitted> <last_update_submitted_qc>June 30, 2021</last_update_submitted_qc> <last_update_posted type="Actual">July 2, 2021</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation> <investigator_full_name>Hyo-Seok Na</investigator_full_name> <investigator_title>Associate Professor</investigator_title> </responsible_party> <condition_browse>  <mesh_term>Hemostatic Disorders</mesh_term> <mesh_term>Blood Coagulation Disorders</mesh_term> </condition_browse> <intervention_browse>  <mesh_term>Dexmedetomidine</mesh_term> </intervention_browse>  </clinical_study>

Dexmedetomidine may alter whole blood coagulation. However, little is known about the dose-response relationships according to the blood concentration of dexmedetomidine. The investigators have therefore performed the present study to measure the effect of dexmedetomidine on the coagulation pathway according to the drug concentration level using a rotational thromboelastometry test. Healthy volunteers Inclusion Criteria: - Healthy volunteers - Age: 20 to 65 years - Body weight > 50 kg - Volunteers who provided informed consent Exclusion Criteria: - Hematologic disease - Anticoagulant medication

NCT0426xxxx/NCT04269291.xml

<clinical_study>  <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/NCT04269291</url> </required_header> <id_info> <org_study_id>7703</org_study_id> <nct_id>NCT04269291</nct_id> </id_info> <brief_title>An Investigation Into an Objective Measure of Muscle Quality, Function and Ability</brief_title> <official_title>An Investigation Into an Objective Measure of Muscle Quality, Function and Ability</official_title> <sponsors> <lead_sponsor> <agency>Cardiff and Vale University Health Board</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Cardiff and Vale University Health Board</source> <oversight_info> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> The assessment of muscular function, quality and ability is of high importance in a diverse range of clinical disciplines from anaesthetics to physiotherapy. This study will look at the range of measurement techniques currently in use and development and considers their effectiveness and objectivity. It will also investigate whether an objective measurement technique can be found or developed that can be used both in the clinical environment and the community setting. This will focus on upper limb function and ability; ability is used here instead of strength since ability better describes functions needed for daily living rather than the maximum output a muscle is capable of. </textblock> </brief_summary> <detailed_description> <textblock> A literature review (available on request) explores what can be measured, the problems of measurement and its objectivity. The aim is to investigate whether there is a method of measuring muscle quality, function and ability that can be used objectively in the clinical environment or the community with equal ease or whether such a method can be developed.  The literature review identified electrical impedance myography (EIM) as a potentially objective technique to measure muscle quality and ability. Two hypotheses are proposed to test the objectivity:  The EIM measurement of passive and active muscle is not significantly different.  EIM measurements in younger and older adult volunteers is significantly different.  There is only one study visit for this study, so all study activities will occur on the same day at the Posture and Mobility Centre, Treforest or the Artificial Limb and Appliance Centre, Rookwood Hospital.  Eligibility for the study will be checked against the inclusion and exclusion criteria, including the requests to not have done heavy exercise for an hour before the measurements and also to have emptied their bladder before attending for the visit.  Any concerns will be also be addressed appropriately  Following the eligibility check, the CI will ensure the participant has read the PIS and fully understand it before obtaining informed consent.  Participants will be assigned a number in order to anonymise their data and only the main investigator will have access to this database of participants.  The following data will then be collected by the CI and written in a Case Report Form (CRF):  - Gender  - Date of birth (to ascertain age)  - Height (to calculate BMI)  - Weight (to calculate BMI)  - Waist measurement (to calculate RFM index, considered an alternative indicator of health).  - Medical history to ensure no existing neuromuscular, active arthritis or cardiac conditions or active implanted devices  - Perceived level of fitness - using the NHS scale https://www.nhs.uk/live-well/healthy-weight/bmi-calculator/ (to gauge muscle ability)  - A quantitative measurement method will be used in conjunction with a structured initial questionnaire relating to physical characteristics (e.g. height, weight, waist measurement, date of birth to indicate age and perceived level of fitness https://www.nhs.uk/live-well/healthy-weight/bmi-calculator/).  The CI will then attach electrodes to the arm of the participant and they will be asked to relax for 10 minutes.  The measurement device is an ImpediMed IMP SFB7 (CE 0129 marked) and is portable. EIM passes an imperceptible AC current (less than 1 mA) through the muscle under investigation and the impedance of that muscle is then recorded through a range of frequencies or at chosen frequencies.  Measurements of EIM of the relaxed muscles will be recorded in the CRF followed by measurements of EIM in the contracted muscle.  Electrodes will be carefully removed from the participant and they are invited to relax for a further 5 minutes and have a drink of water.  The participant's involvement in the study will end after the measurements have been taken. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">June 18, 2020</start_date> <completion_date type="Actual">September 1, 2021</completion_date> <primary_completion_date type="Actual">September 1, 2021</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Observation of healthy volunteer measurement of Electrical Impedance Myography in arm muscles.</measure> <time_frame>One visit per volunteer. Data to be accumulated over approximately 1 year</time_frame> <description>Primary Objective To measure EIM in sketetal arm muscle. Measurements to be made when the muscles are passive and when they are contracted. EIM measurements are reactance and resistance which are both measured in Ohms. At least 20 eligible and consented volunteers to be recruited and measured. To be measured at the one healthy volunteer visit. No other visits are part of the study.</description> </primary_outcome> <secondary_outcome> <measure>Age of participants</measure> <time_frame>through study completion, an average of 1 year</time_frame> <description>DOB recorded to classify healthy volunteers into age ranges. This will be recorded at the one visit.</description> </secondary_outcome> <secondary_outcome> <measure>Fitness health measure of participants</measure> <time_frame>through study completion, an average of 1 year</time_frame> <description>To calculate an indication of the health of the volunteers the following will be measured and recorded. Height (m) Weight (kg) waist size (cm) Measured to calculate BMI index and RFM index (considered an alternative indicator of health). All will be measured at the one visit. .</description> </secondary_outcome> <enrollment type="Actual">20</enrollment> <condition>Electric Impedance</condition> <condition>Healthy Volunteers</condition> <eligibility> <study_pop> <textblock> Healthy volunteers </textblock> </study_pop> <sampling_method>Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - be volunteers  - be over the age of 18  - no pre-existing neuromuscular disease  - not have an implanted cardiac device  - be well at the time of measurement  - be able to give informed consent  Exclusion Criteria:  - Any existing neuromuscular disorder (eg multiple sclerosis, ALS, MND, CP)  - Any existing cardiac disease (including having a pacemaker or ICD)  - Active arthritis  - Be pregnant  - Any other implanted electrical device  - Not able to give informed consent </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>N/A</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Stephanie Wentworth</last_name> <role>Principal Investigator</role> <affiliation>stephanie.wentworth@wales.nhs.uk</affiliation> </overall_official> <location> <facility> <name>Cardiff and Vale University Health Board.</name> <address> <city>Cardiff</city> <zip>CF14 4XW</zip> <country>United Kingdom</country> </address> </facility> </location> <location_countries> <country>United Kingdom</country> </location_countries> <verification_date>March 2022</verification_date> <study_first_submitted>January 15, 2020</study_first_submitted> <study_first_submitted_qc>February 12, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>March 11, 2022</last_update_submitted> <last_update_submitted_qc>March 11, 2022</last_update_submitted_qc> <last_update_posted type="Actual">March 14, 2022</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Cardiff and Vale University Health Board</investigator_affiliation> <investigator_full_name>Stephanie Wentworth</investigator_full_name> <investigator_title>Chief Investigator</investigator_title> </responsible_party> <keyword>electrical impedance</keyword> <keyword>skeletal muscle</keyword>  </clinical_study>

The assessment of muscular function, quality and ability is of high importance in a diverse range of clinical disciplines from anaesthetics to physiotherapy. This study will look at the range of measurement techniques currently in use and development and considers their effectiveness and objectivity. It will also investigate whether an objective measurement technique can be found or developed that can be used both in the clinical environment and the community setting. This will focus on upper limb function and ability; ability is used here instead of strength since ability better describes functions needed for daily living rather than the maximum output a muscle is capable of. A literature review (available on request) explores what can be measured, the problems of measurement and its objectivity. The aim is to investigate whether there is a method of measuring muscle quality, function and ability that can be used objectively in the clinical environment or the community with equal ease or whether such a method can be developed. The literature review identified electrical impedance myography (EIM) as a potentially objective technique to measure muscle quality and ability. Two hypotheses are proposed to test the objectivity: The EIM measurement of passive and active muscle is not significantly different. EIM measurements in younger and older adult volunteers is significantly different. There is only one study visit for this study, so all study activities will occur on the same day at the Posture and Mobility Centre, Treforest or the Artificial Limb and Appliance Centre, Rookwood Hospital. Eligibility for the study will be checked against the inclusion and exclusion criteria, including the requests to not have done heavy exercise for an hour before the measurements and also to have emptied their bladder before attending for the visit. Any concerns will be also be addressed appropriately Following the eligibility check, the CI will ensure the participant has read the PIS and fully understand it before obtaining informed consent. Participants will be assigned a number in order to anonymise their data and only the main investigator will have access to this database of participants. The following data will then be collected by the CI and written in a Case Report Form (CRF): - Gender - Date of birth (to ascertain age) - Height (to calculate BMI) - Weight (to calculate BMI) - Waist measurement (to calculate RFM index, considered an alternative indicator of health). - Medical history to ensure no existing neuromuscular, active arthritis or cardiac conditions or active implanted devices - Perceived level of fitness - using the NHS scale https://www.nhs.uk/live-well/healthy-weight/bmi-calculator/ (to gauge muscle ability) - A quantitative measurement method will be used in conjunction with a structured initial questionnaire relating to physical characteristics (e.g. height, weight, waist measurement, date of birth to indicate age and perceived level of fitness https://www.nhs.uk/live-well/healthy-weight/bmi-calculator/). The CI will then attach electrodes to the arm of the participant and they will be asked to relax for 10 minutes. The measurement device is an ImpediMed IMP SFB7 (CE 0129 marked) and is portable. EIM passes an imperceptible AC current (less than 1 mA) through the muscle under investigation and the impedance of that muscle is then recorded through a range of frequencies or at chosen frequencies. Measurements of EIM of the relaxed muscles will be recorded in the CRF followed by measurements of EIM in the contracted muscle. Electrodes will be carefully removed from the participant and they are invited to relax for a further 5 minutes and have a drink of water. The participant's involvement in the study will end after the measurements have been taken. Healthy volunteers Inclusion Criteria: - be volunteers - be over the age of 18 - no pre-existing neuromuscular disease - not have an implanted cardiac device - be well at the time of measurement - be able to give informed consent Exclusion Criteria: - Any existing neuromuscular disorder (eg multiple sclerosis, ALS, MND, CP) - Any existing cardiac disease (including having a pacemaker or ICD) - Active arthritis - Be pregnant - Any other implanted electrical device - Not able to give informed consent

NCT0426xxxx/NCT04269304.xml

<clinical_study>  <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/NCT04269304</url> </required_header> <id_info> <org_study_id>IRAS - 256931</org_study_id> <secondary_id>47270</secondary_id> <secondary_id>210572/Z/18/Z</secondary_id> <nct_id>NCT04269304</nct_id> </id_info> <brief_title>Deciphering AMD by Deep Phenotyping and Machine Learning- Prospective Study - PINNACLE</brief_title> <acronym>PINNACLE</acronym> <official_title>Deciphering AMD by Deep Phenotyping and Machine Learning- Prospective Study - PINNACLE</official_title> <sponsors> <lead_sponsor> <agency>University of Southampton</agency> <agency_class>Other</agency_class> </lead_sponsor> <collaborator> <agency>University College, London</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Imperial College London</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>University of Basel</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>Medical University of Vienna</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>University of Michigan</agency> <agency_class>Other</agency_class> </collaborator> <collaborator> <agency>King's College London</agency> <agency_class>Other</agency_class> </collaborator> </sponsors> <source>University of Southampton</source> <oversight_info> <has_dmc>Yes</has_dmc> </oversight_info> <brief_summary> <textblock> We will conduct a prospective non-interventional study including 400 early AMD patients (=600 untreated early AMD eyes, including both unilateral (AREDS IV) and bilateral (≥AREDS II)) over a minimum of 1 year to specifically investigate the morphological sequence of events preceding the conversion towards late AMD. All patients will be followed by Optical Coherence Tomography (OCT) imaging every 4 months to detect the earliest focal sites of disease progression. As soon as focal areas of change are observed by the Vienna Reading Center (VRC), a targeted follow-up schedule will be triggered to investigate the events at that area of change in a targeted manner. </textblock> </brief_summary> <detailed_description> <textblock> We will recruit patients with 1) intermediate AMD in one eye and advanced AMD in the non-study eye or 2) patients with bilateral intermediate AMD (where both eyes will be included). As some participants are symptomless at the stage of intermediate AMD, we will recruit from hospital databases including imaging databases and ophthalmology and optometry practices and engagement with Patient Societies e.g. the Macular Society and patient public involvement meetings.  There will be four clinical sites performing detailed assessments on 50 patients each and, to increase sample size, an additional eight referral sites in the United Kingdom who will each enrol and follow 25 study patients by Spectral Domain Optical Coherence Tomography (SD-OCT) every 4 months. The acquired images from these referral sites will be sent to the Vienna Reading Centre for morphological identification of focal events. If a focal event is detected, participants will then be referred for a detailed, targeted assessment at either the University of Southampton or Moorfields Eye Hospital as detailed below.  After consent, patients will undergo visual function tests (ETDRS visual acuity, microperimetry) and multimodal imaging including fundus photographs, OCT scans, OCT angiography, autofluorescence and adaptive optics imaging. The visual function tests will be repeated annually and the multimodal imaging will be done at 4 monthly intervals for a minimum of 1 year. Blood will be taken within the first year for DNA analysis.  200 patients (main cohort) will undergo dense retinal phenotyping at a minimum of 4 visits.  Medical and smoking history, genotype and body mass index will also be included in the analysis as has been done previously. As well as structural tests, functional tests will be performed at baseline and end of the study using both microperimetry (a type of visual field test to create a "retinal sensitivity map" of the quantity of light perceived in specific parts of the retina) to identify focal changes and low luminance visual acuity to assess global changes. To increase sample size but make the study feasible an additional 200 patients at UK referral sites will undergo 4 monthly OCT and be referred to Southampton / Moorfields for dense phenotyping only if a focal event is detected by OCT. </textblock> </detailed_description> <overall_status>Active, not recruiting</overall_status> <start_date type="Actual">October 28, 2019</start_date> <completion_date type="Anticipated">June 2024</completion_date> <primary_completion_date type="Anticipated">June 2024</primary_completion_date> <study_type>Observational</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <observational_model>Cohort</observational_model> <time_perspective>Prospective</time_perspective> </study_design_info> <primary_outcome> <measure>Sensitivity / specificity of OCT and autofluorescence parameters.</measure> <time_frame>3 years</time_frame> <description>Identified by machine learning (ML) at predicting disease progression defined as focal conversion towards advanced AMD e.g. change in drusen volume, development of new geographic atrophy / choroidal neovascularisation.</description> </primary_outcome> <secondary_outcome> <measure>Sensitivity / specificity of novel imaging characteristics</measure> <time_frame>3 years</time_frame> <description>For example, Adaptive Optics OCT (AO-OCT), OCT-A, at predicting disease progression; Receiver Operating Characteristic (ROC) curves; time from development of imaging change to development of these end-points; structure-function correlation; structure-genotype correlation; predictive risk models.</description> </secondary_outcome> <number_of_groups>1</number_of_groups> <enrollment type="Actual">428</enrollment> <condition>Age-related Macular Degeneration</condition> <arm_group> <arm_group_label>Observational</arm_group_label> <description>Intermediate Age-Related Macular Degeneration Patients</description> </arm_group> <biospec_retention>Samples With DNA</biospec_retention> <biospec_descr> <textblock> DNA for genotype analysis. </textblock> </biospec_descr> <eligibility> <study_pop> <textblock> Patients with 1) intermediate AMD in one eye and advanced AMD in the non-study eye or 2) patients with bilateral intermediate AMD (where both eyes will be included). </textblock> </study_pop> <sampling_method>Non-Probability Sample</sampling_method> <criteria> <textblock> Inclusion Criteria:  - Subjects ≥ 55 years with either intermediate AMD (as defined by Ferris et al PMID: 23332590) in both eyes, i.e. large drusen > 125 um and/or any definite hyper- or hypopigmentary abnormalities associated with medium or large drusen; or intermediate AMD as defined above in one eye (study eye) and advanced AMD (geographic atrophy or choroidal neovascularization secondary to AMD) in the other eye.  - Subjects should have media clarity and pupillary dilation for adequate imaging and functional tests.  Exclusion Criteria:  - Co-existent ocular disease, which might affect visual function or retinal morphology  - Established glaucoma in either study eye or fellow eye with evidence of visual field loss or retinal nerve fibre loss (ocular hypertension is not an exclusion criterion unless associated with visual field loss or retinal nerve fibre loss in either eye).  - Cataract sufficient to affect retinal imaging  - Myopia > minus 6 diopters or a history of myopia > minus 6 diopters if patient has had cataract / refractive surgery.  - Major ocular surgery 3 months prior or anticipated within the next 6 months following enrolment.  - Taking drugs known to cause retinal toxicity such as hydroxychloroquine or tamoxifen  - OCT evidence of geographic atrophy (or complete Retinal Pigment Epithelium (RPE) and outer retinal atrophy (cRORA). This is (1) a region of hypertransmission of at least 250 mm in diameter, (2) a zone of attenuation or disruption of the RPE of at least 250 mm in diameter, (3) evidence of overlying photoreceptor degeneration, and (4) absence of scrolled RPE or other signs of an RPE tear.  - OCT evidence of choroidal neovascularization e.g sub-retinal scar tissue, sub-retinal fluid or intra-retinal fluid associated with a pigment epithelial detachment </textblock> </criteria> <gender>All</gender> <minimum_age>55 Years</minimum_age> <maximum_age>90 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Andrew J Lotery, Prof</last_name> <role>Principal Investigator</role> <affiliation>University of Southampton</affiliation> </overall_official> <location> <facility> <name>Medical University of Vienna</name> <address> <city>Vienna</city> <zip>1090</zip> <country>Austria</country> </address> </facility> </location> <location> <facility> <name>University Hospital Basel</name> <address> <city>Basel</city> <zip>4031</zip> <country>Switzerland</country> </address> </facility> </location> <location> <facility> <name>The Princess Alexandra Hospital Nhs Foundation Trust</name> <address> <city>Harlow</city> <state>Essex</state> <zip>CM20 1QX</zip> <country>United Kingdom</country> </address> </facility> </location> <location> <facility> <name>University Hospital Southampton</name> <address> <city>Southampton</city> <state>Hampshire</state> <zip>SO16 6YD</zip> <country>United Kingdom</country> </address> </facility> </location> <location> <facility> <name>St Mary's Hospital</name> <address> <city>Newport</city> <state>Isle Of Wight</state> <zip>PO30 5TG</zip> <country>United Kingdom</country> </address> </facility> </location> <location> <facility> <name>John Radcliffe Hospital</name> <address> <city>Oxford</city> <state>Oxfordshire</state> <zip>OX3 9DU</zip> <country>United Kingdom</country> </address> </facility> </location> <location> <facility> <name>Frimley Health Nhs Foundation Trust</name> <address> <city>Frimley</city> <state>Surrey</state> <zip>GU16 7UJ</zip> <country>United Kingdom</country> </address> </facility> </location> <location> <facility> <name>Salisbury Nhs Foundation Trust</name> <address> <city>Salisbury</city> <state>Wiltshire</state> <zip>SP2 8BJ</zip> <country>United Kingdom</country> </address> </facility> </location> <location> <facility> <name>University Hospitals Bristol and Weston Nhs Foundation Trust</name> <address> <city>Bristol</city> <zip>BS1 3NU</zip> <country>United Kingdom</country> </address> </facility> </location> <location> <facility> <name>Moorfields Eye Hospital</name> <address> <city>London</city> <zip>EC1V 2PD</zip> <country>United Kingdom</country> </address> </facility> </location> <location> <facility> <name>Guy'S and St Thomas' Nhs Ft</name> <address> <city>London</city> <zip>SE1 9RT</zip> <country>United Kingdom</country> </address> </facility> </location> <location> <facility> <name>St Mary's Hospital, Imperial College Healthcare NHS Trust</name> <address> <city>London</city> <zip>W2 1NY</zip> <country>United Kingdom</country> </address> </facility> </location> <location_countries> <country>Austria</country> <country>Switzerland</country> <country>United Kingdom</country> </location_countries> <link> <url>https://clinicalresearch.uhs.nhs.uk/take-part</url> <description>Opt-out of PINNACLE (Retrospective)</description> </link> <link> <url>https://pubmed.ncbi.nlm.nih.gov/35614343/</url> <description>Protocol and statistical analysis plan PMID: 35614343</description> </link> <verification_date>February 2023</verification_date> <study_first_submitted>February 11, 2020</study_first_submitted> <study_first_submitted_qc>February 11, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>February 22, 2023</last_update_submitted> <last_update_submitted_qc>February 22, 2023</last_update_submitted_qc> <last_update_posted type="Actual">February 27, 2023</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <condition_browse>  <mesh_term>Macular Degeneration</mesh_term> </condition_browse> <patient_data> <sharing_ipd>Yes</sharing_ipd> <ipd_description>Requests to access anonymised Individual Participant Data (IPD) can be made on application to the Trial Management Group Data Access Committee.</ipd_description> <ipd_info_type>Study Protocol</ipd_info_type> <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type> <ipd_time_frame>Currently available and can be accessed indefinitely.</ipd_time_frame> <ipd_access_criteria>Requests for further information such as a clinical study report will be considered by the investigators following the end of the study and publication of primary outputs.</ipd_access_criteria> <ipd_url>https://pubmed.ncbi.nlm.nih.gov/35614343/</ipd_url> </patient_data>  </clinical_study>

We will conduct a prospective non-interventional study including 400 early AMD patients (=600 untreated early AMD eyes, including both unilateral (AREDS IV) and bilateral (≥AREDS II)) over a minimum of 1 year to specifically investigate the morphological sequence of events preceding the conversion towards late AMD. All patients will be followed by Optical Coherence Tomography (OCT) imaging every 4 months to detect the earliest focal sites of disease progression. As soon as focal areas of change are observed by the Vienna Reading Center (VRC), a targeted follow-up schedule will be triggered to investigate the events at that area of change in a targeted manner. We will recruit patients with 1) intermediate AMD in one eye and advanced AMD in the non-study eye or 2) patients with bilateral intermediate AMD (where both eyes will be included). As some participants are symptomless at the stage of intermediate AMD, we will recruit from hospital databases including imaging databases and ophthalmology and optometry practices and engagement with Patient Societies e.g. the Macular Society and patient public involvement meetings. There will be four clinical sites performing detailed assessments on 50 patients each and, to increase sample size, an additional eight referral sites in the United Kingdom who will each enrol and follow 25 study patients by Spectral Domain Optical Coherence Tomography (SD-OCT) every 4 months. The acquired images from these referral sites will be sent to the Vienna Reading Centre for morphological identification of focal events. If a focal event is detected, participants will then be referred for a detailed, targeted assessment at either the University of Southampton or Moorfields Eye Hospital as detailed below. After consent, patients will undergo visual function tests (ETDRS visual acuity, microperimetry) and multimodal imaging including fundus photographs, OCT scans, OCT angiography, autofluorescence and adaptive optics imaging. The visual function tests will be repeated annually and the multimodal imaging will be done at 4 monthly intervals for a minimum of 1 year. Blood will be taken within the first year for DNA analysis. 200 patients (main cohort) will undergo dense retinal phenotyping at a minimum of 4 visits. Medical and smoking history, genotype and body mass index will also be included in the analysis as has been done previously. As well as structural tests, functional tests will be performed at baseline and end of the study using both microperimetry (a type of visual field test to create a "retinal sensitivity map" of the quantity of light perceived in specific parts of the retina) to identify focal changes and low luminance visual acuity to assess global changes. To increase sample size but make the study feasible an additional 200 patients at UK referral sites will undergo 4 monthly OCT and be referred to Southampton / Moorfields for dense phenotyping only if a focal event is detected by OCT. DNA for genotype analysis. Patients with 1) intermediate AMD in one eye and advanced AMD in the non-study eye or 2) patients with bilateral intermediate AMD (where both eyes will be included). Inclusion Criteria: - Subjects ≥ 55 years with either intermediate AMD (as defined by Ferris et al PMID: 23332590) in both eyes, i.e. large drusen > 125 um and/or any definite hyper- or hypopigmentary abnormalities associated with medium or large drusen; or intermediate AMD as defined above in one eye (study eye) and advanced AMD (geographic atrophy or choroidal neovascularization secondary to AMD) in the other eye. - Subjects should have media clarity and pupillary dilation for adequate imaging and functional tests. Exclusion Criteria: - Co-existent ocular disease, which might affect visual function or retinal morphology - Established glaucoma in either study eye or fellow eye with evidence of visual field loss or retinal nerve fibre loss (ocular hypertension is not an exclusion criterion unless associated with visual field loss or retinal nerve fibre loss in either eye). - Cataract sufficient to affect retinal imaging - Myopia > minus 6 diopters or a history of myopia > minus 6 diopters if patient has had cataract / refractive surgery. - Major ocular surgery 3 months prior or anticipated within the next 6 months following enrolment. - Taking drugs known to cause retinal toxicity such as hydroxychloroquine or tamoxifen - OCT evidence of geographic atrophy (or complete Retinal Pigment Epithelium (RPE) and outer retinal atrophy (cRORA). This is (1) a region of hypertransmission of at least 250 mm in diameter, (2) a zone of attenuation or disruption of the RPE of at least 250 mm in diameter, (3) evidence of overlying photoreceptor degeneration, and (4) absence of scrolled RPE or other signs of an RPE tear. - OCT evidence of choroidal neovascularization e.g sub-retinal scar tissue, sub-retinal fluid or intra-retinal fluid associated with a pigment epithelial detachment

NCT0426xxxx/NCT04269317.xml

<clinical_study>  <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/NCT04269317</url> </required_header> <id_info> <org_study_id>CLN 0472</org_study_id> <nct_id>NCT04269317</nct_id> </id_info> <brief_title>Clinical Study to Evaluate the Safety and Effectiveness of the Treatment With Tixel C on Acne Scars</brief_title> <official_title>A Prospective Study With Blinded Assessment to Evaluate the Safety and Effectiveness of the Tixel C Fractional System in the Treatment of Acne Scars</official_title> <sponsors> <lead_sponsor> <agency>Novoxel Ltd.</agency> <agency_class>Industry</agency_class> </lead_sponsor> </sponsors> <source>Novoxel Ltd.</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>Yes</is_fda_regulated_device> <is_unapproved_device>Yes</is_unapproved_device> <is_us_export>No</is_us_export> </oversight_info> <brief_summary> <textblock> The purpose of this research is to evaluate the safety and effectiveness of the Tixel C device for the treatment of acne scars, for improvement in the appearance of surface texture. </textblock> </brief_summary> <detailed_description> <textblock> 44 participents between two research locations with moderate acne scars will receive 3-5 treatments sessions with the Tixel C device according to investigator's review of subject response. Improvement of acne scarring will ve evaluated at 1 month, 3 months and 6 months post treatment.  Post-treatment response will be evaluated as well as any incidence of side efects throughout the study. </textblock> </detailed_description> <overall_status>Withdrawn</overall_status> <why_stopped> Delay in opening the study due to COVID-19, and following the sponsor's decision </why_stopped> <start_date type="Anticipated">March 1, 2020</start_date> <completion_date type="Actual">January 10, 2021</completion_date> <primary_completion_date type="Actual">January 10, 2021</primary_completion_date> <phase>N/A</phase> <study_type>Interventional</study_type> <has_expanded_access>No</has_expanded_access> <study_design_info> <allocation>N/A</allocation> <intervention_model>Single Group Assignment</intervention_model> <primary_purpose>Treatment</primary_purpose> <masking>None (Open Label)</masking> <masking_description>Blinded assessed of the improvement would be done between Last FU images and before first treatment after randomization of the images.</masking_description> </study_design_info> <primary_outcome> <measure>Safety Adverse Events report</measure> <time_frame>up to 12 months</time_frame> <description>Safety of the investigational device shall be assessed via quantification of the incidence of devicerelated/non-related undesired effects, which shall be documented and reported as an Adverse Event (AE) or as a Serious Adverse Event (SAE). Known undesired effects may be any of the list stated in the previous paragraph of Expected Possible Side Effects, or any other undesired effect, not described in the said list. The incidence of the device related undesired effects should be analyzed considering severity, causal relation to the investigational device and duration, whether it is transient or permanent.</description> </primary_outcome> <primary_outcome> <measure>Effectiveness using Goodman and Baron Assessment scale</measure> <time_frame>up to 12 months; Improvement between last follow up and baseline (before first treatment)</time_frame> <description>Before starting therapy and at one and six months follow up visits, the subjects shall be photographed using clinical photography equipment. The images shall be evaluated by blinded raters. The evaluation shall be performed by three raters. The scores shall be analyzed according to the statistical plan of the study. Scale between 1-4; 1 = Macular, 4= Severe</description> </primary_outcome> <secondary_outcome> <measure>Performance using Goodman and Baron Assessment scale</measure> <time_frame>up to 12 months; Improvement between last follow up and baseline (before first treatment)</time_frame> <description>Live Assessment by a study investigator - In each visit, an investigator or his designee shall examine by observing the subject and photographs will be taken as outlined. Scale between 1-4; 1 = Macular, 4= Severe</description> </secondary_outcome> <number_of_arms>1</number_of_arms> <enrollment type="Actual">0</enrollment> <condition>Scars</condition> <arm_group> <arm_group_label>Tixel C</arm_group_label> <arm_group_type>Experimental</arm_group_type> <description>Tixel Treatment, between 3-5 treatment session according to investigator's review of subject response follow by 3 Follow up sessions, 1,3 and 6 month after last treatment visit. Subject would be questioned about pain levvel, subjective dountime assessment and subjective response assessment. Images would be taken before treatment visit and in Follow-Up.</description> </arm_group> <intervention> <intervention_type>Device</intervention_type> <intervention_name>Tixel C</intervention_name> <description>Thermo-mechanical technology for fractional treatment of human skin. Dermal heating and coagulative effect that occur during the treatment session provide for dermal remodeling and collagen restructuring that promote acne scar appearance improvement.</description> <arm_group_label>Tixel C</arm_group_label> <other_name>Fractional</other_name> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  1. The Subjects will have atrophic mild to severe acne scars.  2. Male or female subjects, age 18-65 years old.  3. The subjects will have Fitzpatrick Skin Types I-VI.  4. Willingness and ability to provide written informed consent, including photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup), prior to the study.  5. Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.  6. Females post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence).  Exclusion Criteria:  1. Subjects pregnant or planning to become pregnant, or have given birth less than three months ago or breast feeding.  2. Subjects with significant exposure to ultraviolet light.  3. Use of drugs that may induce hyperpigmentation such as amiodarone, clofazinmine, minocycline or chloroquine.  4. History of facial acne scar treatments with laser, surgical, chemical, light based or radiofrequency facial treatments.  5. Microdermabrasion, or prescription level glycolic acid treatments within three months prior to study participation.  6. Active HSV-1. May be enrolled only after a prophylactic regime has been followed prior to treatment and according to the Investigator's discretion.  7. History of keloid formation.  8. Permanent facial implant over area of treatment.  9. Injectable filler in area to be treated within nine months of investigation.  10. History of collagen vascular disease.  11. Subjects who have an impaired immune system, suffer from immunosuppressive diseases or are actively on immunosuppressive medications.  12. Subjects currently taking or have taken an oral retinoid in the past six months.  13. Subjects currently taking long-term oral steroid treatment  14. Subjects with any skin pathology which can induce bullous lesions, urticaria, or demonstrate a Koebner phenomenon (psoriasis, lichen planus, etc.).  15. History of autoimmune disease.  16. History of any disease that inhibits pain sensation.  17. History of Diabetes I or II.  18. Concurrent therapy that, in the principal investigator's opinion, would interfere with the evaluation of the safety or effectiveness of the study treatment.  19. Subjects who, in the Investigator's opinion, have a history of poor cooperation, non-compliance with medical treatment or unreliability.  20. Enrollment in any active study involving the use of investigational devices or drugs who in the Investigator's opinion would interfere with the evaluation of the current investigative device.  21. Any other contraindication stated in the guidance documents of the treatment device.  22. Any existing skin disease that in the investigator's opinion would interfere with the evaluation of the safety of the study treatment and any other cause per the principal investigator's discretion.  23. Hypertrophic facial acne scarring or other hypertrophic scarring.  24. Failure to acquire adequate baseline and final photography. </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>65 Years</maximum_age> <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers> </eligibility> <overall_official> <last_name>Jerome M Garden, MD</last_name> <role>Principal Investigator</role> <affiliation>Physicians Laser and Dermatology Institute</affiliation> </overall_official> <location> <facility> <name>Physicians Laser and Dermatology Institute</name> <address> <city>Chicago</city> <state>Illinois</state> <zip>60611</zip> <country>United States</country> </address> </facility> </location> <location> <facility> <name>The Lehavit Akerman Main Clinic</name> <address> <city>Herzliya</city> <zip>4672553</zip> <country>Israel</country> </address> </facility> </location> <location_countries> <country>Israel</country> <country>United States</country> </location_countries> <verification_date>January 2021</verification_date> <study_first_submitted>February 6, 2020</study_first_submitted> <study_first_submitted_qc>February 12, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>January 10, 2021</last_update_submitted> <last_update_submitted_qc>January 10, 2021</last_update_submitted_qc> <last_update_posted type="Actual">January 12, 2021</last_update_posted> <responsible_party> <responsible_party_type>Sponsor</responsible_party_type> </responsible_party> <keyword>Acne Scars</keyword> <keyword>Post Acne</keyword> <keyword>Scars</keyword> <condition_browse>  <mesh_term>Cicatrix</mesh_term> </condition_browse>  </clinical_study>

The purpose of this research is to evaluate the safety and effectiveness of the Tixel C device for the treatment of acne scars, for improvement in the appearance of surface texture. 44 participents between two research locations with moderate acne scars will receive 3-5 treatments sessions with the Tixel C device according to investigator's review of subject response. Improvement of acne scarring will ve evaluated at 1 month, 3 months and 6 months post treatment. Post-treatment response will be evaluated as well as any incidence of side efects throughout the study. Inclusion Criteria: 1. The Subjects will have atrophic mild to severe acne scars. 2. Male or female subjects, age 18-65 years old. 3. The subjects will have Fitzpatrick Skin Types I-VI. 4. Willingness and ability to provide written informed consent, including photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup), prior to the study. 5. Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study. 6. Females post-menopausal or surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, IUD, contraceptive implant, barrier methods with spermicide, or abstinence). Exclusion Criteria: 1. Subjects pregnant or planning to become pregnant, or have given birth less than three months ago or breast feeding. 2. Subjects with significant exposure to ultraviolet light. 3. Use of drugs that may induce hyperpigmentation such as amiodarone, clofazinmine, minocycline or chloroquine. 4. History of facial acne scar treatments with laser, surgical, chemical, light based or radiofrequency facial treatments. 5. Microdermabrasion, or prescription level glycolic acid treatments within three months prior to study participation. 6. Active HSV-1. May be enrolled only after a prophylactic regime has been followed prior to treatment and according to the Investigator's discretion. 7. History of keloid formation. 8. Permanent facial implant over area of treatment. 9. Injectable filler in area to be treated within nine months of investigation. 10. History of collagen vascular disease. 11. Subjects who have an impaired immune system, suffer from immunosuppressive diseases or are actively on immunosuppressive medications. 12. Subjects currently taking or have taken an oral retinoid in the past six months. 13. Subjects currently taking long-term oral steroid treatment 14. Subjects with any skin pathology which can induce bullous lesions, urticaria, or demonstrate a Koebner phenomenon (psoriasis, lichen planus, etc.). 15. History of autoimmune disease. 16. History of any disease that inhibits pain sensation. 17. History of Diabetes I or II. 18. Concurrent therapy that, in the principal investigator's opinion, would interfere with the evaluation of the safety or effectiveness of the study treatment. 19. Subjects who, in the Investigator's opinion, have a history of poor cooperation, non-compliance with medical treatment or unreliability. 20. Enrollment in any active study involving the use of investigational devices or drugs who in the Investigator's opinion would interfere with the evaluation of the current investigative device. 21. Any other contraindication stated in the guidance documents of the treatment device. 22. Any existing skin disease that in the investigator's opinion would interfere with the evaluation of the safety of the study treatment and any other cause per the principal investigator's discretion. 23. Hypertrophic facial acne scarring or other hypertrophic scarring. 24. Failure to acquire adequate baseline and final photography.

NCT0426xxxx/NCT04269330.xml

<clinical_study>  <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/NCT04269330</url> </required_header> <id_info> <org_study_id>Konya EAH</org_study_id> <nct_id>NCT04269330</nct_id> </id_info> <brief_title>Normal and Small Size Mesh in Open Inguinal Herni Repair</brief_title> <official_title>Comparison of Size Mesh and Undersized Mesh in Open Inguinal Hernia Repair: A Prospective, Randomized Study</official_title> <sponsors> <lead_sponsor> <agency>Konya Meram State Hospital</agency> <agency_class>Other</agency_class> </lead_sponsor> </sponsors> <source>Konya Meram State Hospital</source> <oversight_info> <has_dmc>No</has_dmc> <is_fda_regulated_drug>No</is_fda_regulated_drug> <is_fda_regulated_device>No</is_fda_regulated_device> </oversight_info> <brief_summary> <textblock> Recent years, lots of treatment teqnique have development. We aimed that comparising the normal and small size meshes in the inguinal hernia patients. </textblock> </brief_summary> <detailed_description> <textblock> Data Collection Method: The research will be a multicentric, prospective and randomized clinical study to be conducted between 01.11.2018 and 28.02.2019 by the general surgery clinics of Mogadishu-Somalia Recep Tayyip Erdogan Training and Research Hospital and Health Sciences University Konya Training and Research Hospital.  Male patients with inguinal hernia repair will be included in the study. Patients will be randomized into two groups. While the normal size of 15 x 7 cm (105 cm2) mesh was used in the first group, In the second group, a small size 11 x 5 cm (55 cm2) mesh will be used.  Dismissal criteria are; Female patients, relapse hernias, bilateral inguinal hernia, laparoscopic hernia repair, diabetic patients using insulin, patients with COPD, peripheral vascular disease, emergency inguinal hernia repair, patients with high ASA score, patients with serious cardiological problems, heavy smokers, transfusions during the perioperative period.  Patients will be given clear and understandable information about the study. Patients who agree to participate in the study will receive a consent form explaining that they have participated in the study voluntarily.  Randomization is done by the secretary with a computer program. A note stating which group the patient is in is placed in a closed envelope and an envelope is opened at the preoperative surgery table.  The method of operation will be open inguinal hernia repair (Lichtenstein hernia repair). The patient will be repaired with mesh suitable for the randomization group. Operations will be performed under the supervision of an experienced surgeon or experienced surgeon.  Surgical Method: Patients will receive open inguinal hernia repair, known as Lichtenstein hernia repair. According to the Gilbert classification, the hernia type is recorded in the patient file.  Evaluation of patient characteristics and pain: the researcher will not know in which group the patients are. Demographic features, duration of surgery, hernia type, early postoperative complications, return to work will be recorded in the study forms. If there is a suspicion of recurrence in the physical examination, a recurrence assessment will be performed by ultrasonography and magnetic resonance examination if necessary. Recurrences will be detected at 1, 6, 12, and 24 and recorded on the study form.  Values will be recorded in the form by using the Sheffield Scale in the assessment of chronic pain. </textblock> </detailed_description> <overall_status>Completed</overall_status> <start_date type="Actual">February 20, 2020</start_date> <completion_date type="Actual">October 2, 2020</completion_date> <primary_completion_date type="Actual">September 20, 2020</primary_completion_date> <phase>N/A</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> <primary_purpose>Treatment</primary_purpose> <masking>Single (Participant)</masking> </study_design_info> <primary_outcome> <measure>The success of treatment.</measure> <time_frame>1 year</time_frame> <description>The success of normal size mesh with small mesh as a result of hernia treatment</description> </primary_outcome> <secondary_outcome> <measure>patient satisfaction</measure> <time_frame>1 year</time_frame> <description>As a result of hernia treatment, the patient's satisfaction in normal size mesh with small mesh is achieved.</description> </secondary_outcome> <number_of_arms>2</number_of_arms> <enrollment type="Actual">200</enrollment> <condition>General Surgery</condition> <condition>Inguinal Hernia</condition> <condition>Ventral Hernia</condition> <arm_group> <arm_group_label>1-Normal size mesh in open inguinal herni</arm_group_label> <arm_group_type>Sham Comparator</arm_group_type> <description>Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.</description> </arm_group> <arm_group> <arm_group_label>2- small size mesh in open inguinal herni</arm_group_label> <arm_group_type>Active Comparator</arm_group_type> <description>Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.</description> </arm_group> <intervention> <intervention_type>Procedure</intervention_type> <intervention_name>Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.</intervention_name> <description>Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.</description> <arm_group_label>1-Normal size mesh in open inguinal herni</arm_group_label> <arm_group_label>2- small size mesh in open inguinal herni</arm_group_label> </intervention> <eligibility> <criteria> <textblock> Inclusion Criteria:  - ages must be upper 18  Exclusion Criteria:  - Morbit obesity (BMI>40) </textblock> </criteria> <gender>All</gender> <minimum_age>18 Years</minimum_age> <maximum_age>80 Years</maximum_age> <healthy_volunteers>No</healthy_volunteers> </eligibility> <overall_official> <last_name>Alpaslan Şahin, MD</last_name> <role>Principal Investigator</role> <affiliation>Konya Training and Research Hospital, Department of General Surgery</affiliation> </overall_official> <location> <facility> <name>Konya Training and Research Hospital</name> <address> <city>Konya</city> <zip>42090</zip> <country>Turkey</country> </address> </facility> </location> <location_countries> <country>Turkey</country> </location_countries> <reference> <citation>Kulacoglu H, Celasin H, Oztuna D. Individual mesh size for open anterior inguinal hernia repair: an anthropometric study in Turkish male patients. Hernia. 2019 Dec;23(6):1229-1235. doi: 10.1007/s10029-019-01993-x. Epub 2019 Jun 20.</citation> <PMID>31222460</PMID> </reference> <reference> <citation>Anitha B, Aravindhan K, Sureshkumar S, Ali MS, Vijayakumar C, Palanivel C. The Ideal Size of Mesh for Open Inguinal Hernia Repair: A Morphometric Study in Patients with Inguinal Hernia. Cureus. 2018 May 3;10(5):e2573. doi: 10.7759/cureus.2573.</citation> <PMID>29974028</PMID> </reference> <reference> <citation>Seker D, Oztuna D, Kulacoglu H, Genc Y, Akcil M. Mesh size in Lichtenstein repair: a systematic review and meta-analysis to determine the importance of mesh size. Hernia. 2013 Apr;17(2):167-75. doi: 10.1007/s10029-012-1018-y. Epub 2012 Nov 11.</citation> <PMID>23142904</PMID> </reference> <verification_date>October 2020</verification_date> <study_first_submitted>February 3, 2020</study_first_submitted> <study_first_submitted_qc>February 12, 2020</study_first_submitted_qc> <study_first_posted type="Actual">February 13, 2020</study_first_posted> <last_update_submitted>October 2, 2020</last_update_submitted> <last_update_submitted_qc>October 2, 2020</last_update_submitted_qc> <last_update_posted type="Actual">October 5, 2020</last_update_posted> <responsible_party> <responsible_party_type>Principal Investigator</responsible_party_type> <investigator_affiliation>Konya Meram State Hospital</investigator_affiliation> <investigator_full_name>Alpaslan Şahin</investigator_full_name> <investigator_title>Medical Doctor, principal investigator, General Surgery Department</investigator_title> </responsible_party> <keyword>mesh size</keyword> <keyword>lichtenstein hernia repair</keyword> <keyword>surgical technique</keyword> <condition_browse>  <mesh_term>Hernia</mesh_term> <mesh_term>Hernia, Inguinal</mesh_term> <mesh_term>Hernia, Ventral</mesh_term> </condition_browse>  </clinical_study>

Recent years, lots of treatment teqnique have development. We aimed that comparising the normal and small size meshes in the inguinal hernia patients. Data Collection Method: The research will be a multicentric, prospective and randomized clinical study to be conducted between 01.11.2018 and 28.02.2019 by the general surgery clinics of Mogadishu-Somalia Recep Tayyip Erdogan Training and Research Hospital and Health Sciences University Konya Training and Research Hospital. Male patients with inguinal hernia repair will be included in the study. Patients will be randomized into two groups. While the normal size of 15 x 7 cm (105 cm2) mesh was used in the first group, In the second group, a small size 11 x 5 cm (55 cm2) mesh will be used. Dismissal criteria are; Female patients, relapse hernias, bilateral inguinal hernia, laparoscopic hernia repair, diabetic patients using insulin, patients with COPD, peripheral vascular disease, emergency inguinal hernia repair, patients with high ASA score, patients with serious cardiological problems, heavy smokers, transfusions during the perioperative period. Patients will be given clear and understandable information about the study. Patients who agree to participate in the study will receive a consent form explaining that they have participated in the study voluntarily. Randomization is done by the secretary with a computer program. A note stating which group the patient is in is placed in a closed envelope and an envelope is opened at the preoperative surgery table. The method of operation will be open inguinal hernia repair (Lichtenstein hernia repair). The patient will be repaired with mesh suitable for the randomization group. Operations will be performed under the supervision of an experienced surgeon or experienced surgeon. Surgical Method: Patients will receive open inguinal hernia repair, known as Lichtenstein hernia repair. According to the Gilbert classification, the hernia type is recorded in the patient file. Evaluation of patient characteristics and pain: the researcher will not know in which group the patients are. Demographic features, duration of surgery, hernia type, early postoperative complications, return to work will be recorded in the study forms. If there is a suspicion of recurrence in the physical examination, a recurrence assessment will be performed by ultrasonography and magnetic resonance examination if necessary. Recurrences will be detected at 1, 6, 12, and 24 and recorded on the study form. Values will be recorded in the form by using the Sheffield Scale in the assessment of chronic pain. Inclusion Criteria: - ages must be upper 18 Exclusion Criteria: - Morbit obesity (BMI>40)